UCL ELIZABETH GARRETT ANDERSON INSTITUTE FOR WOMEN’S HEALTH UCL Elizabeth Garrett Anderson Institute for Women’s Health First Quinquennial Review 2004–2009 UCL Elizabeth Garrett Anderson Institute for Women’s Health First Quinquennial Review 2004–2009 UCL EGA IfWH 1st Quinquennial Review Foreword It is a great pleasure to be writing the foreword for the 1st Quinquennial Review of the UCL Elizabeth Garrett Anderson Institute for Women’s Health (IfWH). The Institute was established in 2004 to bring together the academic team in women’s health at University College London (UCL) and the clinical team at University College London Hospitals (UCLH) NHS Foundation Trust, with a ten-year objective to establish the leading European centre for women’s health. The Institute is built on a long tradition of excellence in obstetrics and gynaecology and has a direct historical connection with the work of Elizabeth Garrett Anderson, the first female doctor in the UK, who founded the New Hospital for Women in London in 1872, later renamed after her. That hospital was the predecessor of our new EGA Hospital Wing at University College Hospital (UCH) which opened in 2008 and the staff in the IfWH share Elizabeth Garrett Anderson’s commitment to improving the health and quality of life of women through excellence in research, education and clinical care. Many of the challenges have changed in the last 137 years, but her ethos and determination to make a difference and improve the lives of others remains an inspiring link. The strategy adopted five years ago in creating the IfWH was to integrate existing activity, broaden its scope, make a series of strategic recruitments, improve space allocation and develop the Institute’s infrastructure. The environment of UCL, one of the world’s leading universities, and UCH, one of the UK’s leading hospitals along with the support of their leadership has made much of this possible. Excellent progress has been made and the IfWH has become established as a key component of UCLH, UCL and this year the new UCL Partners Academic Health Science Centre. The Institute now includes activities in neonatology, sexual health and cancer, as well as obstetrics and benign gynaecology and has numerous collaborative links within and outside UCL. These include collaborations in epidemiology, statistics, computational medicine, imaging, genomics, proteomics, psychology and ethics, as well a series of initiatives in the developing world. During the last five years more than 20 new senior clinical and academic staff have been appointed, a new laboratory established and a major new hospital opened. All aspects of the clinical service have expanded, income has risen and academic output including publications has improved, so that by most metrics the IfWH is amongst the leading European centres in women’s health. A great deal has been achieved, but all of the Institute team are aware that much more needs to be done if the vision to have a major and sustained impact on the lives of women in the UK and globally is to be achieved. This review was commissioned by the IfWH team with the long-term objective in mind, so as to assess the achievements of the last 5 years, identify strengths and weaknesses and to obtain advice from an expert international panel about the future development of the Institute. It is a great pleasure to welcome the review panel, which will be chaired by Sir John Pattison and consist of experts in clinical, research and educational aspects of women’s health. I am grateful to the panel for giving four days to the review and look forward to a challenging, but enjoyable process, which will provide important advice about the next stage of development of the Institute. It has been a great privilege to lead on the creation and establishment of the IfWH and I am enormously grateful to the outstanding clinical, academic and administrative team who have worked tirelessly and with massive commitment to make the achievements described in this document possible. Ian Jacobs Director UCL EGA Institute for Women’s Health 3 UCL EGA IfWH 1st Quinquennial Review CONTENTS Introduction 6 Overview of UCL Elizabeth Garrett Anderson IfWH 8 Neonatal Medicine – Clinical Neonatal Medicine – Research 17 26 Maternal and Fetal Medicine – Clinical Maternal and Fetal Medicine – Research 35 45 Reproductive Health and Benign Gynaecology – Clinical Reproductive Health and Benign Gynaecology – Research 55 64 Women’s Cancer – Clinical Women’s Cancer – Research 71 79 Undergraduate Education Postgraduate Education and Training 89 95 Global Health 101 Clinical and Academic Administration 109 Appendices http://www.instituteforwomenshealth.ucl.ac.uk/staffintranet/appendices.pdf Publications http://www.instituteforwomenshealth.ucl.ac.uk/staffintranet/publications.pdf 5 UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review INTRODUCTION Template for Quinquennial Review of Institute for Women’s Health The University College London Elizabeth Garrett Anderson Institute for Women’s Health (IfWH) was created in 2004 with a mission to bring together individuals with expertise across the spectrum of women’s health, from basic science to clinical skills, with the objective of making a major contribution to the health of women in the UK and internationally, through research excellence, innovation in education and outstanding clinical care. The review panel consists of the following members: In order to assess the initial five years of the IfWH and help guide the next five years a quinquennial review was commissioned by Professor Ian Jacobs, IfWH Director, with the support of Professor Malcolm Grant, University College London (UCL) President and Provost, and Sir Robert Naylor, University College London Hospitals (UCLH) Chief Executive. Sir John Pattison agreed to chair the review and undertook a preliminary visit and review in April 2008. The full review with an external panel will be held from 29 June to 2 July 2009. This document has been prepared to inform the review panel about the activity and status of the IfWH. Professor Jenny Higham (Imperial College London, UK), Education Sir John Pattison, Chairman Professor David Edwards (Imperial College London, UK), Neonatal Medicine Professor Steve Thornton (University of Warwick, UK), Obstetrics Professor Gerard Visser (Utrecht University, Netherlands), Fetal Medicine Professor Allan Templeton (University of Aberdeen, UK), Reproductive Medicine Professor Andrew Berchuck (Duke University, USA), Cancer The review will consist of a site visit, with presentations, and group and one-to-one discussions taking place over the course of three days, following which a report will be prepared. The chapters in this document summarise activity at the IfWH and follow a template given on page 7, which was agreed with Sir John Pattison. The template was followed for each of the twelve areas of activity at the IfWH as listed in the Contents. Review the progress made by the IfWH in advancing the tripartite mission of research, education and clinical care during the last five years. Assess the status of the IfWH nationally and internationally. Identify areas of particular strength and weakness in the activities of the IfWH. Provide guidance to the IfWH management team on future development of the IfWH. Indicate to the senior management of UCL, UCLH, Royal Free Hospital and UCL Partners the steps necessary for the IfWH to achieve the objective of becoming the leading European Centre for Women’s Health within the next five years. 6 2. Strategy, Aims and Objectives Describe the strategy, aims and objectives of your theme and how they will be achieved. 3. Resources Describe the resources available to you, such as: (a) space; (b) finances; (c) staff; (d) equipment. Comment on their suitability for the tasks you face, identifying the key strengths as well as areas of deficiency. 4. Performance and Measurement of Quality of All Activity Define the key performance criteria and output measures for success of your theme. The nature of these criteria will be different for clinical, research and educational activities. For each area of activity described in section 1 provide evidence of quality of performance, based on these criteria. 5. Areas of Excellence This is an opportunity to highlight and provide further details of areas of outstanding performance which have been identified in section 4. Are these areas of activity in which the theme is a leader (a) nationally; (b) in Europe; c) globally? 6. Challenges Describe the key problems you have had to tackle during the last three years, the progress made in dealing with these and outstanding issues. 7. Impact and Importance Explain the importance of your area of activity to the health of women. Provide up to ten examples of activities in your area which have made an important contribution to women’s health during the last five years. The purpose of the full review is to: 1. Overview Describe each area of activity in the theme: how it is organised, managed and led, members of the team and their roles. 8. Future Developments What are the key developments you expect to see in your area over the next five years? Bird’s eye view of Women’s Health: in the foreground are Podium, Tower and EGA Wing of University College Hospital next to Univeristy College London Cruciform Building 7 UCL EGA IfWH 1st Quinquennial Review OVERVIEW OF UCL ELIZABETH GARRETT ANDERSON INSTITUTE FOR WOMEN’S HEALTH (IfWH) CREATION OF IfWH The concept of an IfWH at UCL and UCLH was proposed in 2003 by Ian Jacobs in discussions with Leon Fine, then Dean of the UCL Faculty of Clinical Sciences, and David Fish, UCLH Medical Director, about a move to UCL/UCLH. The proposal was based upon the perception of a unique opportunity to have a major impact on women’s health in view of several factors: A rich tradition of excellence and innovation in women’s health at UCL and partner hospitals, stretching back over 100 years. Existing strengths in clinical care in all specialist areas of neonatal medicine, obstetrics, gynaecology and cancer. Academic excellence in a range of disciplines which could be readily complemented by recruitment of a large gynaecological oncology group. Firm plans for a new hospital build at UCLH to include a new Women’s Hospital wing. The international profile of UCL with excellence in a range of areas of basic science and applied research of relevance to women’s health. Willingness of the senior leadership and staff within Women’s Health (WH) at UCL and UCLH to work together in linking clinical care, education and research in women’s health. The developing national and international agenda to facilitate translation of basic science progress in to clinical impact through effective translational research. The proposal for integration of clinical and academic activity in Women’s Health was formalised in June 2004 by the establishment of the UCL Elizabeth Garrett Anderson Institute for Women’s Health (www.instituteforwomenshealth.ucl.ac.uk) as a joint venture between UCL and UCLH. IfWH VISION As an initial step in the development of the IfWH a series of working groups involving clinicians and academics were established in June and July 2004, which was followed by the 1st IfWH Strategic Away Day in July 2004, at which the mission of the IfWH was agreed: To bring together individuals with expertise across the spectrum of women’s health, from basic science to clinical skills, with the objective of making a major contribution to the health of women in the UK and internationally, through research excellence, innovation in education and outstanding clinical care Through the strategic planning process a number of strategic developments and priorities were agreed and planned with the objective of creating the leading European Centre for Women’s Health within ten years. Progress towards this objective is ahead of schedule as a result of developments since 2004, including recruitment of over twenty senior clinical and academic staff, acquisition of new clinical and research facilities, generating substantial grant income, productivity in publications and a successful global health initiative. Context of IfWH The IfWH was established as a joint venture between one of the world’s leading universities, UCL (www.ucl.ac.uk) and one of the leading NHS Hospital Trusts in the UK, UCLH (www.uclh.nhs.uk). UCL and UCLH are both located in Bloomsbury in Central London and have close interactions in a range of areas, including translational research through the UCLH/UCL Comprehensive Biomedical Research Centre, in which Women’s Health is a theme (www.ucl.ac.uk/cbrc). It was always intended that the IfWH would have close links with local healthcare organisations and this has been facilitated by the establishment of UCL Partners Academic Health Science Centre (www.uclpartners.com), bringing together as Board Member organisations UCL, UCLH NHS Foundation Trust, Royal Free Hampstead NHS Trust, Great Ormond Street Hospital for Children NHS Trust and Moorfields Eye Hospital NHS Foundation Trust, along with a number of organisations in North London, including Whittington Hospital, Primary Care Trusts and Mental Health Trusts. UCL Partners (UCLP) received accreditation from the Department of Health in February 2009. The partnership aims to achieve integration in delivery of the tripartite mission of research, clinical care and education, so as to have a major impact locally, nationally and globally. UCLP serves a population of over 1.5 million, has a turnover in excess of £2.1 billion per annum and is amongst the largest biomedical centres in Europe. At the core of the strategic plan for development of UCLP is a series of UCLP Programmes, based upon disease and system-based areas of strategic importance to the Partners. Crucially from the perspective of the IfWH, Women’s Health is amongst the initial seven approved Programmes, reflecting the progress which has been made in Women’s Health in the last five years. In many ways creation of the IfWH provided the model for UCLP Programmes, which cross conventional boundaries and barriers between the university and NHS, and their academic and clinical activities. UCLP provides an outstanding opportunity to further develop the IfWH, which in July will seamlessly assume its position at the core of the UCLP Women’s Health Programme. ORGANISATIONAL STRUCTURE OF IfWH The IfWH is an overarching structure for strategic planning in Women’s Health, which acts through consensus without governance authority. The Institute is led by Director Professor Ian Jacobs and three Deputy Directors, Professors Judith Stephenson, Donald Peebles and Neil Marlow. A Strategic Planning Committee brings together senior clinical and academic staff, providing a framework for discussion and planning of joint developments. The Clinical Division of the IfWH is the governance structure for delivery of clinical care at UCLH (Clinical Activity section below). This is led by Clinical Director, Tim Mould with General Manager, Susan Sinclair, as well as Clinical Leads for specialist areas. A meeting of the Clinical Board, which involves key staff, takes place monthly. The Academic Division of the IfWH at UCL (Research Activity section below) is led by Director Professor Jacobs with Head of Administration (interim appointment of Marcia Jacks whilst Gemma Escorial is on maternity leave). There are research departments of Neonatal Medicine, Maternal and Fetal Medicine, Reproductive Health and Benign Gynaecology, and Women’s Cancer, as well as Education and Training Department. There is a monthly meeting of the Academic Division Board attended by senior academic and administrative staff. 8 There are important clinical and educational activities at Royal Free Hospital and Whittington Hospital which it is hoped will increasingly be linked with the IfWH following the establishment of UCL Partners. Research Activity Women’s Health research is a theme in the UCLH/UCL CBRC, has over £30 million research funding from MRC, CRUK, WT, DH and NIHR and is organised around 4 main areas primarily on the Bloomsbury Campus: Neonatal Medicine Head of Research Department – Dr Nicola Robertson This group has a focus on neonatal neuroscience and neuroimaging and an international reputation for work on the aetiology, prevention, management and outcomes of perinatal brain injury translated into the use of therapeutic hypothermia for neonatal encephalopathy. There are major collaborations with the Institute of Neurology (piglet model), Institute of Child Health (neuropsychology, respiratory physiology, medical physics, global health, cardiology and pathology), University of Nottingham and the National Perinatal Epidemiology Unit in Oxford. Maternal and Fetal Medicine Head of Research Department – Professor Donald Peebles Research ranges from mouse models of perinatal brain injury and sheep models of viral vector delivered therapy, to a national study of non-invasive diagnosis for rhesus disease, the use of statins to prevent pre-eclampsia and pre-implantation genetic diagnosis. There are joint appointments and collaborations with child health, anatomy, cardiology, neuroscience and HSR. Reproductive Health and Benign Gynaecology Head of Research Department – Professor Judith Stephenson Research includes paediatric and adolescent gynaecology, subfertility, ultrasound diagnostics, chronic disease including obesity, diabetes, PCO and sexual health including teenage pregnancy, abortion and sexually transmitted infections. Research in oocyte physiology and chromosomal disorders has links with physiology and sexual health with population health. Women’s Cancer Head of Research Department – Professor Ian Jacobs This research effort is focused on the use of genetics, epigenetics, proteomics, epidemiology and systems medicine, to develop methods for risk assessment, early detection and prevention of women’s cancers. The laboratory programme is linked to a clinical trials unit which has conducted large scale population based trials including the largest RCT of cancer screening worldwide. Clinical Activity Neonatal Medicine UCLH is the perinatal centre for the North Central London Perinatal Network (NCLPN). Outcomes for very immature infants at UCLH match those of other centres recognised internationally for quality of care. WH runs the largest transitional care service in London, providing special care for babies with their mothers. There is a close clinical partnership with Great Ormond Street Hospital for Children (GOSH), for babies with surgical, cardiac, metabolic, renal and neuromuscular conditions. 9 Overview Overview UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review Maternal and Fetal Medicine Global Health There are delivery units at both UCLH and Royal Free Hopital (RFH), which are managed independently with respectively 4,000 and 3,500 deliveries annually. UCLH provides tertiary maternal and fetal medicine services, accepting referrals as a Perinatal Network hub in North London. There are specialist services linked with Neonatal Medicine, Neurology, the Heart Hospital, Mortimer Market and GOSH as well as the RFH haemophilia centre. In 2005 the Institute team launched a major programme of activity in the developing world, involving clinical care, education and research, encompassing the following initiatives: Services at UCLH and RFH include specialist services in urogynaecology with physiotherapy, rapid access gynaecology diagnosis and outpatient treatment, paediatric and adolescent gynaecology, endometriosis, minimal access surgery, assisted conception, family planning and sexual health. Cervical screening programme in Lagos, Nigeria. Women’s Cancer Resource and Income Generation UCLH is the gynaecological cancer centre for the North London Cancer Network (NLCN) with a catchment population of 1.5 million women. The service involves multidisciplinary expertise in surgery, radiotherapy, medical oncology, nursing, pathology, imaging and palliative care. There are also specialist services in familial cancer and cervical/vulval pre-invasive disease. A NL Breast Cancer Partnership has recently been established involving UCLH, RF and Whittington with links to Barts and The London. Education and Training Undergraduate Education Lead – Heulwen Morgan Module in Women’s Health and Communicable Diseases for 400 students within Phase 2 (Year 4); Web based learning; Major contributions to biomedical sciences, intercalated BSc courses, Student Selected Components and modules in Phase 1 (years 1 and 2); Taught course in Ethics in Reproduction + Women’s Health: 3rd year biomedical sciences BSc module in Fetal and Neonatal Physiology for 60 students/year. Postgraduate Education and Training Lead – Ray Noble Established MSc in Prenatal Genetics and Fetal Medicine: New MSc in Haemoglobinopathies with international collaboration and distance learning components: MSc in Reproductive Science and Women’s Health to start in September 2009. PhD Programme Integrated Programme, with milestones/assessment formally established in 2007 and has 32 PhD students (22 full-time, 9 part-time) covering each of our research themes. Subspecialty Training Royal College of Obstetricians and Gynaecologists (RCOG) recognition for Subspecialty Training in Fetal-Maternal Medicine, Reproductive Medicine, Gynaecological Oncology, Urogynaecology and Community Gynaecology and Diploma in Obstetric Ultrasound. Royal College of Paediatrics and Child Health (RCPCH) National Grid for Neonatal Medicine. Clinical Academic Training The IfWH has been awarded six academic clinical fellows, three clinical lectureships and two new-blood senior lecturer posts in the last three years. 10 Centre for Reproductive Ethics jointly with Nelson Mandela Medical School, Durban, South Africa. Training programme in ethics and reproduction in medical schools in India. Academic Resource Staff The UCL Academic Division of the IfWH has a total of 111 staff and in excess of 30 PhD students. The capacity and capability of the academic team has been enhanced in recent years through recruitment of a number of senior staff, funded by success in income generation with minimal increase in HEFCE funding. There have been 18 senior academic staff appointments and/or promotions in the last 4 years during which just 2 senior academics have left the IfWH. Infrastructure and Facilities Efforts have been made during the last 3 years to rationalise the infrastructure in WH with the long term objective of housing the majority of activity in an ‘Institute’ building. Some progress has been made with the move of the cancer group from the Windeyer to the Paul O’Gorman Building. Discussions are in progress about relocating the Chenies Mews staff and facilities to the Rockefeller building but the IfWH still occupies space at a number of sites. These premises include a broad range of molecular, cell biology and proteomic technologies, clinical research facilities and office based research space. Animal studies are performed in the UCL Biological services labs in the Cruciform Building, the new facility for piglet studies in Queen Square and through a long standing collaboration with the Royal Veterinary College in Camden. Finance Income to the UCL IfWH has steadily increased since the Institute was established with an overall increase in funding of >100% from £3.4 million to £8.1 million annually. Research Council funding has increased from £0.6 million to £1.7 million, and charitable funding from £0.2 million to £1.7 million, whilst HEFCE income has increased from £2.6 million to £3.7 million. This has been achieved through success in grant income generation from the MRC, CRUK, DH, NIH, EU, AMRC and the Eve Appeal. As a result the ratio of HEFCE:other funding sources has improved from 1:0.3 to 1:1.1. Major efforts are underway to further increase grant, industry and charity income. Clinical Skills Laboratories at UCL, RFH and Whittington for UG teaching and examinations. IfWH Gynaecological Cancer Research Unit, 1st Floor, Maple House – High quality clinical trials unit for gynaecological cancer with space for academic staff, researchers and support staff Level 0 Staff At UCLH there are 44 obstetric, neonatal, and gynaecology consultants, 37 training grade doctors, 110 midwives/nurses and a further 30 allied health professionals. At RFH there are 281 senior and junior grade doctors, nurses midwives and allied health professionals. The senior staff have expertise across all specialist areas within neonatal medicine, obstetrics and gynaecology. Infrastructure and Facilities The EGA Wing at UCLH is a new purpose built £70 million maternity and gynaecology building which opened in 2008. The building provides: Level –1 Integrated benign gynaecology/breast outpatient unit. Dedicated area for outpatient diagnostics and treatment including six scanning rooms, four procedure rooms, three recovery rooms, 25 outpatient clinic rooms, dedicated physiotherapy/psychologist rooms and reproductive medicine lab. Paediatric outpatient department – shared with UCLH Paediatrics, an new clinical research unit. Level 1 Integrated Antenatal clinic. 26 clinic rooms and specialist areas comprising obstetric day unit, obstetric ultrasound and fetal medicine unit. Level 2 Twelve bedded labour ward, two dedicated theatres, and four bedded special care area + Neonatal unit with 17 ICU cots and 15 special care cots. Level 3 39 bedded antenatal and post natal maternity ward, as well as a six bedded ‘Home for home’ Birthing Unit with two birthing pools. The UCLH Tower includes a 30 bedded surgical ward on level T13 for patients with benign and malignant gynaecological conditions with 22 theatre lists per week. Consultant gynaecological surgeons cover all lists. UCLH Trust has 40 ICU beds. UCLH has a PERT system which meets the recommendation of the Comprehensive Critical Care Review published in 2000. HEFCE Other Overseas EU 6 UCLH Trust Headquarters at 250 Euston Road – office space for support staff and some clinical academics. Royal Free Hospital – office space for academics and support of undergraduate teaching. Clinical Resource 8 Chenies Mews – laboratories and offices: Neonatal Medicine Research, Maternal and Fetal Medicine Research, including PGD group, and Academic Administration (Teaching and Human Resources). In poor condition and in urgent need of relocation. £m pa Funding Reproductive Medicine and Benign Gynaecology Uganda Women’s Health Initiative, a programme of neonatal resuscitation, prevention of post partum haemorrhage, cervical screening, palliative care and radiotherapy provision involving over 5,000 women and babies with research in premalignancy and perinatal brain injury, the latter leading to a Lancet publication. Institute of Neurology in Queen Square – Facilities for large animal imaging (new 9.4 Tesla MR system) for neonatal group were relocated from EGA Hospital on its closure to Institute of Neurology laboratories at Queen Square. Government Bodies UK Industry 4 UK Central UK Charities Research Councils 2 Margaret Pyke Centre – office space for Reproductive Health and Benign Gynaecology staff. Paul O’Gorman Building – state of the art new IfWH laboratories for 30 staff with Translational Research Laboratory and facilities for molecular, cell biology and epigenetic studies. Cruciform Building – proteomics laboratory forming part of UCL core proteomics facility. 0 2003–4 2004–5 2005–6 2006–7 2007–8 UCL IfWH Funding 2003–2008 11 Overview Overview UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review Continuing the expansion of our external grant award portfolio. Increasing NHS income through planned development of specialist services increasing our referral base. Overview of Areas of Excellence The Women’s Health Theme has a track record and an international reputation across a wide range of activity. There are few other centres in the field of WH which combine: The scope of activity in women’s health from neonatology through obstetrics, gynaecology, reproductive health to cancer; Clinical, research and educational activity in each of these areas: Basic science, translational, clinical and applied research. Examples of particular areas of excellence are as follows: Research Excellence The UCLH Rosenheim Wing includes gynaecological oncology outpatients with 20 rooms used for gynaecological oncology multidisciplinary clinic weekly. There is a private Assisted Conception Unit based at the Eastman Hospital, which has state of the art facilities for IVF and other related techniques. At RFH there is a five bedded labour ward and three bedded birthing unit, two dedicated theatres, a two bedded special care area and a neonatal unit with 14 special care cots. There are 31 ante natal/post natal beds. The emergency gynaecology unit has three rooms, a three bedded observation area and one scanning room. The gynaecology outpatient facility has 24 rooms and there is a 17 bedded ward for women’s health. There are 14 theatre operating lists per week. Finance The UCLH annual budget has risen from £40 million in 2004 to £48 million in 2008. The service was run within budget in 2008. At RFH the WH budget rose from £18 million in 2004 to £21 million in 2008. The service was run within budget in 2008. Income Generation We have ambitious plans for income generation. These involve: Building on our success in fund raising for Gynaecological Cancer via the Eve Appeal (www.eveappeal.org.uk) by establishment of a new charity HOW (Health of Women) which is being developed with the involvement of Marion Allford Associates. We will also continue working closely with the Arem Foundation which has supported our efforts in global health. Developing our intellectual property portfolio to optimise the benefits of our unique biobanks and the diagnostic markers in development with a range of commercial partners. 12 Optimal management of babies requiring relatively low levels of care and transitional care. Major contributions in endometriosis, ultrasound, endocrinology and assisted conception. A strong multidisciplinary approach to infant care, with a very functional and supportive multidisciplinary team. Key cluster randomised trial of pupil-led sex education (RIPPLE) to reduce sexual risk behaviors, and delay first intercourse in young women; inclusion in DH shortlist of Sex and Relationship Education (SRE) programmes to accelerate the Teenage Pregnancy Strategy. Parental satisfaction – high levels of trust, encouraged by staff approachability, optimism and honesty. Maternal and Fetal Medicine Evaluation of sexual risk reduction interventions (DH Sexual Health Strategy) including evidence base for Chlamydia screening in NICE guidance on STI prevention in under 18 year olds. Exceptional breadth and depth of expertise available for the care of women with complex pregnancies and unusually high number of sub-speciality trained consultants. UK Network of community-based sexual and reproductive health services established and directed by Margaret Pyke Centre. The Fetal Medicine Unit (FMU), established in the 1990’s was a pioneering unit in the UK. The tradition of innovative clinical practice has continued e.g. the development and implementation of the integrated test for Down syndrome screening (NICE recommendation for national Implementation). Use of Pre-implantation Genetic Diagnosis to prevent inheritance of a range of genetic disorders. First examples in cancer syndromes including most recently first baby born free of BRCA1 gene mutation through Pre-implantation Genetic Diagnosis. Neonatal Medicine Women’s Cancer Robertson, Marlow, Wyatt Jacobs, Menon, Widschwenter, Ledermann, Williams, Gayther, Tobias Internationally leading pre-clinical and clinical work in asphyxial encepahalopathy; world first in evaluation of xenon as a perinatal neuroprotective agent, with a pilot trial of therapeutic hypothermia in a low resource setting; imaging the term and preterm brain (MRI, MRS and NIRS). University London Hospital – Tower with adjacent Podium Leading European centre for research into intersex abnormalities and paediatric gynaecology. Internationally respected perinatal cohort studies, such as EPICure (2 NEJM publications >360/240 citations respectively). Neuropsychological investigation of preterm development. Leader in Europe for Neonatal EEG and Seizure detection. Leader nationally in NIDCAP and developmental care. RCTs in UK, Europe and international settings – PI on 3 MRC, one Dutch MRC, Australian MRC and one Wellcome Trust funded trials – (I NEJM; 4 Lancet publications to date). Maternal and Fetal Medicine Peebles, Raivich, David, Nicolaides, Jauniaux, Williams, Chitty A leader nationally in pioneering an approach for PGD. European leader Perinatal Brain Injury. Development of models of bacterial infection in the developing brain and investigation of factors causing neurological damage and cerebral palsy. International reputation in Maternal Medicine – described the association between obstetric complications (pre-eclampsia, fetal growth restriction) and later cardiovascular morbidity; Pioneering the use of non-invasive methods of prenatal diagnosis Changed understanding of the role of oxygen in placental development, showing that hyper-oxygenation not hypoxaemia impairs placental growth causing pregnancy complications. Patented novel therapy for severe fetal growth restriction (cell/gene therapy group) which has attracted significant financial support from Ark therapeutics. Reproductive Medicine and Benign Gynaecology Stephenson, Creighton, Serhal, Saridogan, Hardiman, Conway, Jurkovic Internationally leading research in molecular regulation of oocyte and embryo development. Development of Risk of Malignancy Index: used nationally and internationally as a standard approach to triaging patients with ovarian cancer to specialist units. Ovarian cancer high risk screening: leading international trial of screening women at high risk (UKFOCSS) with protocol for screening high risk women and early detection of many cancers. Ovarian Cancer Population Screening: internationally leading research programme. Numerous publications and global impact, 1st evidence of survival benefit, largest RCT performed worldwide (UKCTOCS 202,000 participants – www.ukctocs.org.uk) reports 2014. Cancer epigenetics: understanding role of epigenetics in cancer development and role in risk prediction/screening/diagnosis. Nat Gen paper describing epigenetic stem cell origin of cancer. 1st use of ffDNA detection in maternal circulation for assignment of fetal gender and Rh typing. Spectrum of multidisciplinary services and links with GOSH. Excellence in health care provision for low risk women with a Birthing centre containing three birthing pools and high level midwifery support, led by a consultant midwife. Multidisciplinary joint haemophilia/obstetric and gynaecology clinic at RF. Reproductive Medicine and Benign Gynaecology Urogynaecology including uroneurology and laparoscopic urogynaecology service. Specialist endometriosis therapy unit. Minimal access surgery expertise at UCLH and RF in all fields of gynaecology. Margaret Pyke Centre and Mortimer Market Centre provide internationally renowned contraception and sexual health services. Cancer genetics: lead position within international Ovarian Cancer Association Consortium, largest group analysing of SNP’s in ovarian cancer risk. Leading rapid gynaecology ultrasound diagnostic service. Intra-operative radiotherapy trials in breast cancer. Private and NHS fertility and assisted conception service with leading UK outcomes. Clinical Excellence Specialist paediatric and adolescent gynaecology service with expertise in intersex. Neonatal Medicine Women’s Cancer Extensive experience of managing a complex range of neonatal conditions. Clinical Gynaecological Oncology Service: provision of the highest standards of care and new advances in surgical and therapeutic approaches, to a catchment population of 1.5 million women in North London. Published outcomes for very immature infants match those of other centres recognised internationally for quality of care. Set standards for NCL Perinatal Network centres e.g. referrals out of network now very few and almost all babies of <27 weeks of gestation appropriately receive intensive care at UCLH. Familial Cancer Clinic: screening referral centre for ovarian cancer for South East region. Low central venous line infection rates. Cervical Cancer Screening and Colposcopy: RFH is a leading centre for colposcopy and is 1 of 3 national pilots for HPV testing. The IfWH has introduced screening programmes for cervical cancer in Nigeria and Uganda, involving over 8,000 women, which are now being rolled out nationally. High breast feeding rates, good nutritional status and rates of babies receiving breast milk. Specialist centre at RFH for management of vulval disease, inlcuding pre-malignancy. Senior (consultant) presence 12 hours/day and for any complex case at night. Very low readmission rates after discharge from NNU and in infancy and childhood. Leading national and international centre for highly complex laparoscopic surgery in women with gynaecological cancer. 13 Overview Overview UCL EGA IfWH 1st Quinquennial Review Innovative contribution to the development of the curriculum. Heulwen Morgan, Carole Saunders and Therese Bourne received a Dean’s Team Excellence award in 2007. Ray Noble received the Provost’s Teaching Award in 2007. The final year BSc course in Fetal and Neonatal Physiology is recognised as the most popular and successful in biomedical sciences with excellent feedback from students and external examiners. This now attracts more than 60 students each year. Student Selected Component (SSC) in Ethics in Women’s Health is popular and has high student feedback scores. Neonatal Medicine Neil Marlow, Professor (from Nottingham); Dr Nicola Robertson, Senior Lecturer promoted Reader (from Imperial); Janet Rennie, Consultant (from Kings). Maternal and Fetal Medicine Donald Peebles, promoted to Reader then Professor; Gena Raivich, Reader promoted to Professor (from Berlin); Kypros Nicolaides, Professor (from Kings); Anna David, Lecturer, received HEFCE Senior Lecturer Award; Maggie Blott, Consultant (from Newcastle); Melissa Whitten, Lecturer promoted Consultant/Senior Lecturer. Reproductive Health and Benign Gynaecology Judith Stephenson, Professor (from UCL Population Health); Hayden Homer, Wellcome Trust Clinical Fellow (from Newcastle); Greg FitzHarris, Lecturer and MRC New Investigator (from Canada); Naaila Aslam, Consultant (from Kings); Davor Jurkovic, Consultant (from King’s). Women’s Cancer Ian Jacobs, Professor (from Bart’s/QMUL); Usha Menon, Senior Lecturer (from Barts/QMUL); Simon Gayther, Senior Lecturer promoted Reader (from Barts/QMUL); Martin Widschwendter, Lecturer promoted Senior Lecturer and Reader (from Innsbruck); Alexey Zaikin, Professor (from Essex Univ); Lucy Side, Senior Lecturer/Consultant (from Oxford); Nicola MacDonald, Fellow promoted Consultant; Jayant Vaidya, Senior Lecturer (from Dundee). Innovative ‘Midwifery firm’ at the Archway campus. Grant Funding Innovative ethics teaching in medical schools in India with British Council funding. Grant income has grown steadily since 2004 and includes peer reviewed awards of over £30 million from MRC, DH, CRUK AMRC and NIH (see figure on p11). WH is a theme in the UCLH/UCL CBRC. Postgraduate Education and Training Publications MSc in Prenatal Genetics and Fetal Medicine is renowned internationally with excellent reviews from external examiners. Many students continue studies at the Institute at PhD level. From 2001 to 2008 the WH theme produced over 500 publications including publications in Nature Medicine, Nature Genetics, New England Journal of Medicine and The Lancet. The publication output places the IfWH as one of the leading centres worldwide in WH. Subspecialist training in neonatal, fetal and reproductive medicine and cancer with outstanding record of training specialists, which are now in post throughout UK and worldwide. High quality PhD programme with over 30 students across the spectrum of WH. An analysis commissioned from Leiden University by UCL compared publications in 365 World Universities from 2001 to 2006 and normalised citations in a range of fields with 1.0 being average and >1.2 being high impact. There was no category specifically for WH but UCL scored 1.43 in Obstetrics and Gynaecology, 1.26 in Reproductive Biology and 1.28 in Developmental Biology. 25 20 H-index Research 15 It is important to acknowledge that this performance reflects the broad achievements at UCL and not just the activity within the IfWH. In Neonatal Medicine, Maternal Health and Fetal Medicine the work of the UCL Institute for Child Health is an important contributor. The same applies to Reproductive Health (UCL Division of Population Health and Epidemiology) and Women’s Cancer (UCL Cancer Institute). These related strengths illustrate the added value of locating the IfWH in a centre of excellence with the scope and quality of UCL. 6000 New UCL hires Cancer Reproductive Medicine Fetal Medicine Neonatology 5000 4000 3000 2000 1000 5 Ki ng ’s Co Co Vr pe lle ije n ge Un hag iv en B Ka rus ro sel lin Im ska pe ria l UC Lo L uv H ain Ca elsi mb nki rid Mi ge lan O o Ed xfo inb rd u B rg St olog h Ge na or ge s Lu nd O Ch slo Liv arite er po Pa o Tu l ris r ku V (D O es ur ca lu Ab r tes er ) de e Lu n be ck 0 Athens analysis H-index top 25 European Centres 14 demonstrates that in all areas of research activity in women’s health UCL is amongst the world leaders. 10 Research Assessment Exercise This is a national UK wide review of research performance performed every 5–8 years. In the 2008 RAE WH was in the UCL UoA4 submission which received the highest rating of any UoA return in Biomedicine in the UK. We have undertaken a detailed review of publication key words related to specialist areas of women’s health which is included as Appendix 1.2. This analysis which compares UCL and its affiliated institutions to other organisations in the UK and internationally, An independent analysis undertaken by Athens University compared publications in Obstetrics and Gynaecology in 95 leading European Centres by H Index (a measure of publication quality by citations). UCL Obstetrics and Gynaecology ranked 6th. 30 Metrics and Other Measures of Excellence A separate analysis of publications in women’s health commissioned from 4D Biomedical Cambridge supports the contention that UCL is one of the leading centres worldwide for WH. The uncorrected analysis placed the IfWH 4th worldwide after Harvard, Karolinska, Yale and University of Washington. When the analysis was corrected for recruitment to the IfWH since 2004 UCL was 2nd only to Harvard worldwide and equal to the Karolinska Institute in Europe (see graph below). 0 U I CL ng mpe ’s ria Co l lle g Ox e Ca for mb d Ed ridg inb e u Gl rgh Ma asg nc ow he Liv ster Bi erp rm oo ing l ha Ca m rd if Br f i s Ne to w l Ka cast ro le lin s He ka lsi Er nki a He smu ide s Am lbe ste rg rd am Le ide n Mi lan Jo Ha hn rv s H ard op kin U s of W UC as SF h Ma ingt y o C on Br igh l am St inic an anfo d Y rd ou ng s UC Du L ke A Un iv. UC Ya Be le rke ley Undergraduate teaching in both hospital and community settings is highly regarded. Success in recruitment and retention of international leaders during the last 5 years has been excellent and has assisted with increasing the profile of the IfWH. Senior staff recruited or promoted include: Ki Undergraduate Education Recruitment and Retention Relative publications Education and Training Excellence UCL EGA IfWH 1st Quinquennial Review 4D Biomedical Analysis Publications in WH 2003–8 15 Overview Overview UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review Clinical There are numerous markers of excellence in our clinical service. The table below summarises a range of qualitative and quantitative measures. (a) Neonatal Medicine Regional endometriosis centre for North Central London Regional unit for NC London Perinatal Network Regional urogynaecology centre for North Central London Perinatal mortality rate below the national average Accredited by the RCOG for 2 trainees in Reproductive Health – 1 of only 2 centres in UK The EPICure Study data (figure p. 22) demonstrate a significant increase in survival of very premature babies at UCH compared to the rest of England Leading national centre for Paediatric Gynaecology – strong links to GOSH Only unit in UK providing Integrated Transitional Care service, with multidisciplinary follow up rate 90% and neuro intensive care cots Internationally renowned Margaret Pyke Centre and Mortimer Market Centre Consultant presence 12 h per day and, for complex cases, at night Supraregional referral centre for complex laparoscopic surgery Healthcare Commission Quality indicator – 100% Low central venous line infection rates Very low readmission rates after NNU discharge Optimal management of babies requiring relatively low levels of care and transitional care Parental satisfaction – high levels of trust, encouraged by staff approachability, optimism and honesty National Grid Training centre for neonatal medicine Integrated service with GOSH for surgical and cardiac cases (b) Maternal and Fetal Medicine Patient satisfaction scores over 80% 18 week compliant across whole spectrum of gynaecology (d) Women’s Cancer Regional referral cancer centre for the NL Cancer Network (6 hospitals). Larger clinical work load than any centre in mainland Europe Leading national and international centre for highly complex laparoscopic surgery Familial Cancer Clinic is the supraregional referral centre for South East England Accredited by the RCOG for 3 trainees – more than any other UK centre Peer review in 2001 and 2005 – met 97% of the Improving Outcomes Guidance Tertiary referral centre for North Central London Perinatal Network Peer review team in 2005 awarded Special Merit and recognised as outstanding example of how a network should be organised Referral centre for complex growth restricted fetus Clinical Negligence Scheme for Trusts (CNST) level 2 achieved for Maternity services in 2007 New real time Maternity Information System purchased and being introduced – one of first in UK Dedicated consultant PA for obstetric haematology, cardiology, anaesthetics, neurology and psychiatry Fully compliant with guidelines of Confidential Enquiry into Maternal and Child Health (CEMACH) report Specific obstetric physician – one of four in UK NEONATAL MEDICINE Overview UCL EGA IfWH 1st Quinquennial Review Outperform national standards with 0% breeches for target referrals, 99.4% patients within treatment target times and 92% compliant with guidelines 35% reduction in surgical wound infection highlighted in the Nationsl Audit Office (NAO) report and used as a case study by the National Primary Care Development Team Theatre occupancy is 100% and a Possum® scoring system for assessment of surgical morbidity and mortality has shown consistently low actual against expected morbidity ratios of 0.13 : 0.42 3rd and 4th degree tear rate at 0.95% Royal Free Hospital is the preinvasive referral centre for the North London Cancer Network and a specialist centre for management of vulval disease including pre-malignancy (c) Reproductive Medicine and Benign Gynaecology Fall in asepsis >20 rates from 10% in 2005/6 to 4.7% in 2007/8 post complex surgery IVF conception rates in Assisted Conception Unit – best in UK in 2008, and amongst top 3 in UK for many years Only 1 case of MRSA in 2006/7 Intra-uterine insemination rate of 10% per cycle Accredited for training by the RCOG and the European Society of Gynaecologial Oncology Human Fertilisation and Embryology Authority (HFEA) accredited laboratory for 10 years Embedded psychosocial support and 85% patient satisfaction with Clinical Nurse Specialist (CNS) support Education and Training Women’s Health was the education focus of Quality Assurance (QA) reviews in 2007/8 and excellence of teaching and learning and the high quality of the organisation of the clinical course was highly commended in the reports. GMC QA visits identified innovations and evidence of good practice from Women’s Health in the context of SSC activity for Phase 1 students. 16 17 UCL EGA IfWH 1st Quinquennial Review NEONATAL MEDICINE – CLINICAL CLINICAL Jane Hawdon Janet Rennie Angela Huertas-Ceballos Nikki Robertson Neil Marlow Mark Sellwood Judith Meek John Wyatt The UCH Neonatal Service is the lead for the North Central London Perinatal Network (NCLPN), providing the whole spectrum of the specialist neonatal care pathway. As part of the team based at the EGA Wing and Great Ormond Street Hospital for Children (GOSH), we also manage complex pregnancies where the baby will require transfer for surgery or cardiology care at GOSH. Because of the general lack of capacity for tertiary neonatal care we also take babies from surrounding networks on request, producing a diverse, busy and vibrant service. From November 2008 we have been housed in spacious purpose-built accommodation with 17 intensive or high dependency cots and 15 special care cots, and with a busy transitional care service integrated within the maternity ward. Uniquely we are equipping three intensive care cots to provide neurointensive care, including cotside electroencephalogram (EEG) video-telemetry, therapeutic hypothermia and recyclable gas ventilators. Our specialist practice is the product of close crossdisciplinary working with input from experts in fetal medicine, paediatric surgery, speech therapists, dieticians, physiotherapists, occupational therapists, social workers and pharmacists. A neonatal community nurse and respiratory nurse specialist also provide support for families of infants after discharge into the local area. We have an established followup service, focused on chronic lung disease, neurodevelopment and an echocardiography service. We also provide outpatient support for infants of drug using mothers and those at risk of HIV or hepatitis B and C, and clinics for babies with feeding difficulties. Transfer of children with developmental problems to community services is achieved seamlessly with developmental therapy support provided from within the clinic setting. 18 The unit is amongst the busiest in London and operates at over 80% bed occupancy. In 2007 there were 585 admissions to the neonatal unit (13% births) and 547 to transitional care, reflecting the high risk casemix of our maternity service. Approximately 60 infants per year have surgical conditions and are transferred to GOSH. We are well supported by dedicated 24-hour neonatal and paediatric transport services. Although managed in different divisions, we work closely with the UCH paediatric team, sharing outpatient facilities and moving more mature babies who require ongoing hospitalisation to their care. We also contribute to the paediatric teaching faculty. We remain very proud of our care of babies born at very low gestations and we have published outcomes that compare favourably to other internationally respected studies in terms of survival and developmental morbidity. Almost uniquely amongst tertiary centres and perinatal networks we have low risk-adjusted neonatal mortality at network and unit level in national benchmarking through Confidential Enquiry into Maternal and Child Health (CEMACH) (see figure below). Members of our team provide professional leadership, taking on roles within national bodies and frequently being asked to advise outside agencies. This is a key component of our aim to provide national leadership in the development of neonatal care. The department has a long history of leading research in partnership with UCL. This tradition continues, with a focus primarily on the neonatal brain and the sequelae of perinatal events. The concept of modern neonatal care includes a move towards care that is more responsive to individual needs and involves families closely in their child’s care. This philosophy, which is included within the Neonatal Individualised Developmental Assessment and Care Programme (NIDCAP), is being integrated into our routine clinical practice. The translational nature of our research and the integration of laboratory and clinical studies create a thriving, stimulating working and training environment for staff of all disciplines to the advantage of the babies we care for and their families. Network 3.5 Neonatal death rate (per 1000 live births) NEONATAL MEDICINE Average network neonatal death rate 95% confidence interval 3.0 2.5 2.0 1.5 1.0 0.5 0.0 0 5000 10000 15000 20000 25000 Live births 30000 35000 40000 45000 Adjusted neonatal death rate compared to the average Network neonatal death rate: England, 2007 – NCLPN indicated by arrow (Source CEMACH Perinatal Mortality Report 2007, Feedback Report: North Central London Neonatal Network). 19 NEONATAL MEDICINE – clinical NEONATAL MEDICINE UCL EGA IfWH 1st Quinquennial Review Our vision is to provide clinical leadership across the NCLPN and enhance wellbeing and outcomes for sick newborn babies and their families. We carry this out in a multidisciplinary setting that is responsive to the needs of our patients. We aim to develop a high quality neonatal service of international repute, delivering an integrated, evidence-based symbiotic clinical and academic service that itself is a benchmark of excellence. Our objectives 1. Provide a comprehensive neonatal service for the local population in partnership with other NCLPN units. 2. Develop strategies of care that incorporate evidence-based interventions designed to optimise outcome for high-risk infants. 3. Ensure holistic care for families addressing all their needs and aspirations through pregnancy planning, preconception health, pregnancy, labour, delivery, the neonatal period and subsequently, and including bereavement support. 4. Train and educate our workforce to a high level of competence, including the wider EGA Wing workforce, for whom we provide neonatal life support and clinical examination training. 5. Facilitate research and development in perinatal and neonatal care. 6. Support midwives in developing excellent newborn care, promoting healthy child-rearing practices including exclusive breast-feeding, vaccination, good diet and prevention of SIDS. 7. Support intensive care activity across London, whether because of inadequate local tertiary service provision or for aspects of care in which we or our associated colleagues have specialist expertise (hypothermic neuroprotection; specialist postnatal support at GOSH). Achieving our objectives 4. We have active nursing and medical education programmes, run neonatal life support (NLS) courses and contribute to local and national training opportunities. UCH is a recognised Training Centre for the National Grid (Royal College of Paediatrics and Child Health (RCPCH)). We contribute to the UCH Quality Project. 5. See Neonatal Medicine – Research. 6. We provide daily consultant level support to the postnatal wards in order to encourage good childcare practice. 7. Of our activity 59/578 admissions in 2007 (10%) were from outside the network and 75 babies were transferred to GOSH for ongoing care, with 2008 data not available as yet RESOURCES Space and Equipment Purpose built Neonatal Intensive Care Unit (NICU) on Level 2 of the EGA Wing. • 17 Intensive care stations, each permanently equipped with monitoring, respiratory support and infusion pumps, with paperless notes and clinical workstations to be installed; additional equipment for High Frequency Oscillatory Ventilation (HFOV) and inhaled nitric oxide (iNO) delivery • three cots equipped for neurointensive care, including two Cardinal Health Nicolet 32-channel EEG monitors with polygraphy, video facility and central server; two Brainz twochannel aEEG recorders; two Criticool hypothermia devices; two Tecotherm devices; ventilators with recirculation circuits for delivering xenon (in development) • Practice development nurses (three) • Nursing establishment (130 (currently 16 vacancies)), staffing is not to British Association of Perinatal Medicine (BAPM) 2001 leve,l but provides adequate staffing to 1996 standards and two cubicles at 1:1 nursing with two shift supervisors. A range of specialist nursing roles has been developed to encourage personal development and career progression. • Pharmacy (one pharmacist); other health professional support includes speech and language therapy (1.5 whole time equivalent (WTE)); dietetics (1 WTE); EEG; physiotherapy (1 WTE); occupational therapy (0.1 WTE in Outpatients) with sessional support from counselling and psychotherapy and hospital social work. Neonatal Unit Budget 2007/8 Income £5,885,623 Expenditure Underspend £5,525,750 £359,873 Staffing costs £4,404,517 Bank/agency/locum £54,356 Equipment £63,750 (PFI move associated with near complete refit) • 15 Special Care cots with high dependency capacity. Suitability • three 4-bed bays and one 3-bed. • stabilisation room adjacent to Theatre 2 on Labour Ward. 2. We have an ongoing guideline group in UCH and also assimilate Network guidance. This is married to an active audit plan and journal club; we recruit to external randomised trials and develop our own scientific investigative portfolio to ensure optimal practice. • parent facility: kitchen and sitting area, private area for breast milk expression, interview room, three en-suite bedrooms for rooming in. 3. Holism is encouraged through multidisciplinary working with obstetric, fetal medicine and midwifery colleagues and paediatric specialists, informally and formally in weekly multidisciplinary liaison, or Link, meetings. We contribute to antenatal counselling and two consultants run a specialist neuroabnormality antenatal counselling clinic. Within the neonatal service we engage a range of expert allied health professionals, including dietetic and pharmacy support, with the developmental care practices encouraging holistic care with broad parental support (social work, psychology and psychotherapy). Staff • Medical Physics laboratory on site and clinical investigation room adjacent to reception. • team room for meetings and IT resources. • office space is at 250 Euston Road (NHS) and 86-96 Chenies Mews (academic). Mark Sellwood (Lead Clinician) and Annie Hunt (Senior Nurse) • Eight consultants: Professor Neil Marlow, Drs Leigh Dyet, Sian Harding, Jane Hawdon, Angela Huertas-Ceballos, Judith Meek, Janet Rennie and Nicola Robertson. • Walport Lecturer (1.0); SpR-level staff (including two imaging fellows with clinical responsibility; total of nine posts); Junior Specialty Trainees (twelve, including two Academic Clinical Fellows) PERFORMANCE AND MEASUREMENT OF QUALITY OF ALL ACTIVITY UCH is the lead centre for NCLPN with a high rate of incoming transfers (see table below). Activity has risen from 2006-07, but 2008 data are not currently available from the Network. 