Palliative & Supportive Care Research Development in Wales

Transcription

1 Palliative & Supportive Care Research Development in Wales 5 Year Report

2 Contents Foreword Introduction The Cancer RRG and Our Partners Palliative and Supportive Care Research Portfolio Growth Research Grant Income Portfolio Highlights in each Thematic Area Recruitment into Palliative Care Trials Ensuring we stay focused on who we re doing research for Recent PPI Initiatives Support of the Palliative and End of Life Care Priority Setting Partnership Four Nations: Sharing Practice in Public Involvement Working to overcome deficits in knowledge The Roadshow Methodology Clinics Working to overcome deficits in governance arrangements The Research Governance Toolkit Working to overcome deficits in research practitioner resource Palliative Care Specific Research Nurses Award Winning Work Future Plans Keeping Informed 30 Acknowledgements

3 Foreword Palliative care research development in Wales over the period was supported by the National Institute for Social Care and Health Research (NISCHR) Cancer RRG. The year on year growth in the number of portfolio palliative care studies and participant recruitment highlights the success of Welsh academic and clinical researchers from the Marie Curie Palliative Care Research Centre and from across Wales in attracting inward investment and patient access to research. It also reflects the productivity and efficiency of the collaborations facilitated by the NISCHR Cancer RRG between the research teams, the Wales Cancer Trials Unit, the research workforce and NISCHR support services. In this report we are pleased to present some of our achievements over the past five years. The Cancer RRG s engagement activities have been extensive and fundamental to our capacity building and practice change agenda. In collaboration with our partners, we have engaged with clinicians and healthcare professionals on a regular basis, both by taking our research to them in clinical settings, and by providing methodological support. In supporting cliniciandriven and patient focused research, we recognise the intensity of academic support and clinical engagement which this requires. We believe that the collaborations and innovations outlined below emphasise that this approach is most likely to yield success in terms of patient access and a portfolio capable of delivering future practice change. Our key achievements are summarised below: Development of a programme of palliative care research that has resulted in over 6 million grant funding coming into Wales. Registration of 10 palliative care studies onto the NISCHR portfolio. Development of a growing programme of Pathway to Portfolio studies. Significantly increased recruitment to palliative care portfolio studies from 4 patients a year at the start of the grant period, to over 160 patients a year at the end. These achievements have been made possible by the initiatives outlined below: The Roadshow - a Research Roadshow was taken to every health board in Wales to explain some of the new opportunities which have arisen to either develop a palliative care research idea or recruit patients into existing studies. Methodology Clinics these have been held quarterly by the MCPCRC to provide free advice and support to academics, clinicians and other health professionals who want to develop a research study in palliative care. Research Practitioner Resource the Cancer RRG have secured funding from NISCHR to support four dedicated palliative care research nurses to improve access to palliative care studies for patients and explore sustainable models of recruitment. Facilitating Governance Arrangements guidance for independent hospices has been developed in the form of an interactive Research Governance Toolkit, available at palliativecare. walescancerresearchcentre.com/research. The Cancer RRG has worked closely with Involving People and the MCPCRC to ensure that, throughout our research development program, we stay focused on who we are doing research for. Recent public and patient involvement (PPI) initiatives include: Support of the Palliative and End of Life Care Research Priority Setting Partnership (PeolcPSP): This brought together organisations interested in palliative and end of life care to consult people in the last years of life, current and bereaved carers and families, and healthcare professionals, about what questions they believe need answering through research. Patient and Public Involvement Conference: Four Nations - Sharing Practice in Public Involvement: A joint conference organised by MCPCRC, Cancer RRG, Cardiff University and Involving People. The Conference saw representatives from Wales, England, Scotland and Northern Ireland come together to share perspectives on PPI. As of April 2015 Welsh Government re-structured its seventeen registered research groups into five large research centres with three smaller research units, with NISCHR replaced by a new governing body, Health and Care Research Wales. The Wales Cancer Research Centre is one of the five new centres to be funded by Health and Care Research Wales and is made up of key collaborators from across Wales. The successes achieved over the past five years have resulted in the palliative and supportive care group further consolidating its activities as a key work stream within the newly established Wales Cancer Research Centre and this workstream will be led from the MCPCRC based in Cardiff. We welcome this timely opportunity to report on our achievements over the last five years and to outline our future aims and priorities for palliative and supportive care research in Wales. Dr Anthony Byrne Theme Lead, Wales Cancer Research Centre and Lead, Cancer RRG 4 5

