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RESEARCH AND DEVELOPMENT DEPARTMENT ANNUAL REPORT 2014-2015 Forewords Since arriving in EKHUFT in March 2013 as Interim CEO I have been extremely impressed by the commitment of staff towards research, development & innovation. The recently published NIHR/Guardian league tables (http://www.ekhuft.nhs.uk/patients-and-visitors/news/news-archive-2015/east-kenthospitals-ranked-first-in-kent-for-clinical-research-studies/) show how EKHUFT has risen from 86th position nationally in 2013-14 to 45th this year, and confirm that we continue to be the most research-active NHS Trust in Kent. The fact that we're so active in research means that we're able to offer our patients cutting-edge treatments in cancer, eye & skin disease, and many other conditions that they might not otherwise be able to receive. Moreover, because of the large number of studies we offer across a diverse range of conditions, we're able to respond to East Kent peoples' desire to be really involved in 'local' research. In these straightened financial times, the fact that we're able to generate modest additional income - to reinvest in more R&D - whilst supporting the UK's biosciences industry can only be a good thing. To conclude, I would like to reiterate my congratulations to those staff who've received national and international recognition for their efforts, and to thank all the staff and patients - without whom all this excellent work would not be possible - for their invaluable contributions. Mr Chris Bown Interim Chief Operating Officer November 2015 This has been a truly impressive year for Research & Development in East Kent Hospitals. The numbers and narrative contained within this report only tell part of the story, for behind those mentioned are many other people – staff and patients – that enable all these fantastic achievements. What particularly pleased me was the diversity of studies we now offer: people with conditions aligned to 23 out of the 30 NIHR CRN Specialty groups are able to participate in studies relevant to their conditions. This means that EKHUFT is really delivering for the people of East Kent of whom 87% - in our survey undertaken in May 2014 – told us that they considered it ‘very important for their local hospital’ to be involved in research. Colleagues who act as Principal Investigators and the teams that support them do so because they are passionate about improving our patients’ lives through research that leads to better treatments and outcomes. It is therefore extremely gratifying to see those colleagues achieve national recognition for their efforts, and I offer them my heartfelt congratulations. None of us can have failed to notice the enormous financial strain under which EKHUFT – along with much of the NHS – is currently operating. We know that those of us committed to research will need to do more for the same (or less). But we are also in the fortunate position of being able to generate ‘new’ income through Industry funded- and sponsored-research. Since my appointment as Director of R&D in 2012, our Industry income has grown 10-fold. I do not claim the credit for this – again I have our Principal Investigators, Research Delivery Teams and R&D Department to thank – but I do believe we are now set on a path to eventually deliver sustainable, self-funding R&D activities in the years ahead. Dr Tim Doulton Director of Research & Development November 2015 EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 2 of 40 Contents Forewords 2 Contents 3 Executive summary 4 Key events in R&D during 2014-15 financial year 5 R&D metrics 9 Overview of research activity during 2014-15 financial year 12 Neurophysiology: Dr Jeremy Bland Cardiology: Dr Jane Fisher Dr Konrad Grosser Stroke Research Tissue Viability: Sr Judy Elliott 12 12 13 13 14 Orthodontics: Mr Andrew DiBiase Ophthalmology: Mr Afsar Jafree 14 15 Dermatology: Dr Susannah Baron & Dr Emilia Duarte-Williamson Kidney Research Haemophilia: Dr David Stephensen & Dr Gillian Evans Solid Oncology: Dr Rakesh Raman & colleagues Paediatric Occupational Therapy: Dr Eve Hutton Neonatology: Dr Vimal Vasu Child Psychology: Nicky Wood 15 16 19 22 23 24 25 Microbiology: Prof Fritz Mühlschlegel & colleagues from Kent Fungal Group Dr Matthew Strutt Interventional Radiology: Dr Neelan Das Physiotherapy: Benjamin Chitambira Helen Oakes 26 27 27 28 28 Risk and Legal: Daniel Marsden 29 Pilgrim’s Hospice: Rose Ward 29 List of peer-reviewed publications from Trust researchers (April 2013 to March 2014) 31 Appendix: Finance Report 38 EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 3 of 40 1. Executive Summary 1. During the year a total number of 2364 patients were recruited by East Kent Hospitals University Foundation Trust (EKHUFT, hereinafter referred to as “the Trust”) researchers into National Institute for Health Research (NIHR) portfolio studies. This represents a 41% increase on 2013-14. 2. During 2014-15 there were 79 studies given NHS R&D approval by the Trust of which 50 were NIHR Portfolio studies. Of the 79 newly opening studies, 15 were clinical trials of investigation medicinal products (CTIMPs) and 14 were industry-funded/-sponsored studies. 3. Staff achieved national recognition for their work including Dr Chris Pocock, Consultant Haematologist, Dr Emilia Duarte-Williamson – both for their contributions towards Industry research. Dr David Stephensen was awarded the Best Oral Presentation at the 2014 UK Haemophilia Physiotherapy Meeting. 4. A number of events co-ordinated by the R&D Department took place during the year. These included: a major awareness raising campaign & patient-public survey about attitudes to research, our annual symposium, and a jointly hosted mini-symposium with KentHealth. 5. Total income received on behalf of R&D during the year was £2.56m. Industry-derived income increased 18% to £823k. 6. During 2014-15 financial year the Trust received £1.62m from NIHR/DH (via Research Networks and directly). This included £148,559 from DH Research Capability Funding compared to £109,588 in 20132014. 7. R&D oversaw distribution of funds totalling £54,581 to Trust staff via the Internal Projects Grant Scheme and funding for consultant and AHP sessions (1x 2 years x 1 PA; 1x 8 months x 1 PA; 1x 2 years x 0.2 WTE) via the Research Session Scheme. 8. During 2014-15 Trust researchers published 78 articles in peer-reviewed journals, the same number as last year. 9. NHS R&D approval was granted within 30 days (from receipt of valid application) for 90% of NIHR Portfolio studies, meaning that the Trust achieved the target set down by the NIHR/DH. The median time to obtain NHS permission was 3 days. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 4 of 40 2. Key Events in R&D during the 2014-15 Financial Year R&D awareness raising campaign: “Research: Good for you, Good for the NHS” In May members of the R&D team could be found at different sites across the Trust promoting the importance of research and innovation to patients and the NHS. The campaign was launched on 6th May at QEQM where Sandie Tapsell and Jo Pearson from the R&D team were joined by Nick Wells, Trust Chairman and Andrew DiBiase, Deputy Director of R&D. The R&D team then spent a week at each main site talking to patients and staff, highlighting the Trust's impressive research record and explaining how they could help or even get involved. As part of the campaign a patient survey was conducted to gain patients opinions and views on research. Over 500 questionnaires were collected from patients attending the Outpatient Departments. These showed that patients are very supportive of research and keen to be involved. They just want to be asked! The three week campaign culminated in an open meeting held on 23rd May 2014 in the William Harvey Hall at K&CH celebrating International Clinical Trials Day. Patients, researchers and staff were invited along to share their experiences and to learn how research had impacted on their lives. This was very well attended and again showed how interested and supportive the majority of patients were in the research being undertaken in the Trust. Annual Symposium The R&D Annual symposium took place on 12th June 2014 in the Harvey Hall, Postgraduate Centre, K&CH. The theme for this year was “Imaging in Research” and over 70 attendees enjoyed a wide range of talks from invited internal and external speakers, as well as four oral presentations selected as the best submitted abstracts (Caroline Judge, Renal, EKHUFT; Vanessa Abrahamson, CCCU; Campbell Gourlay, UoK; Samira Bouyagoub, Neurology, KCH). Samira (left, with supervisor Professor Alan Colchester, Consultant Neurologist, EKHUFT) won the prize for best oral presentation and Mark Shepherd (School of Biosciences, UoK) won best poster presentation. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 5 of 40 Internal Project Grant Scheme 2014-15 Using funding from NIHR Research Capability Funding (RCF) the Internal Project Grants Scheme (IPGS) and Research Session Scheme (RSS) were able to support the following Trust staff: Applicant Karen Jenkins Title of Study The experiences of older people in the shared (Consultant Nurse) decision-making process in advanced kidney care Dr Matthew Strutt Characterizing overactive bladder syndrome with a (Consultant view to better diagnostics Microbiologist) and treatments; a crossinstitution basic/clinical collaboration Dr David STABLE- Stability Training Stephensen and Balanced Locomotion Exercises. Intervention (Physiotherapist) programme to reduce falls and balanced dysfunction in people with haemophilia Dr Yvonne To design a shared Morrissey patient database and advice service to GPs to (Consultant prevent adverse events Geriatrician) due to drug induced hypotension Dr Tom Webb Improving Stroke prevention in the Rapid (Consultant Access Neurovascular Neurologist/Stroke Clinic – the role of Physician) obstructive sleep apnoea & cerebral microbleeds Amount Awarded £37,694 Duration Start Date IPGS/RSS 24 months March 2014 IPGS £16,887 1 year March 2014 IPGS 0.2 WTE 2 years December 2014 RSS 1 PA 8 months Continuation of previous award RSS 1 PA 2 years June 2014 RSS KentHealth: Symposia, Vacation & PhD Studentships The Trust have continued to host, in partnership with the University of Kent, quarterly networking symposia around particular health research themes, with invited speakers from both the Trust and Universities. Stroke was the theme on 4th June 2014 where Mike Geeves from UoK presented his work on inherited cardiomyopathies and how it could be relevant to stroke. Tom Webb and Ibrahim Balogun from EKHUFT outlined the prevention and treatment of stroke now and in the future, discussing their research on improving the prevention of stroke, and the treatment of strokes with unknown time of onset. Ben Chitambira, also from EKHUFT then outlined his research using the OKCSIB protocol for upper limb recovery in dense acute strokes. On 10th October 2014, Vimal Vasu, Consultant Neonatologist, and Nicky Wood, Child Psychologist were two of the speakers at the Child Health themed event, along with researchers from Kent Community Health Trust and University of Kent. Organisation of these events has again been undertaken by Dr Julie Hedayioglu, Research & Innovation Officer, KentHealth, we remain extremely grateful to Julie for her hard work in making these events happen. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 6 of 40 This is the fifth year of the jointly funded EKHUFT-KentHealth student vacation scheme. Trust clinicians are invited to submit proposals for projects that are suitable to be undertaken by a second-year undergraduate student during their summer vacation. The scheme provides students with an insight (and hopefully encouragement) into working in healthcare & one of the area’s largest employers and further builds excellent relations (and sometimes collaboration) between the University and the Trust. As in previous years students blogged on the KentHealth website about their experiences. To read the blogs go to KentHealth at http://www.kent.ac.uk/health/student-placements/index.html. This year Emily Betts will be looking at the stability of 5-hydroxyindoleacetic acid – used to diagnosed carcinoid syndrome – in urine and will be supervised by Dr Alan Dodd from the Department of Biochemistry, EKHUFT. As was the case in 2013/14, EKHUFT clinicians have been successful in collaborative bids with University of Kent academics in bidding for KentHealth PhD studentships: Dr Mohamed Sakel (Consultant in Neurorehabilitation) and University co-applicant Dr David Wilkinson (Reader in Psychology) are investigating “Neuropsychological outcomes in military veterans with traumatic brain injury”. National recognition for our researchers Dr Chris Pocock, Consultant Haematologist, has received recognition for his work as Principal Investigator on a number of Industry trials in blood cancer. He received a personal invitation from Professor Dame Sally Davies, Chief Medical Officer for England, to attend a meeting held by the NIHR Clinical Research Network to recognise leading Industry study PIs. The meeting, held at BMA house on February 4th 2015, celebrated the greatly improved recruitment performance by PIs and their teams into Industry trials over the last five years. Dr Pocock was invited under the banner “Always delivers to time and target” recognizing the four completed Industry trials for which East Kent has been the leading centre in the UK. Dr Emilia Duarte Williamson and colleagues in Dermatology, supported by Janine Musselwhite, James Rand and Anthea Potter from the East Kent Research Delivery Team received recognition from the national dermatology Specialty Group Lead for their work in recruiting to the Signature study (CCRN 2278). Dr Nick Levell, wrote: “Very well done on your excellent recruitment so far into this study. Your site has been highlighted by Novartis as performing excellently and this has been recognised and is appreciated. When Novartis originally outlined the Signature study at one of our National Dermatology Specialty Group meetings we agreed that the Network could make a real difference to recruitment and your outstanding performance is helping us to prove this to Novartis”. Other notable events during the year Funding to Dr Eve Hutton for “A postural care training package: feasibility study for commercialisation” Eve Hutton, Head Paediatric Occupational Therapist, was successful in securing Higher Education Innovation Funding (HEIF) which will enable her along with researchers based at University of Kent and Canterbury Christ Church University to explore the feasibility for commercialising an innovative training package designed to improve the confidence of parents and teachers who care for children with postural care needs. The training package was originally developed and rigorously evaluated as part of a National Institute of Health Research, Research for Patient Benefit Study (PB-PG-0110-21045) that concluded in 2013. Award to Dr David Stephensen for Best Oral Presentation At the 2014 Annual UK Haemophilia Physiotherapy Meeting, Dr David Stephensen, Physiotherapist at the Haemophilia & Thrombosis Centre was awarded the Best Oral Presentation for his presentation on "Gait deviations in adolescent boys following ankle joint haemarthrosis". The work was undertaken by a doctoral EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 7 of 40 physiotherapist as part of an NIHR internship awarded to Dr Stephensen in 2013. In this multi-centre UKwide study Dr Stephensen's team completed a comparative analysis of boys with haemophilia aged 11-18 years and age- and maturity-matched typically developing children using a three-dimensional motion capture system to identify any changes in motor performance. In the haemophilia children, they found that in addition to changes in ankle joint motion as bleeding frequencies increased, the boys walked with more extended knees. This study is part of a much larger research programme co-ordinated by Dr Stephensen quantifying muscle and joint characteristics and functional abilities of boys with haemophilia in order to develop a clinical classification tool of early haemophilic arthropathy. Appointment of Lead Research Nurse We were delighted to welcome Ruth Hulbert as Lead Research Nurse for EKHUFT in March 2015. Ruth has spent much of her 30 year nursing career in research. Initially she worked as a clinical research nurse within the pharmaceutical industry, working mainly on Phase 1 clinical trials. In 2003 she returned to the NHS when the Cancer Research Network was set up in Kent & Medway and was appointed as Team Leader for the then new solid tumour cancer research team in EKHUFT. She then joined the Kent & Medway CLRN in 2008 and worked as Lead Research Nurse until April of this year, when the NIHR Clinical Research Networks across England were restructured and the CRN: Kent, Surrey & Sussex was formed. Since then Ruth has worked as one of the Research Delivery Managers and the Workforce Development Lead. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 8 of 40 3. R&D Metrics Study activity During 2014-15 the Trust had 299 active research studies including 190 NIHR Portfolio studies that were open to new participants, with the remaining 109 studies being non-Portfolio studies or “own account” studies. Included within our active studies were 68 clinical trials of investigation medicinal products (CTIMPs). Currently, the Trust has 40 industry-funded and/or -sponsored studies active of which 34 are Portfolio and 6 non-Portfolio studies. The Trust R&D Department issued approval for 79 new studies between 1st April 2014 and 31st March 2015 (50 NIHR Portfolio and 29 non-Portfolio), of which 19 were “Grey Area Projects”, 15 were CTIMPs and 14 were industry-funded/sponsored studies. Participant Accrual During the year there has been 41% increase in recruitment into NIHR portfolio studies. The Trust recruited 2364 participants compared to 1670 participants in 2013-14. We have maintained a healthy balance with complex interventional (usually randomized controlled) and more straightforward observational and largescale studies (see figure 1). NHS Permission From April 2014, the NIHR set NHS organisations are an aspirational target of achieving NHS permission for a research study to open with 15 days of a valid application for 80% of studies. In 2014-15 we approved 50 new NIHR Portfolio studies, of which 45 (90%) were within 15 days. Our mean and median times to permission were 8 days and 3 days respectively. Research Income Research-related income to the Trust was similar to that seen last year (£2.56m vs. £2.44m in 2013-14) with Industry related income up 16% to £823k (see figure 3). During the year the Trust was allocated £148,559 by the NIHR for its Research Capability Funding, and this supported NIHR faculty members (present and future) directly and via the Trust’s Internal Project Grants Scheme (IPGS) and Research Sessions Scheme (RSS). GCP & R&D training for staff Training session GCP Introduction and refresher session R&D Workshop R&D ‘Meet the Governor’ session IRAS training session GCP refresher training GCP Introduction and refresher training session Date 24th June 2014 Venue Kent and Canterbury Hospital 10th June 2014 17th July 2014 17th September 2014 22nd September 2014 15th December 2014 William Harvey Hospital William Harvey Hospital Kent and Canterbury Hospital QEQM Margate Kent and Canterbury Hospital EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Participants Intro – 16 Refresher - 31 9 Intro – 28 Refresher - 33 Page 9 of 40 Statistical Advice Statistical advice was provided by Paul Bassett (StatsConsultancy Ltd) to 19 Trust researchers by phone, email and in face-to-face meetings. Figure 1. Recruitment to NIHR Portfolio studies by financial year and type of study. Figure 2. Industry-funded and/or -sponsored studies opened in each financial year EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 10 of 40 Figure 3. Research income by financial year to NIHR Portfolio studies, by funding source EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 11 of 40 4. Overview of Research Activity during 2014-15 Financial Year URGENT CARE & LONG TERM CONDITIONS DIVISION Dr Jeremy Bland, Neurophysiology/Neurosciences, K&CH The department has continued to add new cases, and follow-up data on existing cases, to the East Kent Carpal Tunnel Syndrome database, adding 1632 new subjects during the year and bringing the total number of cases on the register to over 40,000. The database forms the substrate for a variety of research studies. This year we have published a prospective study of the accuracy of our online questionnaire for the self-diagnosis of carpal tunnel syndrome by patients, confirming that the web-based questionnaire is a usefully accurate diagnostic tool. This publically available instrument now offers a tool which can be used to reduce unnecessary referrals for nerve conduction studies for suspected CTS by approximately 25%. CTS services locally, in Lambeth and Southwark, and Lancashire are looking at formally incorporating use of the web questionnaire into their local management pathways for carpal tunnel syndrome. A study of whether local steroid injection prejudices the outcome of subsequent carpal tunnel decompression has just been completed (in press), and we are currently developing prognostic models for surgical and non-surgical treatment of CTS which promise to improve decision making in choosing an appropriate treatment for individual cases. We have also participated in basic research into the aetiology and physiology of carpal tunnel syndrome and are planning further studies in association with the National Amyloidosis Centre. Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures; invited contributions to books etc.): Invited lectures and research presentations have been given to the British Society for Clinical Neurophysiology, British Society for Hand Surgery Manchester training course, Association of Chartered Physiotherapists in Orthopaedic Medicine/Injection Therapy and the East Kent annual research symposium. We also arranged the first UK one day course in peripheral nerve ultrasound imaging in March which was substantially oversubscribed. Dr Jane Fisher, Cardiology Study: The use of a self-paced VO2max protocol for assessing maximal oxygen uptake in post myocardial infarction and pre- operative care of patients with cardiovascular disease. The aims of this project are to assess the reliability, validity and acceptability of a novel self-paced cardiopulmonary exercise test (CPET) in the: - Phase 1: Assessment of VO2max in post-myocardial infarction patients - Phase 2: Assessment of patient pre-operative cardiovascular fitness to determine suitability for surgery and help predict post-surgery outcome Phase 1: We have recruited and tested 28 patients. We need another 2 in order to complete the study. Phase 2: Data collection was started January 2015. we have now recruited 22 patients and will continue to recruit up until Easter 2016. We aim to have a manuscript completed for phase 1 by October 2016 which we will then submit for publication. Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures; invited contributions to books etc.): Preliminary data from phase 1 was presented at the EBPOM CPET conference July 4th 2014. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 12 of 40 Dr Konrad Grosser, Cardiology EMMACE 4 is a prospective longitudinal observational study of routine clinical care in 6,000 inpatients hospitalised with an acute coronary syndrome. The aim of the study is to use regional data about heart attacks, to identify and measure the effects of hospital care. This research will identify hospital qualities that promote improved patient care. In doing so, best practice will be highlighted and healthcare policy changed so that all patients will have an equal chance of surviving a heart attack. Recruitment closed in June as target was met globally and we achieved 154 participants. Drs Hargroves, Balogun, Gunathilagan, Baht, Webb and colleagues, Stroke Research The last year in stroke medicine research has been an exciting time, with many innovative research developments in both the NIHR Portfolio and locally driven initiatives. The group’s past success in recruitment has encouraged us to set challenging targets, remaining, as we do, the single largest recruiter as a trust into Stroke Research in Kent, Surrey & Sussex. We take a collaborative approach with regard to other specialities, facilitating their portfolios by acting as PIs in some cardiovascular / thrombosis preventative studies (e.g. the GLORIA-AF study on stroke reduction in AF). There are now some exciting new studies on the horizon in hyper-acute treatment and secondary prevention (PRACTISE and Navigate ESUS along with others) which will significantly increase the range of patients we can offer the chance to be involved in improving stroke treatment through research. Work on ‘home grown’ Stroke research is also progressing. Tom Webb is taking the lead on work collaborating with David Werring’s group at University College London to look at the numbers of patients in the Rapid Access Neurovascular (TIA) Clinic who have tiny amounts of bleeding evident on their brain scans (so-called cerebral microbleeds). Work on the incidence of Obstructive Sleep Apnoea in patients attending this same clinic is also continuing. Both of these studies are part of a project to make use of the unique resource of MRI brain imaging in this patient group in order to set up future projects to further understand risk factors for cerebrovascular disease and how it can be prevented. We have received permission to recruit an undergraduate student from Kent University to help with this work. Previously this has only been possible as part of the EKHUFT-KentHealth summer vacation scheme. While this has been very fruitful, we hope that having a student working with us for a day a week over a whole year will be more productive still and enable them and us to get the most out of the experience. This will be taking place on a pilot basis initially but we hope if successful it can be continued in the future. EKHUFT has been an early adopter of CT perfusion (CTP) brain scans in people with stroke of unknown time of onset. Ibrahim Balogun has been analysing our outcomes in patients with stroke of unknown time of onset treated with IV thrombolysis after having CTP. This has been using our stroke research registry database, one of the largest in the UK. Without the use of this technology this patient group would not have stood to benefit from this treatment. Furthermore, the use of multimodal imaging to select patients for thrombolysis, rather than the crude (and often inaccurate) time of symptom onset is increasingly seen as a way forward to improve hyperacute stroke care. This work is shortly to be submitted for publication and we hope it will form an important part of the emerging bedrock of evidence to support this approach and achieve better outcomes for our patients with safer, more effective therapy. The group continues its interest in real world solutions for practical challenges: David Hargroves recently co-authored a peer review of magnetic feeding tubes (see Smithard et al. in publication list) and initiated the ‘Coast’ study, a multi-centre cluster observational studying aiming to understand whether magnetic feeding tube insertion reduces time to feed and complications in a specific subset of patients with stroke. The stroke department in East Kent were one of the first in the country to demonstrate the safety of horizontal telemedicine in the delivery of hyperacute stroke intravenous thrombolysis care and are now in receipt of an NHS innovation grant to place video cameras in the back of SECAMB ambulances in the hope EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 13 of 40 of demonstrating a reduction in door to treatment times. The proof of concept trial is complete and roll out of the project is planned for later in the year. Encouragement of stroke research at the undergraduate level continues with another King’s College medical student presenting their work at the premier UK stroke Forum conference this summer. We are also piloting, with KentHealth’s Julie Hedayioglu, a new quarterly research meeting to work on building on existing connections with the University and foster current and future research programmes by sharing experience and expertise between the academic and clinical arenas. Finally, we are also pleased to have Vanessa Abrahamson with us who is working towards a PhD using qualitative research focused on the review process of patients after Stroke, a crucial and under-studied time in the recovery journey of our patients. Sr Judy Elliott, Tissue Viability PRESSURE-2 is a national-wide multicentre randomised, double triangular group sequential trial led by the Clinical Trial Research Unit (CTRU) at the University of Leeds. The EKHUFT PI is Judy Elliott, Lead Tissue Viability Nurse. The aim of this study is to determine the clinical and cost effectiveness of High Specification Foam (HSF) and Alternating Pressure Mattresses (APM) when both are used in conjunction with an electric profiling bed frame for the prevention of Category 2 (and above) pressure ulcers. The treatment phase begins from randomisation to HSF or APM until the patient is discharged, deemed no longer at risk of developing a pressure ulcer, or up to a maximum of 60 days (whichever of these occurs first). Skin assessments are completed during the treatment phase twice-weekly by a trained research nurse from day 0-30 and once-weekly from day 31-60. A final follow up visit 30 days post-treatment phase is conducted at either home or hospital. Recruitment has been difficult nationally due to the nature of the study (ward-based, equipment required) and the conviction of many nurses that APM are more effective for the prevention of pressure damage, despite there being no evidence to prove this. As a Trust, we have been praised by the study centre for continuing to recruit patients regularly when many Trusts are failing to recruit. SURGICAL SERVICES DIVISION Mr Andrew DiBiase, Orthodontics Research in the Orthodontic Department focuses on innovation and novel treatments. Recruitment was completed and the preliminary results presented nationally of a randomized controlled trial investigating the use of vibrational forces to accelerate tooth movement. We have just started recruitment on a national Portfolio study investigating use of bone anchored plates in early treatment of facial skeletal problems, being one of the few centres in the UK to undertake this procedure. We also undertake research on the psychosocial impact of malocclusion and completed a study looking at the social perceptions made for individuals with overtly disfiguring malocclusion and the benefits of treatment. Ongoing research will investigate how peer relations are affected by the presence of a malocclusion in school children and the impact this has on the psychosocial well-being. Our research is showing the huge benefits of orthodontic treatment for well-being and health. Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures; invited contributions to books etc.): British Dental Association Conference Manchester April 2014 “Malocclusion, orthodontics and bullying” EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 14 of 40 British Orthodontic Conference Edinburgh September 2014 – “Better, stronger, faster; can we move teeth any quicker?” New higher degree supervision: MSc in Orthodontics Kings College London Mr Afsar Jafree, Ophthalmology The CLEOPATRA trial is an ophthalmology trial which is being conducted at the William Harvey Hospital, and is supported by the East Kent Research (Delivery) Team. The trial is looking at “The clinical efficacy and safety of light masks at preventing dark adaptation in the treatment of early diabetic macular oedema”. It is an interventional trial looking at whether the use of a light mask worn during sleep prevents the progression of early diabetic changes in the eye. Patients that entered onto the trial were randomised to either light or dark masks, and then followed up for 2 years in 4 monthly intervals. The trial is led by Kings College Hospital and there are 20 sites taking part nationally. Each site was asked to recruit 25 patients to the trial. East Kent Hospitals – led by Mr Jafree’s proactive approach to participant identification – managed to recruit 21 patients which was just short of target! Patients are now being followed up and study will close in June 2017. SPECIALIST SERVICES DIVISION Dr Susannah Baron & Dr Emilia Duarte-Williamson, Dermatology A new position of Dermatology Research Lead was created from 1st November 2014. Since this date we have rapidly expanded our NIHR research portfolio. Current open studies: 1. Identification of Major Susceptibility Genes for Eczema and Food Allergy 118 – top recruiters in the UK 2. British Association of Dermatology Biologics Intervention Registration (BADBIR) – currently 67 recruited 3. A World-wide Antihistamine Refractory chronic urticaria patient Evaluation (AWARE) - 9 recruited (over target) 4. IMAP – Investigating Medication Adherence in Psoriasis – opened July 15 Recently completed studies: 1. Signature study – a new biologic Secukinimab: we over recruited 8 patients and had a letter of recognition from Dr Nick Levell, national Specialty Group Lead for Dermatology for our excellent recruitment. In addition an article was published in the NIHR newsletter written by one of the Signature patients about his excellent experience. 2. Accrue – measuring the societal impact of psoriasis Involvement in new NIHR Portfolio trials: 1. B-STOP – Biomarkers for systemic treatment outcomes in psoriasis 2. MUSE – Mirvaso Utilization and Patient Satisfaction Study; site has been selected and in set-up phase 3. We have been pre-selected for Secukinimab follow-up study; Long term clear skin maintenance treatment optimization in patients with moderate to severe chronic plaque psoriasis: A randomized, multicenter, open-label with blinded-assessment, comparative, 52 week study to evaluate the efficacy, safety and tolerability of secukinumab 300 mg s.c. OPTIMISE STUDY 4. Hi-Light for vitiligo – site visit being planned 5. Site visit planned with LEO for further Phase III studies on 7 August 2015 EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 15 of 40 Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures; invited contributions to books etc.): 1. July 2014 - C. Duhovic, M. Mohsin, E. Duarte-Williamson and S. Baron. ‘The effectiveness of a written treatment plan in the management of children with atopic eczema East Kent Hospitals University NHS Foundation Trust, Canterbury.’ British Society for Paediatric Dermatology Oral Presentation at the BAD annual meeting. 