NIHR Workshop on Research into Primary Care Interventions 12 February 2013 Welcome Chair: Professor Paul Little 12 February 2013 NIHR Themed Call: Specification Document The National Institute for Health Research (NIHR) is issuing a call for research into the evaluation of health care interventions or services delivered in primary care settings. The following NIHR managed research programmes will be participating: • • • • • • • • Efficacy and Mechanism Evaluation (EME) Health Services and Delivery Research (HS&DR) Health Technology Assessment (HTA) Invention for Innovation (i4i) Programme Grants for Applied Research (PGfAR) Public Health Research programme (PHR) Research for Patient Benefit (RfPB) NIHR Fellowships Programme Application forms will be available from 28 February 2013. Completed forms must be submitted by 22 May 2013. Funding decisions will be made around March 2014. For more information please visit: www.nihr.ac.uk/research/Pages/PrimaryCare or see your delegate packs Session One: Research in Primary Care 12 February 2013 An Introduction to the NIHR programmes Dr Lisa Cotterill 12 February 2013 Primary Care Research • First contact, co-ordinated care undifferentiated by age, gender, disease or organ system • Primary provider of the service dealing with 90% of all health care contacts • Public health interventions delivered in primary care save lives • Research has lagged behind other medical disciplines leading to an ‘evidence gap’ • Workforce is changing and there will be more GPs • Building research capacity Primary Care Not as sexy as secondary care The NIHR Health Research System Faculty Investigators & Senior Investigators Associates Trainees Infrastructure Universities Research Clinical Research Networks NHS Trusts Research Projects & Programmes Patients & Public Clinical Research Facilities, Centres & Units Research Schools Research Governance Systems Research Information Systems Systems The central role of NIHR research in the innovation pathway INVENTION Medical Research Council EVALUATION ADOPTION DIFFUSION Basic Research Development Pathway Funding Efficacy & Mechanism Evaluation Invention for Innovation Biomedical Research Centres Biomedical Research Units Experimental Cancer Medicine Centres Clinical Research Facilities Patient Safety Translational Research Centres Healthcare Technology Co-operatives This pathway covers the full range of interventions - pharmaceuticals, biologicals, biotechnologies, procedures, therapies and practices - for the full range of health and health care delivery prevention, detection, diagnosis, prognosis, treatment, care. Horizon Scanning Centre National Institute for Health Research Research Schools Research for Patient Benefit Public Health Research Programme Grants for Applied Research Health Services and Delivery Research Health Technology Assessment Centre for Surgical Reconstruction & Microbiology Collaborations for Leadership in Applied Health Research and Care Centre for Reviews & Dissemination, Cochrane, TARs Support for Procurement NHS Supply Chain Guidance on Health & Healthcare National Institute for Health & Clinical Excellence Access to Evidence NHS Evidence Innovation Academic Health Science Networks NHS Commissioning Board and Clinical Commissioning Groups Commissioning Patient Care Providers of NHS Services What is Applied Research? • Research with the capacity to improve patient outcomes and NHS services • Clinical research (not only trials) • Not – Discovery science – Animal • See remit of participating programmes - if in doubt ask Call for Research into Primary Care Interventions We particularly welcome applications that address: – Management of long-term conditions, the management of multiple morbidity or interventions that prevent acute admission to hospital – The effectiveness of existing or new interventions – The benefits of new approaches to the delivery of services – Multiple health related behaviours Participating programmes • CCF programmes – Invention for Innovation Programme (i4i) – Programme Grants for Applied Research Programme – Research for Patient Benefit Programme • NETS programmes – Health Technology Assessment – Efficacy and Mechanism Evaluation – Health Services & Delivery Research – Public Health Research • TCC programmes – Fellowships NIHR as a system TCC • Joint calls • Facilitating researchers, speeding review • Transfers between NIHR programmes • Active collaboration between programmes • Directors' meetings • Meeting with networks Fellowships CCF i4i PGfAR RfPB NETSCC HS&DR HTA EME PHR Clinical Research Networks Which programme? Visit the market place • EME – exploratory trials, less pragmatic, phase 2-3, efficacy, mechanisms if possible? • HTA – systematic reviews, large