4 1.0 Introduction In April 2010, the Welsh Governments National Institute of Social Care and Health Research (NISCHR) funded the development of seventeen registered research groups (RRGs) over a three year period. The Cancer RRG was one of these seventeen groups, with the remit to facilitate the development of high quality research studies. In the first instance (April March 2013), Palliative and Supportive Care was the sole focus of this group as it was recognised nationally as an area of unmet need. The aims of the Cancer RRG were to facilitate the development of high quality clinical trials and other well designed studies in palliative care by: Facilitating All-Wales Research Development Group (RDG) meetings to generate, discuss and review ideas for studies and clinical trials which would be suitable for either Welsh or UK project and program calls Organising the provision of support thought NISCHR infrastructure support (e.g. clinical trials units, Involving People, NISCHR Clinical Research Centre) Assisting with the process of adopting research projects onto the NISCHR portfolio Acting as a central point for Welsh researchers Building good communication links At the end of the initial three year funding period in April 2013, NISCHR awarded further funding over a two year period until March This report summarises our achievements over the five year funding period from April 2010 through to March 2015, and outlines our future aims and priorities for palliative and supportive care research in Wales. 6 7

5 2.0 The Cancer RRG and Our Partners The Cancer RRG From April 2010 to June 2014 the NISCHR Cancer RRG was headed by Dr Gareth Griffiths. Dr Griffiths took up a Professorship at Southampton University in June 2014 at which point Dr Anthony Byrne became lead of the Cancer RRG. The Cancer RRG was initially hosted by the Wales Cancer Trials Unit (WCTU), and latterly by the Marie Curie Palliative Care Research Centre (MCPCRC), both based within the School of Medicine, Cardiff University. Our Partners The NISCHR Cancer RRG worked very closely with a number of key organisations: Dr Gareth Griffiths Cancer RRG Lead April 2010 June 2014, Director WCTU to June 2014 Dr Anthony Byrne Cancer RRG Lead June 2014 March 2015, Director MCPCRC, Consultant in Palliative Medicine, Cardiff and Vale Health board Dr Amanda Woodward Palliative Care Senior Research Coordinator Mrs Georgina Gardner Solid Tumour Portfolio Developer Mr Peter Gee Palliative Care Research Coordinator Palliative Care Research Development Group Wales Cancer Trials Unit The WCTU is a Cancer Research UK and NIHR registered core funded clinical trials unit at Cardiff University with three main areas of research, cancer therapies (early and late phase trials in solid tumours); primary care oncology and palliative and supportive care. Marie Curie Palliative Care Research Centre The MCPCRC is hosted by Cardiff University and led by Dr Anthony Byrne, Clinical Director, and Dr Annmarie Nelson, Scientific Director. The Centre is committed to develop and undertake well designed research which will directly improve the care and experience of patients, and their carers, in the palliative phase of their illness. Dr Annmarie Nelson Thematic Lead: Patient Experience; Scientific Director MCPCRC Dr Simon Noble Thematic Lead: Thrombosis; Clinical Senior Lecturer in Palliative Medicine, honorary consultant, Royal Gwent Hospital. NISCHR Academic Health Sciences Collaboration The Cancer RRG had attached to it a number of NISCHR NISCHR Clinical Research Centre The Cancer RRG worked closely with the NISCHR CRC Dr Despina Anagnostou Marie Curie Research Fellow, MCPCRC AHSC research fellows who had ring fenced funding to develop cancer research. This involvement included on a number of initiatives including the Research Roadshow, Patient and Public Involvement and Mr Jordan Van Godwin Dr Emily Harrop Research Assistant, MCPCRC Marie Curie Research Associate, MCPCRC the chairing of Cancer RRG Research Development Groups in the areas in which the fellows were funded to develop research. establishing a network of dedicated palliative care research nurses, these collaborations are detailed later in the report. Dr Stephanie Sivell Marie Curie Research Associate, MCPCRC Dr Cathy Sampson Dr Sophia Taylor Mrs Hayley Prout Dr Noreen Hopewell-Kelly Mrs Kristen Thomas Mrs Alison Evans Miss Lorna Ash Research Associate, MCPCRC Research Associate, MCPCRC Research Associate, MCPCRC Research Associate, MCPCRC Operations Administrator, MCPCRC Administrative Assistant, MCPCRC Administrative Assistant, MCPCRC As part of the restructuring outlined previously, these NISCHR groups above have now become part of Health and Care Research Wales. The shared interests of all these groups provide a wealth of opportunities for collaboration in research and provide a focus for cancer research throughout Wales. 8 9