14-23% admissions are transfers (IUT or NNT) and a significant workload arises from our support of the surgical workload at GOSH. ACTIVITY 2007 2006 UCH % NCLPN activity UCH % NLCPN activity Intensive care 2491 days 59% 2075 days 59% HD care 4434 days 81% 2356 days 40% Special care (incl TC) 7394 days 7814 days Network transfers 48 (8% admissions) 76 (13% admissions) Out of network transfers 34 (6% admissions) 59 (10% admissions) Transfers to GOSH 75 (38 back transfers) 65 (39 back transfers) Finances • arranged as three 4-bed bays, two single cubicles and one 3-bed bay. 1. NCLPN: Jane Hawdon is current clinical lead and crossNetwork audit is reported publicly in the Annual Report. We use a common IT platform and have excellent communication with the other neonatal services locally. Our outpatient work ensures a seamless transition from inpatient to community. 20 • Advanced Neonatal Nurse Practitioners (six: one vacancy) Space has vastly improved since the old EGA hospital, but issues remain in terms of quiet space for counselling and bereaved parents, as well as functional office or private space on the Neonatal Unit for private conversations and telephone calls, and a staff rest room. Furthermore, there is little writing space due to inadequate design of office facilities and clinical workstations. Equipment is otherwise highly adequate and the support is excellent. Staffing levels at present are consistent with those of similar sized neonatal services, but will require expansion to meet 2001 nursing standards. Commissioning arrangements are expected to change with the publication of the Neonatal Taskforce Report in June 2009. It is unclear how the recommendations will affect services, but is envisioned that stronger commissioning should match activity to remuneration better. Activity is constant throughout the year at around 80% occupancy (including transitional care (TC) beds; see graph below). ICU occupancy is greater, averaging >90%. Around 50% of admissions are to TC, which is a major area of activity for the service. 100 80 Percent occupancy STRATEGY, AIMS AND OBJECTIVES UCL EGA IfWH 1st Quinquennial Review 60 40 20 0 Jan Feb March April May June July Aug Sept Oct Nov Dec Occupancy 2008. Target for neonatal services – 70% (DH 2003) Survival compares favourably with national data and other international centres of excellence, for example, Karolinska in Sweden. We have published survival and morbidity data (Riley K, Roth S, Sellwood M, Wyatt JS. Acta Paediatr 2008 97:159-65), a report which prompted two leading articles (Lagercrantz/Fanaroff. Acta Paediatr 2008 97 142-3). Survival has remained constant at 80% (74-90%) for births <29 weeks from 1998-2007. In 2008 survival was 23w: 50%; 24w: 67%; 25w: 93%; 26w: 87%; 27w: 70%. 21 NEONATAL MEDICINE – clinical NEONATAL MEDICINE – clinical UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review Long-term outcome remains a major concern for survivors of in particularly extreme prematurity. Angela Huertas-Ceballos heads the NCLPN Follow-up Group as part of the South East Neonatal Database project. Outcome for babies born at <29 weeks in NCLPN demonstrates close approximation to those in other reports with 43% of children in 2003-4 showing normal outcome and only 9% with severe impairment. (NCLPN Annual report 2007). UCH babies at 2 years have 3% Severe disability, 18% with mild-moderate impairment and 48% free of impairment (21% lost to follow up). 100 • Leading development of European Neonatal Training Curriculum and Assessment Framework (Neil Marlow). CHALLENGES • Developing a neonatal virtual learning environment (3rd Leonardo da Vinci Fund application currently being considered to roll this out under the aegis of ESPR and RCPCH). Staff feedback is obtained through regular staff feedback surveys. In 2008 we took part in a divisionwide staff survey. In 2009 we carried out our own staff survey and results are currently being analysed. An action plan has been based on the 2008 survey results, which is in place, but impacts little on Neonatal Medicine. High quality benchmarked outcomes New EGA Wing The greatest challenge faced by the service in 2006-08 was the planned move to the new building. This was accomplished smoothly and without incident due to exceptional planning, clinical leadership and engagement. However, the new accommodation requires time in which to establish protocols and methodology. The challenge of the Private Finance Initiative (PFI) contract has meant that these problems are not easy to solve where infrastructure changes are required. Quality Project In this UCH project neonatal staff work closely with midwives and obstetricians to identify and develop projects which will improve quality of care and outcomes. Outputs are improved according to mother feedback surveys and monitored with a scorecard. The latter monitors key markers across the perinatal service, for example, readmissions and unexpected admissions to the postnatal wards are monitored regularly and Jane Hawdon is currently designing an audit in response to data and issues raised. EPICure 1 (1995) EPICure 2 (2006) UCH (95% CI; 2003–6) 80 User satisfaction data are collected by questionnaire from all families after discharge. Results of discharges from the new unit are not available. Our old unit suffered from cramped conditions and relatively poor facilities for parents, which attracted comments on a regular basis and should now improve. Staff are regularly praised and rarely the subject of complaints. 60 % 40 PMET-B Trainees Survey Neonatal trainees rate the experience they have at UCH very highly against other areas of the Trust and other neonatal services (http://reports.pmetb.org.uk). 20 Percentile rankings are as follows. 0 22 weeks 23 weeks 24 weeks 25 weeks Gestational age at birth Babies admitted for Intensive Care in England in 1995 and in 2006 compared to UCH 2003–6 Clinical audits 2008 • Management of patent ductus arteriosus (PDA): found in 57% of infants born <29 weekd gestation, 81% received treatment, 8/36 (22%) had surgery. Action – move to prophylactic treatment. • Abnormal abdominal X-rays (AXR): ongoing study correlating AXR report to clinical course. When results were last reviewed, 44/48 AXR were reported to be abnormal, indicating appropriate requests. • Infection screens: 196/202 blood cultures negative, 4 infants had no culture result (prompt for audit). Reasons are being explored. • Jaundice and UTI: 0.6% of prolonged jaundice screens showed evidence of UTI, emphasizing the rarity, but importance of this cause. • High serum sodium: hypernatraemia dehydration was found in 1:1000 deliveries (higher than published data). Increasing age at presentation was associated with higher Na2+ level. Contribution to external audit projects 2008 • National Neonatal Audit Project http://www.hqip.org.uk • CEMACH • NCLPN report and Standardised Electronic Neonatal Database (SEND) project • National Neonatal Surgical Survey (Taskforce/Royal College of Surgeons (RCS)) 22 Overall satisfaction >75% (very good) Clinical supervision 50-75% Workload <25% (i.e. very busy) Handover 50-75% EC working time compliant 100% Adequacy of experience near maximal Educational supervision 50% Feedback 50-75% Induction 25% Learning opportunities 50% Bullying 0% (very low) Work intensity <25% (high) AREAS OF EXCELLENCE Leading the profession • This key role is central to our practice at the Unit, hospital network and national levels as described in other sections. Individuals are involved in work of the RCPCH (Jane Hawdon, Angela Huertas-Ceballos and Judith Meek), RCOG (Neil Marlow and Janet Rennie), BAPM (Neil Marlow and Jane Hawdon), NICE (Janet Rennie, Chair of Hyperbilirubinaemia group, Jane Hawdon and Neil Marlow), NPSA (Neil Marlow), NHS/DH Neonatal Taskforce (Neil Marlow), CEMACH (Neil Marlow (Advisory Board), Jane Hawdon and Nikki Robertson). • Janet Rennie is author of the principal UK Textbook of Neonatology and a manual of care. Janet Rennie, Nikki Robertson and Cornelia Hagmann have co-authored a new textbook on Neonatal Cerebral Investigation. • Published extremely low gestational age (ELGA) survival and morbidity (see above) • CEMACH data (see above) Staffing Unique clinical services Nursing Recruitment and retention are key concerns within neonatal intensive care services. Our current vacancies are inhibiting the opening of the whole unit (we tend to have up to 5 beds closed on a daily basis). Strategies are in place to combat this, which is a national issue, most acutely problematic in London. Retention is improved by full staffing, which also releases nurses to undertake personal development plans agreed at appraisal. • Joint fetal medicine neurology clinic (Janet Rennie, Leigh Dyet and Lyn Chitty). This is a unique service where parents are rapidly seen by two experts following a referral in, with a ‘onestop shop’ regarding ultrasound diagnosis and counselling. Genetic advice is usually available in the same clinic (Dr Alison Male). If MRI is needed it is performed within a week, reported by an expert within 24 hours and the result relayed to the parents immediately afterwards. The service has been audited with parent satisfaction questionnaires and comments were highly favourable despite the difficult and emotive area. It is the focus of a current NIHR bid to obtain accurate prognostic information in collaboration with other neonatal neurological services, led by UCH. • Our multidisciplinary and holistic approach to follow-up clinics for chronic lung disease and infant feeding, which aims to address all aspects of need and minimise long-term complications of premature birth. For example, feeding support (speech and language therapy and dietetics), respiratory therapy advice (respiratory specialist nurse) and integrated developmental assessment and therapy. Medical staff Consultant levels are appropriate for full cover of the maternity and neonatal service during office hours, but increasingly consultants are having to remain in hospital overnight or return frequently, because of training grade staff vacancies, inexperience of trainees, and casemix. Medical staffing is a national issue in paediatrics and initiatives are underway to help resolve this, although UCH is a popular destination for trainees, both for those in National Grid Neonatal Training and for those who are not career neonatologists. Changes in training and European Working Time Directive (EWTD) have led to a reduction in trainee experience, necessitating increased supervision. Strategies to improve the experience of bedside medical support are required. Leading clinical outcome research • Longitudinal UCH cohort studies - the cohorts from UCH, starting in the 1970s with the first outcome studies following very preterm birth in the UK, whose earliest survivors are now young adults. These studies provide valuable and unique insight into the progress of preterm birth. • National outcome studies of high international impact (EPICure – two key papers cited 410 (Wood, NEJM 2000) and 272 times (Marlow, NEJM 2005)) Developmental care With one individual qualified NIDCAP Trainer and three more staff in training as facilitators, we are preparing to integrate developmental care more fully into our care bundles. Engagement with community and global health • Teaching and training of neonatal skills in Mulago Hospital, Kampala, Uganda • Published pilot of low-technology cooling for perinatal asphyxial encephalopathy (Robertson Lancet 2008). • Supporting perinatal charities (Best Beginnings, the Bobath Centre (Judith Meek) 23 NEONATAL MEDICINE – clinical NEONATAL MEDICINE – clinical UCL EGA IfWH 1st Quinquennial Review AHP and support staff Recruitment into these posts has not been problematical and we have highly expert individuals in posts with specialist neonatal expertise. Receptionists are more isolated within the new unit and higher levels of staffing are required to maintain the entry-exit arrangements. Funding Commissioning the service has only recently changed to a more equitable footing compared to that in other London Neonatal Commissioning areas, but is not yet completely competitive. The Neonatal Service should be a net ‘gainer’ from payment by results due to high levels of activity and occupancy, but delays mean that that the introduction of payment by results (PbR) may be delayed until after 2012. The Neonatal Taskforce Report should result in better funding for the base service and support for data collection and follow-up of high risk groups, but the impact of this will not be felt until 2010-11. IMPACT AND IMPORTANCE Neonatal care is one of the success stories of modern medicine. Over the past 25 years neonatal mortality has decreased and survival at extremely low gestational ages is continuing to improve. These changes are due to improvements in obstetric, as well as neonatal care, due to improved team communication and coordination, and have been generally evidence-based. Current practice is focused on enhancing the development of babies admitted for neonatal care, and the family experience to ensure optimal outcomes and minimise disability. The Neonatal team at UCH has been at the forefront of advances in modern neonatal care. It has pioneered therapies that have become central to the standard care of sick babies: parenteral nutrition, ventilation strategies, fluid balance, neonatal cranial ultrasound, transcutaneous blood gas monitoring, near-infrared spectroscopy, magnetic resonance spectroscopy and therapeutic hypothermia. We are continuing in the spirit that has had such significant impact on neonatal care to the benefit of babies and their families. In addition to the two academic senior appointments three consultants (Janet Rennie, Judith Meek and Angela Huertas-Ceballos) hold Comprehensive Biomedical Research Centre (CBRC) PAs to encourage and protect time for academic activity. We are currently setting up the facility to use xenon as neuroprotection following asphyxial encephalopathy in a unique study funded by the MRC, which will be a world first (Nikki Robertson). We have funded and are working to integrate continuous video EEG into neonatal intensive care with the intention of trialling new anticonvulsants and evaluating neural development (Janet Rennie and Neil Marlow). We are evaluating the use of NIRS and single shot evoked potentials to improve understanding of the preterm newborn’s response to noxious stimuli (Judith Meek). 24 UCL EGA IfWH 1st Quinquennial Review Advances in MRI technologies (with the impending introduction of a clinical and research 3T Scanner) are being harnessed to study longitudinal cohorts in new neuro-developmental outcome studies (Nikki Robertson and Neil Marlow) and to investigate the fetal brain (Janet Rennie, Lyn Chitty and Neil Marlow). Furthermore, the long-term health of the babies and their families is of paramount importance. Much concern has been expressed at the frequency of intellectual, behavioural and physical problems experienced by children born at very low gestations. We have one of the longest running follow-up programmes in the world, now led by Angela Huertas-Ceballos, and our department has made significant contribution to the academic literature in this area. In addition, we have organised our care to optimise the outcomes for these infants by assiduous attention to their intensive care, growth and the use of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) – kangaroo care to engage parents more contructively in the care of their child. There is robust evidence that neonatal care produces the best outcomes when organised hierarchically. We are providing clinical leadership in this area at local level (NCLPN), and nationally through BAPM (Jane Hawdon and Neil Marlow) and the Neonatal Taskforce (Neil Marlow). Janet Rennie is leading the development of NICE guidance in the management of neonatal jaundice. Jane Hawdon has been a member of NICE Guideline Development Groups (GDG) for antenatal care, postnatal care, diabetes in pregnancy and hypertension in pregnancy, and was on the working groups for Safer Childbirth and the CEMACH Diabetes in Pregnancy Enquiry. Neil Marlow is a member of working groups developing professional guidance around termination and fetal awareness (RCOG), following on from the influential Nuffield Council for Bioethics report into fetal and neonatal practice (2007). He has contributed to several RCOG Green-top guidelines, for example, virus infections in pregnancy and electronic fetal monitoring. He is also on the Safer Neonatal Practice Board (NPSA/RCPCH) and an investigator on the Birthplace Project (www.NEPU.ox.ac.uk). Neil Marlow is the current President of the ESPR and of the IPRF and Tertiary specialty representative at the European Academy of Paediatrics (UEMS section of Paediatrics). Nikki Robertson is Head of the ESPR Brain Section. These roles have important international developmental and service elements. In research terms, centralising neuroprotective services should not only enhance clinical outcome, but also allow academic study in detail utilising the state-of-the-art facilities we have at UCH. We are also supporting the adaptation and introduction of developed world technologies, such as neonatal life support (Mark Sellwood) and intentional hypothermia in sub-Saharan Africa and India (Nikki Robertson and Sudhin Thayyil). We are working in partnership with local investigators to try and translate some of the advances improving neonatal mortality and morbidity elsewhere to places where this remains a huge issue. FUTURE DEVELOPMENTS Clinical Capacity The report of the Neonatal Taskforce will recommend further centralisation of intensive care for extremely preterm and sick newborn babies. This has major capacity issues for the UCH Neonatal Service, which is already working at full capacity. Careful collaboration with commissioners, primary care and partner units within the network is critical to solving these problems and will need to involve good fiscal planning. Developing our Neonatal Neurology Service We intend to develop the service based around the neuro intensive care cots. We would seek a part-time consultant to lead and facilitate the service and give us critical mass to do so. Such development is dependent upon adequate capacity as above. Goals of this service would include providing a clinical investigative and diagnostic service, running of clinical trials, identification of biomarkers for later impairments and it would be a joint academic and NHS development. Developing the microenvironment for the baby Clinical practice will change as we become more facilitative and engage the baby more as an individual. We have embraced the NIDCAP model to achieve this and have funded training for three medical and nursing menbers of staff in addition to the one post we have as a trainer. In the new EGA environment it is easier to develop such practices. Organisational Surgery Transfer of sick small babies for neonatal surgery is not an ideal practice. Neonatal surgery was previously carried out at UCH but this is a very low volume service and maintaining anaesthetic cover proved difficult leading to centralisation at GOSH. We wish to repatriate this activity if at all possible, as the care afforded babies requiring emergency surgery would be enhanced by on site care. Experience for the neonatal staff would also be enhanced, both for medical training purposes and nursing. Combining with paediatric services, we may be able to find a suitable solution, and we are aware of support from both surgeons and paediatric colleagues for this. Administrative issues The lack of combined office space and separation of academic from NHS colleagues leads to fragmentation of all teamwork. Furthermore, there is little resource available for NHS colleagues who wish to undertake academic activity and the lack of critical proximity threatens the potential advances. Little academic space is available in the unit, making support of academic activity difficult. We need to identify space to achieve appropriate research activity. Nursing developments Enhanced nursing and midwifery roles are essential if the service is to survive. Enhanced responsibility encourages retention. Goals for the Neonatal Service are as follows. • Nurse-led special care • Advance neonatal nurse practitioner (ANNP) support for each shift to provide continuity and training opportunities for inexperienced medical trainees • Midwifery-led examination of the newborn • Achievement of Baby-friendly Status (WHO) Medical staffing The specialist nature of neonatal intensive care and increasing inexperience of trainees means that we do have to look at alternative models of medical care. Devolving traditional areas to nursing is a limited solution in light of nursing recruitment difficulties. Sub- or junior consultant grade development is being piloted at present at Manchester Strategic Health Authority (SHA) and is an area we will need to evaluate. We believe we have the talent and capacity to remain one of the UK’s leading neonatal services, providing leadership in professional and research activity and developing a model service over the next five years. 25 NEONATAL MEDICINE – clinical NEONATAL MEDICINE – clinical UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review NEONATAL MEDICINE – RESEARCH UCL has been at the forefront of perinatal brain research for over 30 years. In the late 1970s the team at University College Hospital (UCH) first reported outcomes following ultrasound examination of the brain in the preterm baby, pioneering a series of highly focused outcome studies based upon correlation with recognised patterns of ultrasound appearances, defining the risk of disability associated with specific findings (Stuart, Arch Dis Child, 1983). This focus on the preterm then widened to include the term asphyxiated infant. In 1982 UCL clinicians and physicists acquired phosphorus-31 magnetic resonance (MR) spectra from a newborn infant, the first ever from a human brain (Cady, Lancet, 1983; Hope, Lancet, 1984). These landmark studies contributed towards identification of the great prognostic capability of magnetic resonance spectroscopy (MRS) (Azzopardi, Pediatr Res, 1989; Penrice, Pediatr Research, 1996), the concept of a window following a hypoxic-ischaemic insult, during which cerebral energetics are preserved and therapy may be possible. This led directly to the development of hypothermic neuroprotection for the newborn. Today therapeutic hypothermia is being introduced into clinical practice and is an excellent example of laboratory-to-bedside translational research. Our aims are currently focused around the following. Medical Physics, UCL: Professor Roger Ordidge • The study of hypothermic neuroprotection and other novel neuroprotective agents that act additively with cooling in term encephalopathy. Department of Statistical Science, UCL: Dr Rumana Omar • Application of neonatal neuroprotection in low and mid resource settings, ensuring rigorous evidence base and safety. • Automated EEG detection of seizures. Research Areas Research into perinatal brain injury and development, in particular using MR biomarkers, has continued to thrive at UCL. Currently the research spans two main areas: • in vivo models of neuroprotection (pre-clinical piglet and rodent models) • clinical studies of the term and preterm infant, both mechanistic studies and clinical trials. The application of MR imaging (MRI), MRS, electroencephalography (EEG) and near infrared spectroscopy (NIRS) is common to both research areas, as per diagram below. Preclinical focus Clinical Focus Xenon and hypothermia neuroprotection Psychological outcome Defining optimal temperature for neuroprotection in brain injury Image analysis and correlates Physiological responses to pain Role of inflammation RCT into preterm delivery, fetal growth restriction, SaO2 targets etc. Melatonin and hypothermia neuroprotection Piglet Rodent MRI MRS EEG NIRS Preterm brain and development Term hypoxic-ischemic encephalopathy and neuroprotection Preconditioning for endogenous neuroprotection Inhaled Xenon trial Pre-clinical model of seizures Automated seizure detection Cooling in low resource settings Non-invasive autopsy Two main areas of neonatal research with projects and common techniques Academic Leadership Research lead for Neonatal Medicine is Dr Nikki Robertson, who is a Reader in an NHS funded academic post. Since 2003 she has built a team of pre-clinical and clinical researchers focused on the perinatal brain. Key group members include Drs Janet Rennie (EEG), Judith Meek (NIRS) and Angela Huertas-Ceballos (Developmental Outcome), each a Consultant Neonatologist with Comprehensive Biomedical Research Centre (CBRC) funding (1 PA) (see Appendix 2.2 for further details of staff members). In 2007 a search was made for a complementary established academic to build further the clinical research profile at UCH. We were fortunate to attract Professor Neil Marlow, who is a senior academic figure and a Fellow of the Academy of Medical Sciences, with an international reputation for outcome studies in perinatal medicine, including large cohort studies and focused explanatory neuropsychological studies, and wide collaboration in multicentre randomised trials. He commenced in post in September 2008. He also assumes the role of Deputy Director of the Institute for Women’s Health, working closely with Nikki Robertson as the Research Lead. 26 Academic Neonatal Medicine was awarded a Walport Lecturer in 2007, Dr Giles Kendall, and two Academic Clinical Fellow posts in 2007-08. Current research team also includes one Lecturer in psychology, one Senior Research Fellow, two Research Fellows, one Neuro-imaging Fellow, as well as a range of PhD, MSc and other categories of students. The preclinical team comprises one Postdoctoral Researcher and MR Laboratory Manager, Dr Stuart Faulkner, and two neonatologists, Drs Takenori Kato and Dorottya Kelen, who are funded by external grants. These members of staff are responsible for maintaining 24-hour intensive care for the model during experiments. The group has produced a substantial number of high impact clinical and research publications and secured significant external research funding. In addition to the staff listed above, close collaboration exists with Professors Donald Peebles and Gennadij Raivich in the Perinatal Neuroscience Research Group in Maternal and Fetal Medicine, as well as with a range of groups within UCL and beyond, as specified in the section below. STRATEGY, AIMS AND OBJECTIVES A critical body of expertise in the evaluation of neonatal brain development exists in a range of pre-clinical and clinical settings at UCL and UCH. Against the background of a longstanding culture of research and enquiry and large research programmes, the neonatal service fosters an ethos of collaboration and facilitation for research, supporting multicentre trials and facilitating research with external groups from the Institute of Child Health (ICH) and other areas in UCL. All India Institute of Medical Sciences: Dr Vinod Paul Makerere University Medical School: Dr Margaret Nakakeeto • Understanding of the relationship between preterm MRI markers and outcomes. 2. Understanding neurocognitive outcomes for preterm infants • Investigating underlying psychometric deficits in relationship to prematurity. To determine patterns of brain injury using quantitative MRI in the developing preterm brain and long-term consequences of these patterns of injury. • Developing a rational analgesic strategy in preterm babies. • Evaluating the MRI as a postmortem tool. OVERVIEW Department of Biological and Environmental Sciences, University of Helsinki: Dr Sampsa Vanhalato and Professor Kai Kaila • Supporting outcome evaluations as part of multicentre randomised trials of perinatal interventions. To study the interactions between environment, genes and outcomes in extremely and moderately preterm children. To relate structure with function in the preterm brain and relate these changes to perinatal risk factors. Specific objectives To understand the cortical processing of pain in preterm infants and its neurological consequences. 1. Neuroprotection of term neonatal hypoxic-ischaemic encephalopathy To measure the effects of analgesia and its potential for neuroprotection. To optimise hypothermic and pharmacological neuroprotection of the newborn using our large animal pre-clinical model, currently evaluating xenon neuroprotection and optimal temperature. Collaborations include To translate important advances observed in pre-clinical studies to the clinical setting as quickly as possible. To develop a closed-circuit neonatal ventilator delivering inhaled xenon to babies for neuroprotection. To develop robust MR biomarkers of outcome in term brain injury. ICH: Professors Faraneh Varda-Khadem and David Gadian, and Dr Michelle De Haan UCL Centre for Medical Image Computing: Professor David Hawkes Department of Anatomy and Developmental Biology, UCL: Professor Maria Fitzgerald To develop automated seizure detection algorithms. University of Nottingham: Dr Nicola Pitchford and Professors Penny Gowland and Tomas Paus To evaluate the use of hypothermia in low resource settings, such as in Uganda, Malawi and India. University of Warwick: Professor Dieter Wolke NPEU, University of Oxford: Professor Peter Brocklehurst Collaborations include Institute of Neurology (IoN), UCL: Professors Xavier Golay, Tarek Yousry and Francesco Scaravilli (retired) Karolinska Institute, Sweden: Professors Hugo Lagercrantz and Lars Olsen University of Edinburgh: Professor Jane Norman Queen Mary, University of London (QMUL): Professor Kate Costeloe University of Leicester: Professors David Field and Elizabeth Draper Institute of Child Health, UCL: Professor Anthony Costello London School of Hygiene and Tropical Medicine: Professor Diana Elbourne Imperial College London: Professor David Edwards and Drs Denis Azzopardi and Frances Cowan National Perinatal Epidemiology Unit (NPEU), University of Oxford: Dr Jennifer Kurinczuk Industry: Air Products plc, SLE ltd, Climator Sweden AB University College Cork: Dr Geraldine Boylan 3. The role of postmortem MRI of the fetus, newborn and children To compare the accuracy of whole body postmortem MR and computed tomography (CT) imaging with those techniques conventional in perinatal and childhood autopsy. To study normal and abnormal fetal brain and heart development using high field MRI at 9.4 T. To develop MR detectable markers of hypoxic brain injury in a postmortem setting. Centre for Biomedical Imaging (CABI), UCL: Dr Mark Lythgoe 27 NEONATAL MEDICINE – reSEaRCH NEONATAL MEDICINE – reSEaRCH UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review Collaborations include Clinical MR studies ICH: Drs Andrew Taylor, Neil Sebire, Tom Jacques and Angie Wade We currently use a clinical 1.5T MR scanner on which we have installed MRS. A 3 T MR scanner will be installed at UCH in 200910, jointly funded by CRBC and UCLH NHS Trust. Heart Hospital, UCLH: Drs Perry Elliot and Petros Syrris Department of Epidemiology and Public Health, UCL: Professor Stephen Morris University of Sheffield: Drs Elspeth Whitby and Marta Cohen QMUL: Professor Susan Dilly John Radcliffe Hospital, Oxford: Dr Waney Squire University of Sydney: Drs Johan Duflou and Raj Puranik 4. To develop and determine childhood outcomes for perinatal clinical trials To design and run appropriate clinical trials To support national and international multicentre trials Clinical Studies Space Neonatal Unit Within the new EGA Wing Neonatal Unit we have identified three cots for neurointensive care. EEG telemetry is currently being installed with a server off site (Level 3). Together with the cooling apparatus and the new recyclable gas ventilators in development, these will form a dedicated service area to focus neurological investigation and treatment in a unique venture. No academic laboratory space is provided within the neonatal unit envelope. NPEU, University of Oxford: Professor Peter Brocklehurst University of Edinburgh: Professor Jane Norman Office accommodation Imperial College London: Dr Denis Azzopardi and Professors David Edwards and Neena Modi We are housed in Chenies Mews, which is substandard accommodation (see Meternal and Fetal Medicine – Research for further description and potential for change). University of Nottingham: Professor Cris Glazebrook International collaborators: Ikaria, Inc, Drs Lisa Askie, Martin Offringa, Fillip Cools and Professor William Tarnow-Mordi RESOURCES Space and equipment Pre-clinical model Following closure of the old EGA Hospital in January 2009 preclinical studies were moved to the Institute of Neurology in a new collaboration with Professors Tarek Yousry and Xavier Golay. A new 9.4T large-bore MR system has recently been installed and the IoN have allowed us to temporarily use the laboratory and office space in order to complete our funded studies, until an alternative is found. We hope that longer-term collaborative links and common funding will occur. Collaborations with IoN and National Hospital MR physicists are likely to improve our MRI protocols. Institue of Neurology in Queen Square 28 The pre-clinical rodent model has been used successfully to evaluate the interaction between systemic inflammatory responses and hypoxia ischaemia (Giles Kendall in collaboration with Professors Peebles and Raivich). This has led to the identification of the TNF family of cytokines as critical mediators in the sensitisation of the neonatal brain to subsequent hypoxia ischaemia. Additionally, Giles Kendall has studied the changes in brain pH during and after a HI insult. These studies have led to the assessment of potential novel neuroprotective strategies. Outcome evaluation clinical research evaluations take place in the setting of the routine neonatal follow-up clinic (now sited in the ground floor outpatients of the new EGA wing). Collaboration with the Institute of Child Health gives access to the neuro-psychological suite at the Wolfson centre (Professor Khadem and Dr de Haan). Current collaborations include Professor Francesco Scaravilli (IoN) collaborates closely with the group and supervises the morphology and immunohistochemistry part of the work. PERFORMANCE AND MEASUREMENT OF QUALITY OF ALL ACTIVITY 1. Neuroprotection in term hypoxic-eschaemic encephalopathy Pre-clinical studies Over the past five years Nikki Robertson has utilised and developed the existing piglet model based around a new portfolio of studies in close collaboration with Ernest Cady and MR Physics. In particular the group has characterised the timing and response of this model to defined hypoxic ischaemic insults and are evaluating the effect different degrees of hypothermia. Over the past two years we have characterised the additional neuroprotection conferred by xenon gas inhalation in combination with hypothermia as rescue treatment as a prelude to an already funded clinical trial to commence in the Autumn as a collaborative venture with Imperial College London (MRC). With the support of a private donation, Nikki Robertson is developing a closed circuit xenon neonatal ventilator with the close collaboration of Air Products plc, SLE Ltd, UCL and Imperial College. Experimental studies remain on target despite the disruption of a laboratory move in January 2009. Nikki Robertson’s group now utilises the new IoN 9.4T MR research facility with adjacent space and equipment for animal preparation and care and has developed a modified model using intermittent MR observations in addition to other multimodal neuro-monitoring (NIRS, EEG). The primary outcome measures for these studies of neuroprotection are quantitative MR measures (bridging biomarkers) and brain histopathology and immunohistochemistry. Clinical studies The clinical MR service runs with the support of Giles Kendall and the neuroimaging fellow. We currently use the UCH 1.5T MR scanner and have an allocated ½ day of scanning time. Clinical MRI reporting is by Dr Roxanna Gunny (Pediatric Neuroradiologist). Our main interest is in quantitative MRI (brain-water T2 relaxometry and diffusion) and MRS. Since 2005, term encephalopathic infants who have had quantitative clinical MRI are currently under follow-up. Clinical service and academic development The equipment and space for the dedicated neuro-intensive care cots are in place. EEG telemetry is in place and remote server connection is being made (Jannet Rennie). We have appointed a dedicated EEG technician and are participating in an automated seizure detection study in collaboration with University College Cork (Wellcome Trust). Clinical reporting of EEG is through UCH Department of Neurophysiology and Dr Ronit Pressler (ICH) is supporting the research aspects of neurophysiology. Global Health The feasibility pilot RCT of therapeutic hypothermia led by Nikki Robertson in Uganda has drawn attention to the facts that NE is 10-20 times more common in low resource settings than in the UK and that we cannot directly translate results from the developed world to low resource settings (Lancet, 2008). Nikki Robertson continues to work closely with the Ugandan colleagues and Drs Frances Cowan and Nikki Robertson will visit Uganda in May 2009 to follow up infants entered in this study. Plans for a collaboration with Indian colleagues were formalised with Sudhin Thayyil during a visit in April 2009, with feasibility studies starting in May 2009 at the All India Institute of Medical Science and Calicut Medical College, Kerala. 2. Understanding neurocognitive outcomes for preterm infants Longitudinal study of outcome following preterm birth Professor John Wyatt continues a close collaboration with the Institute of Psychiatry in the adult evaluation of very preterm survivors. This is a productive partnership continuing the work of the late Dr Ann Stewart. Since 2005, Nikki Robertson has led the recruitment of a cohort of approaching 100 very preterm children who have had scans at term-equivalent age with T2 relaxometry (Cornelia Hagman) and other quantitative MR measures; we are currently acquiring follow-up information (Angela Huertas-Ceballos, Neil Marlow and Sam Johnson). The recent arrival of Neil Marlow at UCL in September 2008 has strengthened our portfolio of neurodevelopmental outcome studies. Professor Marlow is conducting a range of studies, which are transferring their focus to UCL, including the internationally renowned EPICure studies of outcome following extremely preterm birth (NEJM 2000, 2005), with papers in the top decile of ISI Web of Science citations. EPICure has recently been recognised by the MRC as having Programme status and will come up for renewal in 2011. The team based at UCH has provided essential original studies in this area and the EPICure study is an internationally renowned study in this area which has underpinned national guidance (BAPM 2009) and major national reports (Nuffield Council on Bioethics 2007; Parliamentary Science and Technology Committee report 2008) and thereby influences local and national policy in terms of clinical practice and organisation of care. Professor Marlow further collaborates with a team at the University of Leicester in the NIHR funded LAMB study – a cohort investigation of outcomes following moderately preterm birth. Other cohorts Neil Marlow is a PI on the National Birthplace Study – a SDO and DH funded evaluation of the safety of different places of birth such as home birth and midwifery led units. Investigating outcomes for preterm children Detailed studies of psychological development following very preterm birth are critical to understanding the pathways of aberrant or delayed development for which interventions have been designed to ameliorate the developmental disadvantage of preterm birth. Trials of postnatal intervention are ongoing and new areas of targeting under development. Application of neurophysiologic measurements of cortical processing will be related to outcome and used to further develop brain-orientated intensive care. We have established collaborations with Professor Khadem and Dr de Hann (ICH), who are investigating in particular the development of hippocampal function in relation to prematurity, and with Prof Janet Stocks in investigating respiratory outcomes as part of the EPICure 2 study. Neil Marlow has studies of middle childhood outcome in relation to MRI evaluation of brain 29 NEONATAL MEDICINE – reSEaRCH NEONATAL MEDICINE – reSEaRCH UCL EGA IfWH 1st Quinquennial Review development still ongoing in collaborations at Nottingham. Neil Marlow and Dr Sam Johnson are piloting new investigations of neuro-psychological development in childhood in relation to fetal growth restriction and MRI measures of brain development. With Dr Johnson he will continue to develop these areas in the new setting of UCL in collaboration with the fetal medicine department and with Neuoropsychology (ICH). These studies complement Professor Peebles’ studies into inflammatory markers and bacterial 16S-DNA detection, which will form the basis for a new set of cohort studies evaluating the basis of inflammatory influences in Brain development. Pain Physiology Judith Meek has an established research profile with NIRS and close collaboration with Professor Maria Fitzgerald in the investigation of pain physiology. Recent research includes spatial resolution of spectroscopy signals, and the use of NIRS in functional and optical imaging investigations. More recent investigations include the use of NIRS and single shot evoked potentials in assessing cortical responses to pain in preterm babies as part of a large MRC-funded project. 3. The role of MRI in perinatal and childhood post-mortem Dr Sudhin Thayyil and Nikki Robertson are pursuing studies of postmortem MR microscopy work. Over 400 cases have been studied so far and we are confident of completing the 600 cases stipulated by the DOH. In a tangential study, 9.4 T MR microscopy will be used to study whole body (200 micron resolution) and fixed brain (basal ganglia, cortex and water shed areas) and whole heart (18 - 25 microns resolution). 4. Trials Neil Marlow has wide experience in running and outcome evaluation of randomised trials for example developmental interventions (APIP, PIP) and of High Frequency Ventilation (UKOS: NEJM 2004). Such studies require the determination of longerterm outcomes to detect effects or persistence of effects and he has acquired significant expertise in these areas. Recent projects include 7-year outcomes for the ORACLE Children’s Study (MRC with University of Leicester: Lancet 2008 – two papers), teenage outcomes of negative extra-thoracic pressure trials (Neil Marlow PI: Lancet 2006), total body hypothermia (TOBY; MRC with Imperial College/NPEU: revision submitted to NEJM), delivery timing in fetal growth restriction (Neil Marlow Co-CI; MRC GRIT Outcome Study). In addition Professor Marlow and Dr Johnson provide training and QA for outcome evaluations for a wide number of trials. The close collaboration with the NPEU has been particularly fruitful. Current RCT evaluations are undertaken with a wide range of collaborators including: the NPEU (BOOST-II UK (Neil Marlow PI; CI: Brocklehurst), the TOBY Follow up study (Neil Marlow PI, CI: Azzopardi Imperial College), the TOBY register (lead Azzopardi Imperial College), PROGRAMS (Neil Marlow PI, CI: Modi Imperial College)), the University of Edinburgh (OPPTIMUM Neil Marlow PI, CI Norman), 30 UCL EGA IfWH 1st Quinquennial Review Markers of academic esteem Clinical 3T MR system Nicola Robertson – Honorary Secretary Neonatal Society until 2009, Lead for Brain and Development Section, European Society for Pediatric Research. The installation of a multinuclear 3T MR system at UCH is critical for the continuation of world-class neonatal MR research at UCL. Over the last 2 years, the working group has made progress obtaining CBRC funding for 50% of the project and is awaiting a decision on UCLH support for the remainder. Space NeoPROM (first neonatal prospective IPM of oxygen saturation target trials in USA, UK, Canada, Australia and New Zealand (CI Lisa Askie, Sydney). Neil Marlow – FMedSci, NIHR senior investigator, Chair Neonatal Taskforce WG, Past President BAPM, President ESPR, President IPRF, Honorary Life Friend BLISS, Chair of organising committee for Perinatal Medicine 2008. AREAS OF EXCELLENCE Janet Rennie - Honorary FRCOG, Chair of NICE guideline development committee on neonatal jaundice. The University of Cambridge/AMS Amsterdam (TRUFFLE Neil Marlow PI, CI: Lees/Wolf)) Ikaris (industry-funded EUNO trial, Neil Marlow Consultancy) University of Sydney (Australian Placental Transfusion Trial, Neil Marlow International CI) PreVilig (an individual patient meta-analysis (IPM) of High Frequency Ventilation Trials (CI Martin Offringa (Antwerp)/Lisa Askie (Sydney)) Peer reviewed journal publications Since 2004 > 100 publications from the pre-clinical studies, clinical brain research and neurodevelopmental follow-up studies (of which 3 Lancet, 2 New England Journal of Medicine, 2 Annals of Neurology, 1 Brain and 1 Radiology). Please see the Publications Booklet for the full list and end of Neonatal Medicine – Research section for details of the key 10 publications. Research funding More than £2 million has been awarded in grants related to preclinical and clinical brain research at UCL (Nikki Robertson: PI). Professor Marlow brings a substantial number of individual (>£3.5 million) and collaborative grants related to neurodevelopmental outcomes. Judith Meek is a co-applicant on an £800,000 MRC grant evaluating pain in infancy and a further £75,000 in completed projects. Janet Rennie is a co-applicant on a large Welcome Trust grant (£580,000) shared with University College Cork (please see Appendix 2.1 for details of all grants). Books Roberton’s Textbook of Neonatology, ed. Rennie JM Elsevier 2005 Neonatal Cerebral Investigation, ed. Rennie JM, Hagmann C, Robertson NJ. Cambridge University Press 2008 A recent review concluded: “This is a wonderful book… reflecting the academic experience of senior neonatologists. I can think of no comparable book in the U.S. While Volpe’s Neurology of the Newborn… is more comprehensive, it does not equal this book in its clinical approach or the quality of the imaging or figures. Other neuroimaging texts… do not have the clinical depth of this book.” Doody’s Book Review Service. Jay Goldsmith. Teaching: courses We have run neonatal cerebral ultrasound courses annually until 2007. This was restructured and run in 2008 as Neonatal Cerebral Investigation. The course was over-subscribed and rated as excellent and will run annually. Ernest Cady: FInstP, past president European Society for Magnetic Resonance in Neuropediatrics, Health Professions Council Partner. CHALLENGES We require space adjacent to the EGA neonatal unit to facilitate neonatal neuro-assessment using developmental habituation protocols and space yet to be identified within the Institute suitable for clinical assessments. These facilities are critical if we are to take forward hypothesis-based outcome research and effectively study the neuropsychological development of the newborn infant and child. The outpatient setting within the NHS is already maximally occupied. Further issues about the quality and availability of office space are addressed under Maternal and Fetal Medicine: Research. IMPACT AND IMPORTANCE Fulfilment of reproductive potential with a normal, healthy baby is the desired outcome for most women and men. We have aligned neonatal medicine with women’s health to encourage a perinatal focus and to acknowledge the importance of the ultimate fulfilment for a woman. Clinical proximity and dependency work hand-in-hand with research practice. Pre-clinical MR system The key problem faced in the last three years has been the uncertainty about the pre-clinical MR system. In 2006, the 15-year old 7T magnet needed essential maintenance to reduce helium boil-off and internal icing; an upgrade to a new Linux based operating system was also required. The repairs and upgrade were achieved, however delay in re-energising the magnet, which was only stabilised at 4.7 T, delayed funded projects by 6 months. We made excellent progress in 2007/8, although in the summer of 2007 the supply of piglets transiently stopped due to foot and mouth disease. In 2007 the lease by UCL of the UCH MR laboratory space in the EGA Hospital terminated; we negotiated an extension until funded research was completed. Due to the forthcoming demolition of the old EGA Hospital we again negotiated a further extension from UCH until December 2008 when the xenon pre-clinical neuroprotection study was completed. The tight deadlines meant that the team had to work very hard to complete all the experiments before the move. We are very fortunate now to have access to the IoN new 9.4T MR system, provisionally for only 2 years, which has necessitated a change in model (see above). Sir William Ramsey, discoverer of xenon and Professor of Inorganic Chemistry at UCL 1887–1913 Dr Faulkner next to prototype xenon ventilator in pre-clinical piglet MR laboratory Asphyxia NE occurs in 0.5 to 4.0 per 1,000 live births and accounts for a substantial proportion of admissions for neonatal intensive care. Following this potentially catastrophic end to pregnancy, 10-15% of cases will die in the neonatal unit and up to 40% will have other significant severe disabilities including cerebral palsy (10-15%) blindness, deafness, global cognitive impairment, or problems with cognition, memory, fine motor skills and behaviour. The financial and human costs to parents, professionals and wider society are enormous, including the cost of litigation. Research into the prevention and treatment of NE is therefore of importance; the introduction of the first effective therapy (hypothermia) for NE is very exciting. 31 NEONATAL MEDICINE – reSEaRCH NEONATAL MEDICINE – reSEaRCH UCL EGA IfWH 1st Quinquennial Review The focus of research in Academic Neonatal Medicine is to address this problems working to understand and enhance the first successful treatment for NE. Rapid recognition and effective treatment of symptoms may be as important and our work on seizure detection and eventually treatment is key to this area. We are well placed to lead in this area having pre-clinical and clinical research, together with our ambition to set aside cots specifically for treating babies with neurological conditions. Preterm birth is a major health problem in the developed world, in particular in the UK where preterm birth is increasing in prevalence. The cost to the public sector has been estimated at ~£3 billion. Although 7.2% of all births are preterm, this group incurs 10.2% of all costs which comprises significant additional cost. In particular the health burdens are greatest in children born below 30 weeks (1% births) in whom the risk of serious disability is very high (up to 40% have learning problems or cerebral palsy). The burden falls not simply on the family or the health service but also on the educational sector as learning difficulties and behavioural problems become more prevalent with age. Finding interventions that may prevent the sequelae of very preterm birth is challenging and has proved difficult to study in terms of developmental support. The current focus on establishing robust biomarkers for these later impairments to shorten the turn around time for studies of neonatal interventions is critical; this is ongoing work we are carrying out. Furthermore, Neil Marlow has led several studies of developmental interventions, which may provide additional targeted benefit for very preterm babies and their families. We also have unique expertise in the neurophysiology of pain and will continue to develop techniques for quantifying cortical responses which will lead to an understanding of the role of pain in adverse neurodevelopmental outcomes of prematurity and thus to methods of minimising its impact. Smaller more pragmatic studies into the use, for example, of Kangaroo Care and other developmental interventions in the neonatal unit will allow us to continue the refine care and thereby outcome. Autopsy has a crucial role following perinatal, childhood and adulthood deaths, but its uptake has declined in recent years following high profile adverse publicity. 