multicentre pragmatic trials or other studies (phase 3-4), effectiveness in the NHS • HS&DR – organisational, patient experience, qualitative or other • i4i – translational R&D projects aimed at cultivating new techniques or technologies into innovative interventions to address healthcare needs • PHR - evaluates public health interventions • PGfAR – £2m for up to five years, awards made to NHS bodies • RfPB – max £350k for up to three years, awards made to NHS bodies • Fellowships – doctoral, postdoctoral and senior fellowships Themed Call on Primary Care Interventions • Watch the NIHR website for dates and information • Engage collaborators, CTUs, RDS as soon as you can • Talk to NIHR centres • Application forms available 28 February 2013 • Completed forms submitted by 22 May 2013 • NIHR Fellowships opened in October 2012 and will again in October 2013 • Process steps – timing varies between programmes • Final funding decisions - March 2014 Thank you and good luck! 12 February 2012 Engaging and Supporting Primary Care Research: RDS David Crook PhD (Research Design Service SE) 12 February 2013 How the PCRN can help you • Local knowledge of complexities and difficulties of 1y care recruitment and retention • Unrivalled knowledge of what NIHR will fund • Investment in 1y care research infrastructure – practices signed up to deliver feasibility work – GCP training – ‘Research Ready’ certification of practices – databases of practices and their interests • Ability to cross barriers – geographical, 1y vs. 2y, NHS vs. social care etc RDS versus PCRN? • RDS . . . provides help for researchers to prepare proposals for submission to NIHR and other national, peer-reviewed funding competitions for applied health or social care research by providing expert advice on research design and methodology. • PCRN . . . provides researchers with practical support they need to make clinical studies happen in a primary care setting in the NHS, so that more research takes place [. . .] and more patients can take part. http://www.ccf.nihr.ac.uk/Pages/Home.aspx; http://www.crncc.nihr.ac.uk/about_us/pcrn RDS versus PCRN? • RDS . . . provides help for researchers to prepare proposals for submission to NIHR and other national, peer-reviewed funding competitions for applied health or social care research by providing expert advice on research design and methodology. • PCRN . . . provides researchers with practical support they need to make clinical studies happen in a primary care setting in the NHS, so that more research takes place [. . .] and more patients can take part. http://www.ccf.nihr.ac.uk/Pages/Home.aspx; http://www.crncc.nihr.ac.uk/about_us/pcrn UK Health Research Support • RDSUs and other organisations were good in some regions, less good in others – statistics support a postcode lottery? – emphasis on training up researchers • Best Research for Best Health (2006): – the DH commits to providing NHS research support and infrastructure, involving a major shake-up of RDSUs and 1y care networks The RDS Network • 10 RDS in England, based on SHA • Official brief: to increase the number of high quality grant applications for applied health research • A tool to modify behaviour of health researchers? • Now starting to work together and share best practice Contacting your RDS • google NIHR RDS and click the site at the top of the list • click on map for your local RDS details • phone up and chat or book online for a meeting Contacting your RDS • google NIHR RDS and click the site at the top of the list • click on map for your local RDS details • phone up and chat or book online for a meeting Working with your RDS • Face-to-face meetings really help start things off • May involve a trip to a University, Medical School or NHS Trust or they may come and visit you – look out for RDS ‘clinics’, CLRN Specialty Group meetings etc • First contact is often with a ‘generalist’, other team members being brought in later on • Are they advising pro bono or are they looking to be a paid coapplicant? The Initial Assessment • Who is this person, what do they want out of me? • Can they describe their proposal on a side of A4? • Are colleagues supportive, do they need a mentor? • Is the proposed work interesting/plausible/timely? • Is their target scheme appropriate? • Do they need specialist input (statistics, user involvement, health economics)? • NIHR funds: do they know how to effect change? Work with both RDS and PCRN • Contact your RDS as early as possible to: – develop your idea into an outline proposal suitable for registering your interest with the PCRN – help identify potential local/national collaborators – expand your team as appropriate e.g. statistical support, health economics, clinical trial