nihr workshop on research into primary care interventions 12 february 2013

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NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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Page 1: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

NIHR Workshop on Research into Primary Care Interventions

12 February 2013

Page 2: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Welcome

12 February 2013

Chair: Professor Paul Little

Page 3: NIHR Workshop on Research into Primary Care Interventions 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/PrimaryCareor see your delegate packs

Page 4: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Session One: Research in Primary Care

12 February 2013

Page 5: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

12 February 2013

An Introduction to the NIHR programmes

Dr Lisa Cotterill

Page 6: NIHR Workshop on Research into Primary Care Interventions 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

Page 7: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Primary Care

Not as sexy as secondary care

Page 8: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

The NIHR Health Research System

Research

Research Projects & Programmes

Research Governance

Systems

Research Information

Systems

Patients&

Public

Universities

Investigators &Senior

InvestigatorsAssociatesTrainees

Research Schools

NHS TrustsClinical Research Networks

Clinical Research Facilities, Centres

& Units

Infrastructure

Systems

Faculty

Page 9: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Biomedical Research Centres

Basic Research

National Institutefor Health Research

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.

Patient Safety Translational Research Centres

Research for Patient Benefit

Programme Grants for Applied Research

Health Technology Assessment

Invention for Innovation

Collaborations for Leadership in Applied Health Research and Care

Centre for Reviews & Dissemination, Cochrane, TARs

Development Pathway Funding

Public Health Research

Health Services and Delivery Research

INVENTION EVALUATION ADOPTION DIFFUSION

Efficacy & Mechanism Evaluation

NHS Commissioning Board and Clinical Commissioning Groups Commissioning

National Institute for Health & Clinical Excellence Guidance on Health & Healthcare

NHS Supply Chain Support for Procurement

NHS Evidence Access to Evidence

InnovationAcademic Health Science Networks

Patient CareProviders of NHS Services

Clinical Research Facilities

Experimental Cancer Medicine Centres

Horizon Scanning Centre

Centre for Surgical Reconstruction & Microbiology

Biomedical Research Units

MedicalResearch Council

The central role of NIHR researchin the innovation pathway

Healthcare Technology Co-operatives

Research Schools

Page 10: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 11: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 12: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 13: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

NIHR as a system

• Joint calls

• Facilitating researchers, speeding review

• Transfers between NIHR programmes

• Active collaboration between programmes

• Directors' meetings

• Meeting with networks

NETSCCHS&DR

HTAEMEPHR

CCFi4i

PGfARRfPB

Clinical Research Networks

TCCFellowships

Page 14: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 15: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 16: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

12 February 2012

Thank you and good luck!

Page 17: NIHR Workshop on Research into Primary Care Interventions 12 February 2013
Page 18: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Engaging and Supporting Primary Care Research: RDS

12 February 2013

David Crook PhD(Research Design Service SE)

Page 19: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

How the PCRN can help you

Page 20: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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?

Page 21: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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?

Page 22: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

UK Health Research Support

Page 23: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

The RDS Network

Page 24: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

Page 25: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

Page 26: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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 co-applicant?

Working with your RDS

Page 27: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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?

The Initial Assessment

Page 28: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

Work with both RDS and PCRN

Page 29: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

Final Thoughts

Page 30: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Thank you

12 February 2013

Page 31: NIHR Workshop on Research into Primary Care Interventions 12 February 2013
Page 32: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Engaging and Supporting Primary Care Research: Clinical Research Networks

12 February 2013

Brendan Delaney, Clinical Lead, NIHR PCRN and Paul Wallace, Director, NIHR PCRN

Page 33: NIHR Workshop on Research into Primary Care Interventions 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)

Page 34: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Infrastructure

Clinical Research Facilities, Centres

& Units

Clinical Research Networks

Research

Research Projects & Programmes

Research Governance

Systems

Research Information

Systems

Systems

Patients&

Public

Universities

Investigators &Senior

InvestigatorsAssociates

Faculty

Trainees

Research Schools

NHS Trusts

The NIHR Health Research System

Page 35: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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”

Page 36: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

NIHR CRN Portfolio

• Eligible studies only

– Academic

– Industry funded, industry sponsored

– Industry funded, academic sponsored

Page 37: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 38: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

CoordinatingCentre

Page 39: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Proposed new NIHR CRN structure

NA

TIO

NA

LL

OC

AL

PA

RT

NE

RS

NIHR CRN Coordinating Centre

Clinical Theme 1

Clinical Theme 2

Clinical Theme 3

Clinical Theme 4

Etc…..