6 3.0 Palliative and Supportive Care Research 4.0 Palliative Care Portfolio Growth Over the past five years the Palliative Care Research Development Group has focused not only on increasing the number of studies on the NISCHR portfolio, but also to improve the methods we use, and to develop or refine outcome measures, other than survival, to create the evidence base to improve routine clinical practice. Each of the three leads focused on a specific theme within palliative and supportive care: Rehabilitation / Cachexia Lead: Dr Anthony Byrne Workstreams: Physical Activity / Exercise Medical Devices Nutritional Intervention Pharmacological Intervention Outcome Measures Patient Experience Lead: Dr Annmarie Nelson Workstreams: Patient / Carer Experience Clinical Trial Methodological Development Patient & Public Involvement Assessment / Outcome Development Implementation Research Thrombosis Lead: Dr Simon Noble Workstreams: Patient Experience of venous thromboembolism (VTE) in advanced disease Thrombophylaxis in advanced disease Biological activity of drug intervention Natural history of VTEs in palliative care patients 4.1 Research Grant Income The main aim of the Cancer RRG has been to develop high quality Welsh led clinical trials and other well designed studies in palliative care, that are funded through open competition, peer reviewed pathways to ensure they meet the standards required for inclusion onto the NISCHR portfolio. Over the past five years the Cancer RRG have developed 39 Welsh led funding proposals, 21 of these have been successfully awarded and outcome is awaited on one. This is a significant achievement that has resulted in over 6 million funding coming into Wales and registration of ten studies onto the NISCHR portfolio. There is also a growing program of Pathway to Portfolio studies developed both via external funding routes and via funding from the MCPCRC. Breakdown of Grant Income Funder Health Technology Assessment # Proposals approved to date Value 3 3,314,108 Tenovus 4 119,000 Velindre Stepping Stones 3 423,516 Marie Curie Cancer Care 1 113,000 NISCHR 5 351,763 Cancer Research UK 1 613,968 Prostate Cancer UK 1 448,064 Leo Pharma 1 250,000 Pfizer 1 80,000 NIHR RfPB 1 300,000 TOTAL 21 6,013,

7 4.2 Portfolio Highlights in each Thematic Area The primary criterion for inclusion of studies onto our portfolio is that they will change practice, and include and take account of the patient and family experience. Patient Experience Rehabilitation / Cachexia Thrombosis Improving the Wellbeing of Men by Evaluating and Palliative radiotherapy in addition to self-expanding Patient Experiences of LIving with CANcer associated Addressing the Gastrointestinal Late Effects of Radical metal stent for improving outcomes of dysphagia and thrombosis Treatment for Prostate Cancer survival in advanced oesophageal cancer Funder: Leo Pharma Funder: Prostate Cancer UK Funder: Heath Technology Assessment Developing an intervention to support lung cancer Patients and their clinicians when considering systemic Anti-Cancer Therapy Establishing the palliative care needs of patients with Idiopathic Pulmonary Fibrosis and their carers Funder: Marie Curie Cancer Care A Tenovus study Optimising the Patients journey with Cancer Associated Thrombosis Funder: Tenovus Funder: Velindre Stepping Stones Charity Developing a simple screening tool to detect chronic The role of exercise in patients with cancer cachexia: A feasibility study to inform the design of a gastrointestinal symptoms after pelvic radiotherapy in cancer survivors Funder: Tenovus a study of preferences, motivation and outcomes of importance in patients with advanced cancer. Funder: Tenovus randomised controlled trial to identify the most clinically and cost effect length of anticoagulation with low molecular weight heparin in the treatment of cancer associated thrombosis Full details of all studies can be found at palliativecare. walescancerresearchcentre.com Funder: Health Technology Assessment 12 13

8 Number of patients 4.3 Recruitment into Palliative Care Trials The Cancer RRGs success in developing the palliative care portfolio of studies has led to a marked increase in recruitment of patients to palliative care studies in Wales. In 2009 only four patients were entered into portfolio studies, this figure rose to over 160 patients a year by the end of the grant period in This marked increase in recruitment was not only a result of development of the portfolio, but also due to the RRGs efforts to improve access to palliative care studies for patients, and efforts to explore sustainable models of recruitment. 5.0 Ensuring we stay focused on who we re doing research for The MCPCRC and WCTU have an active and high profile approach to Public and Patient Involvement (PPI) and disseminate their unique model across the UK via peer reviewed journal papers and abstracts, as invited speakers at national conferences and contributing to national guidance. From April 2010 to March 2015, a total of 683 patients were recruited into NISCHR palliative care portfolio studies in: Pain & Pain Assessment Exercise Radiotherapy regimes Anticoagulation Fatigue Patient Experience Breathlessness Idiopathic Pulmonary Fibrosis Screening Tools Gastroenterology Patient recruitment into NISCHR Portfolio Palliative Care Studies Dr Annmarie Nelson leads on PPI across the MCPCRC and WCTU and is Academic lead on PPI for the newly established Wales Cancer Research Centre. Dr Nelson is supported by a volunteer Research Partner Coordinator, formerly Dr Jim Fitzgibbon, and now recently recruited Barbara Harrington. Dr Fitzgibbon s role has expanded to include development and assessment of outcomes of PPI involvement, and he sits on the PPI steering committee of the WCRC. The MCPCRC and WCTU have involved lay people in the development and governance of research since their inception. The Units currently have an active group of 30 lay people recruited over time in partnership with Involving People. Research Partners are mentored by Trial Managers and Qualitative Researchers and are provided with an induction and training. Training can be tailored to specific needs but most of it is drawn from Involving People s suite of opportunities, including a course on Good Clinical Practice. Travelling expenses and honoraria are offered to lay people in line with Involving People s guidelines. It is the MCPCRC s and WCTU s aim to involve lay people in their research at the earliest possible stage, including recruiting Research Partners as coapplicants. They provide input to the development of protocols, patient facing documents and sit on and actively engage in Trial/Study Management and Steering Groups. These activities are supported by Standard Operating Procedures and are subject to regular review. Moving forward, we aim to further develop this strand of work by evaluating the impact of PPI on specific projects an area that in routine practice otherwise goes unmeasured Year 2008/ / / / / / /15 Four Nations Conference: Sharing Practice in Public Involvement Four Nations Conference: Sharing Practice in Public Involvement 14 15