design – develop user involvement for the bid and the project • If your project involves/may involve 1y care and the RDS does not bring this up, then just ask Final Thoughts • the RDS tells you how many patients you will need • the PCRN tells you where you might find them • the RDS suggests you work with networks/organisations • the PCRN gives you the names you need • the RDS helps you select recruitment strategies • the PCRN will tell you which ones might actually work Thank you 12 February 2013 Engaging and Supporting Primary Care Research: Clinical Research Networks Brendan Delaney, Clinical Lead, NIHR PCRN and Paul Wallace, Director, NIHR PCRN 12 February 2013 Development of primary care research networks in UK • 1967 Weekly returns service - RCGP • 1969 UK GP Research Club • 1973 MRC General Practice Research Framework • 1984 Midlands Research Network • 1993 NoReN and WReN • 1996 NHS R&D funds for primary care • 1998 UK Confederation of PCRNs • 2006 NIHR Primary Care Research Network for England (NIHR PCRN) The NIHR Health Research System Faculty Investigators & Senior Investigators Associates Trainees Infrastructure Universities Research Clinical Research Networks NHS Trusts Research Projects & Programmes Patients & Public Clinical Research Facilities, Centres & Units Research Schools Research Governance Systems Research Information Systems Systems Remit of the NIHR Clinical Research Networks “ to develop mechanisms to ensure that patients and healthcare professionals from all parts of the country are able to participate in and benefit from clinical research” NIHR CRN Portfolio • Eligible studies only – Academic – Industry funded, industry sponsored – Industry funded, academic sponsored NIHR CRN Portfolio • Eligible studies – Academic – Industry funded, industry sponsored – Industry funded, academic sponsored In: Studies to derive generalisable (i.e. of value to others in a similar situation) new knowledge by addressing clearly defined questions with systematic and rigorous methods Out: Audit, needs assessments, quality improvement, local service evaluations, tissue banks NIHR Clinical Research Networks PCRN (Primary Care Research Network) 6 TCRNs •Stroke •Cancer •Diabetes •Mental Health •Medicines for Children •Dementias and neurodegenerative diseases CCRN (Comprehensive Clinical Research Network) 25 CLRNs (Comprehensive Local Research Networks) NIHR Clinical Research Network Coordinating Centre NATIONAL Proposed new NIHR CRN structure NIHR CRN Coordinating Centre Clinical Theme 1 Clinical Theme 2 Clinical Theme 3 Clinical Theme 4 Etc….. PARTNERS LOCAL 15 Local NIHR CRNs covering all clinical areas NIHR PCRN – key features • Managed national network of research active primary care sites • Provision of support of different kinds to facilitate practice involvement in research • Portfolio of nationally approved and funded primary care research studies PCRN Vision • To provide improved treatment and services for NHS patients by working in partnership with patients, researchers and primary care practitioners in efficient and effective ways to conduct important and relevant research to the highest standards PCRN is the primary care delivery arm of the NIHR CRN Infrastructure support • All eligible research studies with high quality design • Dedicated network teams in 8 regional networks to provide information to practices and support for research activity • Access to technical support (eg for database patient searches) and research nurse support • Funds from NIHR to cover the real costs to the practice of involvement in research (mainly staff time) – “NHS Service Support Costs” Eight PCRN Local Research Networks (LRNs) in England • Central England • East of England • East Midlands and South Yorkshire • Greater London • Northern and Yorkshire • North West • South East • South West The PCRN LRNs • Partnerships between practices, NHS and academics • Comprehensive geographical coverage in England • Sharing best practice across and between LRNs • Experts in primary care delivery of studies • Direct provision for “standing” infrastructure: – – – – – Clinical lead(s) Network Manager Recruitment officers/Research nurses Data managers Administrative staff Primary Care engagement • Over 50% of all general practices in England have actively contributed to research delivery of at least one NIHR CRN study in the last 5 years • Many other primary care providers are also involved: – Dentists – Pharmacists – Community care sites Primary care sites supporting PCRN led and jointly supported, commercial and non-commercial studies Between April 2007 and March 2012 All sites General Practices Dentists 4501 4135 Pharmacies 59 81 Community care sites 226 PCRN Strategy • To improve the set-up