15 Local NIHR CRNs covering all clinical areas

Page 40: NIHR Workshop on Research into Primary Care Interventions 12 February 2013
Page 41: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 42: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 43: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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”

Page 44: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• Central England

• East of England

• East Midlands and South Yorkshire

• Greater London

• Northern and Yorkshire

• North West

• South East

• South West

Eight PCRN Local Research Networks (LRNs) in England

Page 45: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 46: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 47: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

All sites 4501    General Practices

4135 Pharmacies 59

Dentists 81 Community care sites 226

Primary care sites supporting PCRN led and jointly supported, commercial and non-commercial studies Between April 2007 and March 2012

Page 48: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 49: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 50: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 51: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

NIHR PCRN portfolio activity

• Open primary care studies - 166• Open supported studies (in total) - 201• Studies supported since set up - 1231

• Participants recruited into primary care studies – 466,158

2012/13Total Recruitment

PCRN Led 118152 466158PCRN supported 45311 297575Total 163463 763733

PCRN Supported 600Total 1231

Page 52: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 53: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Resources

• Core offer to researchers

• Primary care costings template

• RSI schemes

• PCRN nurses

• PCRN nurse banks

• Named PCRN contact

• Agreement of responsibilities

Page 54: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 55: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

PCRN recruitment :current year / since 2006

2012/13 Total Recruitment0

50000

100000

150000

200000

250000

300000

350000

400000

450000

500000

118152

466158

45311

297575

PCRN Led PCRN supported

All data correct as of 28/01/2013

Page 56: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Numbers of NIHR studies on PCRN Portfolio : current year/since 2006

PCRN Led

166, 45%

PCRN Sup-

ported

201, 55%

Open PCRN studies

PCRN Led

631, 51%

PCRN Sup-

ported,

600, 49%

Studies supported since set up

All data correct as of the 04/02/2013

Page 57: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Source: Pharma Times onlinehttp://www.pharmatimes.com/Article/12-10-30/NIHR_sees_big_increase_in_primary-care_research_participation.aspx

Page 58: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Thank you

12 February 2013

Page 59: NIHR Workshop on Research into Primary Care Interventions 12 February 2013
Page 60: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Session Two: Developing Primary Care Research Projects

12 February 2013

Page 61: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

What makes a good NIHR application?

12 February 2013

Professor Chris Salisbury

University of Bristol

Page 62: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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 Question Important?’

Page 63: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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 the Research Question in Remit?’

Page 64: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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 it the Right Method?’

Page 65: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

‘Is the Research Feasible?’

Page 66: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

‘The Science’

Page 67: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

‘Is it Clear, Logical and Persuasive?’

Page 68: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

‘The Team and Support’

Page 69: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

‘Patient and Public Involvement’

Page 70: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• How will your research really make a difference?

• How will people know about it?

• Plan and cost for dissemination at the outset.

• Think imaginatively

‘Dissemination’

Page 71: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• Is the research realistically costed and does it offer value-for-money?

• 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.

‘Costings’

Page 72: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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!

‘Other Tips’

Page 73: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

‘Feedback from Funding Boards / Committees’

Page 74: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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’

Page 75: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• Gaps in expertise on the research team

• Unrealistic plans or costings

• Incorrect or inconsistent numbers

• Submissions have not been proof-read

‘Common Pitfalls’

Page 76: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Good Luck!