2 July 2014 - Invited Guest Speaker Dr Susannah Baron at the British Society for Paediatric Dermatology at the BAD annual meeting. ‘Paediatric Dermatology at the Regional Dermatology Training Centre at Moshi, Tanzania’ 3. Oct 2014 - Duhovic. C and Duarte-Williamson E. 'A case of necrobiotic xanthogranuloma treated with prednisolone'. Poster at the EADV Annual Congress, Amsterdam, The Netherlands, October 8-12, 2014. 4. Jan 2015 - Duhovic C and Birnie A. 'A giant fungating tumour on the buttock'. Presentation at the CPC Meeting, Royal Society of Medicine - Dermatology Section. 5. Jan 2015 – Invited Guest Speaker Dr Susannah Baron at the UK Psychodermatology Meeting at the Royal College of Physicians .‘A pilot study of hypnotherapy to treat adults and children with moderate to severe atopic eczema’. 6. Mar 2015 - Duhovic. C and Duarte-Williamson E. 'A case of necrobiotic xanthogranuloma treated with prednisolone'. Poster at the AAD Annual Congress, San Francisco, California, March 20-24, 2015. 7. Two invited book chapters by Susannah Baron: Systemic therapy in children and Propanolol chapters in 2nd Edition of Handbook of Systemic Drug Treatment in Dermatology, edited by Sarah Wakelin, Howard Maibach and Clive Archer. CRC Press, published 2015. Kent Kidney Research Group The Kent Kidney Research Group has a research strategy linked to the understanding and prevention of chronic kidney disease (CKD) and acute kidney injury (AKI), resistant hypertension and the better management of established renal failure. The group contributes to many studies in the UK CRN Portfolio and is the lead centre for several UK-wide studies. A key priority has been investigation of the value of a novel marker of renal function, serum cystatin C, as part of the HTA/NIHR funded eGFR-C study. We are the lead centre (and leading recruiter) for this multicentre study which has recruited >500 patients in the past year towards its target of 1320. The group continues to analyse data and publish results generated from the RfPB/NIHR-funded study investigating the validity of equations for estimating GFR in older people. We have completed an RfPB/NIHR-funded study investigating the biological variability of markers of acute kidney injury, including neutrophil gelatinase associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), cystatin C and others, and this project is being prepared for publication. A British Renal Society funded study investigating the value of bone alkaline phosphatase as a predictor of outcome in haemodialysis patients opened to recruitment in March 2014 and has recruited >1300 haemodialysis patients. A variety of other projects have been undertaken and published in collaboration with clinical biochemistry. Studies investigating the utility of clinical decision support systems in the fields of both CKD and AKI are ongoing, funded by NIHR (11/200428). This work is being carried out in collaboration with The University of Kent (Department of Statistics) and Canterbury Christchurch University and is due to complete in mid-2014. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 16 of 40 The group are actively collaborating with the University of Kent (Medway School of Pharmacy) using in vitro models to assess the mechanism of nephrotoxicity seen with some common drugs, and investigating more accurate methods of identifying urinary tract infection in kidney transplant recipients. The KKRG group is one of two renal research groups within the Kent, Surrey and Sussex Clinical Research Network (CRN). The Renal Research Nursing Team is supported by the NIHR (HTA grant, supporting Gillian Eaglestone – Team Leader), the BiCARB and PIVOTAL studies (supporting Elizabeth Clarke, Research Nurse) and CRN: KSS (2.8 WTE posts: Research Nurses Sarah Knight & Frances Morris and CTA Zara Garratt). A research scientist, Aisling Potter, also supports many of the studies. The team work incredibly hard to deliver at least 15 NIHR Portfolio studies in a wide range of conditions, of which examples. PRED4 is a large gastroenterology study looking at prevention of proton pump inhibitor induced nephritis. The BiCARB study addresses the question of whether there are benefits to treating acidotic CKD3/4 patients with sodium bicarbonate. In addition, Dr Tim Doulton is PI for a number of open NIHR Portfolio studies – with outstanding support from Elizabeth, Frances and the rest of the team: PYRENEES – an Industry-funded study (Astellas) – is looking at the efficacy and safety of Roxadustat, a novel agent used to treat anaemia in people with CKD. We are well on track to hit our recruitment target. PIVOTAL – an RCT looking at high vs. lose dose IV iron in people on haemodialysis. This is the largest RCT ever undertaken by the UK renal community and EKHUFT is the third highest recruiting centre (from over 50) in the UK. PEXIVAS – a globally-recruiting RCT (2x2 factorial) comparing standard vs. lower dose glucocorticoids and plasma exchange (PLEX) vs. no PLEX in patients with life/organ-threatening systemic vasculitis. Since opening in early 2013 we’ve recruited 7 patients. PSV Genetics – a genome-wide association study (GWAS) in people with vasculitis RaDaR – a registry study in people with rare renal diseases Other NIHR Portfolio studies which we have recruited to in the last year include UK calciphylaxis, Pred4, aHUS, Direct, STOP-ACEI, and FEPOD. Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures; invited contributions to books etc.): Alshaer I, Stevens PE, Kilbride HS, Eaglestone G, Knight S, Carter JL, Delaney MP, Farmer CKT, Irving J, O'Riordan SE, Dalton N, Lamb EJ. External validation of the Berlin equations for estimation of GFR in the elderly. Poster presentation at: Kidney Week, Joint Meeting of British Renal Society and Renal Association, Glasgow, May 2014. Carter JL, Stevens PE, Knight S, Eaglestone G, Farmer CKT, Lamb EJ. Biological variation of neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule (KIM-1) in chronic kidney disease (CKD) patients. Poster presentation at: Kidney Week, Joint Meeting of British Renal Society and Renal Association, Glasgow, May 2014. Charter C, Thomsett K. Accuracy of Body Mass Index used in Renal Association Guidelines for undernutrition: The importance of patient height measurement. Poster presentation at Kidney Week, Joint Meeting of British Renal Society and Renal Association, Glasgow, May 2014. Lamb EJ. Biological variation – implications for renal medicine. Oral presentation (invited speaker) at IFCCWorldLab, 22nd International Congress of Clinical Chemistry and Laboratory Medicine, Istanbul, Turkey, June 2014. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 17 of 40 Lamb EJ. The updated KDIGO guideline for chronic kidney disease. Oral presentation (invited speaker) at IFCC-WorldLab, 22nd International Congress of Clinical Chemistry and Laboratory Medicine, Istanbul, Turkey, June 2014. Lamb EJ. Biological variation and kidney disease. Oral presentation (invited speaker) at ACB Wales Autumn Regional Meeting, Newport, Wales, November 2014. Lamb EJ, Brettell EA, Cockwell P, Dalton RN, Deeks JJ, Harris K, Higgins T, Kalra PA, Khunti K, Loud F, Ottridge RS, Sitch AJ, Sharp CC, Stevens PE, Sutton AJ, Taal M. The eGFR-C Study. Accuracy of glomerular filtration rate (GFR) estimation using creatinine and cystatin C and albuminuria for monitoring disease progression in patients with stage 3 chronic kidney disease: prospective longitudinal study in a multiethnic population (study registration number ISRCTN42955626). Poster presentation at: Kidney Week, Joint Meeting of British Renal Society and Renal Association, Glasgow, May 2014. Stevens PE. Integrating Multiple Guidelines: Geriatric Perspective. Distinguished International Award Lecture, Spring Meeting of the US National Kidney Foundation, Las Vegas, April 2014. Stevens PE. KDIGO Clinical Practice Guideline on Evaluation and Management of CKD. International Lecture by Webcast in 3 Indian Cities, Mumbai, Hyderabad, Delhi and Chennai, May 2014 Stevens PE. CKD Epidemiology: Views From Outside Japan. Invited guest lecture, 57th Annual Meeting of the Japanese Society of Nephrology, Yokohama, July 2014. Stevens PE. NICE Clinical Guideline On Acute Kidney Injury (CG169). Oral presentation (invited speaker) at the 2014 EDTNA/ERCA UK Seminar, Ashford, November 2014. Stevens PE. Detection and Management of Chronic Kidney Disease. Oral presentation (invited speaker) at the Acute & General Medicine Conference, London, November 2014. Stevens PE. NICE Chronic Kidney Disease. Invited lecture to GP Update Meeting, Maidstone, December 2014. Thomsett K, Judge C, Head C, Lam M, Wells K, Greenfield L, Willey J, Pendleton S. Establishing a Diabetes:Kidney Care Working Group Poster presentation at Diabetes UK annual conference, March 2015 Higher degree supervision during 2014-15: Christopher Parker, MSc Clinical Biochemistry, University of Manchester, research project on biological variability of TIMP-2 and IL-18. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 18 of 40 Dr David Stephensen & Dr Gillian Evans, Kent Haemophilia and Thrombosis Centre Investigator initiated research Haemophilia: Investigating Physical Performance Outcomes (HIPPO): This study linked to an NIHR Clinical Lectureship award by Dr David Stephensen indicates that in children aged 6-11 years greater frequencies of bleeds into the knee were significantly associated with reduced muscle strength of ankle plantarflexors, walking distance and ability to stand on one leg. Additionally, increased incidents of bleeding into the ankle were significantly associated with reduced knee extensor strength and time taken ascending and descending stairs, with close relationships between age at first bleed and strength. (UKCRN ID 13597) Stability Training And Balanced Locomotion Exercise intervention programme to reduce falls and balance dysfunction in people with haemophilia (STABLE): Dr David Stephensen in collaboration with colleagues from Canterbury Christchurch University is exploring if falls or the fear of falling is a problem for people with haemophilia and to see if this has any effect on mobility and balance. If a problem exists we plan to develop a targeted exercise intervention to be evaluated in a clinical trial. Haemophilia Arthropathy: Inter-rater Repeatability Of an Ultrasound Imaging Score (HORUS): The aim of this multicentre study lead by Dr David Stephensen aims to determine the inter-rater repeatability of the HEAD-US score performed by haemophilia physiotherapists who have undergone a short training programme and to evaluate the association of the HEAD-US with the clinical examination, Haemophilia Joint Health Score. Development of a peri-operative isometric-resistance exercise intervention programme (Basic Exercise Training To Enhance Recovery - BETTER) for patients undergoing elective abdominal and thoracic surgery for cancer: In collaboration with colleagues at Maidstone & Tunbridge Wells NHS Trust and the University of Kent, Dr David Stephensen is aiming to improve functional outcomes for this patient group by exploring the feasibility of a RCT. Participation in NIHR Portfolio research ITP Registry: An observational investigation of disease progression, treatment effectiveness and co-morbid conditions of ITP. (UKCRN ID 14145) GAPP: Study involving genotyping and platelet phenotyping in patients with mild bleeding disorders. (UKCRN ID 9858) AHEAD: Non-interventional, multi-centre international study to describe the natural history of haemophilia A disease and long term outcomes in terms of effectiveness, safety and quality of life. (UKCRN ID 12416) So-Fit: Multi-centre study comparing haemophiliac joint scores, prophylaxis treatment regimes and links to physical activity