of NIHR CRN primary care studies ensuring they recruit to time and to target • To ensure recruitment to primary care studies is achieved in the most effective and efficient ways • To increase the number of primary care sites which contribute to NIHR portfolio research • To improve access to studies for patients in all areas of the country PCRN Strategy cont’d • To involve patients and the public in our work in relevant and effective ways • To support industry by delivering commercial portfolio studies to time and to target in cost effective ways • To retain a well qualified and skilled PCRN workforce • To ensure transparency and value for money in all our activities Practical support for researchers • Doorway to primary care research support • Feasibility and do-ability • Help with attribution of costings • Liaison with R&D teams for approvals • Advice on recruitment strategies • Access to service support resources • Tailoring of site selection – local intelligence • Site liaison and trouble shooting • Piloting of studies NIHR PCRN portfolio activity • Open primary care studies • Open supported studies (in total) • Studies supported since set up - 166 201 1231 PCRN Supported Total 600 1231 • Participants recruited into primary care studies – 466,158 Total 2012/13 Recruitment PCRN Led 118152 466158 PCRN supported 45311 297575 Total 163463 763733 Practical support for researchers • Continual monitoring of recruitment levels • Provision of additional/alternative strategies • Menu of involvement – Study promotion to network staff resource • Simpler wider roll-out • Coordination of all CRN support • Access to primary care specific GCP • Not just General Practice Resources • Core offer to researchers • Primary care costings template • RSI schemes • PCRN nurses • PCRN nurse banks • Named PCRN contact • Agreement of responsibilities High Level Objectives • Double the number of participants recruited • Increase the proportion of studies delivering to recruitment target on time • Increase the percentage of commercial contract studies delivered • Reduce the time taken to achieve NHS permission through CSP for NIHR studies • Reduce the time taken to recruit first participant • Increase the percentage of NHS Trusts participating PCRN recruitment : current year / since 2006 500000 466158 450000 400000 350000 297575 300000 250000 200000 150000 118152 100000 50000 45311 0 2012/13 PCRN Led Total Recruitment PCRN supported All data correct as of 28/01/2013 Numbers of NIHR studies on PCRN Portfolio : current year/since 2006 Open PCRN studies PCRN Supported PCRN Led 166, 45% 201, 55% Studies supported since set up PCRN Supported, PCRN Led 600, 49% 631, 51% All data correct as of the 04/02/2013 Source: Pharma Times online http://www.pharmatimes.com/Article/12-1030/NIHR_sees_big_increase_in_primarycare_research_participation.aspx Thank you 12 February 2013 Session Two: Developing Primary Care Research Projects 12 February 2013 What makes a good NIHR application? Professor Chris Salisbury University of Bristol 12 February 2013 ‘Is the Question Important?’ • The ‘so what’ question – Does the NHS need to know the answer? • How will patients or the NHS benefit? • Is there a clear trajectory into patient benefit? • Has the research question and its importance been explained well – burden of disease, impact on service / population, gaps in knowledge, how this research will address these gaps ‘Is the Research Question in Remit?’ • Is the research question within the remit of the themed call • Is the research question within the remit of the specific NIHR programme being applied to? • Consult the NIHR web pages for advice • Read the briefing document ‘Is it the Right Method?’ • The right method for the question • Both in terms of obtaining robust answers and being feasible • Combining qualitative and quantitative methods • Assessing cost-effectiveness ‘Is the Research Feasible?’ • Design • Complexity and challenge • Recruitment rate – Centres – Eligible patients – Patient consents – Patient follow-up • Interest/expectations/incentives for service providers & patients • The NHS context • Timing ‘The Science’ • Use checklists e.g. CONSORT, SPIRIT, EQUATOR • Use headings • Clear, simple, succinct, logical • Cover all the essential elements relevant to the design e.g. – Participants – Setting – Intervention and control – Outcomes – Sample size and power – Analysis ‘Is it Clear, Logical and Persuasive?’ • Is it easy to follow for a non-specialist? • Clinical, methodologists, patient and public • Plain English summary • Is there an inexorable logic in the links between: – The problem – The research question and objectives – The method(s) – The outcomes ‘The Team and Support’ • Research team – appropriately multi-disciplinary, sufficiently experienced – Roles/responsibilities of each member described – the right size – management arrangements • Involvement with a CTU from an appropriate stage in the research development where appropriate • Research Design Service • Involvement with appropriate research networks ‘Patient and Public Involvement’ • Patient and public involvement is of key importance • Researchers need to involve patients and the public during development and delivery of the project • Patients and public will be involved at all stages of the assessment process (referees, board members) • Funding boards will explicitly look for evidence of appropriate patient and public involvement • Allow for costs, training, support of PPI members ‘Dissemination’ • How will your research really make a difference? • How will people know about it? • Plan and cost for dissemination at the outset. • Think imaginatively ‘Costings’ • Is the research realistically costed and does it offer value-formoney? • Is the cost to address the disease / health issue in question justified, and does the topic clearly account for the cost requested? • Is it costed within the limits of the proposed programme e.g. RfPB up to £350K over 36 months. ‘Other Tips’ • Follow the application guidance notes • Visible headings (e.g. sample size, outcomes) • White space – there should be some (use paragraphs) • Flow diagrams • Be aware of the idiosyncrasies of the online form • Do as much editing as possible on the Word form • Don’t leave it to the last minute before the deadline! ‘Feedback from Funding Boards / Committees’ • Feedback from funding boards at all stages is meant to be helpful to the applicants • Applicants should respond to all areas highlighted as necessary by the funding board ‘Common Pitfalls’ • Apparent lack of awareness of major related work • The method won’t answer the question • Insufficient detail: ‘ poorly specified’ • Muddled detail particularly in the methodology sections – even at full proposal • Not responding to feedback from funding board ‘Common Pitfalls’ • Gaps in expertise on the research team • Unrealistic plans or costings • Incorrect or inconsistent numbers • Submissions have not been proof-read Good Luck! 12 February 2013 How to get a Fellowship in Primary Care Research Professor Richard McManus University of Oxford 12 February 2013 Overview • Introduction – a bit about me • Getting started • Consolidation (What to do when it goes pear shaped) • Underpinning Success • Conclusions Background • Trained at St Mary’s 1985-1991 • House jobs / medical rotation / VTS • Started in Birmingham in 1997 immediately following qualification as a GP • Prior to that had done intercalated BSc, audit and some data collection for studies but had not been able to take projects to the next level • Started with clinical research fellow job (no academic trainee posts available apart from London) • Did MSc in Primary Care Getting started • 1999: failed to get fellowship (heart failure) • 2000: new project (self monitoring in hypertension) – successful application for Doctoral Fellowship (RDA) • 2001-4: PhD based on a RCT • Trial funding from the fellowship with backfill for a part time research assistant and service support costs for the practices Targets and self monitoring in the control of hypertension (TASMINH) • First UK RCT of self monitoring in hypertension • 441 people from 8 practices randomised to self monitoring vs usual care • Participants monitored BP in GP waiting rooms and attended GP if consistently above target • Follow up at 6 and 12 months • Primary Outcome change in SBP over time • Self monitoring cost effective • Clinical Bottom Line – Self monitoring alone leads to small reductions in blood pressure at 6 months that are not sustained at 12 months – Possible mechanism of action via non pharmacological changes (weight loss) – Self monitoring reduces consultation rate hence cost effective Doctoral fellowship lessons learnt • Pick something you are interested in! • Look for a gap in the evidence that’s relevant • You can never have too many patients/practices • Its hard to do a big study on your own • Think about what next even at the beginning • Side projects keep output up in lean years (routine data, systematic reviews…) Post Doctoral Work • TASMINH evolved into Telemonitoring and self management in the control of hypertension (TASMINH2) • New intervention developed comprising self monitoring with self titration • Patient and practice training packages • Post Doc Award 2005-7 • Back fill supported full time research fellow Post Doc Award • Co-Funding from Policy Research Programme (£330k) but long delay between recommendation for funding and funding • Expanded team – Qualitative arm – Increased health economics – External collaborators • Paul Little and Bryan Williams • Did systematic review in parallel McManus et al Lancet 2010 TASMINH2 Research Questions Does self management with telemonitoring and titration of antihypertensive medication by people with poorly controlled treated hypertension result in: 1. Better control of blood pressure? 