12 February 2013

Page 77: NIHR Workshop on Research into Primary Care Interventions 12 February 2013
Page 78: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

12 February 2013

How to get a Fellowship in Primary Care Research

Professor Richard McManusUniversity of Oxford

Page 79: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Overview

• Introduction – a bit about me

• Getting started

• Consolidation (What to do when it goes pear shaped)

• Underpinning Success

• Conclusions

Page 80: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 81: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 82: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

Targets and self monitoring in the control of hypertension (TASMINH)

Page 83: NIHR Workshop on Research into Primary Care Interventions 12 February 2013
Page 84: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• Self monitoring cost effective

Page 85: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

Page 86: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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…)

Page 87: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 88: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 89: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

McManus et al Lancet 2010

Page 90: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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?

Page 91: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 92: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Intervention

• Self Monitoring – 1st week of every month

Page 93: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 94: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

Page 95: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

ResultsInvited (n = 7637)

Declined Invitation (n = 5987)

Assessed for eligibility (n = 1650)

Excluded (n = 1123) Not Eligible (n = 1044) Declined to participate (n=79)

Control (n = 264)Received usual care

(n = 264)

Randomised (n = 527)

Analysed (n = 246)Incomplete cases excluded

(n = 18)

Did not attend follow up (n=14)*

Discontinued usual care (n = 0)

Intervention (n = 263)Received intervention

training (n = 241)

Did not attend follow up (n=26)#

Discontinued intervention (n = 53)

Analysed (n = 234)Incomplete cases excluded

(n = 29)

110% recruitment

91% follow up

80% completed intervention

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Baseline Results

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Results - primary outcome SBP

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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”

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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)

Page 100: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

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

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NIHR Professorship

4 Strands

• Self Monitoring in Hypertension

• Self Monitoring BP in Pregnancy

• Self Monitoring Collaborations

• Supporting Others

Starts 1/3/2013…

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Underpinning success

• Getting a mentor

• Becoming a mentor

• Synergistic funding

• Building collaborations

• Training

• Outcomes on different levels

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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!

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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

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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)

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Building collaborations

• Multidisciplinary working– Social scientists– Health economics– Academic and service clinicians– Specialists and generalists

• Within institutions

• Between institutions

• National and International

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Training

• Improve basic skills– Epidemiology (LSHTM)– Statistics (Oxford MSc)

• Expand horizons– Qualitative (NatCen)– Health Economics (HEF)

• Leadership– RCGP leadership programme– Brisbane Initiative

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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

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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?

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12 February 2013

Thank you

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12 February 2013

NIHR-funded Primary Care Research: NIHR Research for Patient Benefit Programme

Dr Scott Wilkes

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Overview of the presentation

• Aims of NIHR RfPB• Structure of RfPB • Application process/tips for applying• My experience of RfPB

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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

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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

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• 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

Structure of RfPB

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Research for Patient BenefitSpend across health category(2011-2012) Generic Health

Relevance 12%

Mental Health 20%

Reproductive 5%

Cancer 10%

Oral and Gastrointestinal

5.5%

Neurological 4.5%

Stroke 7%

Cardiovascular 9%

Metabolic and Endocrine 5%

Respiratory 3.5%

Page 118: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

Making an RfPB application(www.rfpb.nihr.ac.uk)

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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

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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

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• 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

Common areas for feedback

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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!

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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

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12.02.2013

• Check programme specific guidance documents and website resources at www.rfpb.nihr.ac.uk

• Queries to [email protected] or 020 8843 8057

• NIHR Research Design Services (RDS)

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12 February 2013

Thank you

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12 February 2013

NIHR-funded Primary Care Research: NIHR Health Services and Delivery Research Programme

Professor Bruce Guthrie

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• 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…

What do I know about it?

Page 129: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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)

One programme, two streams

Page 130: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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)

How to apply

Page 131: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

Getting good at forms

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• 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

Why is the research needed?

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• 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

Is the team right?

Page 134: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

Research questions and methods

Page 135: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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)

How much money to ask for?

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• 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

Easy things to forget

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• 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 – prescribing variation project

Page 138: NIHR Workshop on Research into Primary Care Interventions 12 February 2013

• 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

An example – Better Guidelines project

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12 February 2013

Thank you

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NIHR Workshop on Research into Primary Care Interventions

12 February 2013