9 5.1 Recent PPI Initiatives Support of the Palliative and End Of Life Care Priority Setting Partnership (PEOLCPSP) There are many unanswered questions to be addressed in palliative and end of life care. But with scarce resources, it is important that researchers and research funders ensure that they address questions which will bring direct and tangible benefits to patients and their carers, families and friends. The Palliative and end of life care Priority Setting Partnership (PeolcPSP) was initiated by Marie Curie in 2013, and involved around 30 other organisations and groups. The partnership was facilitated by the James Lind Alliance (JLA) and overseen by a Steering Group. The MCPCRC supported the partnership by hosting project staff and providing resources to undertake in-depth analysis of emerging research themes INITIAL SURVEY Over 1,403 respondents generated over 600 PICO questions DATA ANALYSIS These were checked against current evidence and 83 questions generated INTERIM PROPOSITION 1,331 respondents priortised the 83 questions WORKSHOP 24 participants prioritised 28 questions TOP 10 Priorities pubished Who responded to the initial survey? 10% 4% 13% 13% 3% 35% 48% I am in the last few years of my life I am a carer or family member or partner or friend of someone in the last few years of their life I am a bereaved carer of family member or friend I am a professional working with people in the last few years of life I am a volunteer working with people in the last few years of life I am a member of the public who has an interest in the subject Other The Top 10 unanswered questions in palliative and end of life care in order of priority are: 1 What are the best ways of providing palliative care outside of working hours to avoid crises and help patients to stay in their place of choice? This includes symptom management, counselling and advice, GP visits and 24-hour support, for patients, carers and families? 2 How can access to palliative care services be improved for everyone regardless of where they are in the UK? 3 What are the benefits of Advance Care Planning and other approaches to listening to and incorporating patients preferences? Who should implement this and when? A survey asked people likely to be within the last years of life, current and bereaved carers, and health and social care professionals to submit their unanswered questions about palliative and end of life care responses from across the four nations and Ireland were received and analysed to draw out research questions. Searches assessed whether any of the questions had already been answered by an up-todate systematic review of existing research evidence. The resulting longlist of 83 questions were ranked in order of highest priority to lowest priority in a second survey, 1331 responses were received which were reviewed by the Steering Group and resulted in a shortlist of 28 questions. A final prioritisation workshop was held on 21st November 2014 to identify the top 10 unanswered research questions, or evidence uncertainties, in palliative and end of life care. SUPPORTED AND GUIDED BY SUPPORTING PARTNERS What information and training do carers and families need to provide the best care for their loved one who is dying, including training for giving medicines at home? How can it be ensured that staff, including health care assistants, are adequately trained to deliver palliative care, no matter where the care is being delivered? Does increasing the number of staff increase the quality of care provided in all settings? To what extent does funding affect these issues? What are the best ways to determine a person s palliative care needs, then initiate and deliver this care for patients with non-cancer diseases (such as COPD, heart failure, MND, AIDS, multiple sclerosis, Crohn s disease, Parkinson s disease, dementia, and stroke)? 7 What are the core palliative care services that should be provided no matter what the patients diagnosis is? What are the benefits, and best ways, of providing care in the patient s home and how can home care be maintained as long as possible? Does good co-ordination of services affect this? What are the best ways to make sure there is continuity for patients at the end of life, in terms of the staff that they have contact with, and does this improve quality of palliative care? Would having a designated case-coordinator improve this process? What are the best ways to assess and treat pain and discomfort in people at the end of life with communication and/or cognitive difficulties, perhaps due to Motor Neurone Disease (MND), dementia, Parkinson s disease, brain tumour (including Glioblastoma) or head and neck cancer, for example? 16 17