2. Changes in reported adverse events or health behaviours or costs? 3. Is it achievable in routine practice and is it acceptable to patients? The Trial • Eligibility – Age 35-85 – Treated hypertension (no more than 2 BP meds) – Baseline BP >140/90 mmHg – Willing to self monitor and self titrate medication • Patients individually randomised to self-management vs usual care stratified by practice and minimised on sex, baseline SBP, DM status • Practice GPs determine management Intervention • Self Monitoring – 1st week of every month Intervention • Blood Pressure Targets: – NICE (140/90 or 140/80 mmHg) – minus 10/5 mmHg i.e. 130/85 mmHg or 130/75 mmHg • Patients agreed titration schedule with their GP after randomisation • Traffic Light system to adjust medication Outcomes • Follow up at 6 & 12 months • Main outcome Systolic Blood Pressure • Secondary outcomes: Diastolic BP / costs / anxiety / health behaviours/ patient preferences / systems impact • Recruitment target 480 patients (240 x 2) • Sufficient to detect 5mmHg difference between groups Results Invited (n = 7637) Declined Invitation (n = 5987) Assessed for eligibility (n = 1650) Excluded (n = 1123) Not Eligible (n = 1044) Declined to participate (n=79) Randomised (n = 527) Control (n = 264) Received usual care (n = 264) Did not attend follow up (n=14)* Discontinued usual care (n = 0) Analysed (n = 246) Incomplete cases excluded (n = 18) 110% recruitment Intervention (n = 263) Received intervention training (n = 241) 80% completed intervention Did not attend follow up (n=26)# Discontinued intervention (n = 53) 91% follow up Incomplete cases excluded (n = 29) Analysed (n = 234) Baseline Results Results - primary outcome SBP Post Doc lessons learnt • Recruitment is getting harder • Everything takes longer than you think • Surround yourself with experts and take their advice • Get a good trial manager and research secretary • Continue with the side projects • 2007 – failed Career Scientist Application “…too early” Career Development Fellowship • Improving the management and understanding of hypertension in primary care (2009-12) • Programme had three parts – TASMINH3 – extension of self management work into stroke and TIA – Blood pressure measurement in different ethnic groups – Cardiovascular and renal prognosis in chronic kidney disease • 75% FTE over 4 years (rest HEFCE and service funded) Linked projects • NIHR Monitoring programme with Oxford – Systematic review of different methods of diagnosing hypertension – Economic analysis->NICE guideline / Lancet • ESRC/MRC Studentship – Sabrina Baral: Self-monitoring of blood pressure in patients with hypertension and diabetes: • UK Self Monitoring Collaboration – HTA funded national conference – Subsequent BMJ publication NIHR Professorship 4 Strands • Self Monitoring in Hypertension • Self Monitoring BP in Pregnancy • Self Monitoring Collaborations • Supporting Others Starts 1/3/2013… Underpinning success • Getting a mentor • Becoming a mentor • Synergistic funding • Building collaborations • Training • Outcomes on different levels Getting a mentor • Having a good mentor formalised through my fellowships has made a big difference to my progression • This started off as a supervisor / student relationship and has matured into a colleague / colleague collaboration • Since we started we have achieved an MD, PhD, several £ms income, 32 joint publications and counting, both now chairs • Hardest thing is probably finding the right person but once you have a mentor hang onto them… mine moved to Cambridge! Becoming a mentor • More senior fellowships give opportunity to develop mentor roles for others • Currently mentor for x4 • Current supervision – 3 PhD students – 1 MSc students – 1 Academic Clinical fellow – 2 medical students (electives) • Vital role in growing the discipline and providing a pipeline for new talent Synergistic funding • Co-funding of fellowship projects – Research funding – Service support / Treatment cost funding – Linked studentships • Bridging the gaps between fellowships • Linked projects make up career narrative • Institutional support (backfill) Building collaborations • Multidisciplinary working – Social scientists – Health economics – Academic and service clinicians – Specialists and generalists • Within institutions • Between institutions • National and International Training • Improve basic skills – Epidemiology (LSHTM) – Statistics (Oxford MSc) • Expand horizons – Qualitative (NatCen) – Health Economics (HEF) • Leadership – RCGP leadership programme – Brisbane Initiative Outcomes on different levels • Funding • Publications • Markers of esteem (funding committees, editorial boards, guideline development groups, guest lectures, ACCEA) • Training • Developing others • Career progression Don’t forget a broad range of success drives progression To sum up… All right... all right... but apart from seventeen out of eighteen years (2001-18) and paying for my education and funding most of my research and paying my team... what has the NIHR done for me? … …maybe they can do the same for you? Thank you 12 February 2013 NIHR-funded Primary Care Research: NIHR Research for Patient Benefit Programme Dr Scott Wilkes 12 February 2013 Overview of the presentation • • • • Aims of NIHR RfPB Structure of RfPB Application process/tips for applying My experience of RfPB Aims of the RfPB programme • Intends to support research which is related to the day-to-day practice of health service staff and is concerned with having an impact on the health of users of the NHS • Funded research projects are likely to fall into the areas of health service research and public health research, although other areas are not excluded from the programme • Applications which have emerged from interaction with patients and the public, which relate to patient and service user experience and which have been drawn up in association with a relevant group of service users will be particularly welcome Aims of the RfPB programme • Supports high quality investigator-led research projects that address issues of importance to the NHS • Supports qualitative or quantitative research that could: – Study the way NHS services are provided and used – Evaluate whether interventions are effective and provide value for money – Examine whether alternative means for providing healthcare would be more effective – Formally assess innovations and developments in healthcare – Pilot or assess feasibility of projects requiring major applications to other funders Structure of RfPB • Response-mode funding programme for small grants • Maximum award £350k for up to three years • Awards made to NHS organisations in England with subcontracts to academic partners • Ten Regional Advisory Committees and a national Programme Director • Three funding competitions per year • Single stage application process • > 520 awards made to date totalling over £100m • Local committee, national reviewers Research for Patient Benefit Spend across health category (2011-2012) Generic Health Relevance 12% Stroke 7% Cancer 10% Cardiovascular 9% Respiratory 3.5% Reproductive 5% Oral and Gastrointestinal 5.5% Mental Health 20% Neurological 4.5% Metabolic and Endocrine 5% Making an RfPB application (www.rfpb.nihr.ac.uk) NIHR Application Process • NIHR standard application form and online submission • Invited co-applicants must confirm • Hard copy declarations and signatures must be signed by contracting NHS organisation • Applications first assessed for fit to scope – Good potential for achieving patient/public health benefit – Methodology and research design is of sufficient standard to allow for peer review – All administrative rules have been met • Applications sent for peer and lay review What makes a successful RfPB application? • Consulting and involving others – Using local resources and building appropriate partnerships – Inclusive working with patients and public • Keeping the decision criteria in mind – Achieving a convincing and appropriate research design – Explaining the context for the study and how the research will benefit patients – Tackling patient and public involvement – Specifying outcomes for the NHS – Providing a well crafted proposal • Seek advice from the Research Design Service Common areas for feedback • Detail in the methodology lacking or appropriateness of the design questioned • Overall lack of clarity and focus of the application • Inappropriate outcome measures • Particular areas of expertise lacking in the research team • Insufficient quality of the patient and public involvement • Justification or detail of the intervention lacking • Insufficient detail provided in the background information • Inappropriate statistics or health economics analysis • Concerns with the recruitment, sampling and overall feasibility • Questions regarding project impact, timescales, generalisability or dissemination Other things to keep in mind • • • • • • • Patient and public involvement must be adequately thought through and planned as part of design Plain English summary should be reviewed Relevance to patients and NHS is