Research & Development Annual Report

Research & Development Annual Report 2016-17

Index Page 1. Introduction 3 2. Background 3 3. Research-based activity Progress Reports 4 3.1 National Institute for Health Research (NIHR) Portfolio Study Activity 4 (Non-funded by NL CCG) 3.2 North Lincolnshire Non-portfolio Studies - (Non CCG funded) 4 3.3 North Lincolnshire Non-portfolio Studies - (CCG-funded) 4 4. Work in Development 4 4.1 Northern Lincolnshire Research and Development Working Group 4-5 4.2 Gap analysis Work 5 4.3 Evidence Informed Commissioning R & D Baseline Survey 5 4.4 Engaging Further practices in Research with CRN 5-6 5. National R&D Updates 6-7 5.1 5.1 Excess Treatment Costs New Guidance, Pathway and Procedure 6-7 Recommendations 8 Glossary 9 References 10 Appendix 1: NIHR Clinical Research Network Portfolio Study Report 11-12 Appendix 2: NL CCG ETC Pathway 13 NL Annual Report V1.0 April 2017 Page 2 of 13

1. Introduction The purpose of this Research and Development (R&D) Annual Report is to present information to the Committee on the R&D activity for full year period 1st April 2016 31st March 2017. The report provides the evidence that North Lincolnshire (NL) CCG is striving to meet its statutory duty for promoting research, innovation and the use of research evidence (Health and Social Care Act, 2012). 2. Background The UK government has stated its firm commitment to promote research throughout the NHS which it sees as essential to continually improve effectiveness of health services and patient outcomes. Indeed, there is an expectation that the UK will be the first research-led health service in the world. A number of current policy documents have placed a strong emphasis on research activity in the NHS: The NHS Constitution 2015 (DoH, 2015) One of these principles includes a commitment to the promotion and conduct of research to improve the current and future health and care of the population. The NHS White Paper, Equity and Excellence: Liberating the NHS The government is committed to the promotion and conduct of research as a core NHS role. Research is vital in providing the new knowledge needed to improve health outcomes and reduce inequalities. (DoH, 2010, p.24) The government response to the NHS Future Forum report made the following commitments with respect to CCGs and research: CCG s legal duties should reflect their key role in making sure that, at a local level, the need for good research, innovation and a strong evidence for clinical decisions is paramount. (DoH, 2011, p.26) This mandate is recognised within the latest NHS Planning Guidance 2016/17-2020/21 which raises the issue of how commissioners can support research, innovation and growth by building on the research infrastructure which can be a pathway to generate new innovative approaches to service development that impact on service delivery and improve patient outcomes. NL Annual Report V1.0 April 2017 Page 3 of 13

3. Research-based Activity Progress Reports 3.1 National Institute for Health Research (NIHR) Portfolio Study Activity (Non-funded by NL CCG) The data from the NIHR portfolio study report presents the study activity from the period 1 April 2016 to 31 March 2017. The report is shown in Appendix 1 and lists the number of practices recruiting and current studies open to more sites. 3.2 North Lincolnshire Non-portfolio Studies (Non CCG-Funded) There is 1 non-portfolio study taking place in the North Lincolnshire CCG area for the period 1 April 2016 to 31 March 2017. Details of the study, including a status update from the study team, are shown below: Study title Funding Status Update The socioeconomic determinants of cancer presentation and diagnosis for patients with lung and head and neck cancers This project is part of a programme grant totalling 749,828 from the University of Hull Endowment Yorkshire Cancer Research, 2012-2017. Recruitment for the head & neck aspect of the study has reached the target of 80 participants (the revised number agreed with the project statistician). Initial analysis of the head and neck data has been completed and all recruitment efforts are now focused on lung participants. The recruitment target for lung participants has been revised to 155 after consultation with the project statistician. 3.3 North Lincolnshire Non-portfolio Studies (CCG-Funded) There are currently no CCG-funded studies taking place in the North Lincolnshire CCG area for the period 1 April 2016 to 31 March 2017. 4. Work in Development 4.1 Northern Lincolnshire R&D Working Group The first meeting of the Northern Lincolnshire R&D working group took place in early September 2016. The principle aim of the meeting was to bring together representation from across the North and North East Lincolnshire health/ research community in order to support and encourage the growth of research; this should assist in establishing a translation of knowledge to underpin commissioning priorities and the Five-year Forward View (2014) for Integration. The meeting continues to take place quarterly and seeks to link in with Hull, York Medical School and NL Annual Report V1.0 April 2017 Page 4 of 13