10 Next steps For research funders For charities. Funding for palliative and end of life care research is Charitable funders and their policy teams will be limited. The findings of PeolcPSP will enable existing able to use this project to demonstrate the need for funders of research including many of the project increased funding in the area of palliative and end of partners to target their funds to the priorities that life care, and campaign to achieve this. We hope that matter most to patients, current and bereaved carers there will be an increased awareness and interest in and health and social care professionals. Additionally, funding and conducting research in palliative and end research funders will be able to co-ordinate their of life care as a direct result of the PeolcPSP. efforts to tackle the highest priority questions, together. For researchers For PeolcPSP. The results will enable researchers who are applying Out-of-scope data: the original survey returned for funding on these topics to demonstrate that over 1400 responses, many of which included their research will be valuable to the people who comments and questions that did not fit with the most need it. All of the long-listed questions will be JLA methodology of identifying and prioritising made publically available via the UK Database of interventional research questions. The PeolcPSP is Uncertainties about the Effects of Treatments (UK looking at ways to further analyse the data to highlight DUETs), which publishes treatment uncertainties questions and comments that could be addressed by from patients, carers, clinicians, and from research other types of research, e.g. qualitative research. recommendations, covering a wide variety of health problems. This section is taken from The Palliative and end of life care Priority Setting Partnership (PeolcPSP) final report. The full report is available at Recent PPI Initiatives Four Nations: Sharing Practice In Public Involvement A one-day conference to share and build on public involvement contributing to health research in the UK was held on 9 May 2014 at University Hall, Cardiff University, with keynote speaker Sir Iain Chalmers of the James Lind Initiative. The conference was hosted by the MCPCRC and Involving People and provided an exciting opportunity to share examples of public involvement in health research, with speakers from across the UK. Dr Annmarie Nelson opened the conference and the keynote speech was delivered by Sir Iain Chalmers who spoke on the need for patients and the public to help the research community to reduce waste in research. Sir Iain urged patients and members of the public to ensure the research community: Include patients in selecting research questions; Systematically review evidence before designing new studies; Publish research results in full; Work with patients and clinicians to embed evaluative research in clinical practice. The second Plenary presentation was from Dr Sabine Best (Head of Research, Marie Curie) who went on to describe how some of these points were being addressed by the Palliative and End of Life Care Priority Setting Partnership. Speakers from each of the four nations presented perceptions of public involvement from around the UK which highlighted the differences in approach taken by each nation. However, all agreed that the principle aim was to engage the public in all aspects of research, resulting in research that is more relevant to the end user. Keynote speech from Sir Iain Chalmers L-R: Speakers: Rosemary Hill, Barbara Moore, Martin Lodemore, Dr Sabine Best, Ruth Boyd, Sir Iain Chalmers 19

11 Workshop sessions were held in the afternoon which focused on encompassing public involvement in the areas of expecting and promoting research as part of routine care, recruitment, training, research and evaluation. The aim of the workshops was to address issues surrounding the most relevant topics and to find key outcomes identifying areas which need to be addressed. Public Involvement Evaluation Dr Noreen Hopewell-Kelly and Dr Jim Fitzgibbon, Marie Curie Palliative Care Research Centre Public Involvement: The Perspective from Wales Barbara Moore, NISCHR CRC Involving People is the principle public involvement organisation in Wales. The public are supported by both Involving People and NISCHR CRC through training and honorarium expenses. Ms Moore was joined by Angela Martin, NISCHR Lead for Public Involvement & Engagement, who stressed the promotion of a culture of engagement, involvement and participation achieved through increasing public awareness. Lay participation in Scotland ongoing commitment and innovation in a fluid policy environment Rosemary Hill, Scottish Health Council There are many opportunities for the Scottish public to participate within research. Two main points that were discussed were the Participation Toolkit comprising 32 tried and tested methods and innovation tools to inform, engage, empower and evaluate, as well as the Participation Standard which is used to measure how well NHS Boards involve the public within their work. Key messages: Evaluation should be an ongoing collaboration between funders, researchers and public members involved in research. Evaluation should involve mixed-methods and consider the input of researchers and public members. Impact can hold different meanings to different individuals. Public Involvement Recruitment Natalie Simon, Involving People, and Richard Stephens, National Cancer Research Network Key messages: An appropriate involvement representative would depend on the needs of the research group and the needs of the public member/patients/carers. It is important to know what it is that you want the member of public to do or to be before considering from where and how you might recruit them. When exploring how to recruit involvement representatives, speak to someone who has already done it. Public Involvement Training Zoe Whale, NISCHR CRC, and Alan Meudell, Involving People Network Member PPI in Clinical Research the Northern Ireland Perspective Ruth Boyd, Cancer Research UK PPI in Northern Ireland is a statutory duty for all Health and Social Care Organisations, each with a different level of responsibility. Research methods, questions and outcomes must be patient centric and Ms Boyd identified the organisations and channels through which the patient voice can be heard. Training and development, as well as cultural integration, was identified as important in evaluating PPI for future delivery. The changing landscape in England...? Martin Lodemore, INVOLVE The patient voice is heard across service delivery, such as HealthWatch, and research across England. PPI has been rebranded to Patient Care and Public Involvement and Engagement (PCPIE). A positive impact of the public s involvement in all aspects of research was highlighted. To conclude the National Institute of Health Research strategic review of public involvement and development was addressed. Key messages: There is opportunity to collate and publicise the training available across the UK. There is opportunity to share training development. Patients and the public want to be involved in the development and delivery of training. Expecting and promoting research as part of routine care - the role of the public Barbara Moore, NISCHR CRC, and Mel Doel, Involving People Network Member and former clinical trial participant Key messages: Rebrand the NHS the NHRS National Health and Research Service. Public awareness of research is needed at a national level, with a multifaceted and creative approach. Local initiatives and networks are needed to disseminate research knowledge