and quality of life in children and adolescents with haemophilia. In addition the monitoring of the methodology of the collection of data by these young patients is being studied. (UKCRN ID 16059) Nurse facilitated adherence therapy for haemophilia (AnThem) Trial: Will determine if nurse facilitated adherence therapy for haemophilia improves patient adherence to clotting factor replacement therapy, clinical appointments and health advice; and, affects the level of patient engagement and ownership of treatment. (UKCRN ID 12708) Rivaroxaban Observational Safety Evaluation Study (ROSE): Monitor the Safety and Utilization of Rivaroxaban (Xarelto®) for the Prevention of Stroke in Patients with AF, Treatment of DVT and PE, and the Prevention of Recurrent DVT and PE (UKCRN ID 13911). An observational study to monitor the safety and EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 19 of 40 efficacy of rivaroxaban versus warfarin therapy for treatment of venous thromboembolism and stroke prevention in atrial fibrillation. BRIDGE Study NIHR BioResource- Rare Diseases (NIHRBR-RD) study: Genetic analysis of inherited platelet conditions (UKCRN ID 11131). A thrombogenomics study to identify novel genes causing rare bleeding disorders and platelet function defects. FIT-RIGEL 047: Phase 3, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic ITP (UKCRN ID 13685) FIT-RIGEL 049: Follow on study from the FIT-RIGEL 047 (UKCRN ID 16835) Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures; invited contributions to books etc.): Conference proceedings European Association of Haemophilia and Associated Disorders (EAHAD) Congress, Helsinki, Feb, 2015 THE AHEAD STUDY: INTERIM RESULTS AFTER ONE YEAR OF OBSERVATION J. Oldenburg, D. Tsakiris, C. Hermans, K. Khair, M.G. Mazzucconi, L. Abad-Franch, A. Loew-Baselli on behalf of the AHEAD study group. Haemophilia Chartered Physiotherapists Association Annual Scientific Meeting, February 2015 INFLUENCE OF LOWER LIMB JOINT BLEEDING ON PHYSICAL FUNCTION IN YOUNG BOYS WITH HAEMOPHILIA Stephensen, Taylor , Bladen, Drechsler British Society For Haematology Annual Scientific Meeting 2015 BURDEN OF THROMBOEMBOLISM AND THROMBOPROPHYLAXIS AT EKHUFT IN PATIENTS WITH MYELOMA TREATED WITH IMMUNOMODULATORY DRUG CONTAINING REGIMES BETWEEN 2009 AND 2014. A RETROSPECTIVE STUDY. CA Roughley, M Capomir, J Lindsay, C Pocock, V Ratnyake, K Saied, G Evans British Society For Haematology Annual Scientific Meeting 2015 PROSPECTIVE AUDIT OF RIVAROXABAN AS THROMBOPROPHYLAXIS AND TREATMENT DURING MYELOMA THERAPY WITH IMMUNOMODULATORY DRUGS AT EKHUFT. CA Roughley, M Capomir, J Lindsay, C Pocock, V Ratnyake, K Saied, G Evans British Society For Haematology Annual Scientific Meeting 2015 THROMBOPOEITIN RECEPTOR AGONISTS IN IMMUNE THROMBOCYTOPENIC PURPURA. OUR EXPERIENCE AT EKHUFT. T Vatopolou, K Fletcher, K Kaminaris, G Evans Grant awards during 2014-15: 2015 – 2016 Pfizer Haemophilia Investigator-Initiated Research Program; £11,905 Stephensen, Bowles, Classey, Taylor, Hooper, Wells, Patel Haemophilia Arthropathy – Inter-rater Repeatability of an Ultrasound Imaging Score (HORUS) Study 2014 – 2016 Kent University Hospitals NHS Foundation Trust Research Session Scheme; £25,636 Stephensen & Swaine EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 20 of 40 STABLE (Stability Training And Balanced Locomotion Exercises) intervention programme to reduce falls and balance dysfunction in people with haemophilia 2015 – 2018 NIHR Research for Patient Benefit (RfPB) Programme: PB-PG-0613-31107; £338,000 Ali, Swaine, Stephensen, Hashem, Sherrington Development of a peri-operative isometric-resistance exercise intervention programme (Basic Exercise Training To Enhance Recovery - BETTER) for patients undergoing elective abdominal and thoracic surgery for cancer 2012 – 2015 William Scholl Podiatric Research & Development Endowment Fund; £132,403 Izod, Drechsler, Stephensen, Bowen What is the impact of early adult rheumatoid arthritis on the biomechanical and functional characteristics of the foot & leg? 2012 – 2015 William Scholl Podiatric Research & Development Endowment Fund; £220,340 Bowen, Arden, Dohoughty, Drechsler, Stephensen Prevalence and risk factors for radiographic foot osteoarthritis in middle-aged women: the Chingford Study 2011 – 2014 NIHR Clinical Lectureship for Allied Health Professionals; £99,440 Stephensen Development of outcome tools and an evaluation pathway to monitor clinical progression in young boys with haemophilia Higher degree supervision during 2014-15: Stephensen, University of East London, Are there changes in muscle function and gait in adolescents with haemophilia? (PhD, Suckling, awarded February 2015) Stephensen, University of East London, Alterations in muscle and gait characteristics in young adults with haemophilia: Impact of continued prophylaxis (PhD, Chatzifragou, 2012-) Stephensen, University of East London, What is the impact of early adult rheumatoid arthritis on the biomechanical and functional characteristics of the foot and lower limb? (PhD, Izod, 2013-) EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 21 of 40 Dr Rakesh Raman & colleagues, Oncology (Solid Tumour) Research Team This year has been both challenging and rewarding for the Solid Tumour Research Team. We have attracted outside funding in order to recruit a Clinical Trials Officer to support the colorectal cancer study portfolio, and the team has now expanded to encompass the gynaecological oncology team at QEQM Hospital. The Solid Oncology Research Team Back row, left to right: Louise Allen, Nikki Crisp, Sarah Lines, Margaret Lipsham, Bonny Appleby, Louise Gladwell, Dr Rakesh Raman; Middle Row: Karen Robinson, Hilary Zurakovsky, Sue Drakeley – Lead Cancer Research Nurse; Front Row: Cindy Slater East Kent Hospitals Oncology research activity has continued to perform well in 2014-15 and not only have they met their recruitment targets, but have exceeded recruitment in a number of studies: RADICALS – A randomised controlled trial in prostate cancer. East Kent are amongst the top 10 highest international recruiters with a total recruitment of 87 patients. As a Trust, EKHUFT is amongst the top recruiters into the PERSEPHONE breast cancer trial which is not always easy to recruit into as the experimental arm gives less treatment than the current gold Standard. 70 patients had been recruited up to end March 2015. We have recruited almost 100 patients into the practice changing prostate cancer trial STAMPEDE, the abstract of which has recently been presented at American Society of Clinical Oncology (ASCO). The total recruitment for cancer studies within the Trust for the year 2014-15 was 190, as indicated in the individual tumour sites illustrated below. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 22 of 40 We look forward to the continued expansion of the team to meet the ever-increasing requirements of complex cancer trials. Dr Eve Hutton, Child Health This year I have focused on dissemination of the findings from the NIHR, Research for Patient Benefit Study ‘The effectiveness of a postural care education programme for parents and teachers of children with physical disabilities’ which concluded in 2013. Papers have been accepted at national and international conferences (poster and oral presentations). I have been working with the co-investigators on a series of publications. We have one article published in Child, Care Health & Development and a further article in preparation. The study was included as an example of good practice in the annual Parliamentary report ‘Research & Development in Assistive Technology’ Department of Health (2013-14). This report has impact on policy and practice in the field of assistive technology and it is a mark of esteem that the study was included. The research partners (CCCU, EKHUFT, UoK) submitted applications for Higher Education Innovation Funding (HEIF) from Canterbury Christ Church University and the University of Kent in September 2014 and we were successful in securing funding. This has enabled the development of a business case to support the sustainable development of the postural care training programme. The intention is to improve care for children with disabilities, not only in East Kent but to identify a sustainable way of providing the training within the wider NHS. There is considerable interest from across the UK for this novel training programme amongst therapists and educators and we anticipate that later this year we will be in a position to take plans for commercialisation forward. The HEIF project has strengthened the collaboration between the partners laying the foundations for further research in this area. Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures; invited contributions to books etc.): Conference oral presentations Hutton E and Crombie, S (2014) Researching together, inter-professional research in postural care for children with disabilities. APCP and CYPF specialist sections conference. November 21st. Edinburgh. Hutton E, Hotham S, and Hamilton West K (2014) The effectiveness of a postural care training package in supporting parents and educators optimise function and promote the well-being and participation of EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 23 of 40 disabled children at school and in the home. ‘Count me in’ childhood occupations conference. 19-20th May. The Royal Society of Medicine. Wimpole Street. London. Public Lecture Hutton E (2014) ‘New ways of working in paediatric occupational therapy’. Canterbury Christ Church University. July 26th. Hutton E ( 2014) ‘Involving parents in research about their children’. Organised by Kent Health. Canterbury Christ Church University. Grant awards during 2014-15: Higher Education Innovation Funding. £3,100.00, November 2014- July 2015. Lead Applicant. ‘Postural Care training programme – proposed feasibility study for commercialisation’. In collaboration with the University of Kent & Canterbury Christ Church University New high degree supervision during 2014-15: PhD Site Supervisor. Kikuba M, ‘A Multi-method inquiry to develop a training package on squatting positions to increase the likelihood of normal vaginal births: an innovation study.’ Continuing Professional Development Centre, University of Oxford. Dr Vimal Vasu, Neonatal Medicine The neonatal unit has continued to be active in clinical research recruiting to NIHR portfolio studies (Speed of increasing milk feeds - SIFT Trial and the Platelets for Neonatal Transfusion - PLANET 2 Trial). 48 patients were recruited to the SIFT and, so far, 5 patients have been recruited to the PLANET 2. We are hoping to begin recruitment to the Enteral Lactoferrin In Neonates (ELFIN) trial which is a large multicentre RCT of prophylactic enteral lactoferrin supplementation to reduce late onset sepsis in preterm infants. In addition, our collaboration with the School of Biosciences at University of Kent continues and we are about to embark upon a pilot study to establish the feasibility of using neonatal urine samples to extract DNA to measure DNA methylation. Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures; invited contributions to books etc.): Lectures Telomere biology in preterm infants. 1st October 2014. Presentation at the Kent Health Research Symposium (invited) Abstracts Turner KJ, George S, Greenall J, Griffin DK, Vasu V, “Is preterm birth associated with accelerated telomere shortening?” presented at the Spring meeting of the Neonatal Society (19th March 2015) Higher degree supervision during 2014-15: Dr Vasu has co-supervised a PhD student at the University of Kent (Kara Turner) who submitted her Thesis entitled “Telomere length and distribution in three developmental stages” and was awarded her PhD recently. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 24 of 40 Nicky Wood, Psychological Services in Child Development & Paediatrics Psychological Services in Child Development & Paediatrics have had an active research year. We have developed our book based on our previous two projects about barriers to participation in children with cerebral palsy. Our treatment study looking at the effectiveness of hypnosis in children who wet the bed has been fully recruited to, early indications are that for the majority of children with primary enuresis the intervention is moving them significantly towards partial or almost complete dryness at night. We have undertaken two separate audits of Child Health multi-disciplinary autism assessment and diagnostic pathways and service delivery in East Kent. We have just started a service evaluation asking teenagers with diabetes type 1 about their experiences of clinic services in East Kent in line with National Paediatric Diabetes Audit Peer Review recommendations. We have just gained ethical approval for an upcoming study which looks at perceptions of family carers regarding challenging behaviour displayed by children with autism. We have collaborated with the Psychology Department, University of Kent in research which looks at predictors of imagination and creativity in children with autism. We continue to be involved in studies run by the Tizard Centre, University of Kent – acting as Principal Investigators on two parent intervention studies of children with developmental disability. Also with Tizard, we are involved jointly in a grant application to RfPB - Research for Patient Benefit looking at the adaptation and feasibility trial of FRIENDS for Life (an anxiety management and resilience building programme) adapted for children and young people with learning disabilities. We are collaborating with the Drama Department, School of Arts, University of Kent, to an extension of their ‘Imagining Autism’ project, which looks at the benefits of immersive environments in improving social communication win children with autism. Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures; invited contributions to books etc.): We undertook podium presentations of the findings of our cerebral palsy studies at the Occupational Therapy Show conference in November 2014; at the Kent Community Health Trust Clinical Audit & Research Conference October 2014, and at a seminar at the Centre for Health Services Studies, University of Kent, November 2014. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 25 of 40 CLINICAL SUPPORT SERVICES DIVISION Professor Fritz Mühlschlegel, Consultant Microbiologist On behalf of colleagues Alistair Balfour, Sarah Stevens, Mark Baker, Julie Hawes-Reekie, Leila Williams & Campbell Gourlay (Departments of Surgery, Speech and Language Therapy & Pharmacy, EKHUFT and Kent Community Health NHS Trust; School of Biosciences, University of Kent) A multi-disciplinary approach to clinical management and research of surgical voice prosthesis failure A total laryngectomy is the surgical removal of the larynx, usually to treat cancer. Surgical voice restoration (SVR) is the “gold standard” in speech restoration and involves insertion of silicone voice prostheses. The voice prosthesis can fail and oesophageal contents leak into the airway. The most common cause of early prosthesis failure is due to Candida colonisation of the device and there are no nationally agreed guidelines or pathways for managing this. A team of specialists from Microbiology, ENT, Cell Biology (University of Kent), Pharmacy and Speech and Language Therapy, have formed the East Kent Voice Prosthesis Infection Management MDT. This team has considered the evidence-base (and reached consensus where the evidence-base is lacking) to devise a clinical care pathway for managing voice prosthesis failure. This has led to an up to six-fold increase in voice prosthesis lifespan improving patient care and reducing costs. We integrate basic research into our approach to underpin and facilitate clinical practice. The research aims to determine how Candida colonise voice prosthesis and develop into a treatment‐refractory bio‐film that leading on to device failure. By using a high-throughput model we investigate how elevated levels of CO2, as found in exhaled breath, trigger Candida to form a biofilm on the voice prosthesis and looks into biomaterials preventing and novel ways of early detection of biofilms. We are working towards influencing national practice in this specialist field. The team represents a fantastic combination of talent from a variety of disciplines coming together and “pooling” expertise in order to comprehensively address a clinical question – a combination of basic sciences & clinical research and clinical practice at its very best! EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 26 of 40 The Kent Fungal Group From left to right: Daniel (PhD student, School of Biosciences, University of Kent); Julie Hawkes-Reekie (Lead Antimicrobial Pharmacist); Thazhath Veettil Madhusoodanan (ENT Nurse Practitioner); Dr Campbell Gourlay (Senior Lecturer, School of Biosciences, University of Kent); Prof Fritz Muhlschlegel (Consultant Microbiologist); Viktoria (PhD student, School of Biosciences and School of Electronic Engineering, University of Kent); Sarah Stevens (Macmillan Speech and Language Therapist); Mr Alistair Balfour (Consultant ENT surgeon); Leila Williams (Speech and Language Therapist) Dr Matthew Strutt, Consultant Microbiologist Project: “Characterizing overactive bladder syndrome with a view to better diagnostics and treatment” Joint project with University of Greenwich School of Pharmacy (Dr Scott Wildman) and Medway NHS Foundation Trust (Prof. Jonathan Duckett) evaluating role of occult intracellular infection and nucleotide release from uroepithelium. We are determining, using mid-stream urine samples (MSU), and where possible catheterised urine samples (CSU), from carefully characterized patients with OAB and asymptomatic controls: 1. Whether intracellular bacteria are found in shed urothelial cells of OAB patients, and not asymptomatic patients (using histology and microscopy). 2. The species of bacteria (extracellular and intracellular) present (through sediment culture of urine samples and PCR). 3. The urinary concentration of nucleotides (by means of a luciferin-luciferase bioassay). Project: “Factors affecting decay of antibody titres in non-dialysed CKD patients following hepatitis B vaccination” Study in conjunction with Dr Doulton and recipient of EKHUFT-University of Kent studentship grant looking at persistence of hepatitis B immunity following vaccination in non-dialysed chronic kidney disease patients. This study, undertaken by Natasha Hunt (2nd year undergraduate, University of Kent) looked at factors influencing longevity of immunity following primary immunisation course against hepatitis B and effectiveness of further boosters. The results will be presented by Dr Doulton at the British Renal Society in June 2015. Dr Neelan Das, Interventional Radiology I am currently the Principal Investigator for an actively recruiting NIHR Portfolio study (UK ROPE) as well as being co-investigator of a second Portfolio (BASIL 2) study. I am PI for two further studies (PAVE and BASIL 3) which are due to start in the New Year. UK ROPE: This is a registry based study approved by NIHR/NICE/BSIR/BAUS, looking at prostatic arterial embolisation (PAE) for the treatment of BPH. It is a comparator study of the traditional TURP and PAE. We are the largest UK recruiter for the TURP arm and are the third largest recruiter for the PAE arm. This study was opened in June 2014 but locally started in December 2015. Target recruitment is for 15 to each arm. Currently, I have achieved 25 to the TURP arm and 11 to the PAE arm. BASIL 2: This trial is assessing surgical bypass versus endovascular treatment for infra-popliteal atherosclerotic disease. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 27 of 40 PAVE: I have been selected to be the local PI for this site and I expect to recruit 2 patients per month minimum. Recruitment starts in January. BASIL 3: I have been selected as the local PI for this trial investigating what is the best endovascular therapy for patients presenting with severe limb ischaemia. Total recruitment target in this multicentre trial will be 861. Ben Chitambira, Senior Physiotherapist in Stroke, Richard Stevens Ward My research focus is the use of optokinetic chart stimulation in stroke and other neurological conditions. Preliminary evidence suggests that dense parietal strokes that do not simultaneously involve the temporal lobe recover voluntary movements from complete paralysis when treated with the optokinetic chart based OKCSIB protocol. This is a huge benefit to stroke patients as it prevents dense strokes from leading to permanent impairment and disability which often lead to depression. Dramatic results are also being seen in critical illness polyneuropathy and traumatic brain injuries where minimally conscious and completely paralysed traumatic brain injuries have regained at least assisted mobility and function. The OKCSIB protocol is less intensive hence it provides value for money in that more patients can be seen. For the health economy the potential benefits are huge as preventing permanent impairment and disability saves on care costs. The research has led to optokinetic chart stimulation being directly requested for by consultants whenever they have seen patients with balance problems whether from ears or from the processors of the ears in the brain. There is more awareness of the benefits of optokinetic chart stimulation at the William Harvey Hospital. On an international scale there are increasing enquiries from patients’ relatives in Europe to have this form of treatment. Links are starting to develop with other clinicians in Europe as a result of the interest generated by the research. Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures; invited contributions to books etc.): 2 poster presentations, 1 locally and one in Spain 2 invited oral presentations , 1 in Italy and 1 in the UK 1 invited keynote speaker invitation in the UK 1 original research publication in press 1 invited contribution to a book 2 scientific journals editorship Helen Oakes, Physiotherapy ‘A comparative study exploring whether group acupuncture and physiotherapy care has comparable outcomes to individual targeted acupuncture and physiotherapy care with regards to numerical rating scale (NRS) pain scores and Measure Yourself Medical Outcome Profile (MYMOP) scores for patients with low back pain.’ The group acupuncture treatment was found to be non inferior to the individual targeted acupuncture with regard to the primary outcome measure; the NRS scores at 1-5 weeks but not at 5 weeks. The results were uncertain whether the group acupuncture MYMOP scores were non inferior; non inferiority could not be established. The MYMOP scores are individual to the patient and measure main symptom, an activity that is problematic, wellbeing and medication usage. As with both outcome measures at 5 weeks non inferiority could not be established it may be more appropriate to offer individualised targeted acupuncture. 