important Read the guidance and website resources Be aware of eligibility criteria All project costs are scrutinised by NIHR – particular attention should be paid to NHS service support, treatment and excess treatment costs Deadlines at 1pm exactly so don’t leave it to the last minute! My experience of RfPB • Open access doppler ultrasound for rapid diagnosis of DVT in primary care (OADUS) • Self-sampling for HPV testing in cervical smear non-attenders (SHINE) • Back up donor sperm for male factor infertility and IVF treatment (BUDS) • Open access investigations in general practice and delay in cancer diagnosis (OACD) • Subclinical hypothyroidism and optimum treatment in elderly patients (SORTED) • Two/three more applications in process • Check programme specific guidance documents and website resources at www.rfpb.nihr.ac.uk • Queries to rfpb@nihr-ccf.org.uk or 020 8843 8057 • NIHR Research Design Services (RDS) 12.02.2013 Thank you 12 February 2013 NIHR-funded Primary Care Research: NIHR Health Services and Delivery Research Programme Professor Bruce Guthrie 12 February 2013 What do I know about it? • Previous funding from Service Delivery and Organisation of Care Programme • Two current projects from NIHR HS&DR researcher-led stream • NIHR HTA trial just funded • Brief was to speak to the less experienced… One programme, two streams • HS&DR = merged SDO and HSR programmes – Health Delivery Research – Health Services Research • Differ in important ways – Different focus – Variable eligibility by country – Commissioned (≈HDR) vs Researcher led (≈HSR) How to apply • NETSCC Management Information System – Online forms and tasks – Good in some ways (highly structured) – Bad in some ways (which you have to learn) – Lots of buttons saying “submit”… • Several elements – Online form – Project proposal – Flow diagram(s) Getting good at forms • There’s no substitute for writing them – Hard to get good as a co-applicant unless you write at least a section • Read successful project proposals (all online) • Read successful and failed forms (not online) • Speak to programme managers (nothing to lose) • Become a reviewer • Become a panel member Why is the research needed? • The key question to answer at outline especially in the researcher-led programme • Most readers won’t know much about the topic • Many types of need – explicitly cover them all • Being common or serious isn’t enough – why this project and why now? • Previous research or “pilot data” ideal Is the team right? • Appropriate mix of expertise • Expertise has to be explicit if might be challenged – Methodological and disciplinary expertise – Can be a problem for health services researchers – Project management expertise – NHS, policy and public expertise • Co-applicants require non-spendable funding Research questions and methods • No correct way to write but several wrong ways • Personally: – One aim, a few objectives (not questions) – Each objective explicitly linked to a phase or study or method – Mix of clearly achievable and some element of risk (ambition is a Goldilocks problem) – Identify and discuss risks and problems – Always use “theory” appropriate to project How much money to ask for? • Another Goldilocks problem – Asking for too little riskier than asking for too much – Not enough direct costs can be worse than not enough researcher time – Value for money matters, but I think it matters less to panels than other considerations – Post-award negotiation often involves downwards pressure on costs (but rarely upward) Easy things to forget • • • • Direct costs Advisory Group membership and costs Patient and public involvement Interim reporting and monitoring – Think carefully about timing and milestones • Final report writing – PhD sized final reports – Have to budget for writing them An example – prescribing variation project • Need had to be established – Variation in high-risk prescribing by prescriber and by practice (bad apples vs risk-tolerant cultures) – We had strong pilot data • Team = statistical analysis, struggled with PPI • Complex analysis with important feasibility issues – Three objectives, three studies – Ambitious but do-able (but risks identified) • Straightforward to cost and relatively cheap • Getting nervous about the final report… An example – Better Guidelines project • Clear need – Happened to be a policy hot topic – We had strong ‘pilot’ data • Team = HSR, clinical, guideline development, economics, NICE, SIGN, public via NICE GDG • Three complex and overambitious objectives – No template, panel very helpful, reduced to two (neatly because objectives = methods) • Hard to cost, hard to do Thank you 12 February 2013 NIHR Workshop on Research into Primary Care Interventions 12 February 2013