other stakeholders in academia, the Local Clinical Research Network and Public Health from the local council. 4.2 Gap analysis work. An R and D gap analysis has been initiated across the NL and NEL CCGs in collaboration with the R and D Lead Manager (Humber). The focus of the work is to identify key areas that require further development. The gap analysis has been underpinned by the National Guidance for commissioners published in April 2016. Actions have been identified and the work is still on-going. 4.3 Evidence Informed Commissioning R and D Baseline Survey. The ambition set out by NHS England is that by 2020/21 NHS Commissioners will routinely consult the evidence; this includes using research evidence where it exists to identifying evidence gaps and to ensure commissioning decisions are underpinned by the use of good evidence. To support this NHS commissioners need to have the tools, information, support and skills to make best use of information, knowledge and research. The North Yorkshire and Humber R and D service has produced a baseline survey to establish the following; Establish locally what understanding NHS commissioners have of using and applying good evidence and research in the decision making process. Recognise any gaps in sourcing and appraising evidence Identify any training needs in sourcing and applying good evidence and research. The survey was distributed to the NL CCG commissioners The responses to the survey have been positive and the common themes that have been collated have shown the following: The majority of the respondents had heard of the hierarchy of evidence. None of the respondents had an NHS Open Athens Account to access evidence and research. None of the respondents had used any critical appraisal tool(s). Training gaps were identified which included; sourcing evidence, literature searching techniques and how to appraise evidence. Next steps from the survey have been identified and a workshop on sourcing evidence has been set up for the commissioners in partnership with the library services at the Trust. The feedback will be evaluated and further sessions may be held. In addition the North Yorkshire and Humber R and D service has disseminated information on how staff group(s) can register for an NHS Athens account. 4.4 Engaging further practices in research with CRN - Start Up /Practice Nurse Model Funding Opportunities. The NIHR are currently running a scheme whereby GP practices can receive 6,000 for one year only to identify a practice nurse who would enter into a research nurse development scheme for NL Annual Report V1.0 April 2017 Page 5 of 13

4 hours a week. Additionally, a number of expected outcomes would be required during the funding period, such as: Identification of a lead GP who would take responsibility for clinical research with the practice and would work with and support the practice research nurse and engage with the CRN team member. Work towards RCGP s Research Ready accreditation Consider and provide evidence of how research awareness could be promoted within the practice to all staff and patients. Increase the number of NIHR portfolio research studies (both commercial and noncommercial) and the number of patients involved in research. The above scheme provides an ideal opportunity to engage further practices in the North Lincolnshire area in research. If the CCG could work closely with the NIHR to promote and support this scheme then potentially the opportunity for patients to get involved in research would increase significantly. Increasing the skills and knowledge of practice nurses, GP s and other practice staff would also be a potential outcome of this collaboration. 5. National R&D Updates 5.1 Excess Treatment Costs New Guidance, Pathway and Procedure Excess Treatment Costs are the difference between the standard cost of treating the patient and the treatment cost arising out of the patient s participation in a research study. The NHS in England has a statutory responsibility to promote health and social care research, funded by both commercial and non-commercial organisations (Health and Social Care Act, 2012). Further guidance was issued by NHS England in November 2015 that stipulates the basis for attributing the costs of health and social care research including Excess Treatment Costs for non-commercial research. This sets out that Excess Treatment Costs are to be funded through the normal commissioning arrangements and identifies what principles of good practice can underpin the management and administration of Excess Treatment Costs. The Department of Health mandate requires that the NHS: --- ensure that the new commissioning system promotes and supports participation by NHS organisations and NHS patients in research funded by both commercial and non-commercial organisations. (NHS England, 2015) NL Annual Report V1.0 April 2017 Page 6 of 13

The costs of research have to be identified and funded and the NHS responsibility extends to ensuring that the treatment costs, including Excess Treatment Costs (ETCs) of patients involved in non-commercial research are met. The responsibility for meeting patient care costs, resulting from research and development, was set out in HSG (97)32 (AMRC, 2013a) One of the Key recommendations from the Association of Medical Research Charities (AMRC) for commissioners is: Develop a process and earmark a recurring budget to ensure excess treatment costs are managed without causing delays to research. (AMRC, 2013b) In collaboration with the Medical Director and Director of Nursing and Quality at North Lincolnshire CCG the North Yorkshire and Humber R&D service have developed a proposed local pathway to clarify the NL CCG process when a formal request is made for excess Treatment costs. This can be found in Appendix 2. Further development work in 2017-18 will be undertaken to promote good practice and ensure the log of spend on Excess Treatment Costs (ETCs) is accurately managed. The number of ETCs that were funded by the CCG for the 2016/17 financial year is listed below: Study Title BASIL III Study details The study is based at HEY and is investigating the efficacy of treatments for severe Ischaemia of the Leg. The principal research objective is to determine which of these methods plain balloon, drugcoated balloon or drug releasing stent keeps the patient alive and with their leg intact, the longest. The ETC will cover the use of drug eluting stents/balloons to patients. ETC Amount Approved Date Approved 5,025.00 09/02/2017 NL Annual Report V1.0 April 2017 Page 7 of 13