30% of the patients in the group acupuncture group reduced their medication by the end of their treatment EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 28 of 40 compared to 42% reducing their medication in the individual targeted acupuncture group. In conclusion the results of this study suggest that individual targeted acupuncture and physiotherapy may be a better treatment option than group acupuncture and physiotherapy. This research project confirmed that our current method of providing the treatment on a one to one basis is better than offering group treatment. Through publication in the Journal Acupuncture in Physiotherapy we hope to share these findings throughout the UK. Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures; invited contributions to books etc.): The findings are due to be published in the Autumn 2015 edition of the peer reviewed journal Acupuncture in Physiotherapy and as a poster at the therapies clinical excellence day in September. CORPORATE DIVISION Dan Marsden, Risk and Legal, Quality and Operations My Healthcare Passport is a paper based tool to enable ward staff in working with patients with learning disabilities, who may be less able to give a full verbal history. A participatory action research methodology has been employed to engage a Co-Researcher Team, including people with learning disabilities, clinical and administrative EKHUFT staff, a parent carer and a nursing home manager. The Co-Researcher team has been looking at the implementation and evaluation of My Healthcare Passport, and had consulted with stakeholders across the whole system. Three spirals of activity are being pursued:1) Making Improvements to My Healthcare Passport 2) Raising awareness and usage of My Healthcare Passport 3) Using IT systems for delivery of this information. The latter is leading to a joint project with Dr Chris Farmer (Associate Medical Director for IT) to test a third party patient held record system with a sensor embedded in a bracelet. Other significant findings relate to the barriers to participation in research activity within the NHS, particularly for those with learning disabilities, but also more recently other non NHS employees. Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures; invited contributions to books etc.): This work has been presented at two regional conferences, and a poster has been presented at a national conference. OTHER Rose Ward, Pilgrims Hospice In 2014 Pilgrims Hospice participated in NIHR Portfolio study The Validity and Reliability of the IPOS (Integrated Palliative care Outcome Scale; PI Dr Claire Butler, Honorary Consultant in Palliative Care for EKHUFT, Medical Director Pilgrims Hospices). Funded by an NIHR Programme Grant for Applied Research, the study was part of an ongoing programme to develop and validate a patient centred, nationally applicable case-mix classification for adult palliative care provision. Chief Investigator was Dr Fliss Murtagh, Clinical Senior Lecturer, King's College London Department of Palliative Care, Policy and Rehabilitation. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 29 of 40 The study aimed to provide a validated, reliable assessment tool (the IPOS) for global measurement of palliative care concerns, and incorporated two previously validated and widely used assessment tools, the core POS and the POS symptom module. Questionnaires were completed at two different time points by patients and health care professionals (HCPs) in the in-patient unit and community settings. Versions of the questionnaires differed between patients and HCPs, and also across the time points and settings. Despite being a vulnerable and frail patient group, palliative care patients are pleased to participate in research and the Hospice recruited well, success which has resulted in Pilgrims Hospices being invited to participate further with Dr Murtagh in the ongoing programme. Also following previous success, the Hospice has been invited to participate in CTIMP BreatheMOR-HF investigating the efficacy of morphine for the relief of breathlessness in patients with stable chronic heart failure. Working closely with EKHUFT and KCHT the Hospice hopes to open recruitment in October 2015. Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures; invited contributions to books etc.): In March 2015 the summary of findings was published for the NIHR Portfolio study Evaluation Of Pilgrims Hospices Rapid Response Service which examined whether the introduction of a Hospice rapid response service to provide care for patients in their own homes in the last days of life resulted in an increase in the number of patients dying in their preferred place of death. This can be accessed by following the link https://kar.kent.ac.uk/47799/ . Other peer-reviewed journal articles from the project have also been published since April 2015. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 30 of 40 5. Peer-reviewed publications from April 2013 to March 2014 1. AlHassany AA. Night blindness due to vitamin A deficiency associated with copper deficiency myelopathy secondary to bowel bypass surgery. BMJ Case Rep. 2014 Apr 29;2014. pii: bcr2013202478. doi: 10.1136/bcr-2013-202478. 2. Alshaer IM, Kilbride HS, Stevens PE, Eaglestone G, Knight S, Carter JL, Delaney MP, Farmer CK, Irving J, O'Riordan SE, Dalton RN, Lamb EJ. External validation of the Berlin equations for estimation of GFR in the elderly. Am J Kidney Dis. 2014 May;63(5):862-5. doi: 10.1053/j.ajkd.2014.01.013. Epub 2014 Feb 12. 3. Ardeshna KM, Qian W, Smith P, Braganca N, Lowry L, Patrick P, Warden J, Stevens L, Pocock CF, Miall F, Cunningham D, Davies J, Jack A, Stephens R, Walewski J, Ferhanoglu B, Bradstock K, Linch DC. Rituximab versus a watch-and-wait approach in patients with advanced-stage, asymptomatic, non-bulky follicular lymphoma: an open-label randomised phase 3 trial. Lancet Oncol. 2014 Apr;15(4):424-35. doi: 10.1016/S1470-2045(14)70027-0. Epub 2014 Mar 4. 4. Ashworth N, Bland J, Chapman K, Tardif G. What about steroids? CMAJ. 2015 Feb 3;187(2):131. doi: 10.1503/cmaj.115-0001. 5. Bachmann A, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyère F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitán C, Knispel H, Thomas JA. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study. Eur Urol. 2014 May;65(5):931-42. doi: 10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11. 6. Bates T, Evans T, Lagord C, Monypenny I, Kearins O, Lawrence G. A population based study of variations in operation rates for breast cancer, of comorbidity and prognosis at diagnosis: failure to operate for early breast cancer in older women. Eur J Surg Oncol. 2014 Oct;40(10):1230-6. doi: 10.1016/j.ejso.2014.06.001. Epub 2014 Jun 26. 7. Bedford M, Stevens PE, Wheeler TW, Farmer CK. What is the real impact of acute kidney injury? BMC Nephrol. 2014 Jun 21;15:95. doi: 10.1186/1471-2369-15-95. 8. Benson PE, Javidi H, DiBiase AT. What is the value of orthodontic treatment? Br Dent J. 2015 Feb 16;218(3):185-90. doi: 10.1038/sj.bdj.2015.43. 9. Bland JD, Rudolfer SM. Ultrasound imaging of the median nerve as a prognostic factor for carpal tunnel decompression. Muscle Nerve. 2014 May;49(5):741-4. doi: 10.1002/mus.24058 10. Bland JD, Rudolfer S, Weller P. Prospective analysis of the accuracy of diagnosis of carpal tunnel syndrome using a web-based questionnaire. BMJ Open. 2014 Aug 20;4(8):e005141. doi: 10.1136/bmjopen-2014-005141. 11. Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 31 of 40 versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31. 12. Campbell CM, DiBiase A, Fleming PS. Concomitant dilaceration, transposition, and intraosseous migration: report of a patient treated with maxillary canine-central incisor substitution. Am J Orthod Dentofacial Orthop. 2014 Oct;146(4):514-21. doi: 10.1016/j.ajodo.2013.11.024. 13. Carter GD, Jones J, Ketheeswaran M, Shannon J, Singh B, Kearney E, Berry JL. Automated immunoassays for 25-hydroxyvitamin D (25-OHD): Do plasticisers interfere? J Steroid Biochem Mol Biol. 2014 Nov 13. pii: S0960-0760(14)00263-5. doi: 10.1016/j.jsbmb.2014.11.008. [Epub ahead of print] 14. Carter JL, Lamb EJ. Evaluating new biomarkers for acute kidney injury: putting the horse before the cart. Am J Kidney Dis. 2014 Apr;63(4):543-6. doi: 10.1053/j.ajkd.2014.01.005. 15. Carville S, Wonderling D, Stevens P; Guideline Development Group. Early identification and management of chronic kidney disease in adults: summary of updated NICE guidance. BMJ. 2014 Jul 24;349:g4507. doi: 10.1136/bmj.g4507 16. Chitambira B. Does use of the optokinetic chart stimulation based OKCSIB protocol improve recovery of upper and lower limb movements, function and quality of life at 3 year follow up in dense strokes? A retrospective case control series. NeuroRehabilitation. 2014;35(3):451-8. doi: 10.3233/NRE-141135 17. Chow V, Khan S, Balogun A, Mitchell D, Mühlschlegel FA. Invasive rhino-orbito-cerebral mucormycosis in a diabetic patient - the need for prompt treatment. Med Mycol Case Rep. 2014 Dec 23;8:5-9. doi: 10.1016/j.mmcr.2014.12.002. eCollection 2015 Jun. 18. De Cock R, Fajgenbaum MA. Calcification of Rayner hydrophilic acrylic intra-ocular lenses after Descemet's stripping automated endothelial keratoplasty. Eye (Lond). 2014 Nov;28(11):1383-4. doi: 10.1038/eye.2014.175. Epub 2014 Aug 1.. 19. Delaney MP, Stevens PE, Witham H, Judge C, Eaglestone G, Carter J, Bassett P, Lamb EJ. SERUM CYSTATIN C DOES NOT PREDICT MORTALITY OR TREATMENT FAILURE IN PERITONEAL DIALYSIS: A PROSPECTIVE STUDY. Perit Dial Int. 2014 Sep 2. pii: pdi.2014.00071. [Epub ahead of print] 20. de Lusignan S, Sun B, Pearce C, Farmer C, Steven P, Jones S. Coding errors in an analysis of the impact of pay-for-performance on the care for long-term cardiovascular disease: a case study. Inform Prim Care. 2014;21(2):92-101. doi: 10.14236/jhi.v21i2.62. 21. Desai M, John B, Evans G, Eddy B. Prostate cancer: beware of disseminated intravascular coagulation. BMJ Case Rep. 2015 Mar 27;2015. pii: bcr2014206814. doi: 10.1136/bcr-2014-206814. 22. Doulton TW, Farmer CK, Stevens PE. Self-management in Chronic Disease: Clear Benefits for Blood Pressure Control in CKD. Am J Kidney Dis. 2015 Jul; 661(1):12-14. doi: 10.1053/j.ajkd.2015.01.006. Epub 2015 Feb 19 23. Drummond MW, Pocock C, Boissinot M, Mills J, Brown J, Cauchy P, Cross NC, Hartley S, Kell J, Szubert A, Cockerill PN, Bowen DT. A multi-centre phase 2 study of azacitidine in chronic myelomonocytic leukaemia. Leukemia. 2014 Jul;28(7):1570-2. doi: 10.1038/leu.2014.85. Epub 2014 Feb 26 EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 32 of 40 24. Durai R, Doughan S. Using mastoid swab to protect ureter during laparoscopic colectomy. Ann R Coll Surg Engl. 2014 Nov;96(8):621. doi: 10.1308/003588414X14055925059273. 25. Durai R, Thomas D, Doughan S. Fishing method of appendix extraction during laparoscopy. Ann R Coll Surg Engl. 2014 Apr;96(3):247. doi: 10.1308/003588414X13814021679915. 26. Ellis P, Jenkins K. An overview of NICE guidance: acute kidney injury. Br J Nurs. 2014 Sep 1124;23(16):904-6. doi: 10.12968/bjon.2014.23.16.904. 27. Fang S, Argiris K, Padgham N. How we do it: the absorbable gelatin sponge cube, an effective and economical approach to packing in ear surgery. J Laryngol Otol. 2014 May;128(5):475-7. doi: 10.1017/S0022215114000759. Epub 2014 May 1. 28. Graham S, Ye S, Qian M, Sanford AR, Di Tullio MR, Sacco RL, Mann DL, Levin B, Pullicino PM, Freudenberger RS, Teerlink JR, Mohr JP, Labovitz AJ, Lip GY, Estol CJ, Lok DJ, Ponikowski P, Anker SD, Thompson JL, Homma S; WARCEF Investigators. Cognitive function in ambulatory patients with systolic heart failure: insights from the warfarin versus aspirin in reduced cardiac ejection fraction (WARCEF) trial. PLoS One. 2014 Nov 26;9(11):e113447. doi: 10.1371/journal.pone.0113447. eCollection 2014. 29. Hadjiphilippou S, Odogwu SE, Dand P. Doctors' attitudes towards prescribing opioids for refractory dyspnoea: a single-centred study. BMJ Support Palliat Care. 2014 Mar 6. doi: 10.1136/bmjspcare-2013000565. [Epub ahead of print] 30. Hafiji J, Hussain W, Salmon P. Reconstruction of perioral defects post-Mohs micrographic surgery: a dermatological surgeon's approach. Br J Dermatol. 