32 UCL EGA IfWH 1st Quinquennial Review In ~30% of terminations, autopsy information can change the recurrence risks advised to parents. Advances in early antenatal diagnosis have increased the number of pregnancy terminations in the past decade and perinatal autopsy provides important quality assurance for such programmes. Additional findings, unknown before death, are reported at autopsy in up to 50% of neonatal and paediatric deaths: in 10% of these cases the additional diagnosis could have prevented fatality if known earlier. this may impact future reproductive strategies for couples. Only a few such facilities exist worldwide and there are none in Europe giving the potential for partnership with industry, strengthening UCL translational research and complementing the current CABI equipment. FUTURE DEVELOPMENTS Capacity for large animal research One outstanding issue is the need for space and financial resources to set up a pre-clinical MR laboratory so that the piglet work can continue. In 2008, Nikki Robertson discussed the need for a clinical MR system suitable for pre-clinical research and can see an opportunity for setting this up in collaboration with Professors Tarek Yousry and Xavier Golay (IoN) and Andrew Taylor (cardiovascular research, ICH). We envisage such a system being used to i) develop and test devices used in angiographic interventions and assess their impact (MR); ii) develop devices for use in MR interventions but need to be controlled angiographically; iii) pharmacological neuroprotection in term asphyxial encephalopathy and iv) stem cell repair after hypoxic-ischaemic injury. We would like to set up a hybrid 3 T MR-digital subtraction angiography (DSA) suite that mirrors the Great Ormond Street Hospital and National Hospital facility and is capable of holding large animals. Development of biomarkers relevant to preterm neurological and psychological outcome Our dedicated neuro-cot facility at UCL is the first in the UK; staffing will be the key challenge to overcome to enable cot availability at all times. In parallel with this we wish to further understand the complex causal chain of pre-disposing factors, exposures and events which result in NE with the ultimate translational aim of developing novel preventive or ameliorative strategies. We are collaborating on a new study involving CEMACH (Confidential Enquiry into Maternal and Child Health), Imperial College and the NPEU that will be the first population based study of NE risk factors. This aims to shorten the time to develop new interventions and strategies operative in the antenatal and postnatal environment. The installation of the 3T MR system at UCH will allow the development of prospective serial MR studies to assess brain growth trajectories in preterm infants and outcomes. The collaborative team we have assembled to study these areas is well placed to lead UK research in this area. Extension of hypothermia into less developed clinical settings Non-invasive autopsy and the use of MR in particular are important means of improving the acceptability of postmortem examinations which we are currently evaluating. Randomised trials are the bedrock of evidence-based medicine. We have facilitated many such trials and are working to improve the quality of outcome evaluations. Increasingly as gains from trials become smaller, refining trials and outcomes is key to more rapid turnaround and successful results. We are and will continue to be well placed to work within this area as part of the perinatal community to deliver the best care for our patients. Development of a new clinical model for the provision of neuroprotective therapies for the newborn infant Tesla MR system at Queen Square used in the pre-clinical work Within the setting of multicentre RCTs in Africa and Asia, Nikki Robertson will lead the initiative to establish whether therapeutic hypothermia for moderate to severe NE is safe and effective. These investigations also provide the opportunity to assess factors associated with morbidity and mortality in infants undergoing therapeutic hypothermia and to evaluate appropriate methodology. Nested explanatory studies will study potentially important risk factors such as the presence of chorioamnionitis and/or funisitis, early sepsis determined with both conventional laboratory and molecular methods and genetic variation in candidate genes that encode putative mediators of brain injury associated with altered risk of poor outcome after adverse perinatal events. NIKKI ROBERTSON led the submission of a trial outline to the MRC to study populations in sub-Saharan Africa and together with ST has developed new collaborations through the All India Institute of Medical Sciences (AIIMS) and Calicutt Medical College. Pre-clinical research in the next three to five years will be focused on characterising and developing endogenous neuroprotective strategies such as optimising neuroprotection by ischaemic pre-conditioning in which brief non-lethal ischaemia episodes confer protection against a subsequent period of lethal ischaemia. Dr Robertson’s new collaborators in this area are Professors Derek Yellon and Raymond MacAllister, who have experience of pre-conditioning in myocardial reperfusion injury. Nikki Robertson also aims to use the piglet model to define anticonvulsant drug efficacy and toxicity for neonatal seizures. New collaborators include Dr Geraldin Boylan (University College Cork) and Dr Sampsa Vanhatalo (Helsinki). Further development of the rodent model will facilitate short and long term functional assessment alongside MR evaluation and histological outcome. Using these techniques, this model will be used to explore molecular mechanisms of perinatal brain injury and to evaluate a variety of neuroprotective agents both in isolation and in combination. Identification of specific underlying developmental trajectories and impairments This will facilitate the development of targeted interventions in these areas of executive function; we have ongoing studies, which will identify such functional impairment and experience to develop trials of interventions. Further evaluations of the EPICure cohorts (1995 and 2006) are planned and NM/SJ are co-applicants on a FP7 application to study model of care and its influence on 7 year outcomes across 10 European regions. Neurophysiology The continued pioneering of techniques to measure functional evoked responses in awake infants will further increase our understanding of these trajectories and enable us to develop and test interventions to minimise damage due to the adverse sensory environment of intensive care. Neonatal seizures Current research applications will bring close collaboration in the field of evaluation of neonatal anticonvulsants through a range of pre-clinical and clinical trials (EU FP7 application). Evidence-based medicine We already have expertise and track record in meta-analyses (both individual patient data meta-analyses and diagnostic study analyses). We aim to develop and expand our focus on this important area of research. JMR is leading a current NIHR bid to a call to study antenatal MRI and outcomes in CNS abnormalities. Phase 2 of Less Invasive Autopsy Study The clinical roll-out of our current autopsy work is the next phase (Sudhin Thayyil). This will be a multicentre study evaluating clinical benefits, cost-effectiveness and acceptability of a step wise less invasive autopsy with whole body MR and CT imaging and endoscopic biopsy, in cases where conventional autopsy is refused by parents (NIHR programme grant – registration of intention (ROI) submitted in March 2009). Ugandan doctors performing cranial ultrasound as part of the pilot therapeutic hypothermia project 33 NEONATAL MEDICINE – reSEaRCH NEONATAL MEDICINE – reSEaRCH UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review TEN KEY NEONATAL MEDICINE PUBLICATIONS AT IfWH 2004–09 Kenyon S, Pike K, Jones DR, Brocklehurst P, Marlow N, Salt A, et al. Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year followup of the ORACLE II trial. Lancet 2008;372(9646):1319-27. This long-term follow-up study of children who took part in the ORACLE II trial of antibiotics for preterm labour in the presence of intact membranes found an unexpected increase in children with any functional impairment who were exposed to erythromycin. A number of pathways are suggested; this study adds weight to the argument that we must be vigilant about interfering with systems we poorly understand. Marlow N, Wolke D, Bracewell M, Samara M, Group. ES. Neurologic and developmental disability at six years of age after extremely preterm birth. N Engl J Med 2005;352(1):9-19. This is a unique study describing the increased level of impairment at school age faced by extremely preterm infants born in 1995 compared to standarized norms in the United Kingdom and Ireland. Gluckman PD, Wyatt JS, Azzopardi D, Ballard R, Edwards AD, Ferriero DM, Polin RA, Robertson CM, Thoresen M, Whitelaw A, Gunn AJ. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: Multicentre randomised trial. Lancet. 2005;365(9460):663-70. This was the first large randomized clinical trial of selective head and whole body cooling for neonatal encephalopathy; the data were particularly encouraging in infants with moderately abnormal amplitude integrated EEG abnormalities at randomization. Therapeutic hypothermia (whole body) is now being introduced as standard therapy for term infants with neonatal encephalopathy. Robertson NJ, Nakakeeto M, Hagmann C, Cowan FM, Acolet D, Iwata O, Allen E, Elbourne D, Costello A, Jacobs I. Therapeutic hypothermia for birth asphyxia in low-resource settings: A pilot randomised controlled trial. The Lancet. 208; 372(9641):801-3. This study suggested that therapeutic hypothermia with wholebody cooling, screening, informed consent and randomization are feasible and inexpensive in a special-care baby unit in a low-resource setting. The study also suggested that rigorous randomized trial to determine the safety and efficacy of therapeutic hypothermia in this context are urgently needed so that any benefits of cooling are reached in areas of the world that might need it. Iwata O, Thornton J, Sellwood M, Iwata S, Sakata Y, Noone M, et al. Depth of delayed cooling alters neuroprotection pattern after hypoxia-ischemia. Ann Neurol 2005;58(1):75-87.2000;343(6) (378-84). This study suggested that different temperatures provide different degrees of neuroprotection and that different parts of the brain may respond best to varying levels of cooling. 34 Thayyil S, Robertson N, Scales A, Sebire N, Taylor A. Parental consent for research and sudden infant death. Lancet. 2008;372(9640)(715). Post-mortem research is crucial to understanding cases of sudden, unexpected death in children, nevertheless, following organ retention scandals and subsequent changes to Human Tissue Authority Act, such research had virtually become nonexistant in the UK, due difficulties in obtaining parental consent. In a bid to reverse this trend, we developed the first successful prospective telephone consenting model in the UK, using specialist nurses, and achieved over 90% consent rates for post-mortem research; more importantly newly bereaved parents considered such participation as a highly positive experience. Hagmann C, de Vita E, Bainbridge A, Gunny R, Kapetanakis A, Chong W, Cady EB, Gadian D, Robertson NJ. MRI T2 is an objective measure of cerebral white matter signal abnormality in preterm infants at term equivalent age. Radiology 2009; in press. Robust surrogate biomarkers of outcome are needed to be able to efficiently assess interventions in the preterm infant; this study is a first step toward validating a quantitative biomarker of preterm brain white matter signal abnormality on magnetic resonance imaging. MATERNAL AND FETAL MEDICINE NEONATAL MEDICINE – reSEaRCH UCL EGA IfWH 1st Quinquennial Review Thayyil S, Cleary JO, Sebire NJ, Scott R, Chong WK, Gunny R, Owens C, Olsen O, Offiah A, Parkes HG, Chitty L, Price AN, Yousry T, Robertson NJ, Lythgoe MF, Taylor AM. Less Invasive Autopsy: Initial Experience Using High-field 9.4T. Lancet in press We acquired the first whole body “Virtual Microscopy” images using high field post-mortem MR imaging at 9.4Tesla in human fetuses. This technique would not only provide an accurate method for “Less Invasive Autopsy”, but also may significantly advance our current understanding about fetal malformations, particularly relating to heart and brain. Iwata O, Iwata S, Bainbridge A, De Vita E, Matsuishi T, Cady EB, Robertson NJ. Supra- and sub-baseline phosphocreatine recovery in developing brain after transient hypoxia-ischaemia: Relation to baseline energetics, insult severity and outcome. Brain. 2008;131(8):2220-6. This paper demonstrates that baseline brain energetics may influence tolerance to ensuing transient hypoxia-ischaemia and describes biomarkers of outcome within a few hours of resuscitation. This is an important concept and may have relevance for understanding mechanisms and pathways related preconditioning, which can be detected clinically. Marlow N, Hennessy EM, Bracewell MA, Wolke D. Motor and executive function at 6 years of age after extremely preterm birth. Pediatrics. 2007 Oct; 120(4):793-804. This paper describes the motor and executive function of children born extremely preterm at the age of 6 years. 35 UCL EGA IfWH 1st Quinquennial Review MATERNAL AND FETAL MEDICINE – CLINICAL MATERNAL AND FETAL MEDICINE OVERVIEW The maternity services at UCLH provide high quality, safe, accessible and equitable care to women and their families. The move to our new state-of-the-art accommodation has provided the opportunity to redesign, evaluate and improve the service provided. Current organisational structure Rekha Bajoria Ratna Chatterjee Anna David Debbie Gould Maternity services are led by Susan Sinclair, Divisional Manager, Tim Mould, Clinical Director, Debby Gould, Head of Midwifery, Pranav Pandya, Obstetric Lead, and Sue Beatson, Divisional Senior Nurse (Appendix 3.1). In addition, there is a robust statutory framework for midwifery supervision which acts as an independent monitor of maternity services. STRategy, aims and objectives Joyce Harper Joseph Iskaros Pranav Pandya Melissa Whitten 36 Patrick O’Brien Eric Jauniaux Donald Peebles Gennadij Raivich David Williams Our aim is to be internationally recognised as a centre of clinical and academic excellence in maternity services. We are committed to providing services that are woman-focused and family-centred. This commitment is to both high quality midwife-led services for low risk women and excellence in maternal and fetal medicine for women with known risk factors at booking or those who develop complications in pregnancy. The Health Care Commission (HCC) Audit in 2007 highlighted concerns about maternity care in London. In recent years London’s maternity services have experienced a rising birth rate, higher rates of multiple births, more obese women, an increase in social and ethnic diversity, leading to a more complex case mix and an increase in the number of Caesarean section (CS). In addition, stillbirth and perinatal mortality rates were above the national average. In response to this report and national targets set by the Department of Health (DH), we have identified key objectives to ensure high quality midwifeled services and excellence in maternal and fetal medicine for the challenging case mix of women we now care for. UCLH is committed to providing good clinical and psychological outcomes for the woman and baby and seeks to achieve this by the following. Leadership and communication We have created a leadership structure through the Quality Project that is unambiguous, with clear reporting lines to ensure safety. The Quality Project was a venture supported by McKinsey, a management consultancy firm, in order to review maternity services following publication of the HCC report. Various areas of the maternity service were then reviewed and processes put in place to improve the quality of care and the experience of our patients and staff. In addition we have established the maternity leads group to ensure the dissemination of a single vision for maternity services. Facilitating direct access to services The evidence suggests that early access to maternity services can improve outcome. We will continue to promote early booking at 8 to 10 weeks gestation, which will ensure all women have access to screening services, if they wish. However, one of the challenges facing us is that the most vulnerable and excluded families in our society often access services late or lose contact. We are committed to improving the health and well-being of these families and are linking in with community projects, such as Sure Start, to develop strategies that will enable us to identify these women and overcome barriers to access. Providing individualised and flexible service We have developed a service that is sensitive and responsive to women’s needs. This has been achieved by the co-location of maternity services, extended hours of service and service redesign to support multidisciplinary working. For example, the preterm birth clinic provides obstetric, midwifery and ultrasound expertise in a single appointment within the Maternal Fetal Assessment Unit to minimise number of appointments and maximise specialist input. This is integral to our philosophy of care in maternity services. 37 MATERNAL AND FETAL MEDICINE – clinical MATERNAL AND FETAL MEDICINE UCL EGA IfWH 1st Quinquennial Review Facilitating normal birth – home, birth centre or labour ward Increasing continuity of care Continuity of care will be improved by the introduction of team midwifery. It is anticipated that by June 2009 all women choosing UCLH will be cared for by a midwifery team. Advocating choice We will ensure that all women are active partners in their care through the provision of choice. This will include choice in how to access services, place of birth, analgesia in labour, including use of immersion in water and choice of postnatal care. Reducing maternal and perinatal mortality and morbidity High risk obstetric services at UCLH have pioneered the development of fetal and maternal medicine at a local, national and international level for many years. Today we remain at the forefront of clinical and academic excellence within this specialty and our large multidisciplinary team provides a comprehensive and integrated clinical service. We offer rapid access to multidisciplinary expertise when a pregnancy is identified to be at increased risk. For example, a woman with a fetus thought to have congenital heart disease will be assessed and counselled in our combined cardiology clinic. In addition, we are improving pregnancy outcome by continuing to develop and implement advances in maternal and fetal medicine, for example, non-invasive prenatal diagnosis and new treatments for medical disorders in pregnancy. Working in partnership We are working in partnership with the other maternity units in North Central London to ensure we meet the strategy for maternity care outlined in Maternity Matters (DOH, 2007). This will allow supportive working that promotes safety, strategic working and academic research within all of the units, which will mean that the following benefits may be realised: • Potential to continue to improve outcome for women and babies across NCL. • Potential to engage in large scale clinical research. • Potential to work together to ensure that stability is maintained in each unit. 38 UCL EGA IfWH 1st Quinquennial Review Resources Facilities and infrastructure The EGA Wing at University London Hospital is a new, purpose-built, £70 million maternity and gynaecology building, which opened in November 2008. The new facilities have provided a unique opportunity for the co-location of essential maternity services. Level 1 The Integrated Antenatal Service comprises of Antenatal Clinic, Fetal Medicine Unit, Maternal Fetal Assessment Unit and Ultrasound Screening Unit. This is an innovative service that offers all women a fully comprehensive package of antenatal screening and care. Level 2 The Labour and Delivery Unit is a modern and spacious area for intrapartum care. It comprises of twelve delivery suites, two dedicated state-of-the-art operating theatres, a four-bedded Additional Care Unit. The adjoining neonatal unit contains 17 intensive therapy cots and 15 special care cots. Level 3 The Bloomsbury Birth Centre is a midwifeled unit providing a home-from-home environment for low risk women. It features two birthing pools and six spacious en-suite rooms that are fully equipped for active birth. Inpatient maternity services are co-located with modern facilities for 39 inpatients. Financial The annual budget for maternity at UCLH was £14.4 million in 2008 and the service is expected to run within budget this year. In addition we anticipate that our referral base will expand as a result of recent service developments and increase income generated. Recent Service developments include the Integrated Antenatal Service and the introduction of a one-stop clinic for the assessment of risk for Down syndrome. This in contrast to the traditional model, which involves waiting up to seven days for a result. Staff There has been an active policy to recruit midwives in line with the increasing number of births. At present we are fully established for 4,800 births and continuing our recruitment drive to meet increasing demand. Our midwife-to-birth ratio is currently 1:31 and we are working towards 1:29 in line with recommendations of birth rate and the evidence-based workforce planning tool for maternity services. We currently offer 40 hours per week Consultant labour ward cover and will increase this to 60 hour cover later this year in line with the Royal College of Obstetricians and Gynaecologists (RCOG) recommendations. Senior staffing has also been strengthened and expanded by a number of promotions and appointments in the last two years, including Debbie Gould as Head of Midwifery, Pranav Pandya as Clinical Lead for Obstetrics, Donald Peebles as Professor of Obstetrics, Anna David as Senior Lecturer (new post) and two new consultant posts, Elizabeth Peregrine and Melissa Whitten. In addition, we are currently recruiting a Chair of Midwifery. Equipment Maternity services were privileged to have state-of-the-art equipment purchased as part of the move to the EGA wing. These purchases included top-of-the-range ultrasound machines, K2 CTG monitoring throughout the whole unit, maternity information system, fully equipped Additional Care Unit, and theatres and birthing suites designed for active birth. We have capacity to increase births to 5,200 per annum. Since the move to the EGA Wing demand for care has continued to increase and the option of providing care for more than 6,000 women has been considered. Several options are presently available and these include expansion of the birth centre, increasing inpatient beds, service redesign and implementation to reduce admissions, such as outpatient induction of labour and fetal fibronectin testing. In addition to the above we are developing partnerships with other maternity units in North Central London to manage the increasing demand at UCLH without affecting patient safety and destabilising other trusts. The implementation of the Working Time Directive (WTD) has resulted in a reduction in hours for junior doctors and more consultants are now required to provide maternity care. This has led to the creation of two additional posts in line with increasing activity and this will also enable us to increase labour ward Consultant cover to 60 hours per week. Recommendations are that all units should have one whole time equivalent (WTE) consultant midwife for every 900 low risk women. We currently have two substantive consultant midwives: one for normality, based in the birth centre, and one for Public Health, focusing particularly on mental health and postnatal care. In addition, plans are in place to recruit a further consultant midwife for intrapartum care to promote normality, and a clinical practice facilitator to support the development of students. Performance and Measurement of Quality of All Activity Maternity scorecard The maternity scorecard (Appendix 3.2) has been introduced, which is essentially an assessment tool to identify areas that are performing well and identify weaknesses in the system. It is particularly important on two levels. 1) Most of the objectives within the scorecard are key indices of standards set by the National Service Framework (NSF), RCOG, and Confidential Enquiry into Maternal and Child Health (CEMACH). All are auditable and action plans are made where deficits are apparent. Where any standard falls into the red field, the IfWH Clinical Board is made aware of the problem. A clear action plan is then devised to amend the problem. Currently the high rate of Caesarean sections is being addressed, particularly as the EGA has been selected as an early implementer site for reducing the Caesarean section rate as part of a national initiative to develop ways in which to normalise childbirth. 2) It enables divisionwide tracking of key performance indicators and is reported to clinical governance boards on a monthly basis. Improving safety UCLH achieved Clinical Negligence Scheme for Trusts (CNST) level 2 in 2007 and are working towards achieving level 3. Health Care Commission Review and Quality Project The results of the HCC Audit in 2007 were disappointing for UCLH and London as a whole. At UCLH we were particularly disappointed by the user feedback and have since put considerable effort and investment into addressing the core areas identified. This was achieved via the Quality Project, which enabled various areas of the maternity service to be reviewed and processes put in place to improve the quality of care and the experience of our patients and staff (Appendix 3.3). User satisfaction Patient satisfaction surveys were introduced following the HCC Review and are now embedded in all clinical areas. The results of these are collated and displayed both on the Trust Intranet and in the clinical areas on a weekly basis. The questionnaires are specific to each clinical area and are focused around problematic areas highlighted by the HCC. Significant improvements have been noted since the introduction of these, which have proved to be helpful in providing an early warning system (Appendix 3.4). Staff feedback and satisfaction An annual staff satisfaction survey in Women’s Health is undertaken by the Trust. Last year concerns were raised after staff reported that they had experienced bullying or harassment. The Trust has taken this seriously and commissioned a diversity and equality analysis that will attempt to understand the dynamics within the unit and develop strategies to manage unacceptable behaviour. It is anticipated that this work will also be valuable to other divisions and will be rolled out across the Trust. Improving access to services Communication and access are key to delivering high quality care. A daily telephone audit was introduced following concerns about access to services. It was initially introduced in the Integrated Antenatal Service and is now being rolled out to the whole division. In line with recommendations made by the National Service Framework a pathway for self-referral has been implemented at UCLH. Details are available on the Trust website and women can self-refer via telephone, e-mail or fax. The evidence shows that early booking can improve outcome for woman and baby. In line with National Institute for Health and Clinical Excellence (NICE) recommendations we have implemented booking at 8 to 10 weeks gestation. Fetal Medicine key performance indicators The Integrated Test to screen for Down Syndrome has a 90% detection rate for a false positive rate of 2.5% at UCLH, which exceeds recommendations made by the National Screening Committee in 2007 (75% detection rate for a less than 3% false positive rate). 39 MATERNAL AND FETAL MEDICINE – clinical MATERNAL AND FETAL MEDICINE – clinical UCL EGA IfWH 1st Quinquennial Review practice will reduce the risks of prenatal diagnosis (Appendix 3.6) Reducing complaints and serious untoward incidents The Women’s Health Complaints Scorecard documents formal complaints received on a monthly basis. The number of serious untoward incidents (SUI) and serious adverse incidents (SAI) are reported on a monthly basis to the Umbrella Governance Group and a clear action plan is developed (Appendix 3.2). Reduction of maternal morbidity and mortality Implementation of the obstetric early warning chart, MEOWS – modified early warning system. 40 hour Consultant cover on Labour Ward with additional Consultant for elective Caesarean section list three times per week. UCLH is fully compliant with CEMACH organizational standards for diabetes maternity services. UCLH has a lower preterm delivery rate (22% versus 36% nationally), Emergency CS rate (12% versus 38% nationally) and stillbirth rate (26.8 per 1,000 nationally and 15 per 1,000 at UCLH) in women with diabetes compared to national performance indicators. Educational All staff participate in an annual personal development review and compose a personal development plan with their line manager. In addition to this all midwives are allocated a supervisor of midwives and undergo an annual supervisory review. Junior doctors are assessed by feedback forms at the end of their posts. Clinical skills, such as cardiotocograph (CTG) interpretation and resuscitation are assessed and audited at annual mandatory study days. There is also the interactive K2 CTG training package available online to all staff and an initiative is in place to ensure all staff complete this. 40 AREAS OF EXCELLENCE Midwifery Caseload midwifery was introduced last year, this is an organisational model of care, whereby a midwife is responsible for the planning and execution of midwifery care for an agreed number of women, with that midwife being the primary provider of midwifery care wherever the woman is. In this model midwives’ work centres around women, rather than being attached to particular locations, which enables improved continuity of care and communication through building a relationship of trust. UCLH established a team of six WTE midwives to provide caseload midwifery care to women living within a specified geographical area. 79% of women had a normal vaginal delivery and 13% of these births took place at home, with both of these figures exceeding the national average. Although achieving excellence, UCLH plans to move to ‘team midwifery’ to improve continuity of care for all women as the caseload team can only manage small numbers at present. Team midwifery is a model whereby small teams of midwives aim to provide antenatal, intrapartum and postnatal care for women, supported by core staff on the maternity ward and in the delivery suite and antenatal clinics. This model is based on evidence from trials showing clear advantages for women who receive care from a team of midwives. It is anticipated that this will commence at UCLH in June 2009. In addition to the caseloading team’s achievement, Patient Satisfaction Forms completed by women choosing the Bloomsbury Birth Centre demonstrated a very high level of satisfaction in all key performance indicators. Integrated Antenatal Service UCLH has successfully launched the Integrated Antenatal Service (IAS) in response to the NSF and NICE recommendations for antenatal care. This is an innovative service that offers all women a fully comprehensive package of antenatal screening and care. For example we have established new clinics for the management of preterm birth, prolonged pregnancy and multiple pregnancies. Low risk midwifery and high risk obstetric services work side by side to ensure all women and unborn babies receive a rapid and seamless transition to senior medical or midwifery care, should the need arise. Formal complaints have fallen from approximately three per month to less than one and patient satisfaction with the service has increased. Maternal Medicine Services The maternal medicine services have risen to the challenge of our increasingly complex caseload and many of our experts represent their specialty within national bodies, for example, NICE and CEMACH. Our Diabetes and Endocrine team have secured a joint funded project with CEMACH, which will feed directly into the DH Diabetes in Pregnancy Initiative for England. This will investigate the reasons underlying poor uptake of preconception care by women with diabetes and develop a new postpregnancy follow-up strategy to improve the health of the nation. Furthermore, our Maternal Medicine team have established an exemplary service for women with cardiac disease, the single largest indirect cause of maternal death in the UK. Multidisciplinary team work at UCH in collaboration with the Heart Hospital is aimed to provide safe maternity care in the most appropriate environment. Its effectiveness is demonstrated by the fact that in this very high risk group our mortality and morbidity rates are well below the national average. This standard is maintained across all high risk clinics. The mental health team have introduced the NICE prediction and detection questions at booking and are one of the few maternity units in the UK to have a dedicated perinatal psychiatrist and multidisciplinary team to care for these women. The Fetal Medicine Unit (FMU) continues to be internationally recognised as a centre of clinical and academic excellence. The increasing number of referrals shown below demonstrates our success. We have fulfilled our commitment to providing a service that offers parents holistic care by establishing close links with allied disciplines. These include health professionals from the Neonatal Unit, Great Ormond Street Hospital for Children, Institute of Child Health, Wolfson Institute of Preventative Medicine, North East Regional Genetics Service, as well as referring hospitals. In addition, we have close affiliations with patient support groups, such as Antenatal Results and Choices (ARC) and the Genetic Interest Group (GIG). 700 600 500 400 300 200 100 0 Ma 200 rch 7 2 Ap 007 ril 20 Ma 07 y Ju 2007 ne 20 Ju 07 ly 20 Au 07 g2 Se 007 pt 20 Ja 07 n2 0 Fe 08 b2 Ma 00 rch 8 20 Ap 08 ril 2 Ma 008 y2 Ju 008 ne 2 Ju 008 ly 2 Au 008 g2 Se 008 pt 20 Oc 08 t2 0 No 08 v2 De 008 c2 0 Ja 08 n2 0 Fe 09 b2 00 9 Implementation of non-invasive prenatal diagnosis in routine clinical In addition to the above, external study days are organised by various members of the maternity team. Over the past year these have included Dilemmas in Obstetric Ultrasound, Antenatal Screening Update, Amniocentesis Workshop, Fetal Anomaly Workshop and CTG Interpretation. Fetal Medicine Unit Number of consultations is monitored to inform prenatal counselling (Appendix 3.5). There are multidisciplinary teaching sessions held by each discipline of maternity services on a weekly basis. Fe b Neonatal outcome for surgical correction of structural malformations UCL EGA IfWH 1st Quinquennial Review Month Fetal Medicine Unit monthly activity. 1 February 2007 to 28 February 2009 To secure our place at the forefront of fetal medicine and build on our international reputation we have successfully recruited Professor Kypros Nicolaides, a world leader in the field of academic and clinical fetal medicine. Professor Nicolaides has over 900 publications in peer-reviewed journals and major clinical interests in the areas of screening for Down syndrome, preterm labour and intrauterine growth restriction. He is a pioneer in fetal therapy and will introduce a service for laser ablation in twin-to-twin transfusion syndrome. In addition he will help us to establish a state-of-the-art screening service at UCLH, which will increase the referral base for maternity services. In addition, Professor Nicolaides will link into existing research strengths in the IfWH, developing clinical research projects in a number of areas (see Maternal and Fetal Medicine – Research). Quality Metrics and Aspiring to Excellence project UCLH developed and implemented a maternity scorecard in February 2008 as part of its Quality Project. CHALLENGES The move to Phase 2 was the biggest challenge that maternity services have faced in recent years. Prior to the move there were restraints on funding for the development of the environment and equipment and this had an impact on the delivery of effective maternity care. Planning for Phase 2 was initiated over ten years ago and during this time there have been major changes to the provision of maternity care. In order to accommodate recent advances a large number of senior managers and clinicians worked in multidisciplinary teams to restructure the service. The move allowed for an increase in capacity and a change in location to a state-of-the-art unit. It was therefore essential in planning to ensure that there were sufficient staff and resources to cope with increasing demand and that staff were familiar with the new surroundings and equipment. In preparation for this a large recruitment drive took place and we carried out extensive staff familiarisation. In addition antenatal services were simultaneously subjected to care pathway mapping and service development projects to produce a new model of care fit for the 21st century. Caesarean section rate The Caesarean section rate at UCLH is currently 34%. We are committed to increasing the number of women who successfully have a normal vaginal birth and reducing the number of operative deliveries. We will achieve this by promoting continuity of midwifery care through teams, increasing the number of births in the birthing centre, providing oneto-one care in labour, installing a birthing pool on the delivery suite, encouraging Vaginal Birth after Caesarean (VBAC) and implementing the reducing Caesarean section audit tool. 41 MATERNAL AND FETAL MEDICINE – clinical MATERNAL AND FETAL MEDICINE – clinical UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review An obstacle in achieving this is the increasing demands to manage and deliver high risk pregnancies as a result of patient choice, assisted conception, restructuring of the neonatal network and advances in maternal medicine. The recent establishment of UCLH as part of an Academic Health Science Centre, with Women’s Health as one of the themes, will provide a mechanism for planning maternity service provision across the partnership. Capacity Quality metrics and information system The move to the new hospital has resulted in a significant increase in demand which is greater than the capacity available at present. This will be managed by working in partnership with hospitals within the network and by increasing capacity within the EGA Wing. There is a lack of clear national guidance to develop quality metrics in maternity care, although it is likely that booking within twelve weeks gestation, one-to-one care in established labour, reducing the Caesarean section rate and improving the normal birth rate (defined as spontaneous onset of labour, spontaneous vaginal birth, no epidural, no syntocinon, no episiotomy) will be included. Data collection has been particularly difficult at UCLH because we do not have a Maternity Information System and there is no formal process to collect outcome data. Options to achieve this include expansion of the birth centre, increasing the number of postnatal beds and reducing the number of unnecessary admissions, for example, fetal fibronectin or outpatient induction of labour. UCLH already works as part of a clinical network within North Central London, although this is primarily geared towards neonatal referral patterns (for which UCLH is the tertiary referral unit). However, the maternity aspects of the network are being strengthened by improved dialogue with local units to ensure a strategic use of capacity across the network. The Eclipse Maternity Information System will be introduced later this year and this should allow us to collect relevant data easily in the future and provide outcome data for specialist units, such as Fetal Medicine Unit. Meeting expectations Our final challenge is how to meet the rising expectations of women and their families. At UCLH we are focused on accelerating change and meeting the needs of the woman and her family, for example, outpatient induction of labour and Down syndrome screening. The quality of the service provided for the half a million babies born in England every year and their mothers has a long term impact on the health of the nation. UCLH is a centre of clinical and academic excellence and therefore needs to be driving the delivery of high quality care in maternity. Actual deliveries Reducing maternal mortality Actual number of bookings We want all women at UCLH to be active participants in planning their care and believe that choice and continuity are central to improving pregnancy outcome. Choice begins at referral and ends with postnatal care. We aim to offer all women a choice in how to access maternity services, a choice in the type of antenatal care they receive and a choice in the place of the birth. Furthermore, continuity of care has been shown to significantly improve normal birth rates. This finding was replicated at UCLH when 79% of our case loading team’s women had normal births. It is anticipated that by June 2009 we will be able to offer a team midwifery model of care for all women and provide improved continuity of care. Planned number of deliveries 500 400 300 UCLH has a lower preterm delivery rate, CS rate and stillbirth rate in women with diabetes compared to national performance indications. Our team are leaders in this field and have secured a joint funded project with CEMACH, which will feed directly into the DH Diabetes in Pregnancy Initiative for England. Other leading contributors to maternal and neonatal morbidity and mortality include preterm birth, pre-eclampsia, intrauterine growth restriction, obesity and medical disorders in pregnancy. For women at risk of pregnancy complications from these conditions we offer integrated multidisciplinary clinics that provide senior specialist input from a range of disciplines in one appointment. This has enabled us to not only offer a service that fits around the needs of the women, but also to provide continuity of care, reduce hospital appointments and most importantly improve clinical and psychological outcomes for the woman and baby. Developing new techniques and pathways of care Traditional prenatal diagnosis relies on the use of invasive procedures, such as amniocentesis and chorionic villus sampling (CVS) to obtain genetic material from the pregnancy. These procedures are very accurate, because they involve inserting a fine needle into the womb, but carry a risk of causing a miscarriage. Fetal medicine services at UCLH are committed to making prenatal diagnosis safer for women and their families and have achieved this by the following. • Offering all women the Integrated Test to screen for Down syndrome. We were the first unit in the country to implement the Integrated Test and have achieved a detection rate of 90% for a false positive rate of 2.5%. • Offering non-invasive prenatal diagnosis (NIPD) of fetal sex from 8 weeks gestation for parents with a pregnancy at risk of an X-linked genetic disorder or congenital adrenal hyperplasia. This has been extremely successful and has resulted in a 50% reduction in the number of invasive procedures performed in this population, reducing the number of healthy babies lost as a result of invasive procedures. • Leading the country in establishing a non-interventional study in rhesus (RhD) negative women to determine the baby’s RhD status using NIPD. This will mean that in the future we can identify the 40% of RhD negative women who are carrying a RhD negative fetus and therefore do not require anti-D immunoprophylaxis. This will decrease demand for anti-D, avoid unnecessary exposure to human blood products and save the NHS valuable resources. • Conducting a national project funded by the National Institute for Health Research (NIHR) to evaluate NIPD for other indications. This will include the diagnosis of conditions like cystic fibrosis, thalassaemia and Down syndrome with the ultimate objective of making prenatal diagnosis safer and more accessible In addition, early access to maternity services has been shown to improve clinical and psychological outcomes for the woman and baby. The introduction of the Integrated Antenatal Service has ensured all women have direct access to a midwife from early pregnancy. 200 Providing specialist services for North Central London 100 t2 00 No 8 v2 00 8 De c2 00 Ja 8 n2 00 Fe 9 b2 Ma 009 rch 20 Ap 09 ril 20 0 Ma 9 y2 00 9 Ju ne 20 09 Ju ly 20 0 Au 9 g2 00 9 20 08 Oc 08 pt 20 Se 08 20 Au g 00 8 Ju ly 00 8 e2 Ju n ril Ap Number of bookings and deliveries Ma y2 08 20 08 08 20 20 rch Ma 20 08 Fe b Ja n 7 00 7 00 c2 De t2 Oc No v2 00 7 0 42 Disadvantaged and minority groups have a worse outcome. Maternity services need to address this issue by providing high quality care, such as promoting early access, flexible clinic times, encouraging father’s participation, interagency working and linking with Community services, for example, Sure Start. This is a challenge at UCLH, because 70% of the women booked for confinement live outside of our catchment area. This makes establishing continuity and links with the local community more difficult. In addition to the above we want to increase breastfeeding uptake rates to 90% and increase referral for smoking cessation to 5% by birth, both of which require continuity. IMPACT AND IMPORTANCE Predicted number of deliveries based bookings (assuming from Nov 2008 85% of bookings translate into deliveries in 7 months time) 600 Disadvantaged and minority groups Pre-existing diabetes occurs in 1 in 250 pregnancies in England, Wales and Northern Ireland and the prevalence of both type 1 and type 2 diabetes is increasing. Women with diabetes are at an increased risk of losing a baby or having a baby with a congenital anomaly. Good periconceptual glycaemic control reduces the risk of these adverse outcomes. 43 MATERNAL AND FETAL MEDICINE – clinical MATERNAL AND FETAL MEDICINE – clinical UCL EGA IfWH 1st Quinquennial Review Training national leaders UCLH has successfully trained a number of subspecialists in maternal and fetal medicine who are internationally recognised as leaders in the field, for example, seven current Professors of Fetal Medicine were trained at UCLH. In addition, we have an ongoing commitment to training and are the only centre in the UK to have three recognised posts for subspecialty training in maternal and fetal medicine. In addition to training, senior staff perceive an important part of their contribution to be in shaping and informing national developments in maternity care. Some notable examples are Maggie Blott who is Vice President of the RCOG, and Jo Modder who is Obstetric Lead for the Confidential Enquiry into Maternal and Child Health. UCL EGA IfWH 1st Quinquennial Review FUTURE DEVELOPMENTS Maternity services will be committed to providing effective, personal and safe care to improve the health of the nation. This will involve getting the basics right first time every time and having services that are sensitive and responsive to needs of the woman and her family. In the future we will provide a service that is continuously improving quality of care and will implement measures that allow for regular audit, service user feedback and evaluation in order to achieve this. Partnership between health professionals and organisations will be required to ensure equitable provision of high quality, effective maternity care. These partnerships should extend to universities and industry in order to secure implementation of clinical and academic excellence. The implementation of midwifery teams nationally will improve continuity of care for all women and facilitate an increase in the normal birth rate and a reduction in the Caesarean section rate. Women and their families will have greater confidence in their midwife and see them as an expert in normal pregnancy and birth. This is likely to increase the level of job satisfaction within the profession. Maternity services at UCLH should remain at the forefront of developing and implementing clinically effective innovations. These include: • screening and prevention of preterm birth • screening and treatment for intrauterine growth restriction and pre-eclampsia • expanding clinical applications for Non-invasive Prenatal Diagnosis (NIPD) • evaluating the role of gene therapy • introduction of preconception clinics for maternal disease, which could be developed in collaboration with the Margaret Pyke Centre • introduction of fetal surgery MATERNAL AND FETAL MEDICINE – RESEARCH OVERVIEW Lead – Dr Lyn Chitty The UCL Research Department of Maternal and Fetal Medicine, lead since January 2008 by Professor Donald Peebles, is one of four research departments in the Institute for Women’s Health. Obstetric research has a long established track record at UCL and until recently was under the leadership of Professor Charles Rodeck, who retired in September 2007. Currently research activity is centred on six groups, which encompass many of the major causes of UK maternal and perinatal mortality and morbidity. One reader and two research midwives. Collaborative research involving a much larger multinational group with broad interests in aetiology of congenital abnormality and psychosocial and technical aspects of prenatal diagnosis, with a particular emphasis on the development and clinical implementation of novel methods of non-invasive prenatal diagnosis (PND). Maternal Medicine Research groups Lead – Dr David Williams UCL Centre for Preimplantation Genetic Diagnosis Group consists of one consultant and senior lecturer and two PhD students. They conduct clinical research into the role of angiogenic factors and vascular function in pre-eclampsia. Parallel studies assess the prognostic value of pregnancy outcome in determining later cardiovascular health. Research Lead – Dr Joyce Harper, Clinical Lead – Professor Joy Delhanty The Centre consists of one Emeritus professor, one reader, one non-clinical lecturer, one research nurse and nine PhD students. They provide a clinical preimplantation genetic diagnosis service for patients receiving in vitro fertilisation (IVF), mainly in collaboration with the Assisted Conception Unit (ACU) at UCLH, conduct research into preimplantation genetics and run the MSc and Postgraduate Diploma in Prenatal Genetics and Fetal Medicine. Group activity is included in the Department of Maternal and Fetal Medicine. Donald Peebles is line manager for Joyce Harper and Sioban SenGupta. The laboratories are located in Chenies Mews and Fetal Medicine provides a major input into the MSc, but also in the Reproductive Health Department, which has close research links with ACU. Perinatal Neuroscience Lead – Professor Gennadij Raivich Comprises of two professors, one clinical lecturer, one non-clinical lecturer, two research assistants and two PhD students. This is a multidisciplinary group including basic neuroscience and clinical obstetrics and neonatology. Their aim is to identify mechanisms contributing to inflammation-associated injury to developing brain and devise therapeutic interventions to reduce the incidence of long-term neurodisability in infants born prematurely or following peripartum hypoxia-ischaemia. Placental Development Lead – Professor Eric Jauniaux Group consists of one professor, one lecturer who has just left and two PhD students. The aim is to investigate the molecular mechanisms of early placental development and their role in the pathophysiology of placental-related complications of pregnancy. Perinatal Gene and Cellular Therapy Lead – Dr Anna David Group consists of one professor, one senior lecturer, one research assistant and two PhD students. The research aims are to develop prenatal treatment of severe and life-threatening disorders using gene and cellular therapy and to investigate the efficacy, safety and ethical issues of such treatment. 44 Prenatal Diagnosis Research links and collaborations An important factor that supports this translational research activity is the integrated nature of the relationship between senior academic and clinical staff in obstetrics. Professor Peebles combines his role as Head of the Research Department with a clinical role as Consultant in Maternal and Fetal Medicine, as well as Lead for the Women’s Health Theme within the UCL Biomedical Research Centre. Four research groups were included in the Women’s Health theme in the successful UCL/UCLH Comprehensive Biomedical Research Centre (CBRC) bid in 2007 and the three consultants, David Williams, Donald Peebles and Lyn Chitty, receive funding for translational research from the CRBC. Professor Peebles works closely with the Clinical Lead for Obstetrics to ensure a coherent joint strategy for clinical and academic appointments and identification of clinical and research priorities. These research groups are supported by important links across UCL and nationally, for example, Professor Raivich has a joint appointment with the UCL Department of Anatomy, Dr Lyn Chitty is also a senior lecturer at the Institute of Child Health (ICH), and significant collaborations, enabled by jointly held or submitted grants, exist with ICH, Cardiology, Neuroscience and Health Services Research at UCL, as well as Imperial College and Cambridge University. Translational research Research spans the full spectrum from basic to translational and clinical research, for example, the Neuroscience group investigate the mechanisms that make developing white matter vulnerable to infection and inflammation, using transgenic mouse models. Dr David uses a large animal model, in this case fetal sheep, to investigate the use of viral vector-delivered Vascular Endothelial Growth Factor (VEGF) to improve uterine blood flow in complicated pregnancies. At the more clinical end Dr Chitty leads a national study into the use of non-invasive diagnosis to customise treatment of Rh-negative mothers during pregnancy. 45 MATERNAL AND FETAL MEDICINE – reSEaRCH MATERNAL AND FETAL MEDICINE – clinical UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review RESOURCES • Build core strengths in relevant basic science, and at the same time, in order to achieve critical mass and ensure long-term sustainability of research output, aim to appoint scientists who can link with groups within UCL and IfWH Space • Consider development of research infrastructure and collaborations to improve success rate of clinical research, such as statisticians and health services researchers (HSR) • Maintain core laboratory facilities within Women’s Health, co-located with office space to foster team work and identity Research funding Prenatal Cell and Gene Therapy group comprises clinical academics and scientists working together to treat genetic diseases affecting the fetus Theme management All research group leads meet on a monthly basis at meetings chaired by Professor Peebles. They are appraised annually by the Clinical Lead if they are funded jointly by the Higher Education Funding Council for England (HEFCE) and NHS, or CBC and NHS and by Professor Peebles if HEFCE funded. STRATEGY, AIMS AND OBJECTIVES Aims • to perform research that leads to a demonstrable improvement in maternal and neonatal outcomes of pregnancy • to train and enthuse scientists and clinicians in women’s health at the undergraduate and postgraduate stages, with the longterm aim of building research and clinical capacity in women’s health. • to be identified as the leading centre in Europe for obstetric research on the basis of research excellence, indicated by publications and impact on women’s health Strategy We propose to achieve these ambitious aims using a number of strategies to finance and shape the nature of obstetric research over the next five years. The strategy for the Department is not developed in isolation, but as part of an Institutional strategy, with the IfWH Strategic Planning Board and CBC Theme Management Board (Donald Peebles being a member of both) playing an important role in shaping research and clinical goals. 46 Recruitment strategy Recruitment of individuals of high calibre at both senior and junior levels is essential to build research capacity in the Department. This requires funding and occurs against a national background of shrinking expertise and personnel involved in obstetric research. However, the increasing profile of the IfWH and UCL, as well as enormous strengths in biomedical research at UCL, as indicated by the recent outstanding performance of our returned unit, UoA4, in the recent Research Assessment Exercise (RAE), are positive factors. We have recently recruited Professors Kypros Nicolaides and Neil Marlow to Neonatal Medicine, but also with important benefits for Maternal and Fetal Medicine, both of whom have an international track record for high quality research. Research capacity Obstetrics already has a very significant input to the training of clinical academics in the specialty: two Walport Academic Clinical Fellows (ACF) and one Walport Clinical Lecturer (CL), with another clinical lecturer to be appointed in spring 2009, and an academic Foundation Year entry to do obstetric research. In addition there is input into the Masters programme, both in terms of teaching and providing MSc projects, and 14 current PhD students. We propose to maximise these training opportunities, as well as the calibre of candidates who apply, by ensuring ACFs and CLs apply successfully for Research Training Fellowships and enthusing potential academics through Special Study Module (SSM) in Obstetrics early in their medical career. Research strategy The Department of Maternal and Fetal Medicine at UCL has been, and continues to be, a highly productive research organisation. However, new sources of funding, vacancies arising and UCL/ UCLH initiatives, such as the Comprehensive Biomedical Research Centre and UCL Partners, provide the opportunity to make changes to enhance research productivity and its clinical impact. Guiding principles are oulined below. • To map research activity to areas of clinical excellence and nationally identified priorities, and aim to have each aspect of clinical care underpinned by research • To identify unique aspects and areas where IfWH can develop a niche, supported by strengths elsewhere in the Institute and at UCL, for example, use of polymerase chain reaction (PCR) based methods to identify role of placental bacterial infection in preterm birth and brain injury (work by Professors Peebles and Klein, the latter based at ICH) and use of gene therapy to increase uterine perfusion (Dr David, Cardiovascular Medicine at UCL) In addition, Chenies Mews contains 220 m2 of office space, shared with Neonatal Medicine, as well as a recently refurbished seminar room (Theobald Seminar Room), which seats 50 people and has a large staff room adjacent to it. This useful facility is extensively used for meetings, lectures, audit days, as well as running the MSc course. Financial Departmental expenditure for the last five years is shown in the figure below. The HEFCE component includes salaries, as well as other HEFCE funding for teaching and research. 