12 6.0 Working to overcome deficits in knowledge 6.1 The Palliative Care Research Roadshow 6.2 Research Methodology Clinics The roadshows were rolled out in 2011 to cover all local health boards in Wales and were led by Dr Annmarie Nelson and Dr Anthony Byrne. The purpose was to explain some of the new opportunities which have arisen to either develop a palliative care research idea or recruit patients into existing studies. The MCPCRC focuses on studies that will translate into better patient care with patient experience and the complex issues of patients being major strands of their work. The MCPCRC has a team of staff including clinicians, researchers, administration staff, volunteers and two honorary research theme leads, and is expanding rapidly as more staff members are employed on research grant income. The whole research process can seem like a quagmire The contact details collected from those who of regulations and insurmountable barriers and the attended the roadshows helped to establish a Cancer and clinicians locally and across the UK. The centre widely to encourage potential researchers to develop roadshow was intended as a forum to de-mystify and RRG palliative care database. This was used as an introduced Research Methodology Clinics in their ideas, whether a small or a large scale study and simplify the whole process and to provide a single information portal for mass mailings to keep the These are held quarterly to provide free advice and using any methodology. Through this support system, point of contact for those who need information or community up to date with grant calls, new projects support to academics, clinicians and other health inexperienced NHS and academic staff, are able to gain help. The ultimate aim was to provide a coordinated and other research opportunities. professionals who want to develop a research study in research experience and collaborate with established palliative care. research groups. The Clinics provide expert advice approach to ensure all specialist palliative care teams are aware of research development and research A full report can be found on our website at recruitment opportunities and thus maximise access palliativecare.walescancerresearchcentre.com. This to high quality palliative care research for all patients was a collaboration between the Cancer RRG, MCPCRC, in Wales. NISCHR CRC, Wales Cancer Research Network and Advice on how to develop a research idea; Involving People Consumer Representatives. Expert methodological advice; MCPCRC support the research interests of academics Identification of funding routes and assistance The format of the roadshows was very informal with and a supportive role by guiding and supporting The following support and guidance is provided: studies. Dates of the clinics are given on our website a simple role play of how a clinical idea can be developed into a funded study and how that study is research project from idea to completion, using a real life example. palliativecare.walescancerresearchcentre.com. with applications; then rolled out to recruit patients in clinical practice. The panel of speakers took the audience through a investigators in the planning and development of their Guidance on the right options for completing a study; Collaboration with a vital trials unit facility who can manage studies once they are funded. The Research Methodology Clinics are advertised The presentation highlighted the resource that can be provided to develop and support a research idea and also clarified routes for patient access to ongoing palliative care studies. The roadshow initiative represents a unique approach in Wales to raising research awareness amongst clinical palliative care teams. It has introduced multidisciplinary clinicians to local research teams who can provide advice and support. The roadshows have been the first step in developing good communication links, establishing clinical champions and facilitating a coordinated approach to patient access across Wales