2015 Jan;172(1):145-50. doi: 10.1111/bjd.13197. Epub 2014 Nov 30. 31. Hafiji J, Hussain W, Salmon P. Mohs surgery spares the orbicularis oris muscle, optimizing cosmetic and functional outcomes for tumours in the perioral region: a series of 407 cases and reconstructions by dermatological surgeons. Br J Dermatol. 2015 Jan;172(1):294-6. doi: 10.1111/bjd.13218. Epub 2014 Nov 30. 32. Hargroves, D, Ward L. Anticoagulants for stroke prevention in patients with atrial fibrillation. British Journal of Neuroscience Nursing 04/2015; 11(Sup2):31-37. DOI: 10.12968/bjnn.2015.11.Sup2.31 33. Hasegawa H, Samuel M, Douiri A, Ashkan K. Patients' Expectations in Subthalamic Nucleus Deep Brain Stimulation Surgery for Parkinson Disease. World Neurosurg. 2014 Dec;82(6):1295-1299.e2. doi: 10.1016/j.wneu.2014.02.001. Epub 2014 Feb 8. 34. Hess, K.C., J. Liu, G. Manfredi, F.A. Mühlschlegel, J. Buck, L.R. Levin, A. Barrientos. 2014. A mitochondrial CO2-adenylyl cyclase-cAMP signalosome controls yeast normoxic cytochrome c oxidase activity. FASEB J. 28:4369-4380. 35. Hillmen P, Gribben JG, Follows GA, Milligan D, Sayala HA, Moreton P, Oscier DG, Dearden CE, Kennedy DB, Pettitt AR, Nathwani A, Varghese A, Cohen D, Rawstron A, Oertel S, Pocock CF. Rituximab plus chlorambucil as first-line treatment for chronic lymphocytic leukemia: Final analysis of an open-label phase II study. J Clin Oncol. 2014 Apr 20;32(12):1236-41. doi: 10.1200/JCO.2013.49.6547. Epub 2014 Mar 17 EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 33 of 40 36. Hobbs H, Bassett P, Wheeler T, Bedford M, Irving J, Stevens PE, Farmer CK. Do acute elevations of serum creatinine in primary care engender an increased mortality risk? BMC Nephrol. 2014 Dec 22;15(1):206. doi: 10.1186/1471-2369-15-206. 37. Hoskin PJ, Kirkwood AA, Popova B, Smith P, Robinson M, Gallop-Evans E, Coltart S, Illidge T, Madhavan K, Brammer C, Diez P, Jack A, Syndikus I. 4 Gy versus 24 Gy radiotherapy for patients with indolent lymphoma (FORT): a randomised phase 3 non-inferiority trial. Lancet Oncol. 2014 Apr;15(4):457-63. doi: 10.1016/S1470-2045(14)70036-1. Epub 2014 Feb 24. 38. Jesani A, DiBiase AT, Cobourne MT, Newton T. Perceived changes by peer group of social impact associated with combined orthodontic-surgical correction of class III malocclusion. J Dent. 2014 May 27. pii: S0300-5712(14)00134-1. doi: 10.1016/j.jdent.2014.05.002. [Epub ahead of print] 39. Johnston GA, on behalf of the BSCA. The rise in prevalence of contact allergy to methylisothiazolinone in the British Isles. Contact Dermatitis 2014; 70(4):238-40 40. Kerr M, Bedford M, Matthews B, O'Donoghue D. The economic impact of acute kidney injury in England. Nephrol Dial Transplant. 2014 Jul;29(7):1362-8. doi: 10.1093/ndt/gfu016. Epub 2014 Apr 21. 41. Juniat V, Andrew N. Not just a red eye. BMJ Case Rep. 2014 Apr 3;2014. pii: bcr2013203363. doi: 10.1136/bcr-2013-203363. 42. Kumar R, Shrestha AK, Basu S. Giant midline abdominal incisional herniae repair through combined retro-rectus mesh placement and components separation: experience from a single centre. Hernia. 2014 Oct;18(5):631-6. doi: 10.1007/s10029-014-1239-3. Epub 2014 Mar 28 43. Kumaran N, Larkin G, Hollick EJ. Sterile postoperative endophthalmitis following HOYA IOL insertion.Eye (Lond). 2014 Nov;28(11):1382. doi: 10.1038/eye.2014.170. Epub 2014 Jul 25. 44. Lamb EJ, Delaney MP. Does PTH Offer Additive Value to ALP Measurement in Assessing CKD-MBD? Perit Dial Int. 2014 11-12;34(7):687-691. 45. Lamb EJ, Stevens PE. Estimating and measuring glomerular filtration rate: methods of measurement and markers for estimation. Curr Opin Nephrol Hypertens. 2014 May;23(3):258-66. doi: 0.1097/01.mnh.0000444813.72626.88. 46. Lamb EJ, Stevens PE, Deeks J. What is the best glomerular filtration marker to identify people with chronic kidney disease most likely to have poor outcomes? BMJ 2015;350:g7667. doi: 10.1136/bmj.g7667 47. Lau YF, Senaratne J, Ghatwary T. Endograft Limb Occlusion in EVAR: Iliac Tortuosity Quantified by Three Different Indices on the Basis of Pre-operative CTA. Eur J Vasc Endovasc Surg. 2014 Dec;48(6):711-2. doi: 10.1016/j.ejvs.2014.08.021. Epub 2014 Sep 23. 48. Lee RT, Barnes E, DiBiase A, Govender R, Qureshi U. An extended period of functional appliance therapy: a controlled clinical trial comparing the Twin Block and Dynamax appliances. Eur J Orthod. 2014 ct;36(5):512-21. doi: 10.1093/ejo/cjs076. Epub 2013 Jan 4. 49. Macdougall IC, Casadevall N, Locatelli F, Combe C, London GM, Di Paolo S, Kribben A, Fliser D, Messner H, McNeil J, Stevens P, Santoro A, De Francisco AL, Percheson P, Potamianou A, Foucher A, Fife D, Mérit EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 34 of 40 V, Vercammen E; PRIMS study group. Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS). Nephrol Dial Transplant. 2015 Mar;30(3):451-60. doi: 10.1093/ndt/gfu297. Epub 2014 Sep 19. 50. Mangam S, Marzouk D. A simple, safe and effective bedside technique to achieve haemostasis in serious colorectal anastomotic bleeding. Ann R Coll Surg Engl. 2014 Apr;96(3):249. doi: 10.1308/003588414X13814021679915.Oliveira B, Ali T. A difficult diagnosis to SPOT. QJM. 2014 Dec;107(12):1011-3. doi: 10.1093/qjmed/hcs063. Epub 2012 Mar 29. 51. Mangam S, Marzouk D. 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Arch Dis Child Educ Pract Ed. 2014 Apr;99(2):53-60. doi: 10.1136/archdischild-2013-303707. Epub 2013 Oct 23. 57. Salagierski M. Editorial Comment to Combination of lidocaine suppository and periprostatic nerve block during transrectal prostate biopsy: a prospective randomized trial. Int J Urol. 2014 Nov;21(11):1130-1. doi: 10.1111/iju.12541. Epub 2014 Jun 26. 58. Salagierski M. The genetic patterns of bladder cancer. Where do we stand now? Cent European J Urol. 2014;66(4):411-2. doi: 10.5173/ceju.2013.04.art4. 59. Sattianayagam PT, Desmond PV, Jayasekera C, Chen RY. Endoscopic submucosal dissection: experience in an Australian tertiary center. Ann Gastroenterol. 2014;27(3):212-218. 60. Schmid AB, Bland JD, Bhat MA, Bennett DL. The relationship of nerve fibre pathology to sensory function in entrapment neuropathy .Brain. 2014 Dec;137(Pt 12):3186-99. doi: 10.1093/brain/awu288. Epub 2014 Oct 27. 61. Scully M, Thomas M, Underwood M, Watson H, Langley K, Camilleri RS, Clark A, Creagh D, Rayment R, Mcdonald V, Roy A, Evans G, McGuckin S, Ni Ainle F, Maclean R, Lester W, Nash M, Scott R, O Brien P; collaborators of the UK TTP Registry. Thrombotic thrombocytopenic purpura and pregnancy: presentation, management, and subsequent pregnancy outcomes. Blood. 2014 Jul 10;124(2):211-9. doi: 10.1182/blood-2014-02-553131. Epub 2014 May 23. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 35 of 40 62. Shah N, Shah SP, Thakrar A, Rozati H. An adhesion-related small bowel obstruction occurring within 36 h of a total abdominal hysterectomy and bilateral salpingo-oophorectomy. BMJ Case Rep. 2014 Apr 7;2014. pii: bcr2013201507. doi: 10.1136/bcr-2013-201507. 63. Simpson P. Does active surveillance lead to anxiety and stress? Br J Nurs. 2014 Oct 9;23 Suppl 18:S4S12. doi: 10.12968/bjon.2014.23.Sup18.S4 64. Smithard D, Barrett NA, Hargroves D, Elliot S. Electromagnetic Sensor-Guided Enteral Access Systems: A Literature Review. Dysphagia. 2015 Jun; 30(3) :275-85. doi: 10.1007/s00455-015-9607-4. Epub 2015 May 6. 65. Stanley AY, Conner BT. Implementing a clinical practice guideline to manage postpartum urinary retention. J Nurs Care Qual. 2015 Apr-Jun;30(2):175-80. doi: 10.1097/NCQ.0000000000000087. 66. Stevens PE, Lamb EJ, Levin A. Integrating Guidelines, CKD, Multimorbidity, and Older Adults. Am J Kidney Dis. 2014 Dec 4. pii: S0272-6386(14)01376-6. doi: 10.1053/j.ajkd.2014.09.024. [Epub ahead of print] 67. Streeter EH, Brewster SF; BAUS Section of Oncology. Prostate Cancer Active Surveillance: is UK practice leading the world? BJU Int.2015 Jan;115(1):12-3. doi: 10.1111/bju.12752. Epub 2014 Oct 18. 68. Stephensen D, Drechsler WI, Scott OM. Outcome measures monitoring physical function in children with haemophilia: a systematic review. 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EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 37 of 40 Appendix: Financial report - April 2014 to March 2015 CRN:KSS – 2014 -2015 The tabulation below reflects the outturn baseline allocation for the CRN:KSS contract for the financial year 2014 - 2015. Annual Allocation £0000,s Pay Vacancy Factor Total Pay Non pay Host Fees in-year adjs Total Nursing AC Support Pharmacy Radiology Pathology 686 229 101 (34) (11) (5) 652 218 96 27 9 4 26 22 55 18 8 (54) (5) (4) 680 241 104 26 22 Total Core Budget 1016 (51) 965 89 81 (63) 1072 Specialty Leads 17 17 Contingency 206 206 RCF 43 43 Overall CRN Allocation 1282 (51) 1231 17 (95) 112 43 89 81 (158) 1244 In-year adjustments (reductions to allocation) were applied to eliminate any excess variances against plan. These resources were then recycled centrally within the CRN to provide finance for additional funding requests elsewhere in the network. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 38 of 40 Financial Position The cumulative variance as reported to the CRN:KSS to March 31st 2015 is indicated below: Annual Allocation Annual Budget Period Budget Nursing AC Support Pharmacy Radiology Pathology General Non Pay Host Fees 632 225 101 26 22 36 81 632 225 101 26 22 36 81 618 222 117 20 19 35 81 14 3 (16) 6 3 1 sub-total 1123 1123 1112 11 Vacancy Factor (51) (51) (51) sub-total (51) (51) (51) Total Core Budget 1072 1072 1112 Specialty Leads 17 17 17 Contingency 112 112 64 48 43% RCF 43 43 30 13 31% Total Other Budget 171 171 110 61 Overall CRN Allocation 1244 1244 1222 21 £0000,s Period Spend Period Var (40) % 2% 1% (16%) 22% 12% 4% 0% (4%) 0% 2% The adverse variance reported for the year to date on core funded budgets is due to the attribution of the imposed vacancy factor versus actual underspends on pay budgets. This is more than compensated for by the under-spends on other budget headings that provides an overall favourable variance against plan @ £21k. EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 39 of 40 Other Income/Direct Receipts Total income from direct receipts for the period to March 31st 2015 was £2.56 million, broken down as follows: £000's CRN:KSS Baseline Contract M1 - M3 M4 - M6 M7 - M9 M10 - M12 Total (284) (284) (284) (175) (1026) CRN:KSS Contingeny/RCF (217) % Total (217) sub-total CRN (284) (284) (501) (175) (1244) 49% NIHR Projects (63) (165) (66) (80) (374) 15% MRC/Other/Non-commercial (36) (24) (28) (33) (121) 5% Commercial (88) (190) (215) (330) (823) 32% Total (471) (662) (810) (618) (2562) 100% The majority of R&D income received (49%) is sourced from the collective funding streams as provided from the Comprehensive Research Network. Commercial activity contributed 32% of the overall total with Clinical Haematology providing @ 53% of the £824k accumulated to date. Comparison with previous years A financial comparison of previous annual income receipts for the last several years is shown below. Yr 0910 Yr 1011 Yr 1112 Yr 1213 CRN:KSS (718) (752) (649) (709) (1060) (1244) RCF (175) (20) (83) (100) (110) (149) NIHR Projects (27) (214) (378) (247) (456) (226) MRC/Other/Non-commercial (21) (53) (42) (70) (115) (121) Commercial (143) (100) (81) (346) (707) (823) Total (1084) (1139) (1233) (1472) (2447) (2562) £000's Yr 1314 Yr 1415 Source Jacky Douglas, R&D Finance Officer EKHUFT Research & Development Annual Report 2014-15 Author: Dr Tim Doulton, Director of Research & Development Page 40 of 40