4.0 HEFCE 3.5 EU Other EU Government Bodies 3.0 £m pa Funding Dr Williams is clinical lead for a Medical Research Council (MRC) funded randomised controlled trial (RCT) into the use of statins to prevent pre-eclampsia, whilst Dr Harper’s group has been the first to provide preimplantation genetic diagnosis for couples affected by a number of genetic disorders. A major challenge for the Department is to increase the amount of grant funding. This is central to ongoing success and is a top priority. In addition, there is an issue of core funding to maintain essential posts. Laboratory equipment would be of enormous benefit. It is hoped that the Institute Charity, Health of Women, combined with recent investment into the establishment of a fundraising initiative will make a contribution along the lines of current Women’s Cancer funding from Eve Appeal. Research is mainly centred around three laboratories (Preimplanatation Genetic Diagnosis, Perinatal Neuroscience and Placentation) in the Department of Obstetrics in Chenies Mews. These occupy approximately 250 m2 and there is additional laboratory and office space on the ground floor, currently occupied by the Perinatal Haemoglobinopathy service, now a part of clinical Haematology and due to move shortly. The laboratories are equipped to provide a full range of immunohistochemical, PCR, molecular biology and cell culture techniques. In addition, the UCL Centre for Preimplantation Genetic Diagnosis provides a clinical diagnostic service and are seeking Clinical Pathology Accreditation (CPA) of their premises. Animal studies are performed in the UCL Biological Services laboratories in the Cruciform Building (full range of housing, theatre and functional testing services for rodent research, with large number transgenic mouse colonies), as well as a long-standing, successful collaboration with the Royal Veterinary College in Camden (chronic experiments in pregnant sheep with implanted telemetric monitoring of maternal and fetal blood flow and pressure). Full use is also made of centralised genomic and proteomic facilities in the IfWH laboratories in the Paul O’Gorman building, confocal and electron microsocopy in UCL and vascular biology facilities in the Department of Cardiology. UK based Charities Research Councils 2.5 2.0 1.5 1.0 0.5 0 2003–4 2004–5 2005–6 2006–7 2007–8 UCL IfWH Obstetrics Funding 2003–2008 47 MATERNAL AND FETAL MEDICINE – reSEaRCH MATERNAL AND FETAL MEDICINE – reSEaRCH UCL EGA IfWH 1st Quinquennial Review Staff For a full list of staff, their roles and funding, see Appendix 4.1. Obstetric research is supported by three professors, two readers and a recently appointed ‘new blood’ senior lecturer Dr David, who is funded by the Department of Health (DH) and was one of only two in the UK awarded this funding in Obstetrics. In addition, there are two HEFCE funded non-clinical lecturers and two clinical lecturers, who are combining 50% research time with 50% subspecialty level clinical training. The senior faculty has been strengthened by recent recruitments and promotion. In the last 18 months Professor Nicolaides has been recruited to a Chair of Fetal Medicine (50% time), having commenced this employment in April 2009. Professor Peebles was recruited internally to head the Department, in addition to Dr David being appointed to a new senior lectureship. Dr Williams, lead of Maternal Medicine Research, is one of a small number of physicians in the UK specialising in obstetric medicine. He was recruited from Imperial College London as an NHS consultant, but with a significant research component (four PAs, CBC funding). A new post for Professor of Nursing or Midwifery has also been recently advertised, for the future postholder to work with Professor Linda Franck in the Centre for Patient Care Research and Innovation (PCRIC) at ICH. In addition, Dr Lyn Chitty holds her main academic contract at ICH (6), but has clinical PAs (3) and some CBC funded research time (1 PA) within UCLH. As her research predominantly relates to fetal medicine, her research group is included in the Department structure. Approximately 15 PhD students and research fellows are employed on external grant funding at any one time. PERFORMANCE AND MEASUREMENT OF QUALITY AND AREAS OF EXCELLENCE The main key performance indicators for research excellence are number and impact of published papers and the grant income generated. These are detailed fully in the Publications booklet and Appendices 1.2 and 4.2. All data are from 2004 onwards. In total, the Departmental return includes 175 original papers, 58 review articles, 45 book chapters and 5 books. Over the same time period Professor Nicolaides, our most recent recruit, has published over 230 papers. Members of the Department have been applicants on successful applications for approximately £9 million. Of this, however, only £2.2 million has been held by the UCL Department, and £330,000 by UCLH R&D. This research activity is summarised below with reference to other important outcomes, such as the number of students achieving higher degrees, and mention of the wider roles played by academic personnel in research, patient care and education locally and nationally. UCL Centre for Preimplantation Genetic Diagnosis Notable research activity This group provides a clinical service, is active in resaerch and has a major role in education. Professor Delhanty (Emeritus Professor of Human Genetics) runs the clinical service providing 48 UCL EGA IfWH 1st Quinquennial Review preimplantation genetic diagnosis for monogenic disorders, patients carrying chromosome abnormalities (for example, known translocations), embryo sexing for X-linked disease, and aneuploidy screening of embryos for patients with infertility. They have been the first to perform preimplantation genetic diagnosis for a number of diseases, including type 1 diabetes mellitus, Crouzon syndrome, Connexin 26 and, most recently, with a great deal of media coverage, BRCA1. In 2008 they counselled 110 couples and managed 36 treatment cycles resulting in 12 pregnancies. Dr Joyce Harper leads the research arm of the group. Ongoing avenues of research include investigating genomic instability in embryos destined to show chaotic mosaicism, use of whole genome amplification techniques in early stage embryos to assess gene expression and a study of DNA checkpoint genes. Joyce Harper has also run an MSc and Postgraduate (PG) Diploma in Prenatal Genetics and Fetal Medicine since 1996. This is an internationally recognised course of huge popularity. As a result a new MSc and PG Diploma in Reproductive Science and Women’s Health has been established, due to start in 2009. Both courses will run together and share four out of eight modules. • Investigating the endogenous repair mechanisms leading to CNS regeneration following a variety of interventions including axotomy, infection and hypoxia-ischaemia • Clinical studies using novel PCR-based techniques to identify and quantify bacteria in membranes and fetal blood, in collaboration with Professor Klein at ICH, to define the role of bacteria in preterm labour, fetal inflammation and long-term neurological outcome Particular areas of success • Experiments led by Donald Peebles were the first to show that even nanograms of bacterial endotoxin injected into the fetal circulation during a gestational ‘window of vulnerability’ led to extensive necrosis within the developing white matter. Exciting recent research has resulted in identification of unusual bacterial species in a large proportion of samples of placental membrane from preterm labours, which was carried out using an optimised PCR technique. This will allow the true role of bacterial infection in preterm brain injury to be defined. Publications There have been 23 peer-reviewed papers over the same time period including journals, such as Neuron, Neuroscience, National Medicine, and Proceedings of the National Academy of Sciences. In addition there are eight review articles and a book. MD and PhD students Five students have obtained higher degrees – three MD and two PhD degrees, and a further four are currently at various stages of preparation. Markers of esteem Donald Peebles is a recent Editor of BJOG, ex-member of the Royal College of Obstetricians and Gynaecologists (RCOG) Scientific Advisory Committee, member of scientific advisory boards of two charities (Wellbeing and SPARKS), member of two RCOG working parties and one national guideline preparation group, member of executive committees of British Association Perinatal Medicine (recently co-wrote a national guideline on management of in utero transfers), Fetal and Neonatal Physiological Society (FNPS) and an external examiner for Nottingham Medical School. Gennadij Raivich is Editor for NeuronGlia-Biology and Cell and Tissue Research. Since 2004 the group has received approximately £110,000 in peer-reviewed grant funding, as well as PhD studentship support amounting to £346,000. • Gennadij Raivich has an international reputation for his research into the role of inflammatory molecules in promoting and inhibiting endogenous CNS repair following various forms of trauma. Of particular note has been his work describing the central role played by C-jun in neuronal regeneration (Neuron, 2004). Publications Grant income Research activity They have published 65 papers and two editions of a widely recognised textbook on preimplantation genetic diagnosis. Donald Peebles and Gennadij Raivich have been principal investigators (PIs) on grants bringing an income of over £1.8 million since 2004. Professor Jauniaux leads this group, which was supported until March 2009 by Shanti Muttukrishna, non-clinical lecturer. The group has two main research streams: Grant funding Placental Development MD and PhD There are currently nine PhD students and five students have been awarded degrees in the last five years. Markers of esteem Dr Harper has a high international profile, having chaired a PGD consortium for the European Society for Human Reproduction and Ethics, as well has having been a member of a number of their committees. She is a current board member of the International Society of Prenatal Diagnosis and led the PGD International Society (PGDIS) Organising Committee until 2005. Perinatal Neuroscience Research activity This multidisciplinary group brings together basic neuroscience and clinical perinatology. Areas of overlap and collaboration with brain research in Neonatal Medicine, led by Nikki Robertson, include a joint interest in the development of neuroprotective strategies and the neurological consequences of perinatal exposure to potentially neurotoxic factors, such as infection, with this work being being led by Professor Marlow. Main areas of research activity are set out below. • Identification of the molecular signals associated with neuronal and glial cell death following hypoxia-ischaemia or infection, using transgenic mice and with the aim of identifying pharmacological interventions to reduce cell loss Examining vessel contractility using an organ bath 49 MATERNAL AND FETAL MEDICINE – reSEaRCH MATERNAL AND FETAL MEDICINE – reSEaRCH UCL EGA IfWH 1st Quinquennial Review • understanding the role of oxygen and endogenous anti-oxidants in early placentation using human tissue, cell culture and animal experiments • identification of biomarkers for early detection of pre-eclampsia. Particular area of contribution Eric Jauniaux has a long-standing and successful collaboration with Professor Burton in Cambridge. Research conducted over the last ten years has had a profound impact on understanding the processes underlying early placentation. In particular he has shown that the placenta pre-12 weeks of gestation has limited expression of anti-oxidants and is particularly vulnerable to excessive blood supply, rather than hypoperfusion, as was originally thought. This concept led to a number of international trials to assess the role of exogenous anti-oxidants to prevent early pregnancy failure and is fundamental to current understanding of conditions such as pre-eclampsia and miscarriage. His publications on this topic have been cited over 1,000 times and are internationally renowned. Publications The group has published 46 papers in the last five years. Those with the highest impact factor (IF) include American Journal of Pathology (5.5), Journal of Clinical Endocrinology and Metabolism (5.5), Fertility and Sterility (3.7) and Human Reproduction Update (7.2). Professor Jauniaux in addition has published eight chapters and review articles and has been a co-editor of two textbooks. Dr Muttukrishna was the first to publish an observation that inhibin and activin are elevated as early as 15 weeks in pregnancies destined to develop pre-eclamptic toxemia (PET). Grant income Eric Jauniaux has been co-applicant on two Wellcome Trust programmes (just over £2 million, although held in Cambridge); other grant funding since 2004 totals £100,000. MD and PhD students Three MD students have completed in the last four years. Markers of esteem Eric Jauniaux was Laureate of the International Prize for Exceptional Achievement in Research in Placentology of the International Placental Federations Association (IPFA) in 2002, and is an editor of Prenatal Diagnosis and Reproductive Biomedicine Online. Perinatal Gene and Cellular Therapy Research activity This is a relatively new group, initiated in 2000 by Professor Rodeck in collaboration with Professor Coutelle (Gene Therapy) at Imperial College London, funded by an MRC programme grant. Anna David was the first PhD student employed on this grant and now leads the group with support from Donald Peebles. The group has three main current areas of research as follows. • the use of Ad.VEGF vectors to improve placental perfusion with the long-term goal of treating severe clinical fetal growth 50 UCL EGA IfWH 1st Quinquennial Review Markers of esteem restriction (in collaboration with Professors Martin and Zachary in Cardiovascular Medicine, UCL) Dr Chitty is a member of the Down Syndrome Screening and Ultrasound Screening groups of the National Screening Committee, a member of the research advisory board of BDF Newlife and co-convenor of an RCOG study group on reproductive genetics. She recently led the SAFE European Consortium and is a frequently invited speaker on this topic around the world. • isolating haemopoietic stem cells (and possibly mesenchymal in the future) from amniotic fluid to correct thalassaemia in utero, first in a mouse model and then possibly in human studies in collaboration with Dr Paolo De Coppi at ICH • correction of monogenic disorders using gene therapy in utero; initial studies have focused on cystic fibrosis and factor IX deficiency in collaboration Drs Waddington and Nathwani, UCL Haematology Maternal Medicine In collaboration with Clinical Pharmacology at UCL and with the Department of Epidemiology at London School of Hygiene and Tropical Medicine (LSHTN), Dr Williams has established two areas of research: Particular areas of success Babies born severely growth-restricted are at increased risk of perinatal death and morbidity and there are currently no effective therapies. This group have developed a novel technique involving injection of an adenoviral vector expressing VEGF into the uterine artery, leading to over expression of VEGF in the uteroplacental circulation and a sustained increase in uterine blood flow in an animal model. Recent grant funding will support research to determine whether this results in accelerated fetal growth. The vector is patented and the research has attracted significant research and financial support from industry (Ark Therapeutics), as well as winning prizes at recent international meetings. • assessing the association between pregnancy outcome, for example, pre-eclampsia and gestational diabetes on women’s future health • establishing the contribution of maternal, paternal and placental factors towards the aetiology of pre-eclampsia Grant income Scanning a fetus in the Fetal Medicine Unit at UCH Grant income Research is funded by a collaborative industrial grant with Ark Therapeutics (£430,000 until 2010), project grant funding from Action Medical Research (£147,000) and two PhD studentships (Dorothy Hodgkin, £90,000 and Taiwanese Government scholarship, £66000). Publications The research has resulted in eight papers (IF of Gene Therapy – 4.8) and eleven chapters and review articles. Five abstracts have been awarded prizes including two Presidents awards at the Society of Gynecologic Investigation (SGI) meeting in USA. MD and PhD students One PhD student has successfully completed, two more are in the middle of their research. Markers of esteem Dr David was awarded a ‘new blood’ DH senior lecturer award on the basis of this research. Anna David is also a member of the RCOG Guideline Committee, ex-RCOG Academic Committee and Secretary of the Blair Bell Research Society. Prenatal Diagnosis Research tradition Prenatal diagnosis and therapy has been a mainstay of obstetric research at UCL since 1990 with the appointment of Professor Rodeck, who had an international reputation for his pioneering work developing ultrasound-guided invasive procedures, such as fetal blood transfusion. More recently he led the Serum Urine and Ultrasound Screening Study (SURUSS), assessing novel methods of Down syndrome screening, some of which are now incorporated into NICE recommended protocols. Current research Dr Chitty now leads this research theme. She has played a major role in establishing the clinical significance of initial research showing that up to 5% of the cell-free DNA in maternal blood derives from the fetus, probably trophoblast. As a consequence, UCLH have been amongst the first in the world to use this technique for fetal sexing where there is a risk of inheriting an X-linked condition, as well as determining fetal Rh genotype where the mother is allo-immunised. Dr Chitty has recently obtained major National Institute for Health Research (NIHR) funding to extend these studies. Existing expertise at UCL will also allow basic research into the use of ‘deep sequencing’ techniques on her extensive bank of samples to karyotype the fetus. David Williams is clinical lead on a national MRC funded RCT to investigate whether statins can be used to ameliorate early onset pre-eclampsia (£550,000). He is also an applicant on a further £240,000 grant funding application. Publications Since joining UCLH in 2005, the group has produced 5 peerreviewed papers and 19 book chapters and reviews. The highest impact factor publication is in the British Medical Journal (BMJ): Pre-eclampsia and the risk of cardiovascular disease and cancer in later life: a systematic review and meta-analysis. MD and PhD students David Williams is supervising two PhD students, including one newly appointed and funded by UCL CBRC to investigate the paternal phenotype of men who father pregnancies affected by pre-eclampsia and fetal growth restriction. One PhD student has successfully completed. Grant income Lyn Chitty is PI on peer-reviewed grants totalling more than £3.3 million and is a co-applicant on a further £800,000. These include two NIHR grants, one for £247,162, which is entitled ‘Antenatal determination of fetal rhesus status using cell-free fetal DNA in the maternal circulation before 20 weeks: is routine application practical and beneficial?’, and a programme for £1,999,840 to assess non-invasive PND. MD and PhD students One student has recently submitted. Publications The group has published 41 papers, 9 book chapters and 14 reviews. Markers of esteem Dr Williams is a member of the NICE guideline development group for hypertension and ex-president of the UK Obstetric Medicine Society. Education Members of the Department have a major commitment to educational activity, discussed in more detail in the Education theme. In addition to running the MSc in Prenatal Genetics and Fetal Medicine, staff are heavily involved in starting a new MSc in Reproductive Science and Women’s Health. Professor Peebles also manages the MSc in Haemoglobinopathies, led by Dr Ratna Chatterjee. 51 MATERNAL AND FETAL MEDICINE – reSEaRCH MATERNAL AND FETAL MEDICINE – reSEaRCH UCL EGA IfWH 1st Quinquennial Review The Department hosts a very successful module of the Physiology BSc dedicated to Fetal and Neonatal Physiology, lead by Dr Ray Noble, contributes to the Women’s Health Module in Year 4 of the Undergraduate course (Donald Peebles sits on the Undergraduate Committee), and also provides research projects for BSc and MSc students. Professor Peebles is the Academic member of the Specialist Training Committee of the London Deanery and also sits on the Board of the London School of Obstetrics and Gynaecology. Anna David and Melissa Whitten set up the UK Network of Academic Trainees in Obstetrics and Gynaecology, now run through the RCOG Academic Committee, to improve recruitment and retention of academic trainees in clinical academia. CHALLENGES Facilities The Chenies Mews site presents two major challenges. • It is old, has not been redecorated for over 20 years and is isolated from other centres of IfWH activity • Recent recruitments, including David Williams and Kypros Nicolaides, and prospective recruitment of Chair of Midwifery and Neonatology, have highlighted the shortage of office and suitable laboratory space. Possible options include: • splitting the Department up to take advantage of any space that becomes available in more modern buildings and to locate teams with other researchers with shared interests, for example, new IfWH laboratories in Cancer Institute. Disadvantages of this approach would be loss of Departmental identity and team spirit, and absorption of women’s cancer research into other groups. • demolition of the Chenies Mews site and adjacent vacant former Department of Haematology with rebuild of an ‘Institute for Women’s Health’ combining laboratory and office space. This has the great advantage of providing a single, modern centre for women’s health research activity, but would involve identifying a very significant capital outlay and may not be large enough. • identifying existing premises on the UCL/UCLH campus that is vacant and large enough to accommodate women’s health with only minor upgrades. This would be more affordable than the second option above, and therefore more realistic, but require a suitable site. There are potential candidates, but none has been definitively allocated at present. Grant funding The figure on funding provided above highlights several problems with the funding of obstetric research. Firstly, the Department is overly dependent on HEFCE funding, leading to inconsistencies with other research departments in the IfWH, which receive less and secondly, grant income is insufficient and in particular does not include enough from research councils and other prestigious funding agencies who make a significant contribution to overheads. 52 UCL EGA IfWH 1st Quinquennial Review Potential solutions include: • refocusing on the importance of submitting grant applications, as some groups have only written one or two applications in the last four years. • making the applications more competitive by introducing internal peer review and mentorship for more junior researchers • increasing the size and quality of core reproductive science activity in obstetrics through collaboration, particularly within UCL, and recruitment • increasing applications to NIHR for Benefit funding, which will require broadening research remit to include relevant professionals, for example, statisticians, health services researchers, nurses, midwives and user groups. Recent developments supporting this approach include the recruitment of Professor Nicolaides (who has extensive track record of effective clinical research and has demonstrated ability to recruit to large studies), the advertised Chair of Midwifery, recent successful applications by Lyn Chitty for Research for Patient Benefit (RfPB) and Programme funding from NIHR and collaborations with Professor Rosalind Raine, a successful health services researcher and NIHR Panel member. Research remit Six research groups and additional increases in the scope of maternity research pose challenges relating to lack of critical mass and lack of focus. Compared with other departments in IfWH, such as Gynaecological Oncology, that have a central, disease focused theme, it could be argued that obstetrics, which has grown in an organic fashion based on recruitment of personal excellence rather than research compatibility, is spread too thinly to achieve research excellence. Balancing clinical service provision and research: a particular challenge for the UCL Centre for PGD is that a single group, based entirely within UCL, provides a clinical service whilst no one has a primary clinical contract with UCLH, except the genetic nurse specialist, but is also an active research group. Almost all PhD students come with their own funding and the clinical PGD funds some posts. Problems arising from this dichotomy are that there is insufficient time or focus to apply for grant funding, and clinical achievements are not recognised in university appraisal, making it difficult for staff to successfully apply for promotion. This can only be addressed by aligning and integrating the clinical service with UCLH strategy, as well as strengthening research activity through recruitment. IMPACT AND IMPORTANCE Obstetric research at UCL is focused on conditions that lead to maternal and perinatal mortality and morbidity in the UK and the developing world alike. Each year over 200 million women suffer life-threatening complications of pregnancy, while half a million die in childbirth, with over 99% of these in developing countries. The single largest cause of maternal death worldwide is postpartum haemorrhage (see misoprostol initiative in Uganda in the Global Health section). Three million babies die in the first week of life and a similar number are stillborn. Preterm labour and delivery are still poorly understood and efforts at prediction, prevention and treatment are woefully inadequate. It is the major cause of cerebral palsy and mental handicap, the prevalence of which have not changed or even slightly increased in the last 40 years (see Perinatal Neuroscience above). The lifetime costs of care for one child affected by cerebral palsy may exceed £4 million and the Department of Health has reported that approximately 60% of the entire NHS litigation costs each year are accounted for by brain injury at birth, a sum exceeding £200 million per year. Pre-eclampsia, a hypertensive syndrome peculiar to pregnancy is another important cause of fetal and maternal morbidity and mortality. Its cause and successful treatment remain elusive (see Maternal Medicine and Placental Development). Local challenges identified by the London Maternity Services Improvement Board include an increasing birth rate from 104,000 in 2001 to 121,000 in 2006 with particular increases in women from ethnic minorities (by 23%) and women over 40 years old (by 33%), both groups being at an increased risk of perinatal and maternal mortality (see Future Developments below). Prenatal screening for fetal aneuploidy is offered to the majority of pregnant women in the UK. Unwanted consequences of this policy are loss of unaffected fetuses as a consequence of invasive karyotyping (200 per year) and increased levels of parental anxiety (see non-invasive PND above). FUTURE DEVELOPMENTS There are a number of national and local developments that will impact obstetric research over the next two to three years. • widely predicted falls in research funding from HEFCE and medical research charities • potential benefits for increased research scope related to UCL Partners bid to become a DH recognized Academic Health Science Sentre • establishment of the UK Centre for Research and Medical Innovation on the St Pancras site • recruitment of Professor Nicolaides Making use of the opportunities these developments provide in line with strategy outlined in Strategy, Aims and Objectives, we will build on the areas described below. pre-eclampsia. Appointing Kypros Nicolaides provides a realistic opportunity to establish the clinical relevance of some of the more basic scientific research described above. Health services research in Maternity In order to maximise the potential to apply successfully for RfPB funding, but more importantly to tackle local issues such as a high perinatal mortality rate, inequalities in access to healthcare and the difficulties raised by providing high quality maternity care to an inner city population, it will be necessary to build on existing expertise in health services research. An initial NIHR programme bid entitled ‘Changing practice to improve perinatal outcomes in a socially and ethnically diverse population’ with Professor Rosalind Raine, Division of Public Health, was unsuccessful, but provides the catalyst for further attempts. Important contributors to this research stream would be Dr Jo Modder, Obstetric Lead for the Confidential Enquiry into Maternal and Child Health (CEMACH) and an NHS Consultant at UCLH, and Dr Imelda Balchin, a Walport ACF with an impressive track record in perinatal epidemiology. Midwifery research Closely related to the maternity challenges outlined above is the need to develop midwifery research at UCL. This is also an aim that is consistent with the vision for the IfWH, which envisages a broader approach to improving women’ health than is currently provided by a principally medical and biomedical paradigm. Professor Linda Franck from the Centre for Patient Care Research and Innovation at the ICH has obtained CBC funding for a Chair in Midwifery and/or Gynaecologicall Nursing that will be key to developing midwifery research education and career development, specialising in clinical, patient-focused research. Epigenetics The role of epigenetic regulation of gene expression in early placental development, fetal growth and pre-eclampsia is likely to be of extreme importance to pregnancy success and is also under-researched. Bringing together existing expertise within the IfWH (Epigenetics group led by Dr Widschwendter) and ICH (Professor Gudrun Moore, Molecular Genetics) to assess imprinting of candidate genes in first trimester villi (chorionic villus sampling (CVS) from UCLH FMU and Professor Nicolaides, Fetal Medicine Foundation) has already started, is funded by a grant held jointly by Professors Moore and Peebles and Dr Chitty) and will be developed further. Increased translational research An immediate priority is to establish collaborations between the UCL Department of Maternal and Fetal Medicine and Professor Nicolaides’ outstanding research. His proven ability to recruit large numbers of women to trials and observational studies, as well as his expertise as one of the leading academic fetal medicine specialists in the world are both unique advantages. Shared areas of interest include preterm labour, prenatal diagnosis, fetal growth restriction and early identification of women at risk of 53 MATERNAL AND FETAL MEDICINE – reSEaRCH MATERNAL AND FETAL MEDICINE – reSEaRCH UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review TEN KEY MATERNAL AND FETAL MEDICINE PUBLICATIONS AT IfWH 2004–09 Reduction in diagnostic and therapeutic interventions by noninvasive determination of fetal sex in early pregnancy. Hyett JA, Gardiner G, Stojilkovic-Mikic T, Finning KM, Martin PG, Rodeck CH, Chitty LS. Prenatal Diagnosis 2005; 25(12):1111-6 This paper is one of the first to describe the use of non-invasive prenatal diagnosis in a clinical setting and to demonstrate that this technology can reliably be used to reduce the rate of invasive prenatal diagnosis in high risk women. (19 citations) Fetal nuchal translucency scan and early prenatal diagnosis of chromosomal abnormalities by rapid aneuploidy screening: observational study. Chitty LS, Kagan KO, Waters JJ, Nicolaides KH. Br Med J 2006;332:452-4 Data showed that a policy of qf-PCR for all samples and karyotyping only if the fetal NT thickness is increased would reduce the economic costs, provide rapid delivery of results, and identify 99% of the clinically significant chromosomal abnormalities. These data informed the National Screening Committee guidelines on Down syndrome screening. Relationships between TGFbeta proteins and oxygen concentrations inside the first trimester human gestational sac. Muttukrishna S, Suri S, Groome N, Jauniaux E. PLoS ONE. 2008 Jun 4;3(6):e2302. The first study to indicate a direct relationship between the early intrauterine PaO(2) in vivo and inhibin A and sFLT-1 concentrations confirming our hypothesis that specific placental proteins are regulated by intrauterine O(2) tension. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Bellamy L, Casas JP, Hingorani AD, Williams DJ. Lancet 2009; 373: (in press) The increasing incidence of diabetes has highlighted the importance of causative mechanisms. This study shows a clear link between gestational diabetes and the increased risk of developing Type 2 diabetes in later life. Pre-eclampsia and risk of cardiovascular disease and cancer in later life: systematic review and meta-analysis. Bellamy L, Casas JP, Hingorani AD, Williams DJ. BMJ 2007; 335: 974-79. This meta-analysis showed that women who have had pre-eclampsia have an increased risk of cardiovascular disease in later life. This association might reflect a common cause for pre-eclampsia and cardiovascular disease, or an effect of pre-eclampsia on disease development, or both. Widespread and efficient marker gene expression in the airway epithelia of fetal sheep after minimally invasive tracheal application of recombinant adenovirus in utero. Peebles D, Gregory LG, David A, Themis M, Waddington SN, Knapton HJ, Miah M, Cook T, Lawrence L, Nivsarkar M, Rodeck C, Coutelle C. Gene Therapy 2004;11:70-8. For treatment of cystic fibrosis, we developed a minimally invasive ultrasound-guided method of injecting the fetal sheep trachea in mid to late gestation. We showed for the first time, that therapeutic levels of gene transfer to the fetal airways that would be sufficient for prenatal therapy for cystic fibrosis, were achievable. Monocyte MHC Class II Expression in Term and Preterm Labor. Lloyd J, Allen M, Azizia M, Klein N, Peebles D. Obstet Gynecol; 2007, 110: 1335-1342 Demonstrated that monocytes from women in either term or preterm labour are in a hyporesponsive state as a result of previous inflammatory activation. This observation may have major consequences in terms of vulnerability to puerpeural sepsis. Essential role of the AP-1 transcription factor c-jun in axonal regeneration. Raivich G, Bohatschek M, Clive DaCosta C, Iwata O, Galiano M, Hristova M, Wolfer DP, Lipp HP, Aguzzi A, Wagner EF, Behrens A. Neuron 2004, 43:57-67 For many decades, neuronal injury has been known to cause incisive metabolic changes that were suggested to play a critical role in mediating repair. However, the actual drivers of this repair in the living organism were unknown. The study shows for a first time that neuronal transcription factor c-Jun is such a master switch in allowing regeneration to occur. Activation and deactivation of periventricular white matter phagocytes during postnatal mouse development. Hristova M, Cuthill D, Zbarsky V, Acosta-Saltos A, Wallace AS, Blight K, Buckley SM, Peebles DM, Heuer H, Waddington SN, Raivich G. GLIA, 2009, (in press) This study showing that phagocytes are particularly numerous and active in the developing white matter suggests another reason why this area of the brain is so vulnerable to damage at specific gestations and provides new avenues for developing therapy to prevent cerebral palsy. REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY MATERNAL AND FETAL MEDICINE – reSEaRCH UCL EGA IfWH 1st Quinquennial Review Local delivery of VEGF adenovirus to the uterine artery increases vasorelaxation and uterine blood flow in the pregnant sheep. A L David, B Torondel, I Zachary, V Wigley, K Abi Nader, V Mehta, SMK Buckley, T Cook, M Boyd, CH Rodeck, J Martin, DM Peebles. Gene Therapy 2008;15:1344-50. Novel, exciting study describing a potential therapy for severe fetal growth restriction using a viral vector to achieve local over-expression of VEGF in the uteroplacental circulation in pregnant sheep. This resulted in sustained increases in uterine artery blood flow. 54 55 UCL EGA IfWH 1st Quinquennial Review REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – CLINICAL OVERVIEW Benign Gynaecology and Reproductive Health incorporates several key services within the division of women’s health. The clinical director Tim Mould has overall responsibility for these services, as well as the divisional manager Susan Sinclair and gynaecology lead clinician Naaila Aslam. These services consist of the following: Gynaecology Diagnostic and Outpatient Treatment Unit (GDOTU) Rina Agrawal Naaila Aslam Gulam Bahadur Rekha Bajoria The unit provides a diagnostic service as well as outpatient treatment for women with a wide range of both elective and emergency gynaecological problems. The unit has a director Davor Jurkovic and two consultant gynaecologists Naaila Aslam, Rehan Salim. The consultants work closely with other members of the team including four research fellows, one clinical fellow, nursing and administrative staff. Ertan Saridogan, consultant gynaecologist, leads the outpatient hysteroscopy service within the GDOTU. Paediatric and Adolescent Gynaecology (PAG) Service This service consists of two aspects: Ratna Chatterjee Paul Hardiman Sarah Creighton Joyce Harper Suzy Elneil Joseph Iskaros Greg FitzHarris Rehan Salim Gynaecological problems in children and adolescents.This is led by Sarah Creighton ,consultant gynaecologist, and takes place both within UCH and Great Ormond Street Hospital (GOSH). Other team members include a dedicated clinical nurse specialist and clinical psychologist. The surgical aspects of the service are supported by Alfred Cutner and ultrasound diagnosis by Naaila Aslam. An African Women’s clinic has been incorporated into the service dedicated to the care of young women affected by female genital mutilation. Multidisciplinary service for disorders of sex development (DSD) in children, adolescents and adults. Together with GOSH UCLH provides the largest and most comprehensive service both nationally and internationally for individuals affected by this condition. The team includes a gynaecologist, psychologist, endocrinologists, urologists, genetics team and radiologists. UCLH Endometriosis Service This service is provided by a dynamic multidisciplinary team and consists of high quality, evidence based care that aims to assess and treat women with all grades of endometriosis. Ertan Saridogan 56 Judith Stephenson Alfred Cutner, Consultant Gynaecologist, is currently the service lead. The team consists of three further gynaecologists; Ertan Saridogan, Davor Jurkovic and Naaila Aslam. Mr Jurkovic and Miss Aslam provide ultrasound assessment of these women and medium level laparoscopic surgery. Mr Cutner and Mr Saridogan provide high level laparoscopic surgery. There are two dedicated clinical nurse specialists, Elsa Palmer and Sarah Parker and a minimal access surgery fellow. In addition the team includes two colorectal surgeons, one functional gastroenterologist, two urologists, one radiologist and two pain management consultants. Urogynaecology Unit The unit consists of three consultant urogynaecologists – Suzy Elneil, Alfred Cutner and Arvind Vashisht (locum), one physician for the elderly, Adrian Wagg and a clinical nurse specialist, Mary Remy. In addition there are two dedicated physiotherapists, a continence nurse advisor and an HCA in continence, as well as a clinical fellow. The unit works in close affiliation with the departments of urology, functional gastroenterology and colorectal surgery. Furthermore the unit closely interacts with the department of uro-neurology at the National Hospital for Neurology and Neurosurgery. Combined clinics with Professor Clare Fowler and Dr Suzy Elneil take place within this setting. Patients are seen by a neuro-physiologist, a urogynaecologist and a neurologist if necessary. This service is unique within the UK and patients are referred both locally and nationally. 57 REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – clinical REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY UCL EGA IfWH 1st Quinquennial Review In addition the unit offers a dedicated postnatal urogynaecology service, which is supported by a consultant midwife and two consultant obstetricians. Dr Adrian Wagg assists in providing care for elderly incontinent patients, in particular those with multiple medical problems and patients on complex pharmacotherapy. The provision of this service within an urogynaecology setting enables senior patients to be seen and treated in a single visit. Reproductive Medicine Unit (RMU) The RMU runs a dedicated service with the aim of providing a multidisciplinary, patient-centred approach for the investigation and treatment of couples with subfertility, and for women with disorders of reproductive endocrinology, menopause and premenstrual syndrome. The RMU is licensed by the Human Fertility and Embryology Authority (HFEA) to carry out donor insemination of sperm, intrauterine insemination and sperm storage. The RMU lead is Ertan Saridogan and the unit consists of two other consultant gynaecologists: Melanie Davies and Rehan Salim, Dr Gerry Conway is the consultant endocrinologist based within the unit and Dr Elphis Christopher is a consultant in psychosexual medicine. Dr Ratna Chatterjee is the senior lecturer within RMU and Dr Francoise Shenfield is the clinical lecturer. In addition there is an associate specialist, clinical psychologist, clinical scientist and three clinical nurse specialists. There are two sub-speciality trainees in post at present. Assisted Conception Unit (ACU) The ACU is a privately operated unit with a strong working relationship with the Institute for Women’s Health. The unit offers a comprehensive range of treatments including in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI ), and preimplantation diagnosis. The ACU lead is Mr Paul Serhal and the unit has fifty members of staff. The clinical staff comprises of six clinicians, seven embryologists and ten nurses. The ACU has a leading national and international reputation in the field of infertility and preimplantation genetic diagnosis. The ACU is consistently one of the leading IVF units in the UK with a live birth rate of 65% in woman less than 35 years of age per cycle of IVF treatment. The unit works very closely with RMU and has for the last year been treating NHS patients jointly with the RMU. STRATEGY, AIMS AND OBJECTIVES GDOTU The aim of the unit is to provide a comprehensive clinical service to women with both urgent and non-urgent gynaecological problems in a single visit where possible. By employing experienced staff and providing state of the art diagnostic equipment, outpatient care is effective and results in a decrease in the number of follow up visits and a significant reduction in the number of invasive diagnostic operative procedures. This leads to shorter waiting times and more effective utilisation of operating theatre time. 58 UCL EGA IfWH 1st Quinquennial Review PAG service UCLH is the only hospital in the UK to offer such a comprehensive and multidisciplinary service for complex congenital anomalies and is recognised as a National and International Model of Care. The primary aims are to improve transition from paediatric to adult services, to expand laparoscopic reconstructive surgery, educate clinicians and conduct research. To this end a multidisciplinary adolescent Disorders of Sex Development (DSD) clinic has been established. UCLH is the only unit within the UK to offer all aspects of laparoscopic paediatric and adolescent gynaecology. There is an established website for this service (www.uclh.nhs.uk/ middlesexcentre) providing information on the conditions treated. A vast amount of research has been undertaken within this service over the last ten years on gynaecological and sexual outcomes in DSD. UCLH Endometriosis Service This service aims to provide state of the art, high quality, evidence based and patient-centred treatment for the management of all grades of endometriosis. A multidisciplinary team is in place to provide this service. Patients are referred both locally and nationally. There is an established website for this service (www. theendometriosiscentre.co.uk) providing details of the condition and management. Urogynaecology Unit The main strategy over the past few years has been to develop the multidisciplinary team fully. This has involved recruiting nursing and dedicated physiotherapy staff. The physiotherapists roles are currently being developed into those of Expanded Scope Practitioners. We are in the process of recruiting a substantive consultant to join the team. The aim of the unit is to provide a fully integrated multidisciplinary service for problems affecting the pelvic floor and its associated organs. In addition it aims to provide a nationally recognised postnatal urogynaecology service, a specialist service for management of complicated pelvic organ prolapse and urinary incontinence as well as neurological dysfunction of the pelvic floor. Finally it is to provide a nationally accredited centre of excellence in training, education and research in women with urogynaecology problems. Recently a one-stop clinic facility has been set up – allowing patients to be seen by the physiotherapists, clinical nurse specialists and urogynaecologists in a single visit. RMU As well as offering general fertility services, the RMU offers a number of specialist services. These include recurrent miscarriage, premature ovarian failure, late effects clinic and the fertility preservation service run by Melanie Davies. In addition Ertan Saridogan offers advanced minimal access surgery for condition such as endometriosis and tubal surgery. Rehan Salim runs the menopause and premenstrual syndrome (PMS) service. Gerry Conway leads the polycystic ovarian syndrome clinic and the ovulation induction programme. Ratna Chatterjee runs a specialist clinic in the reproductive health of women with chronic disease. Francoise Shenfield has been running the donor insemination unit and is responsible for the clinical co-ordination of this programme. Counselling is an integral part of the service and is provided by a clinical psychologist and Dr Christopher runs a weekly psychosexual medicine clinic. The IUI and ovulation induction services are supported by the fertility clinical nurse specialists (CNS). RMU is currently providing a small number of NHS IVF cycles as a satellite unit in collaboration with the Assisted Conception Unit (ACU). Our aim is to set up an NHS IVF service over the next year by collaborating with ACU. ACU In addition to providing IVF services both for private and NHS patients, the Assisted Conception Unit (ACU) has a leading role in the clinical application of scientific development in the field of preimplantation genetic diagnosis (PGD). This includes the prevention of genetically inherited cancers. In all its activities the unit seeks to be a bridge between scientific endeavour and clinical excellence. Optimising embryo culture is central to our strategy and currently this is the subject of ongoing research involving dynamic embryo culture and metabolomic. The unit has been at the forefront of the introduction of vitrification as a means of cryopreservation of eggs and embryos. The ultimate aim is to establish the UK’s first egg bank of vitrified eggs. Other research includes optimisation of drug regimes for ovarian stimulation in poor responders and the introduction of 3D ultrasound imaging in the investigation and treatment of infertile couples. UCLH Endometriosis Service The clinical nurse specialists see women initially at UCLH and act as a point of contact. Women are scanned at their first visit and a management plan is made by one of the gynaecologists. There is a website available for the service, which details patient management (www.theendometriosiscentre.co.uk). Surgery takes place on one of three operating lists depending on the severity of the disease. There is a monthly joint operating list with the colorectal surgeons for cases where bowel surgery will be required. Two consultant urologists are also involved in cases as necessary. There is now a national database to collect outcome data from these women. There are two dedicated pain management consultants who offer chronic pain management for women affected by this condition. The unit at UCLH is one of twelve units within the UK offering integrated endometriosis care. Due to the large number of women referred with severe disease further support in manpower is required to support advanced laparoscopic surgery. In addition there is inadequate administrative support for this service. The clinical nurse specialists spend a considerable amount of time ensuring clinics are appropriately booked. Urogynaecology Unit The Trust has provided adequate space, staffing and equipment, which has enabled the unit to reach its objectives within 12 months of establishing this new service. The outpatient theatre is fully functional and there are adequate recovery and counselling facilities. This comprises four dedicated rooms in the EGA building: an urodynamics room, two physiotherapy rooms and an uroflowmetry room. All the other clinical rooms are shared with colleagues in the Breast, general gynaecology and RMU services. The unit is financed solely by UCLH. With regards to staff the following substantive appointments need to occur in order to maintain current activity levels: nurse continence advisor, consultant in urogynaecology (locum in post at present) and sub-speciality trainee in urogynaecology. New equipment has been recently installed to support this service. However, in the future more equipment would need to be purchased if the service were to expand. PAG Service RMU The clinics take place within the GDOTU. This has led to a dramatic improvement in access to good quality pelvic ultrasound. The waiting times for clinics are between 10 to 12 weeks and as a result extra clinics have been taking place to try and meet the demand. However, the number of clinic rooms available is limited due to high demand from other areas. There is appropriate access to theatre space as required. The RMU has recently moved into the basement of the new EGA wing. There are four clinical rooms available and three additional rooms for consultation only. The space is limited – two of the clinical rooms are small and cramped. The air conditioning system is noisy and this is particularly noticeable in the smaller rooms. The waiting facilities are inadequate – the chairs are arranged along the corridor, with space that lacks privacy and for only eight couples in total. RESOURCES GDOTU The service is supported financially by the Trust and all the equipment is new and of a high standard. Junior doctors need to be timetabled to attend these activities in order to improve their training. There is one dedicated SpR and a clinical nurse specialist. This service has inadequate secretarial and administrative support – there are no dedicated personnel. This means that the clinical nurse specialist spends a significant amount of time ensuring notes are present and preparations adequate for the clinic. There is a new laboratory adjacent to the RMU, which is responsible for seminology and sperm storage. The laboratory currently stores samples from over 2000 men who were diagnosed and treated for cancer. The fertility laboratory fulfils all the requirements expected from such a laboratory, and has been designed to a high specification. There is the potential to co-locate the current RMU and ACU within the new EGA wing, so that these two entities would combine to form a fully comprehensive reproductive medicine centre. 59 REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – clinical REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – clinical UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review ACU PAG Service The ACU is currently based at the Eastman Dental Hospital. The unit has grown for the last few years and consequently is seeking larger premises particularly to accommodate the potential increase in the number of NHS patients. This is a leading national and international centre for complex congenital anomalies. This service is recognised as the National and International Model of Care. Patients are referred from across the UK and Eire. In 2007, over 60 specialised reconstructive procedures were performed. PERFORMANCE AND MEASUREMENT OF QUALITY OF ALL ACTIVITY Over 400 patients were seen within the service last year. On average the initial consultation for patients with DSD lasts between one to two hours. GDOTU Trainees and consultants visit regularly from around the UK. We provide the PAG module for RCOG subspecialty trainees from all London regions and Oxford. In 2004 the service was recognized as the most comprehensive multidisciplinary joint intersex service by the Royal College of Paediatrics and Child Health (RCPCH). See Publications booklet for list of publications. The Gynaecology Diagnostic and Outpatient Treatment Unit have implemented striking changes in the service. Over 10,500 patients were seen within the last year. An audit of activity over the first year has shown a significant change in the ratio of new to follow-up elective Gynaecology appointments from 1:6 to 10:1. This is largely due to improved diagnostics within the one-stop clinics. The waiting time for the initial appointment has been reduced from 20-40 weeks. There has been a 30% reduction in the number of diagnostic hysteroscopies and waiting times for outpatient hysteroscopy have been reduced from two months to two weeks. The efficacy of diagnosis in early pregnancy has also been improved, with a 30% reduction in the number of non-diagnostic ultrasound findings. The number of women managed expectantly has risen to 70% in cases of miscarriages and to 30% in cases of ectopic pregnancies. The number of emergency gynaecological admissions has decreased by 40% despite the increase in numbers of women seen within the acute diagnostic service. The unit is a major training centre. Currently there are six gynaecology consultants and senior SpRs from other hospitals attending for ultrasound training. We have three senior trainees undertaking the Royal College of Obstetricians and Gynaecologists (RCOG) advanced training skills module in Early Pregnancy and Acute Gynaecology. The outpatient hysteroscopy service has treated over 1,100 patients from 2001 to 2007. Hysteroscopic examination was successfully completed in 96% of women and the majority of women seen were amenable to a see and treat approach. This has obvious benefits for patients, employers and society. It obviates the need for general anaesthesia and theatre time. Outpatient hysteroscopy has been shown to have significant cost savings. UCLH Endometriosis Service This is one of approximately 12 units across the UK offering integrated endometriosis care for women with severe disease. Our service is both nationally and internationally recognised, with the majority of patients being referred for laparoscopic surgical management. We have seen a continued increase in the number of patients referred into the service. 177 women underwent fertility-sparing laparoscopic excision of deeply infiltrating endometriosis over a two year period between 2006 and 2007. Almost one quarter of these cases were performed jointly with the colorectal surgeons and greater than 40% of women overall required some form of bowel surgery. The short-term complication rate was low (3.4%). An advanced endometriosis and laparoscopic surgery course has been running for the past two years. In addition Alfred Cutner and Ertan Saridogan run a yearly advanced laparoscopy course in Hamburg. We have a minimal access surgery fellow undergoing a two year training programme in advanced laparoscopic surgery. This follows the RCOG advanced training skills module. Research has mainly involved outcomes of surgical management of severe endometriosis (see Publications Booklet). Urogynaecology Unit This is a tertiary referral unit offering a comprehensive range of medical and surgical services. Alfred Cutner offers advanced laparoscopic surgery for prolapse and patients are referred nationally. This is the only unit within the UK that offers uterine preservation prolapse surgery. The urogynaecology unit is one of only two laparoscopically-accredited centres for urogynaecology. Alfred Cutner provides a training facility for colleagues and trainees to observe and learn this type of surgery. Suzy Elneil offers complex vaginal surgery and in particular fistula surgery. This unit is one of only two within the UK offering a vaginal approach for genital tract fistulas, which is associated with a lower morbidity compared to abdominal surgery. Patients are referred nationally to this service. 