NIHR Workshop on Surgery
Research
9 February 2012
Session One: Research in Surgery
9 February 2012
Challenges and Opportunities in
Surgery Research
Professor Jane Blazeby
9 February 2012
A good surgeon needs,
“The eye of an eagle, heart of a lion and
hand of a lady”
15th Century English Proverb
Spend of the MRC/NIHR on non-surgical &
surgical research in 2008/9
A paucity of surgical RCTs
(1) Number of Studies Open and In Set-Up in 2008/2009
200
180
Number of Studies
160
140
120
100
80
60
40
20
0
Specialty Group
Operations for morbid obesity
Gastric Bypass
Gastric Band
Sleeve
Other
US Bariatric centres of excellent 2008/9
UK National Bariatric surgery registry
De Maria E. www.surgicalreview.org
NBSR www.dendrite.org
BYpass
BYpass
BAND
BAND
Difficult to select outcomes
• Technical outcomes
• Measuring ‘recovery’
• Complications poorly defined
Operator expertise & culture
MRC Framework
Feasibility/piloting
• Testing procedures
• Estimating recruitment/
retention
• Determining sample size
Development
Evaluation
• Identifying evidence base
• Identifying/ developing theory
• Modelling process and
outcomes
• Determining effectiveness
• Understanding change
process
• Assessing cost-effectiveness
Implementation
• Dissemination
• Surveillance and monitoring
• Long-term follow-up
Research infrastructure, CTUs & Hubs
Edinburgh
Northwest
Midlands
All-Ireland
Oxford
ConDuCT
Cambridge
London
The lady you
saw in clinic
Monday
wants to be
randomized! !
It’s the way I
talk to them
young Jedi.
Trainee-led Surgical Research
Collaboratives
- Lessons learnt from the ROSSINI trial
• Mr Thomas Pinkney
ROSSINI
Reduction Of Surgical Site Infection
using a Novel Intervention
A randomised controlled trial of a wound-edge protection device to reduce surgical site infection
Inclusion:
Exclusion:
All patients undergoing laparotomy
Laparoscopic-assisted surgery
Blinded wound reviews Pre-discharge (5-7 days) & at 30-33 days
Funded by NIHR Research for Patient Benefit programme
Other research collaboratives
•
•
•
•
•
•
•
•
London – LSRG
South West – SPARCS
Mersey – MERGS
Yorkshire
Kent/Maidstone
Trent
Cardiothoracic collaborative
Yorkshire orthopaedic group
Opportunities
• Feasibility work/studies (RfPB, HTA)
• Program research, RCTs (NIHR & HTA)
• Clinical academic pathways, NIHR PhDs.
Where
there’s a will
there’s a way
Thank you
9 February 2012
Engaging and Supporting Surgical
Research: Research Design Service
Andy Barton
9 February 2012
The NIHR Research Design
Service (RDS) supports
researchers to develop and
design high quality research
proposals for submission to
NIHR and other national, peerreviewed funding competitions
for applied health or social care
research.
www.rds.nihr.ac.uk
“To offer fit for purpose
advice and support on
research design and
methodology to
researchers making
funding applications…”
“To increase the number
and proportion of high
quality applications for
funding …”
RDS: Purpose
• To help researchers develop and design high quality
research proposals for submission to national, peerreviewed funding competitions for applied health and
social care research
• To provide consistent national coverage, with a focus
on NHS-based researchers applying to NIHR
Programmes
• To offer access to a range of expertise in research
design and to refer to other sources of expert advice
on the applied health and social care research
system
Delivering the service
•
•
•
•
•
•
•
•
Almost all university-based
Central Co-ordinating Centre
Number of “sites”
Team of Research Design Advisors
Access to more specialist advisors
Close links with other services, eg CTUs
Some training – but limited
Support for Public and Patient Involvement
Helping to build successful
grant applications
•“Self care” – information
• “RDS Direct” – telephone/email queries
• “Primary care” – face-to-face discussions
• “Secondary care” – involving other RDS staff
• “Tertiary care” – other specialist input
• “Follow-up care” – fixable faults and troubleshooting
RDS national figures
2009/10
• 2335 projects
• 217 outline applications (62% short-listed)
• 662 full applications (35% funded)
2010/11
• 2328 projects
• 311 outline applications (54% short-listed)
• 839 full applications (37% funded)
Support infrastructure: Where
the RDS fits
(CLAHRC)
RDS &
CTU
Research Question
Study Design
Funding Application
CLRN
CTU
(CLAHRC)
Study Execution
Analysis
Dissemination
Implementation
Find out more
Visit:
www.nihr.ac.uk/infrastructure/Pages/infrastructure_resear
ch_design_services.aspx
Thank you
9 February 2012
Engaging and Supporting Surgical
Research: Clinical Research Networks
Dr Jonathan Gower
9 February 2012
The Role of the NIHR Clinical
Research Networks
•To provide a world-class research infrastructure
embedded in the NHS to support the successful
DELIVERY of clinical research studies across England
Development
Funding
Delivery
NIHR Clinical
Research Networks
NIHR Clinical
Research
Networks
NIHR Dementias &
Neurodegenerative
Diseases Research
Network
NIHR National
Cancer Research
Network
NIHR Diabetes
Research Network
NIHR Primary Care
Research Network
NIHR Medicines for
Children Research
Network
NIHR Mental Health
Research Network
NIHR Stroke
Research Network
NIHR
Comprehensive
Clinical Research
Network
Covers the whole of
England
Covers all healthcare
sectors
Covers all areas of clinical
need
Support delivered through
25 Comprehensive Local
Research Networks (CLRNs)
All the Research Networks
work closely together to
deliver benefits for
researchers and patients
What the NIHR Clinical