13 RESEARCH GOVERNANCE TOOLKIT Your host organisation responsibilities 7.0 Working to overcome deficits in governance arrangements You or your organisation have been approached to participate in a study If the study is research this needs to be presented and managed with a formalised approach (If audit or service evaluation local procedures should be followed) OR A staff member has a possible project idea to improve patient care/service Is the study research, audit or service evaluation Research, Audit, Service Evaluation 7.1 Research Governance Toolkit - palliativecare.walescancerresearchcentre.com/research Managed Care settings may define a patient s or carer s access to research. Although palliative care research has been growing in Wales over the last 5 years, research taking place within independent hospice settings is limited resulting in the majority of patients being unable to access research opportunities once they leave a secondary care setting. The need for a healthy research culture in hospices, including independent settings, is therefore defined. A clearly identified gap here is the hospice organisations understanding of research practicalities and procedures. In a project led by Dr Anthony Byrne (NISCHR AHSC Fellow) independent palliative care settings in Wales were surveyed and we found that enthusiasm for undertaking research was dampened by lack of knowledge, lack of resources and concerns about financial and clinical impact. With the support of Velindre NHS Trust we therefore proposed the development of guidance in the form of a research governance toolkit for independent hospices, a concept that was universally endorsed in our survey. The aim of the toolkit is to provide guidance on host organisation roles and responsibilities, improving knowledge and minimising workload for staff. In other words, it does not tell you how to design a research project, but how to accommodate and facilitate it. By demystifying research governance we hope to empower boards of Trustees and managers, as well as clinical staff, to promote research as part of everyday care in independent hospice settings. The toolkit has been developed as a web-based resource to improve accessibility and can be found at palliativecare. walescancerresearchcentre.com/research. It is also currently being developed as an App to be launched in the coming weeks. Although developed for Wales, it is equally relevant to practice across the UK.The toolkit has an overview layer which outlines: What you need to do Why you need to do it How you should do it This overview layer links to a more detailed second and then third layer with increasing levels of information and access to source documents. Staff can choose which level suits them best for a particular task. In the how to section there is practical guidance on issues such as training (with links to regional training programmes), resource use and audit trails, and an optional template for risk review which can be incorporated into usual governance activities. The toolkit has been developed using an iterative process, led by Dr Anthony Byrne and supported by collaborations from NISCHR, the WCTU and the MCPCRC at Cardiff University. A draft version was reviewed by a range of hospice staff from across Wales and feedback on content, structure and wording informed the final version. It is therefore structured to be comprehensive but user friendly and practically focused. By encouraging its use we hope to develop the conversation, in Wales and beyond, between independent and statutory sectors around research mentorship and support. We welcome ongoing feedback on the website to further develop and improve the resource. Confirm there is a study Principal Investigator & Sponsor Confirm that the study has received ethical approval Principal Investigator Sponsor Ethical Approval To ensure there is collective responsibility - Individual (PI,CI), Institutional (Sponsor) and Organisational (Host) for the initiation, management and / or financing of the study. To ensure it is ethical for the study to proceed Individual Institutional Organisational Ethical WHAT YOU NEED TO DO Ensure there are adequate resources available for the duration of the study. Ensure the organisation can recruit sufficient patients in accordance with the eligibility criteria Resources Sufficient Patients WHY YOU NEED TO DO IT To ensure it is feasible to undertake the study within your organisation balanced with the demands of the clinical workload Study Feasibility Checklist HOW YOU NEED TO DO IT Establish a process for reviewing and approving project proposals. This might be part of your Clinical Governance Committee or Audit Group Create and maintain a study site file containing all essential documents related to the study ensuring all trial documentation is kept up to date Ensure staff have relevant training, e.g. Informed Consent, Good Clinical Practice (GCP) Establish a process to ensure GCP training is updated regularly (every 2 years) Ensure that all costs to the organisation have been accounted for when costing the study Study Review Checklist Approval letter template Study Site File Training GCP Training Training Log Costing a Study Ensure staff have the appropriate skills to contribute to the study Skills Remember this is to safeguard the public and to ensure the study is run safely by staff who understand all aspects of the research To ensure appropriate clinical oversight (PI) and to ensure the study is run safely by staff who understand all aspects of the study Clinical Oversight HOT LINKS 24 25

14 8.0 Working to overcome deficits in research practitioner resource 8.1 Palliative Care Specific Research Nurses In 2010, working closely with NISCHR CRC, we were able to secure ongoing funding from NISCHR for a dedicated palliative care research nurse to improve access to palliative care studies for patients and explore sustainable models of recruitment. A further 3 part time dedicated palliative care nurses were funded in 2012 with resource now covering Cardiff & Vale, Abertawe Bro Morgannwg, Betsi Cadwaladr and Aneurin Bevan. Palliative care patients wish to be involved in clinical trials and other well designed research of relevance to them. Research studies must therefore be designed to account for the difficulties that this vulnerable group of patients may have in taking part. Particular challenges for patients and their families include difficult and often complex symptoms (such as pain or breathlessness), psychological distress, and loss of usual physical fitness, whilst at the same time needing access to the research information and interventions. Failure to properly account for these needs will compromise study viability and potentially undermine the contributions of individual patients participation. Research practitioners with the right training are therefore crucial in anticipating these challenges, making sure that patients with advanced cancer are appropriately supported and that all aspects of the study design and application are patient focused, making it as easy as possible for them to take part. Many patients needing palliative care will be in hospices, but significant numbers are cared for at home and many patients requiring palliative care will be in hospitals where clinical care is usually delivered in units designated to specific tumour types or medical specialities. By adopting a co-ordinated approach, this widely dispersed patient group, with disparate diseases but common needs, can be brought together and involved in palliative care research that will contribute to improved palliative and end of life care. 9.0 Award Winning Work Many of our initiatives have won Innovation and Engagement Awards from Cardiff University, Institute of Translation, Innovation, Methodology and Engagement (TIME). This award is for researchers who have maximised the impact of their research through public engagement, business innovation, impacting on science policy and engagement with the media beyond the normal expectations of their role. This has been awarded for the following initiatives: November 2012: January 2014: Palliative Care Research Roadshow Research Methodology Clinics. Involvement of the Public in Research. L-R: Prof Gareth Griffiths, Dr Annmarie Nelson, Dr Jim Fitzgibbon, Prof Ian Weeks, Dr Jessica Baillie 26 27