60 Finally the unit runs a multidisciplinary postpartum service offering specialist care to women following childbirth. The team consists of functional gastroenterologists, colorectal surgeons, physiotherapists, continence nurses, midwives and obstetricians as well as urogynaecologists. Initially the clinic reviewed ten patients per month. This has now increased to eleven patients per week. Women are referred from both UCLH and surrounding hospitals. Combined clinics at the National Hospital for Neurology and Neurosurgery (NHNN) offer cutting-edge treatments, such as botulinum toxin therapy to the bladder and sacral neuromodulation. The unit at the NHNN is the national training centre for both procedures. There is also a dedicated integrated urogenital pain service offered at the pain management centre at the NHNN. Patients with complex regional pain syndromes of the bladder, pelvis and perineum are seen by a multi-disciplinary team. Most patients are referred nationally for this service and are seen and treated at a single visit. With regards to training the unit has a sub-speciality trainee and a clinical fellow. In the last year we were joined by an honorary clinical fellow from Europe training in urogynaecology. RMU As a tertiary referral centre, the RMU provides care for a large number of women with cancer, genetic disease and chronic diseases offering reproductive health support. The RMU is a nationally recognised centre for reproductive surgery and fertility preservation. There are approximately 1500 new referrals to the RMU per annum. Over 6,500 patients were seen last year. See Appendix 5.1 for RMU success rates over the past three years. Patient satisfaction surveys are conducted regularly within RMU. The previous three surveys have shown a broad level of high satisfaction (greater than 85%) with the service. Earlier surveys revealed inadequate psychological support – this was addressed and has shown a 15% improvement in scores. The remaining area of weakness is the waiting time for appointments. This is being addressed by the introduction of one-stop fertility clinics. ACU Key performance criteria include laboratory and clinical outcomes, patient satisfaction as well as academic publications. The unit has had one of the highest live birth rates in the country and the patient satisfaction surveys have been very satisfactory. The number of patients being treated has increased steadily as a reflection of our favourable results. The whole of Gynaecology is 18 weeks compliant, i.e. patients are seen within 18 weeks from the time of referral to the start of treatment. AREAS OF EXCELLENCE GDOTU This is one of the few comprehensive diagnostic units within the UK. Davor Jurkovic is recognised as one of the leading world experts in early pregnancy and gynaecology ultrasound. Davor Jurkovic is Chair of the RCOG Early Pregnancy Study Group – which is part of the National Reproductive Research Network. PAG Service The multidisciplinary service offered with Great Ormond Street Hospital is recognised as the national and international model of care. Sarah Creighton is the Chairwoman and founding member of the British Paediatric and Adolescent Gynaecology Society. This service has developed innovative laparoscopic procedures e.g. the world’s first report of laparoscopic treatment for cervical agenesis. UCLH Endometriosis Service This is a nationally and internationally recognised service. Alfred Cutner is the President of the British Society of Gynaecological Endoscopy and has developed the RCOG ATSM in advanced laparoscopic surgery. Alfred Cutner is due to go on a one year secondment from April to assist in setting up an endometriosis service in Cornwall. Urogynaecology Unit The training opportunities offered by our unit are unique, and many trainees from around the UK attend the unit both at UCLH and NHNN to learn about the specialized treatments available. The joint services offered at the NHNN are recognised nationally. Members of the unit are regularly invited to speak at local, national and international meetings. The urogynaecology team regularly run workshops at the International Continence Society meetings, the International Urogynaecology Association, the British Society of Gynaecological Endoscopy and the UK Continence Society. The unit runs a monthly North London Multidisciplinary Team (MDT) Network Meeting. RMU This is the regional centre for preservation of male fertility (sperm storage). Melanie Davies sits on the Human Fertilisation and Embryology Authority (HFEA) advisor body and RCOG working party for National Donor Screening. Francoise Shenfield is a UK member of the European Society of Human Reproduction and Embryology (ESHRE) executive. Ertan Saridogan is a member of ESHRE endometriosis special interest group working party and board member of the International Society of Fallopian Tubes. ACU The Assisted Conception Unit is consistently one of the leading IVF Units in the UK with a live birth rate per cycle of treatment of 65% in women under 35. Research led by the Assisted Conception Unit has contributed to outstanding success rates in IVF. Collaboration with the Prenatal Genetic Diagnosis Group (Joyce Harper) has led to several ‘world firsts’ including the first BRCA1 tested PGD baby delivered in December 2008. The same technology has been applied successfully for patients with familial adenomatous polyposis (FAP), retinoblastoma (RB) and neurofibromatosis (NF1). ACU has led the field and has become the major centre offering pre implantation for all cancer predisposing genes. 61 REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – clinical REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – clinical UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review CHALLENGES ACU Urogynaecology Unit PAG Service GDOTU The major challenge for ACU is to acquire appropriate new premises and to maintain its current position as a leading IVF provider. Urogynaecology conditions may affect women throughout their life cycle. The Patients seen range from teenagers with recurrent urinary infections, to women in their reproductive years with postpartum problems, and finally postmenopausal women with prolapse and urinary incontinence. The unit offers a streamlined multidisciplinary service for all women, of all ages. A one-stop clinic is in development. The unit is nationally recognised for developing laparoscopic and complex vaginal surgical techniques and offers training and education in these areas. The clinical service and training offered in uro-neurology, urogenital pain and neuro-gynaecology is also nationally recognised. The service is moving away from surgical and condition based research to holistic assessment of long-term well being of individuals with DSD. An increase in the number of referrals is expected as general gynaecologists and urologists are less able to deal with complex problems. There will be increased emphasis on psychological interventions and increased involvement of patient groups. Finally we expect to see increasing expectations of young patients, who now have a good life expectancy and the same reproductive and sexual aspirations as their peers. The unit has only been operational for twelve months. There have been a number of minor problems, which were expected to occur before the unit becomes fully established and operational. The added difficulty was the recent move of the service after being in place for ten months. We are now settling into the new space. The amount of clinic space is sufficient. However, the waiting facilities are poor and this is a continuous source of distress to patients and staff. There are 27 chairs in total in the waiting area. There are no facilities provided for leaflets / magazines for patients while they wait. There is no dedicated space available for children. The facilities are currently being reviewed and a patient satisfaction survey is in progress. The clinic is located in the basement, without any natural light, which causes problems for some members of staff who spend their entire working week in the clinic. PAG Service There is a lack of administrative and secretarial support for this service. The outpatient clinic space is limited and there is a lack of recognition by managers of this highly specialised labour intensive service due to perceived low activity. There has been a lack of administrative support available for research in the past. This will hopefully be improved by the recent appointment of a joint UCL/UCLH research co-ordinator. IMPACT AND IMPORTANCE GDOTU This service offers easily accessible, high quality patientcentred care for women. Our early pregnancy service ensures that all women are given rapid clinical and ultrasound assessment, combined with clear management advice. There is a robust follow up structure in place and counselling support. Many women receive supportive non-interventional care, which minimises the impact of their condition on their social and psychological well-being. The gynaecology service has been transformed with the introduction of one-stop clinics – this is reflected in the ratio of new to follow-up appointments. This has enabled us to become 18 weeks compliant. Women with suspected gynaecological cancers are seen within two weeks. The majority of women with benign disease are reassured, whilst a minority with cancer are referred to the gynaecology oncology clinics without delay. PAG Service UCLH Endometriosis Service There is inadequate administrative support for this service. Furthermore there is inadequate medical staffing to support the increased clinical referral base. This is particularly true for surgical capacity for advanced cases. This has been addressed, with an additional substantive consultant due to be recruited soon. Urogynaecology Unit Nursing and medical staffing levels continue to be a cause of concern. This has been partly addressed by recruitment of a new substantive consultant colleague within the next few months. There are ongoing discussions regarding permanent positions for nursing staff. A dedicated urogynaecology office space within the unit would act as a good focal and academic point as well as a research space. There is currently no space available. In the past, this group of women have been poorly treated by the medical profession. A policy of non-disclosure of the diagnosis to the patient and their families has been widespread. Other controversial areas include the role of feminising genital surgery particularly in children who cannot consent. Our multidisciplinary clinic treats patients with respect, dignity and honesty. There is a policy of complete openness and of disclosure of all medical information to patients in a supportive environment. There is a paucity of long-term objective outcome information on psychosexual, gynaecological and psychosocial outcome in DSD. Many of our patients are involved in research studies and Sarah Creighton has published extensively in this field. Research undertaken in this service is informing debate around the world and has already changed paediatric surgical practice. UCLH Endometriosis Service RMU The RMU aims to become a fully comprehensive reproductive medicine service and a national centre of excellence. Achievement of this aim is hampered by the lack of a NHS IVF service. This leads to women being referred to other units for IVF treatment. In addition the lack of IVF is preventing RMU from providing cutting edge services to women who require preimplantation genetic diagnosis (PGD) or egg/embryo freezing prior to cancer treatment. Literature suggests a prevalence of endometriosis of between 3 and 10% of the general population. The prevalence of severe disease within this group ranges from between 5 to 30% and can be debilitating. There is a demand for this service and as a result of the varied clinical manifestations a multidisciplinary team approach is essential. We offer a truly integrated service for patients ranging from expectant and surgical management to chronic pain management and we are a tertiary referral centre. Members of the unit sit on various national and international committees for the development of new pharmacotherapies, development of laparoscopic services and techniques, promoting sacral neuromodulation and overcoming fistulas around the world. The unit is actively involved in raising the public awareness of urogynaecological problems and their solutions by talking at GP surgeries, annual Wellbeing of Women Fair, the European Parliament and at the House of Lords. RMU The unit is nationally renowned for reproductive endocrinology, reproductive surgery and late effects services. ACU The unit has contributed to outstanding success in IVF. It has an international reputation and has had several world firsts including the first BRCA1 tested. PGD baby delivered in December 2008. The same technology has been applied successfully for patients with familial adenomatous polyposis (FAP), retinoblastoma (RB) and neurofibromatosis (NF1). This has resulted in favourable and extensive international media coverage. The ACU has led the field and has become the major centre offering preimplantation diagnosis for all cancer predisposing genes. FUTURE DEVELOPMENTS GDOTU We expect that the number of patients attending the unit will continue to increase, which will require a regular review of staffing and facilities. We have recently established operative outpatient treatment of miscarriages, which we will expect to have a significant impact on the number of patients admitted for inpatient treatment. UCLH Endometriosis Service With the increasing number of referrals it is imperative to increase our medical staff and in fact we are due to recruit a new consultant to the service in the near future. We are planning to expand the role of the clinical nurse specialists. We will continue research into advanced endometriosis and ultrasound diagnosis. Urogynaecology Unit The immediate aims are to complete the move of the urogynaecology unit to the new EGA wing and to ensure the 18 week targets continue to be met by maintaining staffing levels. We aim to introduce one-stop clinics by the end of the year. We aim to promote the monthly North London MDT Network Meetings and become involved in research collaborations across the network. We hope to develop a research base at UCLH, with dedicated sessions for an academic consultant within urogynaecology. Finally we would aim to continue to develop and run specialist courses such as the UCLH perineal trauma course, laparoscopic urogynaecology study day and urogynaecology for continence nurses. RMU The main objective is to develop a NHS IVF service within UCLH. This would lead to provision of a comprehensive PGD and fertility preservation service. UCL has a nationally recognised PGD team, who are currently working with the privately funded ACU. The ACU is one of the most successful fertility clinics in the UK and the potential of a merger of RMU and ACU into a fully functional reproductive medicine centre is exciting. This would inevitably lead to an increase in research output in this area. We are planning to expand the diagnostic service by establishing recurrent miscarriage clinics and outpatient invasive tests of tubal patency in women with subfertility. We are planning to increase our research activity by initiating and participating in multicentre clinical trials in early pregnancy and gynaecology. The current RMU space is limited and this needs to be addressed if the service is to expand. 62 63 REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – clinical REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – clinical UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – RESEARCH OVERVIEW Research in reproductive health is managed/led by a recently established UCL Research Department of Reproductive Health (HoD: Professor Judith Stephenson) with extensive academic and NHS collaborations. Clinicians and scientists work across the spectrum of basic science through clinical research to populationbased research and randomised trials. Basic science research in oocyte physiology and chromosomal disorders is linked closely with the Division of Biosciences in the Faculty of Life Sciences; clinical research is integrated with gynaecology services across UCH, Royal Free Hospital (RFH), the Whittington Hospital, the Institute of Neurology and Great Ormond Street (GOSH), while sexual health research is integrated with community-based services. Study of cardiovascular morbidity associated with polycystic ovarian syndrome links basic science and clinical research with an epidemiological ‘lifecourse’ approach to women’s health, through the MRC Unit for Lifelong Health and Ageing. The scope of reproductive health research is broad in terms of disease focus as well as methodology. It encompasses paediatric and adolescent gynaecology, including rare disorders of sexual development, subfertility, use of gynaecology ultrasound to improve diagnostics and patient management (e.g. in ectopic pregnancy, ovarian tumours), reproductive health in chronic disease, and prevention-related research into major public health issues, including obesity and risk of diabetes associated with polycystic ovarian syndrome, sexual health, teenage pregnancy, abortion and sexually transmitted infections (STI). UCL has established a UK Clinical Research Network of communitybased services to conduct investigator-led trials in sexual and reproductive health. Three themes are led by full time NHS clinical consultants: Research in paediatric and adolescent gynaecology is led by Sarah Creighton Research into long term outcomes of disorders of sexual development is led by Gerard Conway Research in use of gynaecology ultrasound to improve diagnostics and patient management is led by Davor Jurkovic, recruited to IfWH in 2008. Three themes are led by UCL clinical academics: Oocyte/embryo research is led by Hayden Homer Research into polycystic ovarian syndrome is led by Paul Hardiman Research in sexual and reproductive health is led by Judith Stephenson. In addition, clinical research in subfertility is conducted by Paul Serhal (Director of the Assisted Conception Unit), with contribution from NHS consultants Melanie Davies, Rehan Salim and Ertan Saridogan. Research into fertility preservation in cancer patients is led by Gulam Bahadur and Paul Serhal with UCH/RF clinicians, 64 subsequent live birth rates through assisted conception. The objectives of the basic research are to describe the molecular regulation of chromosome segregation during female mammalian first meiotic division; to study mechanisms of spindle assembly and spindle microtubule dynamics, and fundamental aspects of early mammalian embryo development. Owing to limited access to human oocytes, current strategy is to use a mouse model for basic understanding of cellular control mechanisms in oocytes and embryos and, in particular, to develop experimental approaches that can be applied to single cells. This will enable us to extend our research from mouse to human oocytes and embryos. Another strand of research aims to improve fertility preservation in cancer patients through understanding and reducing the gonadotoxic effects of chemotherapy. The objectives of clinical research at the ACU are to improve the diagnosis and management of patients with poor ovarian reserve through development of 3D ultrasound assessment of follicle count and size and investigation of responses to various stimulatory drug regimens; to identify novel, non-invasive tests such as metabolomics, proteomics and genomics in order to improve the embryo selection process; to improve blastocyst survival rates e.g. by minimising cryo-injury from vitrification (ultra-rapid freezing); to optimise oocyte freezing using vitrification in order to establish the first egg bank that will optimise management of cancer patients and egg recipients; and to improve the in vitro environment that influences blastocyst conversion rate and embryo quality, using a novel dynamic culture technique. The strategy is to align these innovative clinical approaches more closely to the oocyte / embryo research to improve pregnancy and birth outcomes. Polycystic ovarian syndrome (PCOS) Margaret Pyke Centre and research into reproductive health in chronic disease (e.g. haemoglobinopathy, cancer and renal disease) is led by Ratna Chatterjee who is currently running the first distance learning MSc course in haemoglobinopathy. The overarching aim of our research is to improve the reproductive and sexual health of women by conducting internationally competitive translational research. Our strategy is to focus on a few key areas in which the IfWH can make a major contribution to the field. STRATEGY, AIMS AND OBJECTIVES Infertility and oocyte and embryo research The aim of this theme is to develop and evaluate new approaches to improve the treatment of subfertility and preservation of fertility. Basic oocyte / embryo research aims to describe the molecular regulation of mammalian oocyte and embryo development in order to understand the mechanisms underlying human reproductive problems, while clinical research aims to improve pregnancy and The aim of this theme is to describe the mechanisms responsible for increased risk of diabetes, cancer and coronary heart disease in women with PCOS and to evaluate interventions to improve clinical outcomes in these women. The objectives are to identify mechanisms leading to viscoelastic and endothelial abnormalities; to describe the molecular abnormalities of the endometrium in relation to neoplasia and implantation; to explore the epigenetic effects of prenatal androgen in babies born to women with PCOS and to evaluate an intervention to reduce the maternal and neonatal morbidity associated with this syndrome. The strategy has been to build up effective collaborations within and outside IfWH in order to obtain further grant income in pursuit of these aims and objectives. Sexual and reproductive health The aim of this theme is to improve sexual health by reducing rates of unintended pregnancy, abortion and STI. Although control of fertility is essential to women’s health, the academic leadership, research capacity and infrastructure needed to support high quality contraceptive research is lacking. UCL has the only senior clinical academic post for contraceptive research in the UK. Our strategy has been to establish a UK research network of community based services to enable high quality multicentre studies with an initial focus on contraceptive research. The research objectives are to help women choose contraceptive methods that suit their needs and respect their values, and to evaluate interventions that lead to more effective use of contraception and prevent unintended pregnancy. Currently underway is a multi-centre trial to compare standard use of the combined pill with a new form of extended use of the same pill. Projects starting in 2009 include a placebo-controlled trial of local analgesia for insertion of intrauterine contraception, a study of spontaneous clearance and response to treatment of genital Chlamydia infection, and the prevalence of Mycoplasma genitalium in women at risk of STIs. Disorder of sexual development and paediatric and adolescent gynaecology Together with GOSH, UCH provides the UK’s largest and most comprehensive service for individuals with disorders of sex development (DSD). We are world leaders in clinical care and research. The aim is to improve the gynaecological, psychological and psychosexual outcomes in those diagnosed with a DSD in childhood. We are the first group to publish objective longterm results for this group of adolescents and young women. Our results have shown a high incidence of gynaecological and sexual difficulties and have led to a world wide re-evaluation of paediatric surgical policy. We have also developed innovative surgical techniques for treatment of complex mullerian anomalies such as laparoscopic vaginal reconstruction. Parallel research into the reproductive endocrinology and genetic aetiology of DSD aims to improve long term medical outcomes. Currently funded projects include heterozygosity mapping of consanguineous families with ovarian dysgenesis and characterisation of well being in older women with Turner Syndrome. The Adult Turner Syndrome service is a reference population for mapping the natural history of this condition which is the major contributor to NIH guidelines on management. This cohort is also the basis of a European collaboration on cardiovascular management. Improving gynaecological diagnosis and management Following the establishment of a world-class gynaecology diagnostic and outpatient treatment unit, a research strategy is being developed to strengthen the evidence base for transforming gynaecology outpatient care. The aim is to provide a modern and effective service that minimises the need for follow up visits and reduces the number of operative diagnostic procedures. The current research themes include: Use of gynaecological ultrasound for diagnosis of ovarian abnormalities Diagnosis and management of endometriosis Diagnosis and clinical significance of adenomyosis Management of early pregnancy complications RESOURCES In general, reproductive health research has been spread across several sites and campuses, including UCH (old EGA hospital), Margaret Pyke Centre (contraceptive service in Charlotte St), Eastman Dental Institute (Assisted Conception Unit, privately managed, Grays Inn Road), Gower Street (Oocyte / Embryos Labs shared with the Department of Cell and Developmental Biology), and the Royal Free. New space is provided in the EGA wing for 65 REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – RESEARCH REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – RESEARCH UCL EGA IfWH 1st Quinquennial Review clinical services in reproductive medicine, with discussion in progress about building up an NHS IVF service. Shared research space could only improve prospects for more collaborative research in reproductive health. Space The oocyte and embryo research laboratory is based in the Research Department of Cell and Developmental Biology in the Division of Biosciences. There is sufficient space to accommodate ten researchers at any one time. The laboratory is well supplied with microscopes and imaging rigs for fluorescence studies in single oocytes. The group have access to two confocal microscopes immediately opposite the main laboratory. We have recently established a new molecular biology and biochemistry laboratory. The Assisted Conception Unit has 50 staff and is fully equipped for clinical procedures and laboratory research including ultrasound imaging. It is currently located at the Eastman Dental Hospital, Grays Inn Road, but plans for the establishment of an IVF Unit in the new EGA Hospital are in progress. Staff and finances Hayden Homer has a Wellcome Trust Clinical Fellowship (£680,000) and one post-doc research associate. Greg FitzHarris is a Lecturer and MRC New Investigator, funded by an MRC grant (£400,000) has one post-doc research associate and one PhD student. John Carroll has funding from MRC (£1.2 million), which supports two post-docs, one research technician and three PhD students. PCOS research is based at the Royal Free. Staff and finances: Paul Hardiman, theme lead, is HEFCE funded. The team comprises Rina Agrawal (locum consultant and honorary senior lecturer), Anne Marie Galagher, a fertility nurse specialist and Jackie Doyle, a clinical psychologist, funded by RF Trust. Research in sexual and reproductive health is located in the Margaret Pyke Centre. Space Three small offices (rent paid by Margaret Pyke Trust). Staff and finances Judith Stephenson (theme lead) funded by UCLH and Camden PCT. Heidi Chandler, PA/research administrator, part-funded by Camden Primary Care Trust (PCT). Sue Mann, SpR in public health, funded by Deanery. Sabeena Panicker (clinical research associate) and Jill Shawe (research nurse) are fully grant funded. PhD and MSc students are registered with UCL Division Population Health. New grant income awarded to Judith Stephenson as PI in 2007–8 is over £800,000 In Paediatric and Adolescent Gynaecology, research is carried out within the confines of NHS clinical practice. Staff include Sarah Creighton (theme lead), a senior psychologist and occasional research fellow. NHS staff have no research sessions and no academic or administrative support. Grant funding: £200,000 since 2000. Long term outcomes of DSD: Gerard Conway (theme lead); Margaret Band (research nurse) funded by Birth Defects; Dr La Rosa (Research Fellow) funded by Child Growth Foundation. Pilot projects are developed with visiting research fellows – two per year recently from Greece, Italy, Hong Kong and Spain. 66 UCL EGA IfWH 1st Quinquennial Review PERFORMANCE AND MEASUREMENT OF QUALITY OF ALL ACTIVITY Long term outcomes of disorders of sexual development The clinical resource of Turner Syndrome, PCOS, Ovarian Failure and Adrenal Hyperplasia are the largest ever developed and have become source material for wide research collaborations and UCLH based projects. In addition, the model of care has been used for new services in Europe Japan and Australia as we were the first to focus on long term outcomes of paediatric conditions. This area is now sought after by visiting research fellows to develop clinical expertise that can be applied to their home centres. Publication output is substantial relative to the size of the department, with over 270 publications since 2004. Grant income is relatively low. See appendices for full list of publications and grants. For research that has had a demonstrable impact on health care or health policy see section Impact and Importance. Other markers of esteem such as prizes and national research leadership roles: Gynaecology Diagnostic and Outpatient Treatment Unit First Walport Lecturer across all specialties in the UK to attain Clinician Scientist status (Homer); RCOG, Harold Malkin Prize and Blair Bell Society Prize (Hayden Homer) Davor Jurkovic, GDOTU Director, has a strong research record in the field of diagnostic ultrasound in gynaecology and management of early pregnancy complications. Recently (Lancet Oncol 2008) his group showed a measurable effect of improved quality of ultrasonography on the management of patients with suspected ovarian cancer in a tertiary gynaecology cancer centre, resulting in a significant decrease in the number of major staging procedures and length of inpatient hospital stay. Millennium prize for innovation for G-Test for assessment of women ovarian reserve CHALLENGES The Academy of Medical Sciences/RCP Young Investigator Award (Hayden Homer) British Fertility Society Best Young Clinician Prize (Hayden Homer) CLRN Lead for Central and East London Priority Group in Reproductive Health and Childbirth (Paul Hardiman) Mouse egg with large polar body. Chromosomes (green) are perfectly aligned at the equator of the spindle (red) Chair of the National Specialty Group in Health Services Research (Judith Stephenson) Chair of the British Society for Paediatric and Adolescent Gynaecology (Sarah Creighton). NIH working party on the Management of Turner Syndrome (Gerrard Conway). Chair of the RCOG Early Pregnancy Clinical Study Group (Davor Jurkovic) Member of National Chlamydia Screening Programme (NCSP) R&D Committee and Advisor to National Audit Office on Value-for-Money Review of the NCSP (Judith Stephenson) National and International Management Guidelines, including Consensus on Management of Intersex Disorders and Guidelines from the British Association of Paediatric Surgeons have been informed by the work of the Paediatric and Adolescent Gynaegology Group (Sarah Creighton and Gerrard Conway) Member of working group of Thalassaemia Clinical Research Network (Ratna Chatterjee) Consultant for Thalassaemia International Federation (TIF) and WHO on maternal and reproductive health in haemoglobinopathies (Ratna Chatterjee and Rekha Bajoria) AREAS OF EXCELLENCE The oocyte and embryo research programme has an international reputation for excellence in research into the mechanisms of oocyte maturation, fertilization and early embryo development. This work is led by Greg Fitzharris, Hayden Homer and John Carroll. The Assisted Conception Unit is consistently one of the leading IVF Units in the UK, with a live birth rate per cycle of treatment in women under 35 years of 65%. This combination has enormous potential to develop new and exciting translational outcomes in treatment options for assisted conception, for measuring oocyte and embryo quality and for improving IVF outcome. Early research into sperm preservation before gonadotoxic treatment was conducted by Gulam Bahadur and is now established clinical practice. Although the first human ovarian cryopreservation was performed at UCL/UCLH, management of patients at risk of infertility remains a key challenge in this field. Research at the Assisted Conception Unit has contributed to outstanding success rates in IVF. Collaboration with the Prenatal Genetic Diagnosis Group (Joyce Harper) has led to several ‘world firsts’ including the first BRCA1 tested preimplantation genetic diagnosis (PGD) baby delivered in December 2008. The same technology has been applied successfully for patients with familial adenomatous polyposis (FAP), retinoblastoma (RB) and neurofibromatosis (NF1). ACU has led the field and has become the major centre offering pre implantation diagnosis for all cancer predisposing genes. In sexual and reproductive health, UCL has the only clinical academic chair in the UK for contraceptive research. This has enabled a new UK community-based research network to be established, providing a unique opportunity for investigator-led, multicentre trials in contraception. This builds on long-established international strength at UCL (Division of Population Health) in sexual health research, including evaluation of sex education, teenage pregnancy and sexually transmitted infections. Paediatric and Adolescent Gynaecology (PAG) at the IfWH is internationally recognized as a centre for research into the long term impact on sexual and reproductive function of congenital anomalies of the reproductive system. Key areas include sexual function in adult women who have had feminizing surgery for ambiguous genitalia in childhood and the optimization of oestrogen replacement both for induction of puberty and maintenance treatment in adolescent girls with hypogonadism. Together, Sarah Creighton and Alfred Cutner’s groups have developed and published innovative laparoscopic procedures for complex mullerian anomies. It is the only unit in the UK to offer these techniques. In general terms, it is a major challenge to bring about the necessary shift in thinking and practice from the ‘old research world’ to the new research landscape of the NIHR. Part of the challenge lies in communicating these radical changes to those who would conduct research in the NHS. A particular challenge for the Department of Reproductive Health is to bring together clinicians and academics whose research has grown along separate paths and who do not necessarily feel confident or sufficiently supported to collaborate across disciplines. Such changes in thinking and working practices will be necessary to exploit the unprecedented levels of research funding that are potentially available to us. The Department of Reproductive Health is a small department with very few UCL employees. A significant amount of research is conducted by NHS clinicians whose job description does not require them to conduct research (e.g. they have no research PAs). People are also split across multiple sites, and there is no obvious ‘home’ for reproductive health. This may improve as women’ health services have moved into the new EGA wing (Phase II) and there are plans to develop an assisted conception service in the new building. Initial enthusiasm to move part of the Margaret Pyke (contraceptive) service into the EGA may not be sustained as there are other plans for integrating contraceptive and GU services elsewhere in the community. There are particular difficulties for the oocyte and embryo research in having poor access to human oocytes, compounded by the lack of an NHS IVF service, and the distance between physiology lab (Gower St) and the Assisted Conception Unit (Grays Inn Road). In Paediatric and Adolescent Gynaecology, it has been hard to obtain research funding for such a complex but small area. Ideally long term funding is needed to follow-up patients from childhood to adult life. Lack of administrative support hampers practical issues with regard to grant applications. To foster greater collaboration, monthly research seminars were held throughout 2007. These were helpful in terms of enabling colleagues to understand more about each others’ research, but attempts to hold meetings to develop a more strategic approach to research development have had limited success. Current strategy is therefore to focus on a few areas with sufficient strength and potential for the IfWH to become a leader in the field and to make a major contribution to women’s health. 67 REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – RESEARCH REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – RESEARCH UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review First demonstration that female fetuses in PCOS pregnancies are exposed to male levels of androgens. Data from animal studies show that such exposure has major lasting effects on offspring, predisposing to diabetes and coronary heart disease and influencing brain development / behaviour in adult life. Blastocyst embryos showing spindles (red) and chromasomes (blue) IMPACT AND IMPORTANCE The infertility and oocyte and embryo research underlies an area of key importance to women’s reproductive health. For IVF, the single most important determinant of success is arguably oocyte quality which is in turn crucial for embryo quality. By understanding what makes a ‘good egg’ this research theme will determine how to evaluate egg quality and manipulate it to improve IVF outcomes. In vitro maturation (IVM) is the process of producing a mature fertilisable egg capable of supporting embryogenesis from an immature precursor. Clinical application of IVM is currently limited due to low success rates. Here again, by better understanding the molecular requirements of oocyte development, our research will significantly improve the success of IVM and its use in preservation of fertility. Fertility preservation is of paramount concern to women whose fertility is threatened, for example, by cancer treatment. Oocyte freezing is one option for preserving fertility, but mature oocytes are vulnerable to spindle damage from freezing. An alternative is to freeze immature oocytes which lack spindles but the subsequent use of such oocytes would depend on reliable IVM which is currently a major stumbling block. Prevention of the inheritance of cancer predisposing genes is of paramount importance to couples at risk. ACU has pioneered PGD techniques and established the first clinical centre for the screening and treatment of patients at risk. PCOS affects around 1 million women in the UK and is associated with major morbidity, including subertility, diabetes, cardiovascular disease, cancer, pregnancy complications and neonatal morbidity. It is the commonest cause of anovulatory infertility, although there are 53,000 births each year in E&W to women with PCOS. Rates of pre-eclampsia and incidence of gestational diabetes and perinatal mortality are all raised in PCOS. Babies born to mothers with PCOS are exposed to an abnormal (hyperandrogenic) intrauterine environment which is believed to increase the risk of developing cardiovascular disease and diabetes in adult life. Examples of work that has made an important contribution to women’s health in the last 5 years include: Demonstration that endothelial abnormality in PCOS depends on elevated ADMA (asymmetric dimethyl arginine), offering prospect of new approaches to improve vascular function, and reduce maternal, neonatal and longterm morbidity. Identification of genes that are dysregulated in the endometrium of women with PCOS that will help elucidate mechanisms responsible for neoplasia and infertility / miscarriage and allow development of novel treatments for these clinical problems. 68 FUTURE DEVELOPMENTS PCOS research Oocyte and embryo research Better understanding of mechanisms responsible for abnormal follicular development in PCOS that will lead to development of more effective therapies to restore ovulation in these women. Improved understanding of the molecular regulation of meiosis in mammalian oocytes Control of fertility is essential to women’s health and an issue of human rights. Family planning is unique among medical interventions in the breadth of its potential benefits: reducing poverty, hunger, maternal and infant mortality, improving prospects for universal education and adaptation to climate change. Voluntary family planning could reduce maternal mortality by 30% by addressing the unmet need for contraception among 150 million couples (mostly in Africa) There have been major advances in understanding how meiosis is regulated in lower eukaryotes, but understanding of mammalian meiotic regulation is far less complete and virtually non-existent for human oocytes. This lack of progress reflects lack of human oocyte availability as well as technical difficulties. With the approaches that our group has developed and continues to refine, we expect to see our group lead the field within five years, making major advances in our understanding of female mammalian meiotic regulation. The huge success of family planning in the second half of the 20th century led to a halving of global fertility (from 5.5 in 1950 to 2.55 in 2005). Since then there has been a disastrous disinvestment in family planning for reasons that include a premature sense that fertility rates are no longer a problem; diversion of funds away from family planning and into HIV/AIDS programmes, and the legacy of previous inept and sometimes coercive programmes (e.g. in China and India). IVM and allied technologies The IfWH contributed to a UCL-Lancet Commission on the Health Impact of Climate Change (due to report 2009) by asserting the importance of bringing the sensitive issue of population growth into discussion about climate change. We highlighted the key role of family planning in determining whether global population reaches 7 9 or 11 billion by 2050, and the importance of meeting the huge global unmet need for contraception as a issue of human rights, as well as a means of reducing the vulnerability of the poorest communities to the effects of climate change. Results of an MRC-funded long-term trial of sex education (Stephenson et al Lancet 2004; Stephenson et al PloS Medicine, 2008) led to the intervention (RIPPLE) being included in a DH short list of sex and relationship programmes recommended to accelerate the Teenage Pregnancy Strategy. A systematic review of the effectiveness of screening for genital Chlamydia (Low et al 2009) contributed to NICE Guidance on STI prevention in young people (NICE 2007) Establishment of a UK community-based clinical research network in sexual and reproductive health, co-ordinated at Margaret Pyke Centre, UCL, has given leadership and infrastructure to support high quality investigator-led research. Disorders of sexual development, and paediatric and adolescent gynaecology Our series of papers from 2001 to 2008 confirmed that clitoral surgery as an infant is detrimental to adult female sexual function. The role of feminising genital surgery in the management of children with ambiguous genitalia has been challenged and clitoral reduction is no longer standard practice. UCLH is perfectly positioned to develop specialist services for women with unusual forms of infertility. The work on Turner Syndrome and Adrenal Hyperplasia have become international reference material for adult care. With respect to congenital adrenal hyperplasia, we have converted a fertility rate of 10% to 90% using novel combined endocrine and fertility approaches. Greater ability to promote oocyte maturation by co-ordinating the progression of meiosis with cytoplasmic maturation during in vitro culture is expected to accompany the advances described above. This will lead to increased capacity for female fertility preservation based on enhanced ability to derive mature fertilisable eggs from frozen immature oocytes. Manipulating oocyte quality Armed with improved knowledge about the cellular elements that make up a ‘good egg’, we would expect to be able to supplement poorer quality oocytes with essential molecules or activate specific signalling pathways to increase the chance of successful in vitro maturation and production of viable embryos. Currently, there are no proven techniques of manipulating oocyte quality and our systematic approaches would subvert the need for untested and potentially risky techniques such as cytoplasmic /nuclear transfer. Clinical correlates for oocyte quality and IVF success At present there is no clinical measure of oocyte quality. Given that our research framework intimately involves the clinical management of IVF patients and the molecular analysis of their eggs, we have an unrivalled opportunity to map for the very first time, clinically measurable parameters that could be used as surrogate markers for oocyte quality. Given that total ovarian reserve along with oocyte quality are the major predictors of IVF success, new clinical measures of oocyte quality will go a long way towards more accurately defining a couple’s chance at successful IVF. Dynamic embryo culture system The introduction of more physiological culture media over the last decade has resulted in improved embryo development in vitro. In vivo embryos develop in a chemically and mechanically dynamic micro environment. The objective of this research is to investigate the effect of dynamic embryo culture on embryo development using a computer controlled tilting /rotating embryo culture device placed within the incubator. If initial research with mouse embryos is successful in improving blastocyst formation, the next phase will be to apply this innovative technology to human embryos. Fertility preservation research Establishing the first egg bank in the UK to optimize the management of egg recipients and cancer patients. Investigation of the long term impact of chemotherapy on ovarian reserve. Investigation of assisted laser shrinkage and vitrification of human embryo in order to minimize cyroinjury to the cell. Development of on vitro maturation of oocytes prior to IVF/ICSI to avoid the risks of ovarian hyperstimulation syndrome (PCOS women are at particular risk). Specific interventions to induce weight loss in the 30% of PCOS women who are obese. These interventions may be non pharmacological, such as the programme of cognitive behavioural therapy that we are currently evaluating. Drug therapy to reduce the excess maternal and neonatal morbidity associated with PCOS. Increased use of preventative therapy in PCOS women to reduce long term morbidity/mortality from diabetes, heart disease and endometrial cancer. Sexual and reproductive health Development and evaluation of family planning interventions in India and Africa in collaboration with a major programme of maternal and child health interventions (Director A Costello) Consolidating new links with Marie Stopes International, a major global provider of family planning. We have evaluated MSI’s global training programmes and plan to evaluate the impact of their highly innovative tubal ligation (sterilisation) outreach programme. Build on the newly–established UK research network of community-based S&RH services to conduct high quality investigator-led research that helps women choose and continue to use effective contraceptive methods to prevent unintended pregnancy. Build on international strength in STI research and improve diagnosis of pelvic inflammatory disease – an essential prerequisite to evaluate the effectiveness of the National Chlamydia Screening Programme (NCSP). We have the opportunity to incorporate sexual and reproductive health care within the new EGA hospital, demonstrating that control of fertility is essential to women’s health, and providing a seamless women’s health service of primary, secondary and tertiary care from puberty to beyond the menopause. Disorders of sexual development and paediatric and adolescent gynaecology Focus on transition of adolescents with DSD and increasing involvement of patient groups and the expert patient. Move away from surgical and condition based research to holistic assessment of long term well being of individuals with DSD. Increasing emphasis on psychological interventions as an alternative to genital surgery. Join international collaborations using the cohorts built over the past five years, including Genetics of Ovarian Failure, GH replacement in older women with Turner Syndrome and cardiovascular management of Turner Syndrome. 69 REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – RESEARCH REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – RESEARCH UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review TEN KEY REPRODUCTIVE MEDICINE AND BENIGN GYNAECOLOGY PUBLICATIONS AT IfWH 2004-09 Costello A, Abbas M, Allen A, Ball S, Bell S, Bellamy R, Friel S, Groce N, Johnson A, Kett M, Lee M, Levy C, Maslin M, McCoy D, McGuire B, Montgomery H, Napier D, Pagel C, Patel J, de Oliveira JA, Redclift N, Rees H, Rogger D, Scott J, Stephenson J, Twigg J, Wolff J, Patterson C. Managing the health effects of climate change: Lancet and University College London Institute for Global Health Commission. Lancet 2009;373:1693-733 Major Lancet-UCL Commission Report showing that climate change is the biggest global threat of the 21st century. (Stephenson is one of 28 multidisciplinary co-authors). Included is the fundamental role of population growth and family planning in mitigation and adaptation responses to climate change. Wilkinson P, French R, Kane R, Lachowycz K, Stephenson J, Grundy C, Jacklin P, Kingori P, Stevens M, Wellings K. Teenage conceptions, abortions, and births in england, 19942003, and the national teenage pregnancy strategy. Lancet 2006;368(9550):1879-86. First independent academic publication describing teenage conception, abortion and birth rates in England before and after introduction of the National Teenage Pregnancy Strategy, with interpretation of falling rates. Wilkinson P, French R, Kane R, Lachowycz K, Stephenson J, Grundy C, Jacklin P, Kingori P, Stevens M, Wellings K. Teenage conceptions, abortions, and births in england, 19942003, and the national teenage pregnancy strategy. Lancet 2006;368(9550):1879-86. First independent academic publication describing teenage conception, abortion and birth rates in England before and after introduction of the National Teenage Pregnancy Strategy, with interpretation of falling rates. Stephenson J, Strange V, Allen E, Copas A, Johnson A, Bonell C, Babiker A, Oakley A, Brodala A, Charleston S, Flux A, Hambidge S, Johnston G, Monteiro H, Petruckevitch A. The long-term effects of a peer-led sex education programme (RIPPLE): A cluster randomised trial in schools in England. PLoS Medicine. 2008;5(11):1579-90. Long-term cluster randomised trial of sex education in schools in England showing that peer-led sex education (RIPPLE) was preferred by pupils, and associated with delayed first sexual intercourse (Stephenson et al, Lancet 2004) and possibly fewer conceptions in girls. Low N, Bender N, Nartey L, Shang A, Stephenson JM. Effectiveness of chlamydia screening: systematic review. Int J Epidemiol 2009;38:435-448 FitzHarris G, Marangos P, Carroll J. Changes in endoplasmic reticulum structure during mouse oocyte maturation are controlled by the cytoskeleton and cytoplasmic dynein. Developmental Biology 2007;305(1):133-144 Demonstration that cytoskeletal components and cytoplasmic dynein are required for reorganising the cytoplasm of the mammalian oocyte in readiness for fertilisation. Mantzouratou A, Mania A, Fragouli E, Xanthopoulou L, Tashkandi S, Fordham K et al. Variable aneuploidy mechanisms in embryos from couples with poor reproductive histories undergoing preimplantation genetic screening. Human Reproduction 2007;22(7):1844-1853 WOMEN’S CANCER REPRODUCTIVE HEALTH AND BENIGN GYNAECOLOGY – RESEARCH UCL EGA IfWH 1st Quinquennial Review Pillay OC, Te Fong LF, Crow JC, Benjamin E, Mould T, Atiomo W, Menon PA, Leonard AJ, Hardiman P. The association between polycystic ovaries and endometrial cancer. Human Reproduction 2005;21(4):924-929 First published study of the prevalence and prognosis of endometrial cancer in women with polycystic ovaries. Bahadur G, Ozturk O, Muneer A, Wafa R, Ashraf A, Jaman N et al. Semen quality before and after gonadotoxic treatment. Human Reproduction 2005;20(3):774-781 Unique large-size study providing data on the quality of semen before and after gonadotoxic treatment over a period of 26 years. The paper also provides information on post-treatment recovery potential and the impact of treatment on the quality of life of the male cancer patient, which can be utilised in patient counselling. Casteràs A, De Silva P, Rumsby G, Conway GS. Reassessing fecundity in women with classical congenital adrenal hyperplasia (CAH): normal pregnancy rate but reduced fertility rate. Clin Endocrinol (Oxf). 2009 Jun;70(6):833-7. Improvement in pregnancy rate from the previous 10-30% per patient to 90% using a new combined endocrine and fertility protocol, which was a hot topic at ENDO 09 Washington DC, June 2009. Koulouri O, Conway GS. A systematic review of commonly used medical treatments for hirsutism in women. Clin Endocrinol 2008;68(5):800-805 The first systematic review of treatments for hirsutism. This paper led on to a request for a Clinical Review for the BMJ published in March 2009. Systematic review for NICE of the effectiveness of different approaches to screening for Chlamydia infection, showing mismatch between the evidence base and current policy and practice in the National Chlamydia Screening Programme. 