Research Network provides:
• Access to experienced Research Management and
Governance staff
• Access to a local network of dedicated skilled
research support staff (eg research nurses)
• Support to service departments such as pharmacy,
radiology, laboratories
• Dedicated research time for clinicians
• Access to free training opportunities
• A local and national support network to ensure the
successful set up and delivery of research projects
What the CCRN budget
is being spent on in 2011/12
£243m
Service Support
18%
RM and G
7%
Other
1%
Clinical staff
51%
Non-Clinical Delivery
staff
10%
Management Cost
4%
85% of the
total CRN
budget
Funding
level being
maintained
Host Cost
1%
Local Contingency
8%
Specialty Groups
• CCRN portfolio broken down into 24 different
specialties
• Each led by a Specialty Group – set up to harness
the enthusiasm and expertise of researchers in the
specialties that they are dedicated to
• Membership through nomination of Local Leads from
the CLRNs (now over 500)
• To actively engage with the research community and
other stakeholders to make the most of what the
Clinical Research Networks have to offer
• National coordinating function linked to local
networks to ensure the successful delivery of studies
to time and target
The number of studies
in each Specialty Group
220
200
Number of Studies
180
160
140
120
100
80
60
40
20
0
Specialty Group
Jan-10
Jan-11
Surgical Research
• “Cross-cutting theme” extends across cancer,
cardiovascular disease, musculoskeletal,
nervous systems disorders, ENT, GI, Injuries and
Emergencies…
– Around 70 active studies on the portfolio funded
by NIHR and NIHR partnership organisations
• Multidisciplinary – vascular, heart, orthopaedics,
GI, neuro-, plastics, head and neck…
• Historically under-represented in the research
arena
• A complex area to do research in
BUT…
NIHR CRN support
to surgical research
• NIHR has established a Specialty Group for Surgery
– Excellent cross-talk across disciplines
– A real focus of enthusiasm and advice
– A vehicle through which to develop partnership
working
• £1.6m of additional network funding directed
specifically to support surgical research in addition to
the significant disease-specific support (cancer,
cardiovascular etc)
• Supporting GRIST (Growing Recruitment into
Interventional and Surgical Trials)
• Identifying the barriers and finding solutions, making
a difference
The Surgical Research
Specialty Group
S
Spec
Surri
Recruitment into Surgical
Research Studies
Where recruitment is
taking place
Practical help we
can offer
• Advice about “deliverability”
– Patient numbers, patient pathway
– Consent rates
– Resources required
• Identification of research active centres with the
commitment and expertise in specific areas
• Help with securing support through the CLRNs
• Ongoing study overview
– Unblocking local blocks
– Help to find new recruitment sites
– Identifying national blocks and addressing these
How to access help
• Visit the Specialty Group stand in the Marketplace
• Pick up a Surgery Specialty Group flyer
• Contact the Surgery Specialty Group Lead for your
CLRN
• The CLRN where the CI resides offers a “Lead
Network Service” to help CIs set up multicentre
studies quickly and effectively across multiple CLRNs
Thank you
9 February 2012
Session Two: Developing Surgical
Research Projects
9 February 2012
What makes a good NIHR
application?
Professor Jonathan Michaels
9 February 2012
‘Is the research question in
remit?’
•Is the research question within the remit of the themed
call, and;
•Is the research question within the remit of the specific
NIHR programme being applied to?
•Talk to the programmes concerned or consult the
NETSCC or CCF web pages: www.netscc.ac.uk/funding
or www.ccf.nihr.ac.uk for advice
‘Is the question important?’
•The need for the research
– How much will patients or the NHS benefit from
the proposed research or healthcare technologies.
– Is there a clear trajectory into patient benefit.
– Has the research question been explained clearly
and the importance of topic made (e.g. burden of
disease, impact on service / population, gaps in
the knowledge identified and how this research
will address these gaps)
‘Is the research feasible?’
• Is the presentation and/or methods appropriate for
the research question?
• Design complexity
• Recruitment rate
• Centres
• Eligible patients
• Patient consents
• Patient follow-up
• Expectations of service providers / patients
• Experience, track record of research team
‘The science’
•Sample size
• Effect size
•Outcomes
• Must be appropriate for programme applied to
e.g. HTA patient centred, i4i healthcare
technologies
• Composite measures (e.g. QALYs) or
surrogates depending on programmes
• Useful to look at completed or on-going
research on the programme websites
‘The science’
•Stage of development of technologies
• Especially for complex interventions
• Some programmes support developmental or
exploratory studies where there is a clear path
to the evaluation
• Some programmes supports pilot or feasibility
studies leading to major applications to other
NIHR funding streams (e.g RfPB)
• Development of innovative medical devices or
technologies that address unmet clinical needs
(e.g i4i)
•Can include qualitative or quantitative research
•Comparators
• Best alternative, treatment as usual, placebos
‘Infrastructure and Support’
•Research team – appropriately multi-disciplinary and
sufficiently experienced. Roles and responsibilities of
each member clearly described.