15 10.0 Future Plans Due to the achievements of the Cancer RRG over the past five years, Welsh Government have awarded a further three years funding from April 2015 to March 2018 for research to continue in palliative and supportive care. This research will form part of the newly re-structured research landscape in Wales. Between 2010 and 2015 the Cancer RRG was one of seventeen research groups to be funded by NISCHR. As of April 2015 Welsh Government re-structured its The Centre is committed to develop and undertake of the clinical and research workforce and a fit for Our aim is to continue the development of the seventeen registered research groups into five large well designed research which will directly improve the purpose partnership with the public and patients is palliative and supportive care research portfolio research centres with three smaller research units, care and experience of patients, and their carers, in central to those ambitions. in Wales via: with NISCHR replaced by a new governing body, Health the palliative phase of their illness. Following a highly and Care Research Wales. The Wales Cancer Research successful three year developmental period, MCPCRC The strategic development of clinical trials and Patient/carer rather than disease focused Centre is one of the five new centres to be funded celebrated their second phase of secured funding supportive and palliative care work streams within outcomes by Health and Care Research Wales and is made up for with a formal launch on 1st April the newly established Wales Cancer Research Centre of key collaborators from across Wales. Palliative and 2014 with Health Minister Professor Mark Drakeford, provide robust environments for continuing the Multidisciplinary team research across all care Supportive Care research is one of ten work packages Baroness Professor Ilora Finlay and Dr Bill Noble, Marie success of the RRG. The Supportive and Palliative settings of the Wales Cancer Research Centre. Curie Executive Medical Director, as invited speakers. Care work stream has a specific focus on clinical Defining and establishing a programme of social The Palliative and Supportive Care work package is engagement and the ongoing development of high care research led from the MCPCRC in Cardiff under the direction of To build on the success of the Cancer RRG requires quality, sustainable and appropriately evaluated public Dr Anthony Byrne, Dr Annmarie Nelson and Dr Simon continued focus on the development of well designed, and patient engagement. It will use an innovative Establishing a repository of existing research Noble. The MCPCRC opened in October 2010 and is patient focused studies which have been driven by approach to identify research questions of importance evidence based at the School of Medicine, Cardiff University. the clinical community and service users. Engagement to clinicians and patients as well as a novel approach to dissemination of research findings to change clinical Engaging with clinical teams and policy makers practice. It will continue to engage fully with the work to place findings straight to practice of the James Lind Alliance and the End of Life Priority Setting Partnership in expanding its applied research Strong focus on PPI portfolio. It will continue to refine a PPI strategy which is already nationally recognised as innovative and Dissemination by traditional routes and by using dynamic. social media Our ambition is to remain at the forefront of research in palliative care. L-R: Mark Drakeford AM, Dr Anthony Byrne, Dr Bill Noble and Professor Baroness Finlay of Llandaff. Photograph Patrick Olner

16 11.0 Keeping Informed Acknowledgements Contact Us If you have general enquires or are interested in developing a palliative or supportive care research idea please contact: Dr Amanda Woodward Palliative Care Senior Research Coordinator woodwardaj@cf.ac.uk Tel: Mr Peter Gee Palliative Care Research Coordinator Geep@cf.ac.uk Tel: The success of the NISCHR Cancer RRG would not have been possible without the support and close working collaborations with groups such as the MCPCRC and the wider NISCHR workforce. We would like to acknowledge Professor Gareth Griffiths input for four years from the groups inception in April 2010 through to June 2014, and the achievements made during this period. In addition we would like to thank the AHSC clinicians for their support and leadership of research development groups. Finally, we would like to thank the patients, whose participation has allowed the palliative care research portfolio to develop so successfully in Wales over the past five years. If you are interested in giving patients an opportunity to take part in research studies In South East Wales Sara Shankland Wendy Wade Research Network Manager Research Network Manager Health and Care Research Wales Workforce Health and Care Research Wales Workforce sara.shankland@wales.nhs.uk wendy.wade@wales.nhs.uk Tel: Tel: In South West Wales Jayne Caparros Research Network Manager Health and Care Research Wales Workforce jayne.caparros@wales.nhs.uk Tel: In North Wales Jackie Morris Research Network Manager Health and Care Research Wales Workforce jackie.morris2@wales.nhs.uk Tel: ext 7667 For further information on our work please visit our website at palliativecare. walescancerresearchcentre. com Why not follow us on 30 31

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