70 71 UCL EGA IfWH 1st Quinquennial Review WOMEN’S CANCER WOMEN’S CANCER – clinical OVERVIEW The Gynaecological Cancer Centre (GCC) at University College London Hospitals (UCLH) NHS Foundation Trust supports a multidisciplinary team (MDT) that aims to provide complete care for women with gynaecological cancers. The clinical lead for gynaecological cancer is Miss Adeola Olaitan and the academic lead is Professor Ian Jacobs (see Appendix 6.1 for details of other members of the core MDT). Simon Gayther Sue Gessler Ian Jacobs Christopher Jones The GCC MDT provides comprehensive care for women suffering from gynaecological cancer within the North London Gynaecological Cancer Network (NLGCN). Referrals are received from five unit hospitals, each of which has a lead gynaecologist for cancer (Appendix 6.1), who liaises closely with the centre MDT about patient care. Referral guidelines, based on the Clinical Outcomes Group (COG) guidelines (1999) were agreed by the Gynaecological Tumour Board in 2001. In addition, the UCLH cancer centre serves as the unit hospital for its local population and direct referrals from General Practitioners are assessed at a weekly Rapid Access Clinic. The catchment population is approximately 1.5 million women and a total of 477 cancers were treated in 2007, of which 312 were new cancer diagnoses. Anne Lanceley Jonathan Ledermann Usha Menon Tim Mould The Breast Service at UCLH is part of the North London Cancer Network (NLCN), and is linked closely to St Bartholomew’s Hospital (Bart’s) to the east. Breast services occur at three levels – screening, diagnostics and cancer treatment. Screening services for the sector are located at Bart’s. UCLH provides diagnostic services for the local population plus oncoplastic surgery and oncology treatments for women with cancer. Adeola Olaitan John Timms 72 Susan Ramus Jayant Vaidya Adam Rosenthal Martin Widschwendter Andy Ryan Alexey Zaikin At present, the service is undergoing a major reconfiguration. The diagnostic services are being redesigned and the surgical input is changing from a service led by UCL clinical academics to one led by trust-funded surgeons. It is expected that referral numbers will increase with this development, and also that clinical research will continue. There are sophisticated video-link facilities with unit hospitals so that cross-site discussions can occur in real time. There are evidence-based centre protocols for the management of all gynaecological cancers but each patient’s care is individualised following MDM discussion. Psychological support is offered by the Clinical Nurse Specialist (CNS) network and integral psychology team. We have built up close working relationships with all major associated specialties as listed in Appendix 6.1 – Extended MDT External Links Colposcopy and Rapid Access Clinics (RAC) The Colposcopy Service is integrated within the Gynaecology Oncology Service and has recently undergone a successful quality assurance (QA) visit. Patients referred by their GPs with suspected cancer are seen in a weekly RAC. If cancer is diagnosed, they are managed through the JOC and MDT. The introduction of the gynaecological diagnostic unit, has transformed the RAC to a truly one-stop service. Familial Clinic This clinic, led by Dr Menon, provides information, risk assessment and management and support to women at high risk of ovarian or endometrial cancer due to a family history of the disease. The main strategies involve prophylactic surgery and screening. Morbidity The Reproductive Medicine Unit provides in vitro fertilisation (IVF) and ovum or ovarian cryopreservation for young patients about to undergo cancer treatment expected to result in loss of reproductive function. Treatment-related morbidity can present as genital tract stenosis, prolapse or incontinence and these patients are managed with the uro-gynae team. Women are referred for symptomatic relief of menopausal symptoms and a range of complementary therapies to the Royal Homeopathic Hospital. Education and Training Links with the medical school, national and international units help to raise the profile of UCLH woman’s health department locally and worldwide and ensure excellent care for women with gynaecological malignancies into the future. STRATEGY, AIMS AND OBJECTIVES Undergraduate Student firms rotate through gynaecological oncology. The GCC aims to provide comprehensive care to women during cancer treatment and beyond, within the core MDT and by strategic links to other important services. The strategy for the breast unit is a complete reconfiguration to a modern lean service linked with our partners within the sector. Postgraduate UCLH GCC has two accredited sub-specialty training posts in gynaecological oncology and is one of the few centres that can offer a combined clinical and academic training. The Royal College of Obstetricians and Gynaecologists (RCOG) awarded training recognition in 2002. The posts received accreditation for European training in 2007. The weekly joint oncology clinic (JOC) and the Multidisciplinary meeting (MDM), both attended by the core MDT, are the main focus of patient care in the GCC. All new referrals are seen at the JOC. There were a total of 4,090 outpatient appointments in 2007. Patient care is supported by MDM discussion. Breast UCLH wishes to keep screening at Bart’s while we will provide rapid one-stop diagnostics for women with breast lumps and 73 WOMEN’S CANCER – clinical WOMEN’S CANCER UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review positive screening tests, and provide high quality surgical treatments and oncology treatments. To address the relatively small numbers of cancer, treatments and protocols will be linked with other members of the NLCN, and with Bart’s, to provide a cancer partnership in which numbers of cases can be pooled. This will provide a critical mass of cases for data presentation. The sector will take advantage of the UCL Academic Health Sciences Partnership (UCLP) to drive forward these changes and to embed clinical research across the units in the sector. Administrative Surgical wound surveillance We do not meet the trust guideline that recommends that letters are received by the GP within five days of the consultation. A fulltime data manager was appointed in November 2008 increasing administrative support at the centre. The duty of the data manager is to collect good quality network wide data in order to fulfil cancer plan standards. Started at UCLH in May 2000, using a grant from the Special Trustees and is now funded by the Surgical and Women’s Health Divisions. The audit data have shown a fall in asepsis >20 rates from 10% in 2005/6 to 4.7% in 2007/8 on T13, where the majority of patients undergoing complex surgery are under the care of gynaecological oncologists. The rates for gynaecological surgery were less than 2% in 2007/8. RESOURCES A business case has been approved by the trust to redesign the MDTs of the breast service. This includes: Two new radiologists for the diagnostic team, 2.5 substantive surgical posts for the diagnostic and oncology MDTs. At present the surgical support comes from colleagues at Bart’s on a temporary contract basis. The team already has breast CNS support, specialist cytology, histopathology and three oncology consultants providing high quality input to the teams. Inpatients Ten surgical beds are available on the gynaecology and breast ward, T13 for gynaecological cancer surgery, which is adequate for our needs. The Trust has 40 Intensive Care Unit (ICU) and High Dependency Unit (HDU) beds and a Patient Emergency Response Team (PERT) system, which meets the recommendation of the Comprehensive Critical Care Review (2000). The planned development of a 24 hour recovery should reduce the (low) surgical cancellation due to lack of Intensive Therapy Unit (ITU) beds. There are still delays with accepting inpatients from units. Approximately one patient is transferred per month and the mean waiting time is 2.5 days, which we aim to reduce to 24 hours, and need beds to accommodate this. There is a move towards more efficient patient care and the enhanced recovery program will ensure more rapid patient turnover and should increase the availability of beds. Outpatients The JOC is temporarily located in a clinic space converted from a ward. The waiting area is inadequate for the large number of patients and their relatives and consulting space for the CNSs and research nurses is limited. The Cancer Centre, due to be completed in 2012, will provide excellent facilities, but there is an urgent need to address the clinic situation in the short term. We have been in consultation with the Outpatients Manager to ensure she prioritises improving the JOC environment. In addition, we are piloting innovations such as nurse-led toxicity-scoring for chemotherapy patients to increase the efficiency of the clinic and reduce waiting times for patients. Staff Surgical The Gynaecology Network Site Specific Group (NSSG) recommends 3.5 whole-time equivalent (WTE) gynaecological oncologists per million population, and that adequate consultant staffing should be included as a measurable standard for the peer review process (Nordin A, Belfast 2007). UCLH GCC has 3 WTE, adequate for demands. Psychology Many of the innovative interventions are run using trainees and volunteers. The peer support service is funded entirely by research grants. Current funding ends in March 2009. Other initiatives include the use of graduate mental health workers to deliver psychological interventions to patients within the community and the use of screening methods such as the ‘distress thermometer’ to identify which patients need increased intervention. 74 Breast Facilities One-stop diagnostic clinics have been created in the new EGA Wing, Level -1. State-of-the-art mammography and stereotactic biopsy equipment has been purchased. This is co-located with the latest ultrasound (US) machines. The service has cytology and radiology reporting facilities in the clinic. The inpatient beds are colocated with gynaecology beds in T13 south ward. All of the beds in this ward are managed by Women’s Health. Breast surgery has four theatre lists. There are two SpRs who have combined breast and endocrine jobs to support the service. PERFORMANCE AND MEASUREMENT OF QUALITY OF ALL ACTIVITY Clinical External assessment Administration The Gynaecological Oncology coordinator post at UCLH has been highlighted by the NHS Modernisation Agency as a case study in support of having an MDT Co-ordinator in all tumour sites. A poster highlighting the difference in service between having and not having a co-ordinator was on show at the 2003 Modernisation Conference (winning 2nd prize) and later at UCLH. Patient satisfaction Nurse-led clinic survey A structured survey in 2007 showed that 62% of women reported being seen within a month of their referral to the nurse led clinic. Women reported that they felt they were offered significant time to discuss issues important to them. Same day pre-assessment survey This showed that 90% of women attending this clinic considered pre-assessment to be a standard procedure and 70% thought it was a good idea. 40% were happy to be offered appointments the same day and 20% highlighted the advantage of fewer visits to the centre. Patients’ views on a centralised service In 2002, women’s attitudes towards service centralisation for the treatment of gynaecological malignancies were evaluated by an independent researcher using a paper-based questionnaire. 77% of respondents indicated a preference for the centralised clinic. Travel costs and proximity of the clinic were given low priority in contrast to the unanimous importance placed on expertise, reputation and availability of appointments (Hackman N, et al Abstract 740 International Journal of Gynaecological Cancer 2004 Volume 14, suppl 1:205). Patient information 85% of patients surveyed said they received sufficient information about their diagnosis, treatment and other services, but only 36 of 70 women surveyed said they had received appropriate information at their unit hospital before coming to the cancer centre. This issue is being addressed by the cross-site CNSs. Yvonne Tapper and Emma Elliott came runner-ups in the poster prize competition in the UCLH Partners in Practice Conference, presenting their work on the nurse-led clinic patient satisfaction survey results. Survival The GCC has prioritised the need for accurate survival data and these will be available in the 1st quarter of 2009. Research UCL is the lead centre for two national screening trials in ovarian cancer and three national studies in ovarian cancer cervix cancer treatment. In addition to clinical trials, there is a strong laboratory research programme. A full account of research within gynaecological oncology is provided elsewhere in the submission. In Clinical Psychology, Nancy Pistrang, Senior Lecturer and joint Research Director in Clinical Psychology UCL, and Sue Gessler have been awarded a Cancer Research UK (CRUK) Proof of Principle Grant to develop their innovative Peer Support Service. This qualitative and quantitative study will test the hypothesis that patients can provide appropriate and effective psychological support for each other. Other projects include a study to examine factors contributing to the psychological resilience of older women undergoing radical treatment, and a ward-based study to examine expressive writing as a psychological intervention to improve recovery from surgery. Dr Gessler is able to advise on appropriate psychological measures for research studies throughout the GCC. The GCC was externally assessed by the Peer review teams in 2001 and 2005 and meets 97% of the Improving Outcomes Guidance Cancer Manual standards. The service outperforms national standards with 0% breeches for target referral appointments, 99.4% cancer patients within treatment target times and 92% of cases in the network compliant with guidelines. There is embedded psychosocial support and 85% patient satisfaction with CNS support. Communication In 2007, GPs across the network were surveyed for their views on the quality of patient-related information they received from the GCC. 86% said they received good, satisfactory or excellent communication from the GCC (GP Links May 2008). An annual report ensures network-wide communication. Surgical outcomes Theatre occupancy is 100%. A Possum® scoring system for assessment of surgical morbidity and mortality used by the gynaecological oncology surgeons has shown consistently low actual against expected morbidity, with a ratio of 0.2. 75 WOMEN’S CANCER – clinical WOMEN’S CANCER – clinical UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review Breast Research • Anne Lanceley was awarded a Senior Lecturer post in 2008. • Target cancer referrals in diagnostic clinics: 100% Cancer Research UK and UCL Cancer Trials Centre (CTC) is a National Cancer Research Institute (NCRI) accredited national trials centre with responsibility for national and local trials in gynaecological cancer. Professor Ledermann, who is the Director, is leading three national and international trials in ovarian cancer, and Dr McCormack is the lead for a national cervical cancer study. The centre will run the PORTEC-3 intergroup study in the UK, which is a randomised Phase III trial, comparing concurrent chemoradiation and adjuvant chemotherapy with pelvic radiation alone in high risk and advanced stage endometrial carcinoma. The Centre also has two further ovarian cancer trials, in set-up or development, in mucinous ovarian cancer and intraperitoneal therapy of ovarian cancer. The CTC provides a resource to develop local translational studies in gynaecological cancers. • Professor Ledermann is Chair of the NCRI Ovarian Cancer subgroup, a member of the NCRI Gynaecological Cancer Studies Group and the executive board of the Gynaecological Cancer Intergroup. • Cancer waiting time targets for diagnosed cancer: 100% • Cancer manual 1* standards in external peer review: 77% • User satisfaction survey: 94% described care as good or excellent AREAS OF EXCELLENCE Education Undergraduate In 2006-07, Miss Olaitan received the medical school recognition award for educational excellence. Mr Silverstone and Mr Mould received the award in 2007-08. Postgraduate Three training fellowships, ESGO, BSCCP and IGCS were awarded in 2008. In addition, gynaecological oncologists from other centres within the UK attend our surgical lists to learn the highly specialised techniques we offer at UCLH. Clinical Psychology Dr Gessler is an accredited trainer for the Department of Health’s Advanced Communications Skills Training. She has set up a training placement for the London doctoral training in Clinical Psychology. The team has links to the Marie Curie Research Unit (Behavioural Sciences) in the Medical School and the Department of Clinical Health Psychology at UCL. Clinical pathways The NLGCN management pathways and guidelines were reviewed in 2007 and ratified by the Tumour Board. This document was picked out by the Peer Review team of 2005 for special merit and displayed on the Peer Review website as an outstanding example of how a network should be organised. The GCC was selected as a test site for the NHS Improvements Survivorship pilot in 2008. The CNS team has been selected as a test site to pilot the national patient information prescriptions. These projects derive from the objectives set by the Cancer Reform Strategy and the team will assist in influencing the development of this nationally in the near future. UCLH is a centre of expertise for minimal access surgery nationally and all laparoscopic procedures for gynaecological cancer are offered. Nurse development At UCL, despite the absence of a school of nursing, nurse-led patient care research, with a focus on gynaecological cancer, driven by Dr Anne Lanceley, has developed within the Institutes of Child Health and Women’s Health. The award of UCLH/UCL Comprehensive Biomedical Research Centre (CBRC) funding of £0.5 million for a new, nurse-led Centre for Patient Care Research and Innovation (PCRIC) will allow for a more coordinated approach to research. Nurse-led research within gynaecological oncology has allowed the development of methodologies that explore the patient’s experience of care and measure patient benefit outcomes. There have, in addition, been innovations in patient/ public involvement in research. 76 Immunotherapy Ovarian Cancer This is a collaboration between the Cancer Institute and Department of Immunology, Windeyer Institute (Professors Chain and Collins). The group has recently received funding from Ovarian Cancer Action for further studies in patients. This will be conducted jointly at UCLH Gynaecological Cancer Centre and the Royal Marsden Hospital, London. • Sue Gessler chairs the North London Cancer Network Psychosocial group. She is on the panel of the ‘Ask-the-Expert’ sessions at the Chai Cancer Centre. She has spoken at the International Psychosocial Oncology Society Conference both in 2006 and 2007, as well as at national meetings on psychological assessment and screening of patients with cancer. Breast The one-stop diagnostic clinics fulfil the ultimate standards in modern breast diagnostics. Oncoplastic surgery is state-of-the-art in breast surgery. Oncologist services in both clinical and medical oncology are outstanding. CHALLENGES Gynaecology Other Chemotherapy on wards to reduce waits All Consultants are invited as experts to speak at local, national and international meetings. With input from the oncology team, the ward sister on the gynaecology ward devised a protocol whereby post-operative patients could receive chemotherapy on T13 under supervision by trained staff from the oncology ward. This has obviated the need for patients to travel back to the centre for their next dose of chemotherapy shortly after leaving the surgical ward. • Ian Jacobs was President of the British Gynaecological Cancer Society 2003-05 and President of the European Society of Gynaecological Oncology 2005-07. • Adeola Olaitan is a lead assessor on GMC peer review and undertakes comprehensive assessments when the practice of a doctor within the specialty is called into question. • Adeola Olaitan is a spokesperson for the NHS Cervical Screening Programme and gives expert opinion to the media. • Adeola Olaitan and Tim Mould are sub-editors of the RCOG flagship publication ‘The Obstetrician and Gynaecologist.’ • The German Obstetrics and Gynaecology Society awarded Martin Widschwendter the prestigious Schmidt Matthiesen Prize at its annual conference in Hamburg in September 2008. • Emma Elliott, lead CNS, is the president for the National Forum of Gynaecological Oncology Nurses. She sits on the national nursing advisory board for Glaxo Smith Kline, manufacturers of Hyacamtin chemotherapy for advanced ovarian cancer. One-stop service Four slots have been made available in the pre-assessment clinic so that patients can be seen and assessed on the same day as they attend the JOC if surgery is planned, as patients often travel in from a long distance. A survey of patient views (see outcome criteria) has shown good satisfaction rates with this service. Timely review of radiology and pathology A courier service has been employed (April 2009) so that patient radiology and pathology can be collected from unit hospitals in a timely and predictable fashion, allowing decisions about treatment to be made without delay. Rehabilitation pathways but the collection of cancer waiting times has reduced the time available for admin staff to collect data. In November 2008, the GCC appointed a full time data manager, Oscar Riches, whose sole duty is to collect good quality data network wide. Breast The transformation of the breast service from a low cancer number unit run by UCL clinical academics with a poor grant income and limited research output, into a trust led service linked into a clinical breast cancer network. The linkage of the clinical units into a single coherent network with clinical and translational research embedded throughout as part of UCLP. IMPACT AND IMPORTANCE Gynaecology The care of women with gynaecological cancers has been restructured over the last ten years in the UK. UCLH is a successful example of how care structure can be effectively changed with the creation of a cancer network with a single site Gynaecological Cancer Centre. This has allowed the creation of a specialist multi-disciplinary team at the cancer centre. Women presenting to any of the unit hospitals in the network are transferred to the specialist team at the Cancer centre to allow them access to the best possible care. Areas in which impact has been greatest are as follows: Psychosocial Dr Gessler, consultant psychologist, has created an integrated and responsive psychology team that has developed over the last four years to strongly influence all aspects of clinical work, teaching and training, and research in gynaecological oncology. Dr Gessler has had an important input to patient leaflets on fertility, menopause and sexuality after treatment. She is an investigator on the Genetic Cancer Prediction through Population Screening (GCaPPS) study, a randomised controlled trial (RCT) looking at the feasibility of offering breast cancer susceptibility (BRCA) gene testing to at risk communities, with a major emphasis on psychological outcome measures. The peer support study is reaching the end of its CRUK funding, but has been reported on at the International Psycho-Oncology Society (IPOS) Congress (London 2007) and will seek further funding. To ensure that rehabilitation after surgery or non-surgical oncological intervention is provided close to the patient’s home, liaisons have been established between palliative care consultants at unit hospitals. Emma Elliott won the Nursing poster prize at the IfWH conference in November 2007 for a poster relating to her work in establishing the North London Cancer Network rehabilitation pathway and is the lead for rehabilitation within the NLCN, now a peer review requirement. In 2008, two pilot studies were completed with doctoral trainees. Dr Gessler also contributes to studies with the General Clinical Research Centres (GCRC), notably Dr Anne Lanceley’s randomised controlled study of nurse-led follow-up in ovarian cancer, and Penny Allen’s study of symptoms of women who subsequently develop ovarian cancer. Outreach Services A psychological screening tool, the ‘Distress Thermometer’ (DT), is being piloted in the oncology clinic. Having identified individuals at risk or in need of help, they are reviewed at the psychosocial MDM and discussed at the clinical MDM with other members of the team, and a variety of interventions offered. The validation of the Distress Thermometer has led to links with Marie Curie and plans are underway to develop an outcome study with Marie Curie funding to measure impact of the DT in clinical practice. Patients referred from Harlow have difficulty travelling to the centre for chemotherapy and in 2009 we agreed a joint protocol to allow eligible patients to receive chemotherapy locally. Data collection The business plan for the development of the GCC included the provision of a data manager to prospectively collect survival data, Distress Thermometer 77 WOMEN’S CANCER – clinical WOMEN’S CANCER – clinical UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review CNS Network FUTURE DEVELOPMENTS The NLCN was the first to appoint CNSs in joint posts between the Unit and the centre and this provides an excellent example of seamless care. Other networks are adopting this model. Gynaecology Nurse-led clinics These were developed at the GCC by the lead Clinical Nurse Specialist in 2004. Since then parallel clinics have been developed at three unit hospitals. The total number of patients seen at UCH has increased from 51 in 2004 to 112 in 2007. Audit The Gynaecological Oncology Department has participated actively in the women’s health audit program and presents audit data at an annual gynaecology oncology audit day. This presents an opportunity for doctors in training to carry out an audit on a subject that interests them (Yu C et al, Delayed Diagnosis of Cervical Cancer in Young Women, Journal of Obstetrics and Gynaecology, 2005; 25(4): 367 – 370; Yu C K et al. Total laparoscopic hysterectomy as a primary surgical treatment for endometrial cancer in morbidly obese women. BJOG 2005(112):1150-117)). Patient information The importance of accurate and complete patient information has been highlighted in the new Cancer Reform Strategy (2008). Re-formatted North London Gynaecological Cancer Network information leaflets were distributed throughout the Network in 2006. Lymphoedema Information A new patient information booklet, ‘Advice for prevention of lymphoedema’, has been produced by Kay Eaton, Lead Oncology Nurse for the Trust. Jan Simmons, Macmillan Lymphoedema project lead for the Trust, has produced a patient ‘bookmark’ or card which women can carry in the postoperative phase and which includes pathways to follow in case of symptoms of oedema or infection, and how to find a lymphoedema clinic. There are also information posters for clinical areas. Familial Ovarian Cancer Clinic This is a tertiary service for women at increased risk of ovarian or endometrial cancer due to a family history of the disease. Referrals are received from the Clinical Genetics Services at Guys and St Thomas, Royal Marsden Hospital North East Thames Genetic Services and the Kennedy Galton centre and North West Thames Genetic services, in addition to GPs and gynaecologists from all over the South East. The team also supports the BRCA carrier clinic at Guys and St Thomas NHS trust. WOMEN’S CANCER – RESEARCH Communication Improved communication with patients is a focus of the new cancer reform strategy and training for Senior Health Professionals in Advanced Communication Skills is mandatory and will be assessed in peer review. Dr Sue Gessler is an accredited trainer and the aim is for all Consultants to have completed the course in the next three years. Training Whilst surgical gynaecological oncologists undergo a formal subspecialist training programme, recognised by the GMC, formal subspecialist gynaecological oncology training programmes do not exist for the other core specialties within the multidisciplinary teams. The GCC is developing a post-FRCR (Fellowship of the Royal College of Radiologists) training fellowship for clinical oncologists wishing to specialise in gynaecology, exposing them to relevant surgical and specialist oncological procedures. Establishing such a post before it becomes mandatory will again strengthen our position as a leading cancer centre. Nurse development We expect an appointment of Chair of Nursing in Women’s Health in the near future to strengthen nurse-led research within gynaecological oncology. The UK Clinical Research Collaboration (UKCRC) plans for building the nurse research workforce will be implemented and at UCL/UCLH the building block of advanced nursing research education will be firmly in place with a new MRes programme starting September 2008. This will help build nurse research profile in women’s health and generally. OVERVIEW This theme, led by Professor Ian Jacobs, has been developed over 20 years through a stepwise progression of cumulative advances in grant funding, research staff recruitment, technological expertise, space and equipment. For diagram of organisational structure, please see Appendix 7.1. The research focus is on the following areas. Gynaecological Cancer Research Unit (GCRU) Lead – Dr Usha Menon A multidisciplinary group of 35 academic and clinical staff and students working in teams to oversee and coordinate four large multicentre trials focused on screening and early detection of ovarian cancer and a multitude of smaller related projects, and run the familial gynaecological cancer clinical services at UCLH. • risk prediction and prevention • screening and early detection Genomics • molecular carcinogenesis Lead – Dr Simon Gayther • disease management. This laboratory team comprises three senior postdoctoral scientists, three research assistants and eight PhD students. The main aims of the research programme are to establish the underlying genetic and epidemiological basis of susceptibility to epithelial ovarian cancer and the molecular basis of ovarian cancer development. Four well-established research groups (first four below) form the core. The nursing research group together with recent recruitment of experts in breast cancer, systems medicine and clinical cancer genetics brings together other core specialties working in these research areas. A weekly group leaders’ meeting and a research seminar series nurture cross-fertilisation of ideas and commitment to a shared vision and strategic approach amongst approximately 55 researchers. Close integration of clinical and basic science expertise is a key strength, with eight joint appointments between UCL and UCLH. Epigenomics Lead – Dr Martin Widschwendter The focus of this group, comprising a postdoctoral scientist, a technician and three PhD and MD students, is the role of epigenetics in carcinogenesis and development of DNA methylation biomarkers for the detection and characterisation of cancers. Cancer Proteomics Diagnostics Lead – Dr John Timms The increased tendency to individualise patient management has, over the years, led to an increased demand for radiological diagnostic and treatment tools including MRI, CT scan, CT PET, radiological-guided biopsies and insertion of inferior vena cava (IVC) filters. It is essential to ensure that the capacity in radiology matches this clinical demand and a constant review of manpower is required. Current staff comprises one post-doctoral scientist, two research technicians and two PhD students. Research aims to identify clinically useful biomarkers for screening and early diagnosis of women’s cancers and advance the understanding of carcinogenesis through the application of proteomic methods. Nursing and Patient Care Research Breast Lead – Dr Anne Lanceley The creation of a breast cancer network with the different units working seamlessly together. One head of service would work across the trusts to co-ordinate this structure. This head of service would also lead the Academic Health Science Partnership for Breast Services, thus embedding translational research and clinical trials across the centre. Dr Lanceley is in the process of expanding her group with a focus on enabling women to proactively manage their health and to identify ways in which carers, including health care professionals, can work to support this objective (Appendix 7.2). Computational and Systems Medicine (CSM) Breast Lead – Professor Alexey Zaikin As part of a linked network, UCLH can reduce both mortality and morbidity from breast cancer and its treatment. The major impact of the service will be as part of a combined centre with 700 cancers across the network. This will create a substantial resource to link to translational research and the biomedical research centre. Currently with three PhD students, the group investigates new biological phenomena and functions related to cancer, and analises high-throughput mass spectrometry, epigenetics and genomics data. The long-term strategy is to develop a systems approach to cancer and establish links between experimental groups of the IfWH and theoretical departments at UCL (Appendix 7.3). 78 Paul O’Gorman Building, where many of Women’s Cancer Research laboratories are now located 79 WOMEN’S CANCER – RESEARCH WOMEN’S CANCER – clinical UCL EGA IfWH 1st Quinquennial Review Lead – Dr Jayant Vaidya The recent appointment of Jayant Vaidya as a Senior Lecturer at the IfWH and Division of Surgery and Interventional Science aims to forge research collaborations between surgery and IfWH on optimal treatments for breast cancer (Appendix 7.4). Clinical Cancer Genetics Lead – Dr Lucy Side Strategic development of clinical genetics services for breast and gynaecological cancers is a priority for the Women’s Health theme of UCL Partners. The appointment of Dr Side as Senior Lecturer in the IfWH is crucial to taking this forward. STRATEGY, AIMS AND OBJECTIVES Mission To reduce deaths and suffering from women’s cancers through a combination of research, training and clinical implementation in the key areas outlined above Strategy There have been fundamental conceptual shifts in identifying risk factors for disease and in implementing screening and public health measures during the last 10-15 years. These advances have led to a reduction in deaths from a number of conditions such as breast cancer and cardiovascular disease. Our aim is to make similar inroads into deaths from gynaecological malignancies by focusing on risk prediction screening and early diagnosis. The ethos is one in which the multidisciplinary team works at the highest levels of mutual support and collaboration to realise the potential of a series of translational research programmes. Aims and objectives Risk prediction and prevention Our ability to lead and contribute to international efforts to establish risk prediction strategies to prevent women’s cancers is built around our long-standing expertise in population-based screening trials and cohort collections, and in the areas of genetic and epigenetic susceptibility to cancer. Current objectives are set out below: • To identify epidemiological and genetic risk factors in the population and develop strategies to predict women at highest risk for targeted intervention, for example screening • To identify novel methods of risk prediction by analysis of vaginal secretions and liquid based cytology • To construct in silico models and classifiers, which are able to explain experimental results, classify or predict them Screening and early detection • To discover and validate new biomarkers for early detection • To enable earlier diagnosis of ovarian cancer through better understanding of symptoms • To apply genomic and proteomic screens of models of carcinogenesis to identify novel, differentially expressed biomarkers for screening • To establish homotypic and heterotypic three dimensional in vitro models of the normal ovary, to study the early stage progenesis of ovarian cancer Egyptian figurine (500-580BC) used in the bedside touch and heritage object-handling project with women with gynaecological cancer • To characterise the basis of stem cell chemoresistence to ovarian cancer • To establish homotypic and heterotypic three dimensional in vitro models of ovarian cancer for identifying and testing novel molecular therapies for the disease • To establish an animal model to test and support the hypothesis that endometrial cells serve as the cell of origin for ovarian cancer • To utilize in vitro and in vivo models of disease described above to follow-up the functional effects of genetic and epigenetic susceptibility markers of disease Management of disease • To test whether intraoperative radiotherapy is sufficient for local control in breast conserving therapy. • To improve risk prediction by exploring the role of systematic screening for known gene mutations in high risk populations • To establish molecular approaches to the clinical diagnosis and management of gynaecological cancers based on genetic and DNA microarray technologies • To develop new diagnostic and treatment methods based on computational and experimental research of new biological phenomena and functions related to cancer There has been an active policy to recruit and retain high calibre clinical and basic scientists. There are currently 55 members of staff. Funding has recently been identified to recruit dedicated staff to manage collaborations involving trial biobanks. Equipment Financial Molecular carcinogenesis We have developed a basic research theme in molecular carcinogenesis for ovarian cancer to complement and support our translational research focus. By establishing models of disease development we aim to both identify and test functionally relevant biomarkers associated with susceptibility, screening and therapeutic intervention. The specific strategies are: Staff The genomics and epigenomics laboratories benefitted from equipment purchased as part of the carefully planned move to UCL in 2004. These laboratories have top-of-therange, high-throughput technologies, including Tecan liquid handling robotics, an Alphelys Mincore semi-automated tissue microarrayer, a CGH microarray facility, Class II Cell Culture Suite, and a Zeiss fluorescence microscope. The proteomics laboratory is well equipped, with four mass spectrometers (including LTQ Orbitrap XL), chromatography and 2D gel running systems for protein separations, clean rooms, MS data analysis software. In addition to this high quality laboratory kit we also have innovative trial management systems, serum processing, storage facilities and equipment for biobanking and facilities for 21st century computer modelling. Funding will be needed in the future for new equipment, for example, multiplex genotyping platform and digital video and audio recording systems for qualitative research, as well as essential equipment upgrades and maintenance. • To optimise screening strategies for familial ovarian cancer (UK Familial Ovarian Cancer UKFOCSS) • To test whether aromatase inhibitors are superior to tamoxifen in adjuvant treatment of early breast cancer 80 • To investigate the therapeutic potential of heritage and arts engagement by women with cancer To establish the need for an ovarian cancer screening programme by assessing the impact of screening on ovarian cancer mortality while comprehensively assessing cost, psychological issues and morbidity though large multi-centre randomised controlled trials in the general (UK Collaborative Trial of Ovarian Cancer Screening UKCTOCS) and high–risk (UK Familial Ovarian Cancer UKFOCSS) population. • To further identify and characterise high penetrance susceptibility genes for ovarian cancer • To identify and validate risk predictors in serum and in free circulating serum DNA for (a) developing disease and (b) dying from breast, ovarian, endometrial or cervical cancer using the UKCTOCS cohort • To evaluate the risks and benefits of nurse-led models of follow-up care RESOURCES Total grant awards to academic gynaecology during the review period was £15.72 million, of which £11.8 million was funding for 2003-08. This included funding from Research Councils (MRC, AICR), UK based Charities (CRUK, Eve Appeal) EU Govt Bodies (FP7), EU Other (EORTC), UK Central (Dept of Health, CBRC), Industry, and Other Overseas (such as NIH) (see figure). Unlike Section 4 below, these figures do not include awards to collaborating centres. In addition, during 2003-8, UCLH funding for salary costs towards time spent by clinical academics on their clinical duties was £2.11 million. Support for core posts through the University by the Higher Education funding stream (HEFCE) amounted to £1.34 million (8.9%). Support for core posts especially at Senior Lecturer and above from the UCL HEFCE budget is limited in gynaecological oncology with only 2 FTE of senior academics being HEFCE funded. The ratio of external grant funding to HEFCE funding is much higher in gynaecological oncology than in other academic sections of the IfWH and this needs correcting in the next phase of development of the IfWH. As can be seen from the figure below the gynaecological oncology group has had great success in generating additional external funding with only limited increase in HEFCE funding. Resources within the Unit are summarised below with additional information detailed in Appendix 7.5-7.7 (grants and other funding; staff and equipment). Facilities and infrastructure The seven research groups operate across three distinct spaces. There is office space in Maple House (324m2), which is home to the gynaecological cancer research unit, nursing, and clinical cancer genetics teams. High quality facilities for molecular and cell biology research in the Paul O’Gorman Building accommodate the Gynaecological Cancer Research and Epigenomics Groups (340m2) and the Tumour Marker (clinical trials) Laboratory (total 36.77m2). Finally, the Cancer Proteomics group is based in a purpose-built facility (166m2) in the Cruciform Building with space for 20 staff. NHS HEFCE Other Overseas EU Other EU Govt. Bodies UK Industry UK Central UK based Charities Research Councils 5 4 £m pa Funding Breast Cancer Clinical Research Unit UCL EGA IfWH 1st Quinquennial Review 3 2 1 0 2003–4 2004–5 2005–6 2006–7 2007–8 UCL IfWH Gynaecology Oncology Funding 2003 – 08 81 WOMEN’S CANCER – RESEARCH WOMEN’S CANCER – RESEARCH UCL EGA IfWH 1st Quinquennial Review PERFORMANCE AND MEASUREMENT OF QUALITY OF ALL ACTIVITY The groups demonstrate quality and high performance across a range of measures summarised below and detailed in Appendices 7.7 (Students), 7.8 (Collaborations), list of 10 key publications at the end of Women’s Cancer – Research section and in separate Publication Booklet. Please note there will be overlap between groups across some of these measures. Gynaecological Cancer Research Unit Publications 56 publications in peer-reviewed journals and 10 chapters since 2004. Funding Total grant funding of ongoing projects is over £33m of which ~95% (£31,716,005) is from major UK funding agencies. PhD and MD Students Five since 2004, three in their final year. Collaborations Numerous national and international collaborations. Other Annual inspection of the trials by their specific independent body as below. Data Monitoring Committees – latest on 28th January 2009, UKFOCSS in May 2009 and GCaPPS in November 2008. In each instance the trials have been commended. Review by scientific boards of the funding bodies – the most recent review by the MRC scientific board was undertaken in July 2008 when UKCTOCS scored 5 and trialists were commended on the quality of what they had achieved in the trial. Clinical Pathology Accreditation Services report following inspection of the Tumour Marker Laboratory (most recent August 2008). The report commended the well managed and well trained team and their overall commitment. Detailed report available on request. Genomics UCL EGA IfWH 1st Quinquennial Review Other Simon Gayther is a member of the UCL Genetics Institute Executive and Advisory Boards, the EGA Institute for Women’s Health Postgraduate Teaching Committee, the Platform Technologies Development Group (Genomics) and the EGA Institute for Women’s Health Academic Board. Epigenomics Publications 34 papers. Funding Austrian Science Fund: “DNA Methylation Markers Analyzed in Serum and Nipple Aspirate Fluid for Early Detection of Breast Cancer”. National Institute of Health (Co-investigator): “DNA methylation based serum markers for early detection of ovarian cancer”. European Union (Co-investigator): “Integrated Biosensor system for label-free in vitro DNA and protein diagnostics in health care applications”. Other Young Cancer Research Award 2004 highly commended (awarded by the European Association for Cancer Research); Alois Sonnleitner Award 2007 (awarded by the Austrian Academy of Science); Schmidt Matthiesen Award for Gynaecological Oncology (awarded by the German Society for Gynaecology and Obstetrics). Special Issue Editor of Disease Markers for an issue on Hypermethylation and Epigenomic Markers. Patents Epigenetic stem cell markers (application filed). Association of Breast Cancer DNA Methylation Profiles. Cancer Proteomics Publications 29 peer-reviewed research articles and 9 reviews, editorials and book chapters, including invited guest editor for Current Opinion in Biotechnology. Funding £4 million in research and equipment funding since 2004 as Principle or Co-investigator from CRUK, MRC, AICR, Eve Appeal and CBRC. PhD Students 63 original articles and 7 review articles and editorials since 2004. Supervision of seven PhD students, four of whom have completed; eight publications with students as lead and co-authors; several travel awards poster prizes. Grants Other £17 million principle and co-investigator funding including MRC, CR-UK, FP7, UCL-CDRC, Geneservice, Eve Appeal and Oak Foundation. John Timms is a member of the IfWH Academic Board and UCL Proteomics Platform Technologies Development Group; an invited journal and grant reviewer for numerous journals and funding bodies; successfully established several novel proteomic platforms for sample analysis and biomarker discovery; and led one of the first groups world-wide to apply and report the 2D-DIGE expression profiling technology. Publications PhD and MD Students Eight current PhD students and one submitted. Collaborations OCAC, COGS, CIMBA, MARIBS, Cambridge, Denmark. 82 AREAS OF EXCELLENCE Gynaecological Cancer Research Unit The group is known internationally for its pioneering work on ovarian cancer screening which commenced with a pilot study of the initial 1010 women screened reported in the Lancet in 1988 on the first 1000 women screened and has progressed through establishment of the ability of screening to detect asymptomatic ovarian cancer (1985-90), proof of a significant survival effect (1985-99), to refinements of the screening strategy (1995, 2000), field testing in a pilot trial (1995-2000) of the new strategy and finally the current trial, UKCTOCS with a report in 2009 in Lancet Oncology. UKCTOCS is the largest RCT ever undertaken worldwide and will establish whether screening will save lives while comprehensively addressing cost, psychological and physical morbidity, compliance and the performance characteristics of two screening strategies. In parallel the UKFOCSS trial of women at high risk of ovarian cancer is a key international trial and is the only one of its kind in Europe. In the UK high risk women who wish to undergo screening can only do so through this trial. Both UKCTOCS and UKFOCSS are part of the NCRN and UKCRRN trials portfolio. Our work on ovarian cancer symptoms is nationally known and the group was part of the advisory committee to the DoH in 2008-09 to contribute to a national statement on ovarian cancer and its symptoms and to help formulate the awareness strategy (http://www.dh.gov.uk/en/Healthcare/Cancer/index.htm). Our Familial Cancer Clinic leads nationally and is one of the few tertiary referral services of its kind in the UK. Most women at increased risk of familial gynaecological cancer in London and the Southeast requiring advice on risk management are referred. Genomics The group is recognised as one of the international leaders in studying susceptibility genetics in ovarian cancer, with a track record stretching back to 1994. The group has led the field in characterising high-penetrance genetic susceptibility to ovarian cancer (BRCA1 and BRCA2 genes) in both families and populations of cases; and more recently, as one of the leads in an international effort to identify more moderate risk susceptibility variants for the disease. This has culminated in completion of the first ever genome wide association study, which has identified novel susceptibility markers for ovarian cancer. The group has also established a unique track record for their ground breaking research in modelling both normal ovarian epithelial cells in vitro and ovarian cancers in 3D systems. These models show great potential in identifying and testing novel therapies for ovarian cancer. Cancer Proteomics Our research is placed highly both nationally and internationally as evidenced by our publication record. There are few groups in the UK who conduct cancer research using such diverse proteomic techniques and who have access to such unique sample collections. We also pride ourselves in our ability to integrate proteomics with other high-throughput data to better understand the molecular mechanisms associated with cancer. Nursing and Patient Care Research In recognition of the national and international quality of our work the first UK Senior Lecturer post for a nurse in gynaecological cancer nursing was established in 2008 and the Nursing and Patient Care Research Group became a separate identity within this theme. Computational and Systems Medicine The group is known internationally for works on the investigation of complex biological systems, in particular, in the following research areas. • proteasome and immune system research, proved by VW grant, publications in JMB and setting a web-based resource www. proteamalg.com • genetic networks with complex dynamics, proved by seven publications, including paper in PRL (IF>7) • systems biology of complex systems with stochasticity, proved by numerous publications, including several papers in PRL Clinical Cancer Genetics This is a new Senior Lecturer post, which is a joint appointment between the NE Thames Regional Genetics Service (RGS) and the IfWH. A business plan has been submitted to develop a register for families with Lynch Syndrome at the RGS. The Familial Cancer Clinic at IfWH is the only tertiary referral service for these women who are at increased risk of gynaecological (particularly endometrial) cancer throughout the London area. With the unique experience in large scale gynaecological screening studies of the GCRU, we are ideally placed to investigate endometrial screening strategies in high risk women. Epigenomics We are the leading group in translational epigenetics in women’s cancer nationally and in Europe, and amongst the leading groups in translational epigenetics globally. This is reflected in our publication track record and in the fact that we are invited to internationally leading conferences covering this theme (e.g. AACR Cancer Epigenetic Conference in Boston 2008). Assessing sample quality and cross-checking identifiers on the database in Tumour Marker Laboratory, which handles samples, tissues and data from more than 200,000 subjects 83 WOMEN’S CANCER – RESEARCH WOMEN’S CANCER – RESEARCH UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review CHALLENGES Multidisciplinary expertise Coherence and integration Opportunities have been missed to perform or lead research that we are well placed to take forward through lack of necessary expertise within our Unit. In particular, we have lacked expertise in biostatistics and epidemiology for ovarian cancer. The appointment of Professor Alexey Zaikin will go some way to addressing the former although there will be a lag in productivity as he builds his group. Many aspects of the strategically planned research have not yet secured sufficient grants and are still dependent on funding from the Eve Appeal. The need for funding is being addressed by more collaborative grant applications (e.g. a collaborative €12 million FP7 project), a series of external grants which are currently under review and development of industry links. The coherence of the research group has benefited from the move of the laboratory from the Windeyer Building to the Paul O’Gorman Building. This means that although the group is based in three locations (Paul O’Gorman Building, Maple House and Cruciform Building), they are no more than five minutes apart. Nevertheless, the varied commitments and priorities of the scientific and clinical research staff mean that ongoing effort is needed to meet regularly and facilitate collaborative research efforts. Weekly and monthly research meetings take place; but daily interaction and informal discussions are required for optimal exchange of ideas. Ideally the three components of the research group would be co-located. Clinical implementation of results Office space and meeting rooms From 2004 to 2008 the laboratory was located at the Windeyer Institute and the geographical separation from the rest of the group was a challenge, which had a negative impact on research productivity. The laboratory moved to the Paul O’Gorman building in June 2008. Substantial time was expended on planning and co-ordination of the move to the space which is of the highest quality and ideal for the nature of the research. The move has not however addressed the lack of office space and meeting rooms, the latter being a pan-UCL issue. The shortage of rooms and teaching priorities often results in space having to be rented outside UCL for research meetings. This compromises our potential to be at the hub of global forums for research in women’s cancer. Equipment Our research requires the latest cutting-edge technologies for high-throughout genomics, but there are few funding avenues for individual groups to purchase the latest technologies and none for service contracts for current equipment. This has partly been addressed through an industrial genomics partnership, which enables onsite-outsourcing of several genetics technologies, and a UCL initiative to develop important technologies as core facilities. However, the group is struggling to find either funding or partnership for multiplex genotyping (a major focus of the research) due to a lack of multi-user need at UCL. Long term nature of our clinical trials The long term, fifteen-year goal of the UKCTOCS project is to provide definitive RCT evidence to governments concerning patient benefit of an ovarian cancer screening programme. There is tension as the core results will not be available until 2015 but there is a need for high impact publications in the shorter term (five years) for RAE, individual promotion and other similar exercises. The release of the prevalence screen results has addressed this to a certain extent, as will use of the Biobank for secondary studies. 84 UKCTOCS has required an extension until 2015 due to a healthy volunteer effect in the control group. This extension will provide the necessary power to detect a significant result. However, the delay will have a significant knock on effect on implementation. Some studies with potentially clinically relevant results require additional validation in prospective clinical trial to further clarify their role in patient diagnosis and treatment (for example augmenting traditional histology with molecular profiling of synchronous tumours to determine if dual primary or metastasis). IMPACT AND IMPORTANCE Actual impact on deaths or suffering • Risk of Malignancy Index: used nationally and internationally as a standard approach to triaging patients with ovarian cancer to specialist units. • Familial Cancer initiative: prevention of cancer in women at high risk through surgery. • Training specialist gynaecological oncologists: contributing to training of over ten subspecialty trainees. • UKFOCSS: implementation of a standardised approach to screening high risk women and early detection of many cancers, which has led to improvements in service delivery. • UKCTOCS programme: evidence of survival benefit in Lancet paper (1999) and more women detected early though impact yet to be ascertained (Lancet Oncology 2009). • Cervical Cancer: introduction of screening programmes for cervical cancer in Nigeria and Uganda, initially involving >8,000 women and now being rolled out nationally. See Global Health theme section Established research and infrastructure with potential to reduce death and suffering Establishment of a multidisciplinary team in genetics, epigenetics, proteomics and systems medicine working in collaboration with a large scale Clinical Trials Unit. Clinical Research Unit with experience of successfully conducting large scale, complex population based trials including the largest RCT worldwide with development of automated systems for data capture and storage. A series of publications in ovarian cancer (OC) screening going back 15 years which are seminal in this field and form a basis for current attempts to reduce mortality worldwide. Unique sample collections suitable for development of new diagnostic and screening tests: the UKCTOCS bank of >500,000 samples from 202,000 healthy postmenopausal women; the UKOPS bank of >700 OC cases and 800 benign cases; UKFOCCS bank of ~8,000 samples from >3,000 women at high risk of OC and BC. Proteomics Establishment of technology platforms for biomarker discovery utilising sample collections to identify new markers for diagnosis and early detection and for the molecular characterisation of cell models of cancer. New direction in proteosomal splicing research which has potential in vaccine development. Epigenomics Establishment of technology platforms for discovery of epigenetic markers for risk prediction and early detection and guiding therapy. A series of 35 publications over last five years which have driven forward the potential for clinical application of epigenetics in cancer including an influential Nat Gen paper in 2007. Genomics Establishment of a state of the art facility for high throughput analysis of population based studies of genetic susceptibility and molecular profiling. Moving from establishing a group in 2002 to generation of 42 publications since 2007. Key role in establishing a major international consortium (the OCAC) to study genetic epidemiology of ovarian cancer. Systems Medicine Establishment of systems medicine unit for analysis of high throughput data and development of recognition and predictive algorithms (e.g. www.proteamalg.com). Organisation of a bidirectional information flow between experimental units of WH and theoretical departments at UCL. Nurse-led research Establishment of the first SL post for nurse in women’s cancer research centre in UK. Clinical Cancer Genetics Recruitment of a SL in Cancer Genetics will enable development in this area and complement and strengthen existing research projects. External income Major peer reviewed external income from MRC, CRUK, DH, EU totalling awards >£30 million. Philanthropic income Long-standing and key link with Eve Appeal charity which has generated >£6 million income over last seven years. Other individual donors notably £600,000 for developing world effort. High quality space CTU in Maple House, molecular and cell biology (epigenomic and genomic) laboratory in POG Building, proteomics in Cruciform Building. 