Recommendations The Quality and Performance Committee are asked to: 1. Consider and discuss this Research & Development Annual Report. 2. Consider and discuss how further work is required for North Lincolnshire CCG to meet the mandate to promote research and the use of research evidence. 3. Explore the potential opportunities for growing further research in North Lincolnshire NL Annual Report V1.0 April 2017 Page 8 of 13

Glossary NHS CCG ETC R&D NIHR PCT HYMS LCRN National Health Service Clinical Commissioning Group Excess Treatment Cost Research & Development National Institute for Health Research Primary Care Trust Hull York Medical School Local Clinical Research Network NL Annual Report V1.0 April 2017 Page 9 of 13

References AMRC (2013a) Costing research in the NHS *Online+. Available at: http://www.amrc.org.uk/sites/default/files/doc_lib/acord%20guidance%20note%20- %20revised%202013_07.pdf AMRC (2013b) Our Research Charter for NHS England and Clinical Commissioning Groups [Online]. Available at: http://www.amrc.org.uk/sites/default/files/2013/05/amrc-vision-forresearch-in-the-nhs-summary-of-calls.pdf# Department of Health (2010) Equity and excellence: Liberating the NHS *Online+. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213823/dh_11 7794.pdf Department of Health (2011) Government response to the NHS Future Forum report [Online]. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216361/dh_12 7719.pdf Department of Health (2015) The NHS constitution *Online+. Available at: https://www.gov.uk/government/publications/the-nhs-constitution-for-england/the-nhsconstitution-for-england# Health and Social Care Act (2012) Embedding research as a core function of the health service [Online]. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/138273/c8.- Research-270412.pdf NHS England (2015) Guidance on Excess Treatment Costs [Online]. Available at: https://www.england.nhs.uk/wp-content/uploads/2015/11/etc-guidance.pdf NL Annual Report V1.0 April 2017 Page 10 of 13

Appendix 1 NIHR Clinical Research Network Portfolio Study Report Recruitment data The table below gives a summary of portfolio study recruitment data for North Lincolnshire CCG for the period 1 April 2016 to 31 March 2017. This data only shows the studies recruited during this period. NHS North Lincolnshire CCG No Practices in CCG 19 No Practices Recruiting 6 % Practices Recruiting 32% CCG Studies 12 CCG Recruitment 207 CCG Population (2016/17) 169,247 Recruitment per million population 1223 Active Studies The table below illustrates the names of the GP practices/sites that had studies that recruited within NL CCG for the period 1 April 2016 to 31 March 2017. It includes the names of the portfolio studies that have recruited during this period. Practice Name THE CENTRAL SURGERY BARTON WINTERTON MEDICAL Study Short Study title Ref 10470 The United Kingdom Aneurysm Growth Study Recruitment 31408 CADPC-II v1 2 18484 Factors that influence antibiotic prescribing habits for acne 18582 PRIM4284 15 25964 DIAB 4831 7 2848 A coordinated programme for improving the outcome of very early inflammatory arthritis 10470 The United Kingdom Aneurysm Growth 1 NL Annual Report V1.0 April 2017 Page 11 of 13 1 115 2

KIRTON LINDSEY SURGERY RIVERSIDE SURGERY RIVERSIDE SURGERY RIVERSIDE SURGERY RIVERSIDE SURGERY THE BIRCHES MEDICAL Study 15979 CCRN 2816 (Major cardiovascular events) 16428 DRN2884 (THEMIS) 1 31408 CADPC-II v1 1 17071 TIME - Treatment in Morning Versus Evening 1 11921 Helicobacter Eradication Aspirin Trial 42 (HEAT) 18001 PRIM3122 6 30295 DERM 5560 3 31408 CADPC-II v1 3 11921 Helicobacter Eradication Aspirin Trial (HEAT) 1 6 NB: Data is owned by and extracted from the NIHR CRN Business Intelligence Unit. NL Annual Report V1.0 April 2017 Page 12 of 13

Appendix 2 North Lincolnshire CCG Pathway for Research Study NHS Excess Treatment costs (ETCs) R&D Lead (or equivalent) receives ETC request from research team/ local CRN (Clinical Research Network) on agreed proforma R&D (or equivalent) requests additional information from study team (if required) R&D Lead (or equivalent) forwards application with summary to Medical Director at NL CCG Application considered by Northern Lincolnshire R&D Working Group additional experts may be invited to join the Working Group as part of decision making process, for example Finance representative Recommendation to NL CCG Quality Group Recommendation considered by NL CCG Quality Group and decision made R&D Lead informed of outcome and informs study team/sponsor. NL Annual Report V1.0 April 2017 Page 13 of 13