85 WOMEN’S CANCER – RESEARCH WOMEN’S CANCER – RESEARCH UCL EGA IfWH 1st Quinquennial Review Critical mass Establishment of a team of 55 staff in house and >50 externally which is thought to be larger than any other grouping in Europe in this field. Training Establishment of a PhD programme involving 5 students, a series of research fellows, and contribution to undergrad and MSc training. FUTURE DEVELOPMENTS The academic gynaecological and breast cancer theme has established a strong clinical and scientific foundation since moving to UCL in 2004 and plans to continue building on its success in the four main areas of translational research described above. The Unit has been augmented by recent recruitments in computational and systems medicine, clinical breast cancer sciences and clinical cancer genetics, and these will grow with the shared vision of the Unit. Some of the future developments continuing on from existing research are as follows. Clinical Trials Unit Completion of current trials Results should be available from UKFOCSS and GCaPPS in 2012. Screening will continue in UKCTOCS till 2011 with follow up complete in December 2014 and key results available in June 2015. These will have significant and lasting impact on screening for ovarian cancer globally. UCL EGA IfWH 1st Quinquennial Review New trials Large scale prospective validation of markers of risk and early detection discovered by the SNP genotyping and epigenetic studies are underway. We are planning well defined strategies to maximise the impact of these findings in large cohorts collected prospectively. Prospective trials of improving ovarian cancer diagnosis in primary care by using a well defined algorithm triggered by a symptom score. Targeted screening in endometrial cancer based on algorithms developed as a result of UKCTOCS. Use of the large serum and data banks for the trials for the study of other diseases in women including other cancers, heart disease so that use of the resource is maximised for the benefit of all women. Epigenomics Group To perform genome wide DNA methylation profiling in white blood cell DNA (from UKOPS and other collections) and to evaluate risks for breast and ovarian cancer associated with these data. To develop DNA methylation analyses in free circulating serum DNA in the UKCTOCS subjects and establish the efficacy of this approach as a screening tool for risk assessment and early detection of breast, ovarian, endometrial or cervical cancer. Analysis of DNA methylation in pre and post-treatment serum samples from women undergoing large clinical trials (e.g. SUCCESS study involving 3600 women with breast cancer) to test the efficacy of systemic adjuvant therapies. PEGASUS (Proteomics, Epigenomics, Genomics Analysis in Samples from UKCTOCS) Our strength in a range of technologies and methodologies (systems medicine, statistics, proteomics, genomics, epigenomics) and unique sample collections provides an outstanding opportunity to bring together all of these resources in a single integrated project aimed at providing major advances in cancer risk prediction and detection. Capacity building Strategic planning within the Unit has highlighted areas that are priorities for capacity building, because they would complement our multi-disciplinary team and help develop further the level of excellence in gynaecological and breast cancer research that we have so far achieved. Specifically, we aim to make appointments in the following areas. Genomics Group Proteomics Group Molecular epidemiology of ovarian cancer: To integrate the themes of epidemiology, genetic susceptibility and molecular characterisation of tumours in ovarian cancer case-control populations in order to model risk prediction and clinical outcome for the disease. Proteomic profiling of ovarian tumour-derived cell lines, tumour tissues and peripheral white blood cells from UKOPS collections using newly developed proteomic technologies. This work aims to identify additional candidate biomarkers which will be tested for in blood, and will combine genomic and epigenetic data. Molecular profiling: Develop molecular profiling strategies in gynaecological tumours that can be taken forward as clinically relevant diagnostic tools and to evaluate their role in improving disease management and patient outcome. Proteomic characterisation of cell models of ovarian cancer chemo-resistance. This work aims to understand at the molecular level why some cancers become resistant to chemotherapy. • Cancer Epidemiology Senior Lecturer appointment to complement and utilise population based cohorts in genetic and epigenetic susceptibility studies and clinical screening trials. Functional characterisation of putative ovarian cancer oncogenes and tumour suppressors identified from cell model studies. The work is aimed at the identification of putative drug targets. • Breast Cancer Professorial appointment in Breast Cancer to enhance capacity and potential of research in this area. Molecular carcinogenesis: Continue to work on creating functionally relevant, cell biology models of ovarian cancer to test the therapeutic potential of genetic risk markers and tumour markers that we find above. Nursing and Patient Care Research Results from the follow-up care study will be available in 2011. These will provide a platform for further testing of nurse interventions for women on radically different treatment schedules with molecular targeted treatment advances. Systems Medicine Group To develop theoretical and computational methods to construct in silico a virtual immune system. Strategically this approach will include studies of degeneracy, ageing, longevity, the role of stochasticity, miRNAs and alternative splicing. To develop a synthetic biology approach to cancer, including theoretical and experimental investigation of synthetic genetic networks and its utilization in the construction of intelligent drugs, biomarkers and cancer chronotherapy. Investigation of new precise control methods of gene expression in synthetic networks. • Pathology Senior Lecturer appointment to fill gap in academic pathology resource. • Cancer Biology Senior Lecturer or Professorial appointment to enhance capacity for functional studies. Links with Cancer Institute A vital component of our future development is the location of the Laboratory facilities with respect to the newly formed Cancer Sciences Institute at UCL. The physical connection between Cancer Sciences in the Paul O’Gorman Building, with the Gynaecological Cancer Research Laboratories, Tumour Marker Laboratory and Cancer Proteomics was a significant factor in establishing a theme in ovarian cancer (together with Cancer Therapeutics (Ledermann) and Pathology (Williams)), to be included as part of the Cancer Institute’s recent application to become a CRUK Centre. In the future, this is likely to bring benefits in the breadth and quality of scientific interactions taking place within the Unit and enhance the links with the UK’s major cancer charity. To construct reliable statistical and machine learning classifiers for cancer detection based on experimental epigenetic and SNP data and setting the link from statistical analysis towards modelling and understanding of biological functions. 86 87 WOMEN’S CANCER – RESEARCH WOMEN’S CANCER – RESEARCH UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review TEN KEY WOMEN’S CANCER PUBLICATIONS AT IfWH 2004-09 GCRU Menon U, Gentry-Maharaj A, Hallett R, Ryan A, Burnell M, Sharma A, Lewis S, Davies S, Philpott S, Lopes A, Godfrey K, Oram D, Herod J, Williamson K, Seif MW, Scott I, Mould T, Woolas R, Murdoch J, Dobbs S, Amso NN, Leeson S, Cruickshank D, McGuire A, Campbell S, Fallowfield L, Singh N, Dawnay A, Skates SJ, Parmar M, Jacobs I. Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Lancet Oncol. 2009 Apr; 10(4):327-40 The paper reports the first findings from the largest ovarian cancer screening trial UKCTOCS which is run from GCRC. It summarises the outcome of the prevalence (initial) screen in women randomised to annual CA125 screening (interpreted using a risk of ovarian cancer algorithm) with transvaginal ultrasound scan as a second-line test (multimodal screening [MMS]; n=50 640); or annual screening with transvaginal ultrasound (USS; n=50 639) alone. 97 of 50 078 (0.2%) women from the MMS group and 845 of 48 230 (1.8%) from the USS group underwent surgery. 42 (MMS) and 45 (USS) primary ovarian and tubal cancers were detected with 28 (16 MMS, 12 USS) of 58 (48.3%; 95% CI 35.0-61.8) of the invasive cancers stage I/II. The prevalence screen has established that the screening strategies are feasible with encouraging performance characteristics. Menon,U., Gentry-Maharaj,.A, Ryan A, Sharma A, Burnell M, Hallett R, Lewis S, LopezA, Godfrey K, Oram D, Herod J, Williamson K, Seif M, Scott I, Mould T, Woolas R,Murdoch J, Dobbs S, Amso N, Leeson S, Cruickshank D, McGuire A, Campbell S,Fallowfield L, Skates S, Parmar M, Jacobs I. Recruitment to multicentre trials--lessons from UKCTOCS: descriptive study. BMJ 2008 Nov 13; 337:a2079 The report describes the factors that contributed to successful recruitment of more than 200,000 women to UKCTOCS which is currently the largest randomised controlled trial in the world. The importance of a committed proactive trial management team, centralisation and automation of trial processes using web based trial management systems and use of information videos and group discussions in recruitment are detailed. Menon,U., Skates,S.J., Lewis,S., Rosenthal,A.N., Rufford,B., Sibley,K., Macdonald,N., Dawnay,A., Jeyarajah,A., Bast,R.C.Jr., Oram,D., Jacobs,I.J. (2005). Prospective study using the risk of ovarian cancer algorithm to screen for ovarian cancer. J Clin Oncol 23(31), 7919-7926. The paper reports the results of prevalence screening in the first prospective trial of use of the ‘Risk of ovarian cancer or ROC’ algorithm in ovarian cancer screening in a pilot randomised controlled trial of 13582 women were recruited. The strategy achieved high specificity and positive predictive value for detection of invasive epithelial ovarian cancer in postmenopausal women. The ROC algorithm is currently being used in UKCTOCS and in the ovarian cancer screening trials in high risk women in the United States and UK. Genomics Quaye L, Dafou D, Ramus SJ, Song, H, Gentry-Maharaj A, Notaridou M. Hogdall E, Kruger Kjaer S, Christensen L, Hogdall C, Easton DF, Jacobs IJ, Menon U, Pharoah PDP, Gayther SA. Functional Complementation Studies Identify Candidate Genes and Common Genetic Variants Associated with Ovarian Cancer Survival. Hum Mol Genet. 2009 18:1869–1878 1927002 The paper describes a novel functional approach to identify genes and common genetic variants associated with survival in ovarian cancer cases. This led to the identification a gene, RBBP8 for which both germline genetic variation and somatic alterations in ovarian tumours were found to be associated with clinical outcome after a diagnosis of epithelial ovarian cancer. Ramus SJ, Harrington PA, Pye C, Dicioccio RA, Cox MJ, Garlinghouse-Jones K, Oakley-Girvan I, Jacobs IJ, Hardy RM, Whittemore AS, Ponder BA, Piver MS, Pharoah PD, Gayther SA. The contribution of BRCA1 and BRCA2 mutations to inherited ovarian cancer. Hum Mutation 2007 28:1207-15. Gayther SA, Song H, Ramus SJ, Kjaer SK, Whittemore AS, Quaye L, Tyrer J, Shadforth D, Hogdall E, Hogdall C, Blaeker J, DiCioccio R, McGuire V, Webb PM, Beesley J, Green AC, Whiteman DC; Australian Ovarian Cancer Study Group, Goodman MT, Lurie G, Carney ME, Modugno F, Ness RB, Edwards RP, Moysich KB, Goode EL, Couch FJ, Cunningham JM, Sellers TA, Wu AH, Pike MC, Iversen ES, Marks JR, Garcia-Closas M, Brinton L, Lissowska J, Peplonska B, Easton DF, Jacobs I, Ponder BA, Schildkraut J, Pearce CL, Chenevix-Trench G, Berchuck A, Pharoah PD; Ovarian Cancer Association Consortium. Tagging Single Nucleotide Polymorphisms In Cell Cycle Control Genes And Susceptibility To Invasive Epithelial Ovarian Cancer. Cancer Res 2007 67:3027-3035 This describes the identification of common genetic susceptibility variants in a series of cell cycle control genes associated with variation in the risks of epithelial ovarian cancer. It is notable for being the first study published by the ovarian cancer association consortium, a group comprising more than 20 ovarian cancer studies from around the world that are trying to find genetic and epidemiological risk factors for ovarian cancer in the population Brinkmann D, Ryan A., Ayhan A, McCluggage WG, Feakins R, Santibanez-Koref MF, Mein CA, Gayther SA, Jacobs IJ., A molecular genetic and statistical approach for the diagnosis of dual-site cancers. J Natl Cancer Inst. 2004. 96:1441-6. 15467033 This paper describes a novel genetic and statistical approach to the diagnosis of patients with dual site ovarian and endometrial cancer, suggesting a future potential for using such an approach in the clinical arena for the molecular diagnosis of these and other dual site cancers where a pathology diagnosis can often be equivocal. EDUCATION AND TRAINING WOMEN’S CANCER – RESEARCH UCL EGA IfWH 1st Quinquennial Review Epigenomics Widschwendter M, Apostolidou S, Jones AA, Fourkala EO, Arora R, Pearce CL, Frasco M, Ayhan A, Zikan M, Cibula D, Iyibozkurt CA, Yavuz E, Hauser-Kronberger C, Dubeau L, Menon U and Jacobs IJ HOXA methylation in normal endometrium from premenopausal women is associated with the presence of ovarian cancer – a proof of principle study. Int J Cancer 2009 in print In this paper we studied HOXA gene methylation in normal endometrium from premenopausal ovarian cancer patients and agematched healthy controls without ovarian cancer and found that the overall risk of ovarian cancer was increased 12.3-fold by high HOXA9 methylation in the normal endometrium for all stages, and 14.8-fold for early stage ovarian cancers, independent of age, phase of the menstrual cycle and histology of the cancer. The results of this proof of principle study demonstrate the potential to detect ovarian cancer via analysis of normal endometrial cells and provide insight into the possible contribution of this novel approach in ovarian cancer risk prediction and prevention. Widschwendter M, Fiegl H, Egle D, Mueller-Holzner E, Spizzo G, Marth C, Weisenberger DJ, Campan M, Young J, Jacobs I, Laird PW. Epigenetic stem cell signature in cancer. Nat Genet. 2007 Feb;39(2):157-8. Embryonic stem cells rely on Polycomb group proteins to reversibly repress genes required for differentiation. We report that stem cell Polycomb group targets are up to 12-fold more likely to have cancerspecific promoter DNA hypermethylation than non-targets, supporting a stem cell origin of cancer in which reversible gene repression is replaced by permanent silencing, locking the cell into a perpetual state of self-renewal and thereby predisposing to subsequent malignant transformation Proteomics Timms JF, Arslan-Low E, Gentry-Maharaj A, Luo Z, T’Jampens D, Podust VN, Ford J, Fung ET, Gammerman A, Jacobs IJ and Menon U. Preanalytic influence of sample handling on SELDITOF serum protein profiles. Clinical Chem 2007. 53: 645-656. This paper describes the effects of sample handling on serum protein profiles using high-throughput MS profiling and identifies unstable proteins which have been previously reported as cancer biomarkers. The study highlights the importance of optimised and identical sample handling for biomarker discovery studies using clinical serum samples. This paper describes the characterization of the BRCA1 and BRCA2 genes in the largest series of ovarian cancer families in the published literature, joining together two familial registers from the UK and USA. The paper also correlates BRCA1 and BRCA2 status with clinical characteristics of ovarian cancer highlighting the potential value of this research in the future in the genetic testing arena. 88 89 UCL EGA IfWH 1st Quinquennial Review EDUCATION AND TRAINING Rekha Bajoria Ratna Chatterjee UNDERGRADUATE EDUCATION Joyce Harper Joseph Iskaros OVERVIEW RESOURCES The breadth of undergraduate education provided consists of contributions to all phases of the University College London medical curriculum, BSc degrees and a learning environment to allow an understanding of a future career in Women’s Health. The overall aim is to provide a broad education beyond the remit of the phase 2 module in Women’s Health. Funding for academic staff is via HEFCEt. A large component of the teachers are NHS staff, their funding being through Service Increment Funding for Teaching (SIFT) to the base campuses at the Royal Free, UCLH and the Whittington Hospitals (HEFCE Undergraduate Teaching Income table – Appendix 8.2). On average 400 students per year are taught during Year 4, with a further teaching input for 400 students within the Reproduction, Development and Genetics module in Year 2 of the course. For the clinical attachment during Women’s Health 17 students are allocated to UCLH, 17 to the Whittington Hospital and 12 to the Royal Free Hospital Trust at any one time. Three times per year in excess of 130 students have a final MBBS assessment comprising an Observed Structural Clinical Examination (OSCE) and a written Extended Matching Question (EMQ) plus Single Best Answer (SBA) examination paper. The undergraduate organisational structure can be seen in Appendix 8.1. Innovations (see below) introduced into the undergraduate curriculum in Women’s Health have been recognized by UCL Medical School and adopted within other modules. Examples are: Allan MacLean Heulwen Morgan Ray Noble Creation and introduction of a logbook for all students and review of student achievements at the OSCE. This has allowed continuing improvements to be made. These are outlined for students within the following year’s Study Guide. Donald Peebles Consent for intimate examinations, now being adopted by surgical specialties. Involvement of Allied Professionals in the education of medical students both as tutors and within interprofessional seminars to create an understanding of differing roles and responsibilities Quality assurance visits assessing Women’s Health and Child Health undergraduate education within the base campuses occurred during the 2007-08 academic year (teaching space – Appendix 8.3, SIFT reports – Appendices 8.6-8.9). The facilities for teaching are partly summarized in the SIFT reports. In addition there are now seminar rooms on each floor of the UCLH tower block and a state of the art Education Centre has recently opened on the Euston Road. Three Clinical Skills Laboratories are available for regular use with manikins and models for teaching and assessment. The WHCD module OSCE takes place at the Whittington Clinical Skills laboratory. The Cruciform Dry Labs are used for poster demonstrations and judging the student presentations. The majority of teaching staff during the clinical weeks are NHS consultants. The number of PAs for medical education within job plans do not always equate with the time taken to prepare, perform, assess and receive feedback for the teaching. It is suggested by UCL Medical School that 1PA per full time equivalent (FTE) student should be the norm. Please see Appendix 8.5, which illustrates 3.5 PA provision for both postgraduate and undergraduate education for a group of consultants who collectively teach and train 9.84 FTE medical students (2007-08) and their postgraduate trainees. More transparency for both SIFT and HEFCEt is warranted. STRATEGY, AIMS AND OBJECTIVES The strategy is to induce an investigative approach to learning with strong enforcement of the value of working in teams, in particular with allied professionals. Anthony Silverstone Melissa Whitten Within the medical school curriculum Women’s Health is partnered with Communicable Diseases (WHCD) in the second clinical year (Study Guide available on request, containing details of components and module). The aims of this course are: to achieve a basic level of understanding of women’s health issues and obstetric and gynaecological conditions, both in hospital and community settings to be able to apply the knowledge and skills acquired when dealing with women’s health issues. The provision of role models is highlighted during Student Selected Components (SSC) of the course when a a one-to-one tutorstudent relationship exists. Teaching involvement during Phase 1 (year 1 and 2 and BSc) gives students an insight into Obstetrics and Gynaecology that is built upon during later years. 90 Cruciform Building with UCH Tower in the background – both important sites for undergraduate teaching at UCL and IfWH 91 UNDERGRADUATE Education Education AND training UCL EGA IfWH 1st Quinquennial Review PERFORMANCE AND MEASUREMENT OF QUALITY IN ALL AREAS Undergraduate Teaching Committee Heulwen Morgan is the obstetric and gynaecological lead and chairs the Institute Undergraduate Teaching Committee that meets each term. Membership is multidisciplinary and includes Professor Peebles, the site leads, NHS consultants and Phase 1 NHS tutors. District General Hospital consultant representatives and medical students attend. The discussion informs and enables an equivalence of learning experience to be achieved for students. Feedback is analysed with a plan of action agreed. This action plan is outlined within the next academic year’s Study Guide as an example of feedback having been acted upon. The minutes are sent to the Institute Academic Board and the medical school curriculum committee. The Institute undergraduate administrator and the Women’s Health course co-coordinator are in attendance. Further evidence of quality performance is contained within the SIFT Quality Assurance reports (Appendices 8.6-8.9). National Undergraduate Curriculum in Obstetrics and Gynaecology Having reviewed the report of the RCOG Working Party into a national curriculum it is apparent that all components of the proposed curriculum are fulfilled within the UCL module. It is evident that the UCL course stretches the student beyond the confines of basic obstetrics and gynaecology. The merit of our emphasis on clinical involvement for students is based on our belief that this is almost the first time during the students’ training that they are exposed to direct clinical care. The opportunity for the student to care for a woman during labour is invaluable, in particular reflecting the importance of continuity of care in medicine. Indeed, we use the student-labouring patient relationship as a paradigm for clinical care in general. At the Institute we understand how the concept of continuity of care in medicine is under threat and use the labour ward experience to highlight its importance. UCL EGA IfWH 1st Quinquennial Review AREAS OF EXCELLENCE Midwifery firm A successful bid for SIFT monies to appoint midwifery Principal Lecturers enabled more midwifery involvement in medical student education. Improvement in feedback from students was documented for this aspect of the clinical course after this innovation. Poster (in Undergraduate Centre) presented, AMEE, 2006. Medical students have a four-week Obstetrics placement at their home base hospital. During this time they will spend between one and two weeks in a midwifery attachment. They work one-to-one with midwives on the labour wards and birthing centres caring for women and their partners during labour, birth and postpartum. Additionally some will work on the wards and all will experience a day in the community with a locally based midwife giving them valuable insight into normal pregnancy, maternity care and the role of the midwife. The students additionally have the opportunity to attend midwifery focused tutorials and clinical skills sessions from senior and specialist midwives. Interprofessional education Scenario sessions involve general practitioners, social workers, midwifery lecturers, medical student tutors, paediatricians and nursing staff for students of medicine, nursing, midwifery and social work courses. The first scenario session was a simulated case conference for a pregnant woman addicted to drugs that could harm her unborn child, a situation that would have involved all members of the multidisciplinary team as above. Some medical students did attend. Feedback indicated the need for further sessions which although labour intensive are being organized. Gynaecology Teaching Assistants (GTA) A pilot project at the Whittington Hospital has been started for trained lay women to teach female intimate examination. Feedback has been excellent and students from all campuses now have this teaching session at the start of their base campus attachment. The funding is from SIFT. Seminar on Women’s Health and Complimentary Medicine Phase 2 (year 3) students have an opportunity for two weeks of self selected learning – within Maternal Medicine and Midwifery at the Whittington Hospital. Students are invited to attend, and this is timetabled within their clinical four weeks at the Whittington Hospital. Phase 3 (year 5) medical students can undertake a four-week SSC within Women’s Health. They have a choice of Complimentary and Alternative Medicine at the Whittington campus, Maternal Medicine and Reproductive Medicine (including polycystic ovaries) at UCLH and the Whittington, Fetal Medicine, Gynaecological Oncology and Fibroids at UCLH. Student involvement with specialists in the above subject areas, plus conducting detailed projects during their attachments provides added motivation for the subject of Women’s Health. This contributes to the objective of recruiting and retaining health professionals in the disciplines covered by the Institute. The SSC with the highest grade is awarded a Royal College of Obstetricians and Gynaecologists (RCOG) prize. The first has been presented at the RCOG in January, 2009. Poster project All students participate in group investigation of an area of their choice within Women’s Health or Communicable diseases. 6-7 students form a group and present the findings of their literature search, research, investigation or survey in the form of a poster at the end of the module. A monetary prize is available for the winning team. The best poster of the year is awarded a prize from the Royal College of Obstetrics and Gynaecology (RCOG), and the first was presented at the RCOG in January, 2009. Moodle: web-based information system Course materials, revision information and questions can be accessed by students both at the base campuses and District General Hospitals via the UCL website. Phase 1 (Years 1 and 2 of 5-year MBBS Medicine course (which takes 6 years with Intercalated BSc) Institute staff contributes substantially to courses in Phase 1 of the medical curriculum providing lectures and workshops on the cardiovascular and respiratory systems in Year 1 and reproductive system and developments in reproductive health care and women’s health in Year 2. This teaching provides continuity with phase 2 with sessions on acid-base balance, microcirculation, pregnancy, treatment of infertility, IVF and preimplantation genetic diagnosis as well as tutorials on clinical scenarios in reproduction. Intercalated BSc Teaching Awards Dr Ray Noble received the Inaugural Provost’s award in 2008 for his innovative teaching and contribution across the breadth of education at UCL. The Dean’s award for teaching was presented to Miss Heulwen Morgan, Miss Carol Saunders and Therese Bourne (the latter two being midwifery lecturers) at the degree ceremony, 2007. CHALLENGES • With changes in SIFT calculations due to the MPET Funding Review the monies available for undergraduate education may become a set amount per FTE resulting in a loss of money for Trusts. Liaison with NHS management will be doubly important to retain as much teaching facility and time as possible in order to maintain the quality of teaching. As mentioned above, transparency in all funding pathways for education will be imperative. Clinical involvement in gynaecology has changed dramatically over the last few years and it has become more difficult to teach at the bedside. We recognise this and as a consequence use both our antenatal clinic setting and all gynaecology clinics as active teaching environments. We aim, for instance, to allow some doctors to see fewer patients to allow more teaching during clinic time, although, as you can imagine, with targets to be met, this is a difficult circle to square. Nevertheless, we recognise that there is simply no substitute for patient contact during student training in obstetrics and gynaecology and it is constantly maintained as a high priority. We believe as a consequence that students find their exposure to women’s health, particularly their involvement on the labour ward, an enormously rewarding experience and one that will inform their expectations for clinical practice (whatever their specialty) in the future. The BSc course module in Fetal and Neonatal Physiology is amongst the most popular and successful of the courses offered for biomedical science and intercalating medical students with over 70 students each year. The course is organized in the Institute with most of the teaching by Institute staff. The aim of the course is to develop a critical understanding of recent developments in reproductive, fetal and neonatal science and clinical practice. The course has been praised by external examiners and in QAA visits for its innovative teaching and continues to receive strong feedback from students. The aim of the Institute is to develop this to an Intercalated BSc in Women’s Health in the future whilst current priority is the new MSc in Reproductive and Women’s Health due to start in September. Laboratory based and library based projects are offered in the BSc year. One objective is to introduce students to the range of exciting developments in research within the Institute. • Patterns of care with increasing day surgery warrant innovative ways of providing student time with patients. In addition NHS targets could increase clinic activity and throughput thus reducing time to teach. Child and Family Health Student Selected Components (SSC) In addition to approximately 400 undergraduate students per academic year in WHCD the Institute contributes significantly to education within the Child Health module. We run an SSC in Reproductive Ethics (Reproductive Medicine, Science and Society) in Year 2 developed in collaboration with the Ethics Unit at the medical school in KwaZulu Natal (South Africa). • Obtaining a portfolio for all educators. Currently a mandatory portfolio is being developed for postgraduate educational supervisors, and ideally this could be combined with the undergraduate portfolio. 92 Undergraduate clinical skills teaching • Junior staff hours becoming 48 hours per week may impact on continuity of care and motivation to teach. Interesting ways of working must be achieved to entice students into the specialty. • “Moodle” – web-based education is bringing innovative initiatives to enhance learning, a challenge that will involve educating some educators! • The perennial challenge of limited time available for education. For example, clinical managers need to agree to reduce clinical activity for assessments to run smoothly. 93 UNDERGRADUATE Education UNDERGRADUATE Education UCL EGA IfWH 1st Quinquennial Review WHCD module From the 2008-09 academic year onwards the module has been reduced from 15 to 14 weeks. This allows a week for career counselling and another for information giving about Foundation Year post applications and preparation for practice. The current module lead is Professor Alan MacLean. The rationale for the changes in response to the shortened course from September, 2009 is to give the students a one-week break between modules to allow reflection and provide guidance for underperforming students. The 14 week programme now consists of a one week Introduction, and a final week for assessment, and 3 x 4 week clinical attachments at one of the base campuses, at a DGH (for 8 weeks Women’s Health), and 4 weeks Communicable Diseases. Additional teaching has been added to the 4th Friday of each 4 week block to allow teaching including ethics, and a revision session (Week 13). IMPACT AND IMPORTANCE There is a wealth of enthusiastic educators amongst the staff of the Institute, which encourages student interest to be developed into a keen motivation to be involved with the medical care of women. The provision of future expertise and careers within Women’s Health will ensure appropriate holistic health care for women in both hospital and the community. UCL EGA IfWH 1st Quinquennial Review Involvement of Gynaecology Teaching Assistants to teach each student a sensitive approach to intimate examination allows insight into improved communication with the patient population, an essential element of medical practice. The Institute has a proven track record within clinical academic training (see postgraduate academic training). This had a knock-on effect to the undergraduate training with provision of academic Y2 posts involving research in all areas of obstetrics and gynaecology as well as in medical education. FUTURE DEVELOPMENTS In consideration of some of the challenges above, a pattern of apprenticeship and student shadowing of career doctors during Year 4 could be considered. With funding from the British Council UKIERE, a short course in Medical Ethics in Women’s Health for medical students was completed successfully in December 2007. Under the auspices of the Institute of Women’s Health the aim is to extend access and opportunities through distance learning both overseas and in the UK. POSTGRADUATE EDUCATION and training OVERVIEW Postgraduate education is provided in the Institute through • clinical training • research for PhD and MD • an established MSc and post graduate diploma (PG diploma) in Prenatal Genetics and Fetal Medicine and a new MSc/PG diploma in Reproductive Science and Women’s Health The Institute provides a supportive, stimulating and accessible learning environment for postgraduate clinical trainees at all levels fulfilling the requirements of the Royal College of Obstetricians and Gynaecologists, the London Deanery School of Obstetrics and Gynaecology, the North Thames Foundation School and the Postgraduate Medical Education and Training Board, and to proactively support the personal and career development of potential future senior appointments within the Institute. Education and training opportunities are provided from Foundation Year 1 through to subspecialty training. We are frequently cited as the most popular trust for obstetrics and gynaecology trainees in our sector based on requests for training rotations within the North East Thames training programme. The Graduate Research Programme, formally established on 1st October 2007, provides a multi-disciplinary and cross cutting environment for students across the breadth of the Institute with tailored academic training and clear milestones (See diagram Appendix A) including generic academic competencies provided by seminars, tutorials and workshops organised by the Institute and UCL. Students have regular scheduled meetings with their supervisors whose responsibility is to facilitate progress. Currently there are 31 PhDs in the programme - 22 full-time and 9 part-time and additionally 12 MD students. The MSc and PG Diploma in Prenatal Genetics and Fetal Medicine were set up in 1997 catering for approximately 12 students each year and are run by Dr Joyce Harper, Dr Sioban SenGupta, Dr Anna David and Professor Eric Jauniaux. Both are one-year full-time or two-year part-time degree programmes designed for biological scientists and obstetricians who wish to specialise in prenatal genetics and fetal medicine. The MSc programme structure consists of a eight month lecture and practical programme and a four month research project. The PG Diploma consists of an eight month lecture and practical programme only. Clinical skills teaching: mechinisms of delivery 94 A new MSc/PG diploma programme in Reproductive Science and Women’s Health starts in September 2009 with the same format. Both courses consist of eight modules, four of which are common between the two programmes. Each module is run over a three week period and examined by workbooks, essays and exams. Each module can be offered as a short, external course. Throughout the course all students have observation days in the IVF and Fetal Medicine unit. The new MSc/Diploma in Haemoglobinopathies, an innovative distance learning course in partnership with Thalasaemia International Federation, is due to start in February-March 2009. Graduate Education is led by Ray Noble (research programme) and Joyce Harper (taught programmes) with oversight by the Graduate Teaching Committee (see diagram Appendix 9.2) with administration provided by a Graduate Administrator (Eleonora Massella). Postgraduate clinical training is led by Joseph Iskaros, RCOG College Tutor. Melissa Whitten is a new consultant appointment for Education and Training at both undergraduate and postgraduate level. Janet Halsey is a midwife educational practitioner. Karla Isaacs provides administrative support. We employ more than 30 junior doctors at all levels of training in line with RCOG Specialty Training Curriculum and organised within the context of clinical service activity including day and night-time work. We run 3 separate rotas: A SHO Rota 3 ST1 and 3 ST2 trainees, 5 GP trainees, 1 FY2 trainee. Trainees rotate through a variety of clinical areas to gain a balanced and broad experience. We participate in the Trust Foundation Programme by providing training for FY2 trainees who are with us for 4 months as part of their second year of training. We also have 2 FY1 doctors who receive daytime training in gynaecology, obstetrics and breast. B Registrars’ Rota A 10 person rota soon to be increased to 11. We have 8 doctors in Deanery recognised funded posts; the majority are a combination of ST3-ST7 posts; all ST6-7 level trainees are registered for specials skills training modules and advanced training skills modules in line with the RCOG advanced training curriculum. Four of these trainees are academic clinical fellows, a result of successful bid for Walport funding. These posts are part of the UK Council for Research Clinicians initiative to encourage academic training with 25% of their time involved in research and academic work. UCLH and UCL’s strength in clinical and academic work has meant that we were able to have 4 of these prestigious posts, the largest number for NHS Trusts in London. We also have 3 trust funded academic fellows, currently in maternal medicine, paediatric gynaecology and urogynaecology. C Specialist Registrars’ Rota We have 8 trainees in RCOG recognised sub-specialty programmes (one of the largest number in the UK for one training environment) and 1 trust funded clinical fellow (currently for advanced laparoscopic surgery, an innovative post which is currently the model for development of this area across the country). We currently have 2 sub-speciality posts in reproductive medicine, 1 in gynaecological oncology, 1 in urogynaecology and 3 in maternal-fetal medicine, one of which is divided between two academic clinical lecturers. 95 postGRADUATE Education and training UNDERGRADUATE Education UCL EGA IfWH 1st Quinquennial Review We have been successful in obtaining additional Walport funding and University funding for Academic Lecturer posts which are senior training posts at subspecialty level. These comprise 50% academic and 50% clinical work over a four year programme of training. The department is further enhanced by a number of senior visiting fellows from outside units, usually from outside the UK, who bring with them ideas and academic contributions. The registrars are allowed appropriate study leave within their allocated slots. There is funding allocated for each registrar for each doctor on the rota including the non-training grades. UCL EGA IfWH 1st Quinquennial Review Strategy, Aims and Objectives Our aim is to deliver a high standard of teaching education and training to carefully selected and enthusiastic trainees. We aim to provide a healthy environment for delivering the College curriculum. The department is fully engaged with the over-riding principles of providing a supportive and encompassing atmosphere for learning. We see education and training as a key component for providing excellent and safe patients’ care. We aim to provide the following: • Being actively involved in regional teaching afternoons for ST1-ST3 trainees as well as regional teaching programme for ST4-ST7 trainees. Effective educational supervision with the help of all the Consultants in the department. Rolling out mentoring programme for junior doctors with Consultants and other senior trainees continues work and relationships with general practice to deliver obstetrics and gynaecology training for the different vocational schemes. • Comprehensive local induction programme to all new trainees in the department. These include policies, guidelines and patients’ safety issues. It also provides practical skills and drills for obstetrics and gynaecology emergencies. • Work closely with the School of obstetrics and gynaecology at the London Deanery to deliver the curriculum as established by the Royal College of Obstetricians and Gynaecologists. • An active teaching programme through regular weekly meetings including perinatal morbidity and mortality, gynaecological pathology meeting, gynaecological ultrasound teaching, cardiotocogram (CTG training), clinical case presentations, as well as dedicated Friday afternoon teaching sessions. This is together with a monthly departmental audit meeting. • Implementation of multiprofessional learning by means of workshops, simulations and practical skills teaching for both doctors and midwives within the department. Several courses held on site are run by consultants within the Institute. These • Peer-to peer teaching of clinical skills include exam-based courses (DRCOG), gynaecological ultrasound theoretical and practical, Dilemmas in Obstetric Ultrasound, and perineal repair. Many of these hold an international reputation. We have in the past year appointed a new post to support organisation and provision of education and training (Melissa Whitten) at both undergraduate and postgraduate level. We have an active postgraduate education committee to plan organisation of training. The New UCLH Education Centre will provide additional educational opportunities not previously provided for including simulation workshops and After Action Review training. The department runs its own education programme as well as actively contributing to regional teaching programmes for ST1-ST5 as well as ST6-7. Our weekly educational programme includes perinatal morbidity and mortality meetings, clinical case presentations, CTG teaching, reproductive medicine, journal club, gynaecological pathology meeting, ultrasound teaching and case presentations, and weekly Friday afternoon teaching programme covering key areas of the curriculum. Multidisciplinary skills and drills teaching is an inherent part of the teaching programme. We also have half a day of departmental audit day which includes presentation of different audits as well as lectures covering different areas of the audit topic. The Institute for Women’s Health runs an annual meeting with outstanding speakers covering not only clinical obstetrics and gynaecology but also other areas of research and midwifery and nursing output. The registrars are encouraged to present posters of their work during that annual meeting. The key strategy or our PhD and Masters programmes is to develop 1) a coherent programme that encourages and attracts high calibre students and fosters scholarship and research in Women’s Health; 2) a robust programme of supervision to ensure success; 3) an enhanced taught Masters programme. The Institute aims to provide an environment in which students can develop and pursue research at the highest level of accomplishment with opportunities for research in groups at the leading edge internationally in a recognised centre of academic excellence. It seeks to develop research and academic skills of scholarship and to enable students to contribute to and learn from the broader objectives in women’s health in basic and clinical science. In conjunction with the UCL Graduate School the Institute graduate research programme, through its supervisory structure and seminar programmes, develops and fosters not only the specific skills required in any particular areas of research but also generic and transferrable skills enabling students to compete in the broadest range of career opportunities. A limiting factor is obtaining funding for graduate positions. We aim to enhance funding opportunities through robust supervision to further improve completion rates and to enrich student experience. PhD duration and completion Teaching in the workplace – obstetric ultrasound 96 • E-learning: all trainees are registered for the K2 CTG e-learning programme, in addition to supporting access to the RCOG StratTOG modules. We have developed an intranet support site for learning. Currently time to completion for PhDs in the Institute is a little above the average for UCL. A key objective is to improve completion rates. The standard period for a full-time PhD programme at UCL is 3 years with completion (PhD examined and awarded) within 4 years. UCL policy is that submission of a thesis should happen within the year following the final registration (18 months for parttime students). Funding and Higher Education agencies (HEFC, CVCP, CPHC, EPSRC, etc.) will only take into account completions within 4 years in their assessments of submission rates which have become a key indicator for funding. For students registered for research degrees part time there is no set limit for completion; however the Institute policy is that part time PhD students should complete within 4 - 5 years. The Institute graduate studies programme is designed to enable completion to be met within these time periods with clear goals and timelines and to prepare students for their subsequent career moves. It is important to ensure that full-time students are able to, and do, complete within their research programme within 3 years. Thus, graduate research projects should be of sufficient substance to constitute work for PhD but also be possible to accomplish within 3 years. The Institute must also ensure that there will be sufficient supervision and resources to enable a 3 year completion. More rigorous milestones and assessment of progress is a key element of the programme adopted in 2007. Development of taught MSc and Diploma Programmes A key objective is to develop opportunities for study at Masters and Diploma level. A new MSc/Diploma in Reproductive science and Women’s Health has now been approved by college and will start in September 2009 with the aim of attracting both biomedical sciences and clinical students. Resources The primary resource is provided by the excellence of the research base providing a breadth of opportunities for graduate research and supervision. Funding for PhD’s is a limiting factor for expanding student numbers and opportunities (See Challenges and Strategy). The taught courses are self funding with student numbers limited to 12 each year because of the research projects (which are always noted as being of high quality and often lead to publication), with income supporting a course tutor and facilities necessary to run them. The seminar room in Chenies Mews provides an ‘in house’ teaching space. We have a dedicated room to provide IT resources for students but this is very small and limited. We are hopeful that any future move from Chenies Mews to consolidate the Institute will include extra facilities for graduate students. A dedicated Graduate Administrator supports all aspects of the graduate teaching working closely with the two graduate tutors (for graduate research and taught course), this could be strengthened by the establishment of a teaching office as we expand the taught graduate courses. Space The move to the new EGA wing has provided us with a dedicated teaching seminar room plus computer facilities. Further resources including upgrading of current AV facilities and provision of a quiet work room are still required. UCLH has recently opened a new Education Centre which provides training support, rooms, AV equipment and simulation rooms to support teaching. 97 postGRADUATE Education and training postGRADUATE Education and training UCL EGA IfWH 1st Quinquennial Review Finance Funding for educational activities comes from several sources including the Medical Postgraduate Education Budget, Deanery funding, and the Postgraduate Education Committee for O&G. We have successfully bid for additional funding from the Deanery for items such as simulators. Staff detailed in Appendix 9.1 Equipment • A dedicated teaching seminar room with AV facilities and a commitment from the Trustees to enhance this with videoconferencing, thus enabling links with other units both within the UK and overseas • Computer access • Ultrasound training models • Minimal access models • Clinical Skills Lab • Obstetric emergency simulation models and mannequins for multidisciplinary learning • Further including provision of a quiet work room with computer access are still required. UCL EGA IfWH 1st Quinquennial Review Performance and Measurement of Quality The graduate programme has expanded significantly since the creation of the Institute and we now have completion rates above the average of UCL. The taught MSc/Diploma in prenatal genetics and fetal medicine receives outstanding approval in reports from external examiners and student feedback in respect of organisation, teaching and the standard set and achieved in examination. The standard of teaching is peer reviewed to maintain and improve quality and performance. A measure of the success of this course is that it is not necessary to advertise specifically to recruit students. The reputation of the course is sufficient to maintain a constant demand for places. The Staff Student Consultation Committee reviews issues as they arise and working through the course organisers and the Graduate Teaching Committee these are dealt with speedily and improvements made in the delivery of the courses. The graduate programmes are reviewed through the UCL quality assurance procedures with annual reports and conform to their guidance and best practice. We have recently established regular meetings of graduate supervisors to discuss issues and develop a robust approach to supervision and student review. The dedicated student seminar programme provides opportunities for assessment and development of student progress and contributes to improving skills and improvement in completion rates and career opportunities for our graduates. Research students have an annual appraisal with a report and a meeting with the graduate tutor to ensure progress is being made. Key performance indicators for postgraduate clinical training • PMETB survey – this has consistently shown our unit to provide a good level of training in comparison to other units (for O&G) and to other specialties (for UCLH) in particular for access to resources, educational supervision and processes such as effective handover. • Annual Assessment of Competency Progress Reports – these Deanery-led reviews have given positive feedback to our trainers in terms of provision of training. All trainees are supported in completing portfolios, undertaking formative and summative assessment and multi-source feedback. • Examinations – we have a high number of trainees who have passed their RCOG Membership examination • 100% compliance with induction processes • ULCH holds an enviable position as one of the most popular Trusts for trainees to rotate to from within the North East Thames Training Programme Areas of Excellence Impact and Importance The MSc/Diploma in prenatal genetics and fetal medicine has been an outstanding success. Many of the graduates go on to do PhDs in the Institute or elsewhere and the course makes a significant contribution to developing capacity in prenatal genetic diagnosis and fetal medicine with many students from a clinical background. It continues to receive excellent approval from external examiners and from the students themselves. The expertise in teaching this course is a factor in being able to expand our taught graduate programme. Our aim as an institute is to attract and retain high caliber biomedical and clinical scientists into a career in women’s health. Creating a vibrant and robust graduate programme provides an environment to achieve this by providing a clear training path, not least for the clinical fellowship and lectureship programme. Many of the graduates of the MSc course either enter or return to a clinical environment in women’s health with greater expertise; many go on to do PhDs and contribute to scholarship and translational research in this field. Graduate research also forges a link between basic biomedical and clinical science which is important for developing skills in translational research. Challenges The main challenge during last three years has been to develop a coherent graduate programme with a clear identity in the Institute, to strengthen the organization and quality assurance of the graduate research programme to improve completion rates and to develop new teaching initiatives. This has been a key priority of the Institute where teaching has been identified as an important contribution to the future of women’s health. The PhD and MD programme, establishing clear milestones and a robust review of progress, has improved the quality assurance process with a concentration of developing transferable skills. This will strengthen our funding capability. This was achieved by bringing supervisors and all graduate students together in regular bi-monthly seminars where the students present their work as part of the review and PhD upgrade process. In addition to the graduate teaching committee we hold meetings of supervisors to discuss developments and ideas for the future. Another key factor in developing this programme was the creation of a small team (graduate tutors, two supervisors and the graduate administrator) to develop and push it forward. Dividing the work of the graduate tutor between research and taught programmes (a mirror of the organization at faculty level) has also been beneficial in concentrating expertise in these areas and developing initiatives. We have developed a number of key areas for education which have made an impact upon supporting training and thereby furthering the effective provision of safe care for women: •Mentoring programme for trainees •Regional training programme •Embedding of curriculum based training and teaching •Practical ultrasound training for junior trainees (ST1-2) to be able to practice effectively in the labour ward environment. •Clinical audit days •Incorporation of junior trainees to teach medical students and midwives in order to achieve part of the teaching skills requirements of the curriculum Clinical training •Institute for Women’s Health Academic Fora and Annual Study Days which provide an opportunity for all those working across Women’s Health to communicate and participate with each other. We have worked hard to implement the new Specialty Training Curriculum since its inception in August 2007. We acted as a pilot site for use of the new assessment tools and this has proved valuable to us in learning how to incorporate these into a busy working environment. Future Developments Ongoing conflict between service and provision with the implementation of the European Working Time Directive. We have addressed this by increasing our numbers of non-training posts and by working with Human Resources to redesign rotas in order to ensure that trainees retain a structured and progressive focus to the weekly work, whilst minimising disruption to training. In recognition of these first two challenges and the potential impact they might have upon patient safety and upon training needs, we developed an education and learning stream as part of a major Maternity Quality Project during 2008. This is ongoing and has proved valuable in identifying needs and addressing them both across obstetrics, gynaecology and midwifery. Space issues within the new maternity wing. 98 Developing taught MSc and PG diploma courses provides training for career progression in women’s health for nurses, midwives, clinicians and biomedical sciences and helps attract and retain staff on a career path in women’s health. The MSc/ PG diploma in prenatal genetics and fetal medicine is a clear example of the success of this approach. The new MSc in Reproductive science and women’s health is due to start in September 2009 and recruitment of students is already under way. Our aim is to develop a portfolio of modules for further development of taught postgraduate degrees. These modules will form part not only of degrees offered in the Institute but will also contribute to courses elsewhere in the college. This will have two effects: 1) to further extend opportunities for study in the institute and 2) to increase the income base to build funding for the education programmes. There are particular opportunities in nursing and midwifery and a strengthened education office bringing together all the components of the education programme in the Institute will provide the resource necessary to support this. We must however be realistic 99 postGRADUATE Education and training postGRADUATE Education and training UCL EGA IfWH 1st Quinquennial Review in terms of the demands on academic staff time and careful use of existing modules should keep this load within reasonable limits. Development of courses in conjunction with other divisions will be a major part of the strategy. Current developments includes funding for a MRes/MSc in Translational Clinical Science under the NIHR Clinical Academic Training Pathway for Nurses, Midwives and Allied Health Professionals (Lead for the Institute: Dr Anne Lanceley) in association with the UCL Patient Care Research and Innovation Centre and UCL Partnerships. The educational strategy within the unit recognises that continued development will be key to maintaining strength in both education and training. Key areas for development have been identified as follows: • Development of e-learning tools • Simulation workshops (to alleviate lack of practical training from reduction in working hours) • Further incorporation of ultrasound training within the curriculum • Expansion of courses for trainees to be able to achieve all objectives of the postgraduate curriculum whilst within our area. 100 UCL EGA IfWH 1st Quinquennial Review GLOBAL HEALTH postGRADUATE Education and training UCL EGA IfWH 1st Quinquennial Review 101 UCL EGA IfWH 1st Quinquennial Review GLOBAL HEALTH Scaleable – we focus on projects which, if proved successful, have the potential to be rolled out nationally and perhaps internationally in similar settings. For example, the cervical screening and treatment project in Kampala. The model used has proved successful and cost-effective; negotiations with the Ugandan Department of Health are currently under way with a view to establishing similar programmes throughout the country. OVERVIEW Currently, the Global Health Division is running projects in several countries, with the majority being based in Uganda. At an early stage these projects were discussed in detail and agreed with counterparts in Uganda, following which the Ugandan Women’s Health Initiative (UWHI) was set up. The UWHI is a collaboration of UCL EGA Institute for Women’s Health, Makerere University, Kampala, and Hospice Africa, Uganda (Appendix 10.2). Charged with supervising all the projects run in Uganda, the UWHI Board is comprised of members from both the IfWH and Uganda, and meets twice a year. Each individual project is assigned joint leads from London and Uganda and they periodically provide progress reports to the Board. Where appropriate, projects have received ethics approval from Makerere University Ethics Committee. Projects • Cervical screening and treatment (Kampala, Uganda) • Postpartum haemorrhage (Jinja, Uganda) • Neonatal resuscitation (Mulago Hospital, Kampala, Uganda) • Radiotherapy machine (Mulago Hospital) • Radiotherapy hostel (Mulago Hospital) • Palliative Care consultant (Mulago Hospital and Makerere University, Kampala, Uganda) 102 The Global Health Division contributes to raising the international profile of the Institute by: The UCLH Trust has taken an accommodating approach, allowing staff some extra time off to contribute to Institute work. For example, clinical activities have been cancelled to maximise attendance at the Institute annual scientific meetings, and some extra days’ leave have been granted to staff spending time working on Institute projects abroad. The UCLH Trust also donated approximately £300,000 of equipment from the Middlesex Hospital when it closed which is now located at Mulago Hospital, Kampala. • Organising an International Women’s Health Conference in Kampala in November 2006). This successful conference was attended by over 350 Ugandan and international delegates. No specific Institute space or equipment is available to support the work of the Global Health Division but the UCLH Trust has been happy to allow its office space, computers, etc to be used. We wish to work when possible within the existing local infrastructure, and establish roles for local trainers to promote the spread of information, innovation and best practice. The Global Health Division of the Institute for Women’s Health is a multidisciplinary team open to all staff (all grades and all disciplines) in UCL and UCLH; the details of the core team are provided in Appendix 10.1. Membership of this group is supplemented by temporary participants such as junior doctors on rotation at UCLH. The division has initiated and oversees a series of international projects, described in further detail below, each of which is led by named members of the team. • Lecturing at national and international conferences about the Institute’s work and international projects. • Collaborating internationally to develop partnerships with the common goal of development in women and children’s health (see below). Resources Family sorting beans • Neonatal cooling to prevent asphyxia (Mulago Hospital) • International Women’s Health Conference, November 2006 (Kampala) • Improving the understanding of ethics in women’s health (UCL, Andhra Pradesh, India and Durban, South Africa) • Cervical screening and treatment (Lagos, Nigeria) • Securing hospital equipment from the Middlesex Hospital on its closure and transportation of this to Mulago Hospital • Six-month secondment of a Specialist Registrar in Obstetrics from UCLH to work in Mulago Hospital and participate in several of the UWHI projects Strategy, Aims and Objectives In line with the Institute’s mission statement, our overall aim is to make a major contribution to women’s health internationally. Specifically, we aim to contribute to a reduction in maternal and child mortality, and to affect positively the health of women, their families and communities. We also want to raise the international profile of the Institute with the ultimate goal of being acknowledged as an influential voice in this arena. With these aims in mind, we have favoured international projects which are: Affordable and feasible – particularly relevant to projects in resource-poor settings such as Uganda. For example, we are investigating the management of postpartum haemorrhage with misoprostol, a drug which is inexpensive and heat-stable, so affordable and appropriate in rural Uganda. Sustainable – when a project finishes, the health intervention must be sustainable within the context of the resources of that country or district. For example, misoprostol can be dispensed through existing antenatal clinics in Uganda, mirroring the existing system for dispensing antiretroviral therapy to HIV positive pregnant women (women in Uganda have little antenatal care, but over 90% have at least one visit). recruit women to the study, then follow them up and collect data after they have given birth. People are a vital resource so we have established several national and international collaborations in order to maximise the impact of our joint projects. Funding for the work of the Global Health Division until now has come primarily from a two philanthropic donors who have contributed £600,000 and £150,000 to support our international projects. These donations have now been entirely allocated, and will be spent by the end of 2009. Further personal donations from these donors are possible. Our major donor has also underwritten another major Institute project, the installation of a new radiotherapy machine in Mulago Hospital, Kampala. This donor and his family have now set up the Arem Foundation, a charity whose aim is to raise money to support the work of the Institute. In September 2008, members of the Institute’s Global Health Division participated in a charity dinner organised and hosted by the Arem Foundation. This successful dinner was attended by over 150 supporters and raised £88,000 for the Institute’s international projects. The Nigerian screening group raised £30,000 at an art auction held at the RSM in 2007. The Leventis Foundation, a Nigeria-based organisation donated a further £50,000 to this program. All UCLH and UCL staff participating in the work of the Global Health Division give of their time freely. The obstetric Specialist Registrar who worked in Uganda for 6 months was paid a salary at Ugandan rates by the Institute. A project manager, previously in a similar role within UCLH, has moved to Uganda and is employed part-time by the Institute to manage all our projects there; his input has proved invaluable. Several projects employ local staff whose salaries are paid by the Institute for the duration of the project. For example, the cervical screening projects employ Ugandan and Nigerian nurses who have been trained to examine and treat cervical lesions, as well as provide health education for local women. The misoprostol postpartum haemorrhage study has employed local midwives and healthcare assistants to educate and Performance and Measurement of Quality of Activity The performance of each project will be measured against the Global Health Division’s aims, specifically whether it provides a health benefit for women and/or their children, is feasible, sustainable and scaleable and whether it raises (or has the potential to raise) the international profile of the Institute. Cervical screening and treatment These projects have been very successful. Over 5,000 women have been educated and undergone cervical screening. In Kampala approximately 20% of women screened have premalignant disease and the screening strategy has been shown to have encouraging sensitivity and specificity – paper in preparation. Approximately 10% of the women screened in Lagos were found to have premalignant cervical lesions, which have been treated. The Nigerian Group held an open day in May 2008, attended by heads of government and the Lagos State Government announced its commitment to one-stop screening. This was widely covered by the local media. Since then a program of training for health care professionals in Lagos and Abuja has been instituted. The Ugandan Department of Health are also excited by the results and are actively exploring the possibility of rolling out this programme across the country. Local evidence of the value given to the IfWH effort is the agreement in 2008 of Janet Musuveni, Ugandan MP and wife of the President of Uganda to become a Patron of the UWHI. Postpartum haemorrhage Recruitment to this project has finished recently and data collection is approaching completion. Data analysis has not yet started but our impression is that this method of distributing misoprostol using the existing limited infrastructure has been safe and effective. If this is the case, we will have proved that the efficacy of the model could be replicated in the poorest areas in Uganda and potentially other resource-poor countries. 103 GLOBAL HEALTH GLOBAL HEALTH UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review Neonatal cooling to prevent asphyxia We investigated early cooling of the newborn to ameliorate the effects of intrapartum asphyxia in a resource-poor setting, using inexpensive equipment. This intervention was shown to reduce significantly the risk of adverse neonatal outcomes. These findings have been published in the Lancet. This technology is affordable to hospitals in most developing countries. International Women’s Health Conference Image from IfWH Ugandan Women’s Health Initiative photoarchives Neonatal resuscitation This success of this project has demonstrated that it is feasible and scaleable. Two Institute staff (a neonatal consultant and neonatal nurse consultant) spent a week training a small group of local staff in basic neonatal resuscitation. Following their departure, that small group cascaded this training so that now most medical and midwifery staff at Mulago Hospital, Kampala are trained. This training is ongoing and the neonatal consultant there has confirmed a significant fall in the number of asphyxiated babies being admitted to the neonatal unit. Radiotherapy machine Project not yet in progress. Measures of success will be successful installation of the machine; doubling of the total Ugandan capacity to treat patients with radiotherapy (currently, there is a single machine for the whole country); ability of local personnel to run and, when necessary, repair this machine. Radiotherapy hostel Currently the rate-limiting factor in treating patients with radiotherapy at Mulago Hospital is the lack of in-patient beds. We have funded the planning and building of a patient hostel which is now complete and can accommodate these patients. Success will be measured by the increase in the number of patients treated by the radiotherapy machine – the only one at present. Palliative Care consultant This consultant is in post and has increased both the capacity for providing palliative care in Kampala and for academic research in this area. Future performance will be judged by audit of both quality and quantity of care, and by relevant publications. We also hope to see the Ugandan Department of Health will be convinced of the added value such that they agree to continue funding the post in the longer term. 104 This conference was a success, attracting more than 350 delegates from many disciplines involved in women’s healthcare. Delegate feedback was very positive. The conference engaged the Ugandan Government, helped us to establish relationships with and increase our influence with Ugandan Government officials. It also significantly raised the Institute’s profile in Uganda and neighbouring countries. Improving the understanding of ethics in women’s health In 2005 the Collaborative Centre for Reproductive Ethics and Rights was established in the Institute for Women’s Health as a collaboration with Professor Ames Dhai, Head of Bioethics at the University of Witwatersrand, South Africa. The centre has published papers on ethics of HIV and Pregnancy, PGD for late onset disorders, ethics of developmental origins of disease, fetal therapy and access to healthcare in India. With support from the British Council UKIERI we are working with colleagues in India to develop short courses in medical ethics for the medical curriculum in India. The course has now been run three times in India. The poster presentation of this work was awarded a prize at the UCL Teaching and Learning Conference in 2008. To facilitate this work, Dr Ray Noble of the Institute has been appointed Honorary Visiting Professor of Medical Ethics at the medical school in India and is Honorary Associate Professor of Ethics at the University of KwaZuluNatal, Durban. We have also carried out research with small cohorts of women in rural India investigating views on informed consent and confidentiality and their impact on health care access. A report of this work has been presented to the British Council and at the Institute International Meeting in 2008. These include: Future success of this work will be assessed by monitoring its incorporation into the medical curriculum in India, by publication of further research, and by progress made in other international collaborations. •Lagos University Teaching Hospital, Nigeria Second hand equipment Securing second hand hospital equipment, furniture, fittings, etc. from the Middlesex Hospital when it closed; transporting all this equipment to Mulago Hospital in Kampala. The outcome has proved the success of this project: selection (by Ugandan colleagues) of suitable equipment, transportation to Uganda, and successful installation and use in Mulago Hospital. While this project was the result of a unique opportunity so is not scaleable, it has been a real success as evidenced by feedback from staff and managers at Mulago Hospital. Obstetric Specialist Registrar Secondment of an Obstetric Specialist Registrar (SpR) from UCLH for 6 months in Uganda, to work in Mulago Hospital and participate in several of the UWHI’s projects there. This project was an experiment which was largely successful. The SpR was satisfied with being paid at Ugandan rates for 6 months but could probably not have sustained it financially any longer. His contribution to the Institute’s projects in Uganda was significant; the rate of progress in the studies with which he was involved was considerably faster during his secondment. Communication with colleagues in Uganda (a major barrier) was considerably enhanced when he was there. On the other hand, the clinical experience he hoped to gain in Uganda, while adequate, was less than expected. A number of national and international collaborations have been established in a relatively short space of time, raising the Institute’s international profile and building a firm foundation for future international studies in women’s health. •Venture Strategies for Health and Development, University of California, Berkeley •British Council (UKIERI) •Makerere University and Mulago Hospital, Uganda •University of KwaZulu-Natal, Durban •University of Witwatersrand, South Africa • Alluri Sitarama Raju Academy of Medical Sciences (ASRAMS), Eluru, Andhra Pradesh, India •Hospice Africa, Uganda •Centre for International Health and Development, Institute of Child Health, London Areas of Excellence Cervical cancer The Institute for Women’s Health at UCLH is an internationally renowned leader in the field of gynaecological cancer, with a wealth of clinical and academic expertise and many publications in this area. Building on this foundation, the Global Health Division has tackled cervical cancer in resource poor settings. Cancers of the cervix and breast are the most common causes of death from cancer amongst women in many developing countries. Both of these cancers are characterised by presentation at an advanced stage by which time treatment is generally limited to palliative measures. Cervical cancer is a preventable disease and screening programmes in western countries have dramatically reduced its incidence and mortality. Developing countries have neither the resources nor the healthcare infrastructure to support such a screening programme. The Global Health Division has utilised an inexpensive, one-stop, ‘see and treat’ method of screening for cervical disease using a validated method of visual inspection with acetic acid and treatment of premalignant lesions with cryotherapy. This model is proving very successful in both Uganda and Nigeria. Recognising the extremely limited radiotherapy facilities in Uganda (a single radiotherapy machine for the entire country), we have built a new patient hostel to improve throughput and are in the process of procuring a second radiotherapy machine. We have also collaborated with Hospice Africa, pump priming a new consultant post in palliative care, thus significantly augmenting the terminal care of women diagnosed late with cervical cancer. Traditional dance at the Prevention of Cervical Cancer Open Day in Nigeria 105 GLOBAL HEALTH GLOBAL HEALTH UCL EGA IfWH 1st Quinquennial Review The Institute is home to a leading perinatal brain injury research programme combining the expertise of obstetricians, neonatologists and clinical scientists, who have published widely in this field. The Global Health Division was keen to try to build on this expertise. The neonatal resuscitation project described earlier has already significantly reduced neonatal unit admissions due to asphyxia in Kampala. The neonatal cooling work pioneered in developed countries by, among others, Institute clinicians has been successfully adapted for our project in Mulago Hospital in Kampala. Publication of these findings in the Lancet has brought them to a wide audience, fuelling the hope that this technique may be introduced in similar settings across the world, and adding to the reputation of the Institute and its international work. Postpartum haemorrhage Postpartum haemorrhage (PPH) is the major cause of maternal mortality in developing countries. Many of these deaths are preventable through administration of a single dose of a drug to stimulate uterine contraction in the third stage of labour. The standard drug used in developed countries for this purpose is syntometrine but it is expensive, unstable unless continuously refrigerated and must be administered parenterally. Ten years ago in UCLH, we pioneered the use of misoprostol as an alternative to syntometrine. This drug is cheap, stable and can be administered orally or rectally. At the Institute, we have led the field by showing that misoprostol is highly effective in preventing and treating established PPH. The challenge now is to find a safe and effective method of getting this drug into the hands of those women who need it most – those delivering in villages remote from medical care. We have addressed this in our PPH project in Uganda. The data will soon be analysed but our initial impressions suggest that it has achieved our aim. Combined expertise The Global Health Division benefits from the combined intellectual capital of experts in varied fields, including obstetricians, gynaecologists, midwives, nurses, scientists, epidemiologists, social scientists, anthroplogists, lawyers, counsellors, etc. The collaboration of UCLH and UCL within the Institute allows us access to expertise in many other fields; colleagues can be co-opted when required. Challenges Communication has proved to be one of the major challenges for the Global Health Division over the past three years. Communication with India has been relatively straightforward but with colleagues in Uganda has been problematic. Even in the capital Kampala, few have good internet access and none have broadband. Phone connections are of poor quality, unreliable and expensive. On occasion, it has been very difficult to continue to motivate, instruct and monitor researchers in Uganda. Having an Institute project manager based in Uganda has helped, and seconding our obstetric SpR there certainly accelerated the pace of several projects for the six months he was there. This lesson has been learned for future projects. 106 A perpetual challenge is the fact that few people working on the Institute’s projects do so full time. The project leads in both the UK and Uganda supervise their project(s) in addition to doing their own full-time jobs. Even the Ugandan midwives and doctors employed by the Institute are mostly part-time, supplementing their income with Institute work. This, combined with the difficulty in communication, made it a constant challenge to keep these projects towards the top of everyone’s agenda. The presence of a project manager and, for six months, an obstetric SpR from UCLH mitigated this to some extent, but the importance of at least some full-time staff for any future projects is clear. The possibility of funding some senior clinician protected time within the Institute could also be explored. The local and national healthcare infrastructure in a country like Uganda is poor and, in some areas, non-existent. This obviously presents major challenges to initiating and maintaining projects there, particularly as we are keen to work within existing structures so that projects are sustainable. Measuring hard outcomes following our interventions has proved difficult in resource-poor settings. Audit is not a priority in developing countries and any healthcare staff (including those we have employed) are invariably too busy delivering care to have time to measure outcomes. There was briefly some tension between the demands of the NHS clinical service at the UCLH Trust and the demands of the Institute on clinicians’ time, but a mutually acceptable compromise was negotiated. Nevertheless, it is conceivable that this tension could again become an issue, particularly if the Trust suffers further financial constraints over the next few years. Impact and Importance The World Health Organisation has made the point that we already have medical interventions capable of preventing or treating many of the major causes of maternal and neonatal mortality in developing countries (for example, rehydration solutions for children with diarrhoea, syntometrine for postpartum haemorrhage, immunisation against common infectious diseases).The real challenge now lies in identifying practical and affordable methods of delivering these interventions to the people with the greatest need, in resource-poor settings. This ethos lies at the heart of several of our programmes. Cervical screening and treatment Cervical cancer is the major cause of death for women between the ages of 20 and 40 in many developing countries. It is often diagnosed late and most women die a miserable death, often in pain, with infections and fistulae, and ostracised by their family and community. This is all the more tragic because cervical cancer is an almost entirely preventable disease in countries with the resources and infrastructure to provide a national screening and treatment programme. There is an urgent need to address this disease in developing countries. The Institute’s programme has tackled this issue in a comprehensive way. In Uganda, women’s awareness of cervical cancer and screening is very limited. We addressed this by training Image from IfWH Ugandan Women’s Health Initiative photoarchives Perinatal brain injury UCL EGA IfWH 1st Quinquennial Review local nurses to educate women in some of the poorest areas. The one-stop screen-andtreat technique we employed is inexpensive, portable, and does not require an electricity supply. We have demonstrated that it is feasible and effective. In Nigeria, efforts have been concentrated on raising awareness. A public information film, explaining the importance of screening was made with the support of Armand Eye Films, London. This has been distributed widely in Nigeria and there is a plan to show it in the High Commision offices in London where statistics have shown that black and ethnic minority individuals are less likely to accept screening. Treatment facilities in Uganda for women diagnosed with advanced cervical cancer have been extremely limited: a single radiotherapy machine supported by insufficient hospital beds. We have addressed both of these barriers by working to provide a second machine and build a patient hostel nearby. Palliative care for terminally ill women is in its infancy in most developing countries. We have extended the clinical and academic capabilities of palliative care in Uganda by appointing a consultant in this specialty. We have thus contributed to all points in the care pathway of these women which will have a major impact on prevention and treatment of this disease. Of greatest importance is that we have demonstrated a pathway of care that is affordable and sustainable in many developing countries. Our model of education, screening and immediate treatment could have a significant impact in many countries. Although we obviously cannot afford to provide radiotherapy machines in other countries, it is important to note that we have identified that the expertise and resources to support its use already exist in Uganda. By studying patient flows and identifying that a lack of beds was limiting patient throughput, we found a relatively inexpensive solution. This systematic analysis could be applied in other settings. Postpartum haemorrhage The WHO estimates that 100,000 women die in childbirth every year, 99% of whom die in developing countries. The major cause of maternal death in those countries is postpartum haemorrhage. Syntometrine, the drug commonly used in affluent countries, is very effective at preventing PPH but is not affordable in developing countries. We initially showed that misoprostol is almost as effective as syntometrine at preventing major PPH. Our current study describes a simple, effective and affordable method for delivering this drug to women in the poorest, most remote villages in Uganda. We believe that this method, if implemented across Uganda and other similar countries, has the potential to reduce the incidence of maternal death and morbidity from PPH by around 50%. In the past two years, Tanzania, Bangladesh, Ghana, Kenya, Nepal, Sudan, Uganda, and Zambia have succeeded in registering misoprostol for this critical use, influenced in part by our earlier work. The next step is to persuade Governments in these and other developing countries to implement our system of distribution and make our goal of reducing maternal mortality and morbidity a reality. We plan to collaborate with Venture Strategies for Health and Development and the University of California, Berkeley, to lobby the Ugandan Government, and have already made preliminary approaches to the Indian Ministry of Health and Federation of Obstetricians and Gynaecologists of India. In January 2009, Zambia successfully launched a programme promoting the use of misoprostol for PPH in five districts. Neonatal resuscitation This project was motivated by the observations of a consultant neonatologist colleague in Kampala. We were surprised to learn that many babies were admitted to her neonatal unit with asphyxia which could have been prevented, had the midwife attending the birth been armed with basic neonatal resuscitation techniques. Our training programme, which has been successfully cascaded throughout the department there, has had a significant impact on reducing such birth asphyxia. Enquiries abroad have found that a similar problem exists in hospitals in other developing countries. This simple, inexpensive and sustainable intervention has the potential to have a similar impact on birth asphyxia in other countries. Neonatal cooling to prevent asphyxia Neonatal cooling to reduce the impact of intrapartum asphyxia is a very promising technique. Until now, however, it had seemed that its application would be 107 GLOBAL HEALTH GLOBAL HEALTH UCL EGA IfWH 1st Quinquennial Review limited to developed countries because of the expense of the equipment used. However, the Institute has shown that in resource-poor countries (where the incidence of birth asphyxia is relatively high), an inexpensive adaptation of this technique can produce similar benefit. The potential of this technique in other similar settings is exciting. Improving the understanding of ethics in women’s health In collaboration with the WHO, the Medical Council of India aims to incorporate the study of ethics into the curriculum of medical schools in India. Most schools have not yet begun to do this. Major problems include a shortage of staff trained in medical ethics and the need for training and development. Introducing ethics into doctors’ training can have a major impact on women’s health. Reproductive health can be a cause of domestic violence against women in India; poor ethical practice, such as the insistence of spousal consent and lack of confidentiality, can be a major factor in preventing access to healthcare. Lack of informed consent in medical practice remains a problem. The Institute’s Collaborative Centre for Reproductive Ethics and Rights aims to improve understanding of ethics in women’s health by: (a) running courses in ethics in the medical curriculum at UCL and incorporating ethics into existing programmes by running workshops for students at UCL; (b) research and scholarship in ethics in women’s health; (c) international collaboration in teaching and scholarship. If successful, this ground-breaking collaboration could be replicated in other developing countries with emerging medical ethics curricula. Future Developments We wish to continue to have an impact on women and children’s health in developing countries. The projects underway will be completed and the data analysed. Publication will follow, relating to both the research findings and the practicalities of running studies and implementing health interventions in resource-poor settings. UCL EGA IfWH 1st Quinquennial Review We plan to continue to raise the national and international profile of the Institute by publishing and presenting our findings widely and by collaborating with other organisations and individuals who share our goals. Funding will be critical to achieving these aims and to conducting further studies. The Institute’s International division will work with the Arem Foundation to continue to raise funds; it is hoped that the fund-raising dinner will become an annual event. The Institute as a whole will work with UCL to raise money through corporate and personal sponsorship. It is likely that the international projects will prove attractive to potential donors. clinical and academic administration GLOBAL HEALTH UCL EGA IfWH 1st Quinquennial Review Our aim is to use our evidence demonstrating the effectiveness of interventions to influence decision makers with a view to rolling out these interventions across Uganda and other developing countries. We hope that by demonstrating that our interventions make a real difference to women and children’s health, and are affordable and scaleable, local policy makers will be convinced to consider implementing them on a wider basis. Professor Ian Jacobs has been invited to take part in the Ugandan Health Ministry’s working party to consider national implementation of the cervical screening programme. Adeola Olaitan is working with the Lagos State Government to ensure that screening is phased in in a manageable fashion and that quality assurance is in place. The Institute will collaborate with Venture Strategies for Health and Development and the University of California, Berkeley; initial discussions have already taken place with the Ugandan Ministry of Health with regard to developing a national misoprostol distribution programme. The Government of India has also shown some interest in further discussions. Plans are already underway to carry out an RCT in neonatal cooling in Uganda and Malawi. 108 109 UCL EGA IfWH 1st Quinquennial Review clinical and academic administration CLINICAL AND ACADEMIC ADMINISTRATION OVERVIEW The IfWH is an overarching structure for strategic planning in Women’s Health, which acts through consensus without governance authority, as explained on pp. 8–9. The Institute is led by Director Professor Ian Jacobs and three Deputy Directors, Professors Judith Stephenson, Donald Peebles and Neil Marlow. Strategic Planning Board brings together clinical and academic staff to agree and plan joint developments. Tamara Davies Marcia Jacks Shahina Mohamed Susan Sinclair The Institute is a joint UCL/UCLH structure, but the main administration for the IfWH runs through the academic UCL side of the partnership. UCLH The Women’s Health Division is one of six divisions in the Specialist Board within the Trust, and both the Clinical Director and Divisional Manager report to the Medical Director for Specialist Hospitals (Appendix 11.1). The Division consists of four specialist clinical units: Gynaecology, Breast, Maternity and Neonatal Medicine. Each is supported by a Medical Clinical Lead and a Senior Manager. There is a single divisional nurse or midwife, who reports to the Divisional Manager and is supported in her role by the Head of Midwifery and Head of Nursing for Specialist Hospitals, who are professional leads for midwifery and nursing services respectively. The Clinical Director, Tim Mould, and Divisional Manager, Susan Sinclair, have overall accountability for the operational performance of the division.This includes quality of care, governance of the division, financial and staff performance. In order to support the division, a business partner model exists with human resources, finance and information, which means that we have dedicated support to the division. UCL The Administration team for the Institute belongs to the UCL academic component of women’s health and supports academic staff, both clinical and non-clinical. The lead individual is the Institute Manager, Gemma Escorial, who at the time of writing is on maternity leave and is being replaced by Marcia Jacks for the duration of one year, from February 2009 to February 2010. Staff There are curently 13 members in the team, including the manager. The team is divided into four areas of administration: staffing, teaching, research and finance, and laboratory management. The teams are made up as folllows: Staffing – two full time staff Finance and research administration – one full time senior administrator and two part time finance officers Teaching – two full time staff, specialising in postgraduate and undergraduate teaching Laboratory management - a full time manager and part time purchasing officer Outside of the teams above is also the Institute Research Coordinator, Dr Tamara Davies, who facilitates research on both the UCL and UCLH sides. The whole team is supported by two office assistants. In addition to the core administration team, Shahina Mohamed is the Institute Coordinator and Executive Assistant to Professor Jacobs, and is supported by an assistant. There are also several personal assistants who provide support to professors and research leads. STRATEGY, AIMS AND OBJECTIVES UCLH A key priority of the Women’s Health Team is to link both strategically and operationally with the Institute for Women’s Health in order to ensure that academic and clinical excellence are achieved in the clinical setting. The objectives of the team within Women’s Health include: Care objectives Providing consistently high quality care Treating people with compassion Using treatments and interventions which are evidence based and up to date. Access to services Ensuring our services are easy to access, whether by telephone, fax or walk in Ensuring our services meet the needs of vulnerable groups Treating women, babies and their families as individuals, and recognising their needs. Seeking to continuously improve the service by: Listening to the feedback received Engaging with internal and external stakeholders Measuring clinical outcomes and the quality of it’s service Investigating situations which have not gone well and ensuring the individuals and the organisation learns from its mistakes. 110 111 CLINICAL AND ACADEMIC ADMINISTRATION CLINICAL AND ACADEMIC ADMINISTRATION UCL EGA IfWH 1st Quinquennial Review Managing the Division in order to ensure that the above objectives are met Ensuring that there is a career structure and opportunity for all members of staff Performance managing all staff to ensure that they reach their full potential Ensuring financial rigour and accountability underpin decisions made within the division. UCL The team will support the overall aim of the Institute which is to bring together the expertise of clinicians and research from a diverse range of disciplines so that they can deliver excellence and innovation in research and clinical practice, in order to make a real and sustainable difference to women’s health locally, nationally and worldwide. The staffing team is responsible for providing a comprehensive and effective service by facilitating the smooth employment administration for all categories of staff (see Appendix 11.2 for categories of academic staff at IfWH). They will advise staff on human resources policies and procedures and with the Institute Manager ensure the implementation of relevant policies and procedures throughout the Institute. The team will liaise with UCLH personnel for the administration of joint and honorary contracts. The teaching team is responsible for providing a comprehensive and effective service by facilitating the smooth teaching administration of postgraduate, undergraduate teaching and short courses, within the Institute. This includes the management of student numbers and reporting of student statistics for internal and external purposes (see Appendix 11.2 also for categories of graduate students). An important aspect of the work of the Undergraduate Teaching Administrator is coordination of medical students’ clinical attachments in Women’s Health and Communicable Diseases. The finance and research team is responsible for providing financial support to the Institute. The senior administrator is responsible for providing a comprehensive and effective service UCL EGA IfWH 1st Quinquennial Review at Institute level, facilitating the coordination, management and administration for research grant applications, awards as well as financial aspects of the Institute. The post holder provides initial advice and guidance on all aspects of UCL Finance procedures, as well as Pre-award and Post-award guidance for research grants. The Research Coordinator coordinates, facilitates and assists both academic and clinical research activity within the Institute, and leads the administration of key research-related strategic initiatives. The Coordinator will liaise with both UCL and UCLH in the areas of research administration and governance as required. The laboratory management team is a new team within administration and is an additional resource for the laboratories in the Institute. The Laboratory Manager is responsible for the coordination of laboratory work across the Institute, instigating and developing systems that will be beneficial to all the laboratories. In particular the role holder will oversee the whole purchasing process for the laboratories, ensure facilities are always at the required standard and oversee accreditation processes. The objectives will be achieved by: Maintaining the morale of the excellent administration team that is currently in place. Supporting the team and ensuring training is given and that training becomes an important part of their development. Liaising with leads in the various groups to ascertain objectives in respective areas of activity and ensuring this is communicated to administration team who will be involved in specific areas. Communicating effectively with group leads and other staff with respect to procedures and policies that will impact on their work. Each role holder will ensure they are up to date with the relevant policies and procedures for their area of work in order to communicate effectively to staff on request or through routine work. Each role holder will adhere to good work ethics, for example, consideration of the team members, a willingness to contribute to tasks outside of their immediate work area when required. Each role holder will be aware of the organisations’ equal opportunities policies and will respect and treat work colleagues fairly. The staffing administrators will ensure the smooth running of recruitment, and management of appraisals and promotions. The Institute Manager and senior members of the team will ensure attendance at relevant meetings in order to gain a wider knowledge of the work of the various groups within the Institute. The manager with the help of the relevant administration team will, where necessary, instigate policies and procedures. They will ensure up to date knowledge in the areas of human resources, finance, research and communications, amongst others, in order to effectively share this information with relevant staff. They will ensure that, as much as is possible, that all groups work in a similar fashion, yet at the same time recognising the peculiarities of each group. The manager will keep track of all the work that Launch of Haemoglobinopathies MSc 112 goes on in the Institute, in order to ensure coordination across the Institute. The team will bring together the expertise of clinicians and researchers by ensuring effective communication channels are in place. The research coordinator will ensure that policies on research governance is disseminated and acted upon. The manager will advise on all issues that affect the work of the Institute and will be the channel for procuring information on areas of unfamiliarity to the various groups. RESOURCES UCLH The division is funded primarily through payment by results, and in line with Commissioning guidance will be increasingly managed on the quality of care it offers. The divisions overall direct costs budget is circa £30 million, with a total income of £50 million. Changes in the funding arrangements will mean that over the next 2 years, the Trust as a whole will be required to save approximately 15% of overall expenditure. There are over 550 staff employed through the Women’s Health Division, notably medical, midwifery and nursing staff, allied health professionals, secretarial and management staff. The overall performance of the division is reported to the Medical Director each month, and areas of review include: Financial position Activity profile Workforce performance Quality, complaints and risk issues Attainment of National Targets such as Cancer Waiting Times, 18 weeks UCL Within the admin team this can be defined as: Completion of given tasks Meeting of deadlines, e.g. processing of research grant proposal to meet sponsor’s deadline. Successful organisation of conferences, e.g. the international women’s health conference, the annual meeting Efficient provision of service in relevant area, e.g. satisfied staff, lack of complaints, good feedback Meeting the evolving needs of the Institute Nursing and Midwifery postgraduate training is provided through City University, with the contract managed centrally through the Trust. AREAS OF EXCELLENCE The Trust also has an education centre and teaching and training programmes that support a wide range of in house training. UCLH UCL The staffing budget for the admin team for 2008-09 academic year is £478,467 of which £324,982 comes from HEFCE funding, £108,851 from UCLH and £44,634 from other sources, such as research grants and discretionary funds. There is currently one unfilled vacancy in the teaching team, that of a short courses officer. The staffing team is currently split over two buildings and for optimum working, this will need to be addressed in due course. The teaching team is also split over two campuses but this is relevant as the undergraduate teaching takes place at the Hampstead Campus. The Teaching Administrator spends two days in Bloomsbury and this goes someway to addressing coordination between the two administrators. Overall the core team is spread over four buildings. The administration team currently have equipment to the worth of £7,500. Recruitment The management team have an excellent track record in building clinical services. Davor Jurkovic and his team have been recruited in the last year to set up the new gynaecology outpatient diagnostic and treatment service which has reduced emergency gynaecology admissions by around a quarter, reduced consultant to consultant referrals and reduced follow up. The gynaecological oncology cancer centre clinical team have been recruited over the last seven years, and the business case for the recruitment of Professor Jacobs had significant input for the trust as well as UCL. Quality of care The Women’s Health Division has undertaken multidisciplinary work in partnership with McKinsey’s regarding quality of care. This work continues to be built upon, and this year in-patient gynaecology services are participating in a quality project that focuses upon the patient experience. PERFORMANCE AND MEASUREMENT OF QUALITY OF ALL ACTIVITY UCLH The Divisions success is increasingly being measured through the use of scorecards, which evaluate outcomes and quality of care. These are reported through the Umbrella Governance Group each month. Clinical administration staff work closely with clinicians 113 CLINICAL AND ACADEMIC ADMINISTRATION CLINICAL AND ACADEMIC ADMINISTRATION UCL EGA IfWH 1st Quinquennial Review UCL EGA IfWH 1st Quinquennial Review As the Institute continues to develop, so does the team. Over the past five years it has undergone extensive expansion and restructuring. Several key posts have been introduced, including those of Finance Administrator, Teaching Administrator and Research Coordinator. As well as quickly reacting to the changing needs of the Institute itself, the team has been just as efficient at introducing the necessary improvements following the Faculty of Biomedical Sciences Administration Review in 2007. At IfWH this was promptly followed by the introduction of Senior Administrator roles across the following areas: Finance and Research, Human Resources, and Postgraduate and Undergraduate Teaching. This has resulted in a much greater degree of specialisation and clearer lines of accountability, overall leading to more efficient operation across all the areas. Finance and Research Academic administration at Maple House There is a strong emphasis on getting the basics right, for example the telephone being answered, and audits are carried out in order to ensure this is the case and remedy the situation if it is not the case. Leadership and team work The focus of the management team over the next year is to build and work in effective partnerships. An example of where we have successfully done this is in fetal fibronectin where the management team at UCH worked with procurement to negotiate a sector wide price for this technology. UCL UCL IfWH Innovations and Progress in Healthcare for Women Annual International Meeting. In April 2008 the IfWH convened its first International Meeting, which was an exciting and challenging undertaking. It was a great success and has resulted in a number of positive outcomes for the Institute, raising its profile and enabling numerous new research and business connections to be established. The Meeting took place at the Queen Elizabeth II Conference Centre in Westminster and brought together up to 400 international clinical and research experts in women’s health. Several world-leading keynote and invited speakers gave talks over the course of two days, complemented by 24 oral and 108 poster presentations. One of the highly valuable outcomes of the International Meeting was the Ovarian Cancer UK Consensus Statement, produced as a result of the Ovarian Cancer Symptom Awareness Consensus Conference hosted by the Meeting, which was later used to inform a set of key messages from the DoH. The preparations for the next International Meeting are currently underway, with the Research Coordinator as the administration lead. This will take place in November 2009 and this time focus on Prevention, Screening and Risk Prediction in Women’s Health. The Institute’s aspiration is for the International Meeting to grow in reputation and prominence every year. 114 One of the significant contributions that the Finance and Research team has made to the development of the IfWH was assisting with the process of negotiations and arranging a partnership between the Medical Solutions (Nottingham) Limited and IfWH Medical Solutions. The latter is based in the one of the Institute’s laboratory areas. The partnership is a key part of developments at the Faculty level in our Platform Technology Initiative. Teaching The teaching team has participated in the process of setting up the new MSc in Reproductive Science, which is designed for biological scientists and obstetricians and will run from September 2009. The MSc in Prenatal Genetics and Fetal Medicine was also restructured to introduce modularisation. It is envisaged that modularisation will lend towards modules being shared more easily across departments in the Faculty and the NHS. In October 2008, the Virtual Learning Environment (VLE) Moodle was introduced with the view that it could be used for Self Directed Learning particularly for gynaecological pathology where interactive teaching may be useful. Since October 2008 the Women’s Health Communicable Disease (WHCD) Moodle site is being utilised and developed to help communicate teaching and settle timetabling issues. It has received positive feedback from students as an extremely useful resource in enabling access to lecture materials during the introductory week, as well as practice questions. CHALLENGES UCLH The economic situation in the UK, coupled with changes in the Market Forces Factor (a regional uplift to funding) and Research and Development Funding mean that the next years will be difficult ones within the Health Service. The response to this challenge is to ensure that the care within the division is second to none, and that the patients and referrers are treated well. UCL One of the problems that the team has had to face over the recent years was the high turn-over of staff, in particular those employed on a temporary basis through recruitment agencies. It took considerable time and effort on behalf of the existing staff to train the new-comers, yet due to the nature of this recruitment route it was necessary to repeat this on several occasions. The problem was addressed through reviewing the situation and priorities of the team, following which the necessary funds were allocated and steps taken to recruit staff on a more permanent basis. IMPACT AND IMPORTANCE UCLH The administrative team are in a position to provide leadership and guidance to the clinical work in the division. To this end, clear strategy and objectives are made, and fed through the division. The main objective for the next 1-2 years is a comprehensive safety strategy across the division. The administrative team provide the financial basis to allow the developments for the division to proceed. The administration system set up in the UCLH NHS Foundation trust is one of individual autonomy for divisions. Thus the Women’s Health Division is responsible for its £50 million budget. If the division is within budget, it is able develop services through its own regulatory systems. Furthermore, the division is able to generate business plans that can be approved by the trust and that enable the division to effectively ‘borrow’ funds from the trust in order to pump prime the initiative. UCL Due to the very nature of our work its impact somewhat differs from that of most of the other themes. Less direct and measurable, but nonetheless vital, this is delivered by means of providing an efficient support network, addressing a variety of professional needs of the Institute’s academic staff. The finance team enables financial accounting, monitoring and reporting of the £8 million budget, the team also ensures processing of the Institutes research proposals and management of research grants. The team, along with the Institute Coordinator is responsible for maintaining the website and this is in the context of the website being the gateway to the external world. The team is responsible for project managing office moves and coordinating changes within the 1,700 square metres of space occupied by the Institute. FUTURE DEVELOPMENTS UCL/UCLH EGA Institute for Women’s Health administration teams will be vital to drive through the expected changes that occur as part of the Academic Health Sciences Partnership (AHSP). Collaboration between UCL and the trusts in the partnership is the cornerstone of the venture. The Institute is ideally placed to achieve the aims of the AHSP. UCLH Key clinical developments over the next year include: Providing an IVF service as part of the fertility unit, developing midwifery care further for low risk women, developing and enhancing the diagnostic and surgical care for women with breast cancer. UCL The team will play an important part in the development of staff by assisting in the management of training, for example ensuring staff with management responsibilities are trained in UCL/UCLH management competencies. In teaching the team will assist graduate tutors with the marketing of new MSc degrees and the administration of short courses for income generation. The administration is key to the work of the Institute in that the work of the Institute needs to be organised and linked together. The support of the administration team is vital to enable this to happen. Each team within administration is organised to ensure systems are in place to deal with every aspect of their area of expertise. The teams set up systems to enable the work of the Institute to run smoothly and efficiently. They keep abreast of the relevant regulations, policies and procedures to ensure governance in all areas of work. The work of the administration team frees up academic and clinical staff time to focus on research and teaching activities. The staffing team is responsible for ensuring the recruitment and induction of new staff to the Institute is processed efficiently and that procedures that affect the 111 members of staff are carried out satisfactorily, ensuring compliance with the various employment laws. 115 CLINICAL AND ACADEMIC ADMINISTRATION CLINICAL AND ACADEMIC ADMINISTRATION UCL EGA IfWH 1st Quinquennial Review First Quinquennial Review www.instituteforwomenshealth.ucl.ac.uk