•Involvement with an RDS / CTU from an appropriate
stage in the research development
•Involvement with appropriate research networks
•INVOLVE
‘Costings’
•Is the research realistically costed and does it offer
value-for-money?
•Is it costed within the limits of the proposed programme
e.g. RfPB up to £250K over 36 months.
•Is the cost to address the disease / health issue in
question justified, and does the topic clearly account for
the cost requested?
‘Other advice’
•English for mixed audience
– Clinical, methodologists, patient and public
– Tell the story well for the non - expert
– Plain English summary
– Follow the application guidance notes.
•Visible headings
– (e.g. sample size, outcomes, technologies)
•White space – there should be some (use paragraphs)
•Flow diagrams
‘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’
•Inconsistent accounts of planned research
•Incorrect or inconsistent numbers e.g. sample size
calculations or missing entirely.
•Apparent lack of awareness of major or related work in
train
•Insufficient detail, or muddled detail particularly in the
methodology sections – even at full proposal
•Gaps in expertise on the research team – even after
feedback from funding board
‘Common pitfalls’
•Inadequate detail given on the health issue or
demonstrations of benefit to patients
•Inadequate detail given on the intervention to be
evaluated or the medical device or technology to be
developed.
•Application has not stuck to programme remit and/or
the call
•Application has not paid enough attention to board
feedback between outline and full proposal
•Unrealistic / inaccurate costings (both under and overcosting)
•Submissions have not been proof-read
‘Patient and Public Involvement’
•Patient and public involvement is of key importance
•Researchers need to involve patients and the public
during the development and delivery of the research
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
Thank you
9 February 2012
An Introduction to the NIHR
programmes
Professor Tom Walley
9 February 2012
Decline in clinical research in
surgery
•
•
•
•
Service demands
Lack of equipoise
Lack of expertise in clinical trials
Easier ways to keep RAE/university happy (consent,
regulation of clinical trials etc)
But:
• Lack of information to inform practice
• Professional (eg RCS, ASGBI) enthusiasm for more
clinical research
Call for Applied Research in
Surgery
• Application forms available on 23 February. Closing date
25 May 2012
• Particular interests
– Surgical procedures
– Alternatives to surgery (surgical comparators)
– Patient safety/experiences
– Devices
– Organisation of 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
Participating programmes
• CCF programmes
– Invention for Innovation Programme (i4i)
– Programme Grants for Applied Research Programme
– Programme Development Grants
– Research for Patient Benefit Programme
• NETS programmes
– HTA
– EME
– HS&DR
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
INVENTION
EVALUATION
ADOPTION
DIFFUSION
Basic Research
Development Pathway Funding
MRC
Efficacy & Mechanism Evaluation
Invention for Innovation
Biomedical Research Centres
National Institute
for Health Research
Biomedical Research Units
Patient Safety and Quality
Research Centres
Research for Innovation,
Speculation & Creativity
Research for Patient Benefit
Health Services & Delivery Research
Programme Grants for
Applied Research
Public 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.
Health Technology Assessment
Collabs for Ldrshp in Appl Hlth Res and Care
Ctr for Reviews & Dissemination, Cochrane, TARs
NHS Purchasing & Supplies Agency
Centre for Evidence-based Purchasing
Guidance on Health & Healthcare
National Institute for Health & Clinical Excellence
NHS Evidence
Access to Evidence
NHS Institute for Innovation & Improvement
Support for the NHS
Strategic Health Authorities
Duty of Innovation
Primary Care Trusts Healthcare Commissioning
NHS Providers
Patient Care
NIHR as a system
• Joint calls
• Facilitating
researchers, speeding
review
• Transfers between
NIHR programmes
• Active collaboration
between programmes
• Directors' meetings
• Meeting with networks
Clinical
Research
Networks
CCF
i4i
PGfAR
RfPB
NETSCC
HS&DR
HTA
EME
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 - translation of bright ideas for new high-tech products into
methods of prevention, diagnosis and treatment £100-300K
• PGfAR- £2m for up to 5 years, awards made to NHS bodies
• RfPB – max £250k for up to three years
Themed Call on Research in
Surgery
• Watch the website for dates
• Engage collaborators, CTUs, RDS as soon as you can
• Closing date for outlines (vary by programme, not RfPB)
• May 25th
•
•
•
•
Closing dates for fulls (vary by programme)
October
Final funding decisions
March 2013
Thank you
9 February 2012
NIHR-funded Surgical
Research: NIHR RfPB Award
Holder
Matt Costa
9 February 2012
Research for Patient Benefit
“Its main purpose is to realise, through evidence, the huge potential
for improving, expanding and strengthening the way that healthcare
is delivered for patients, the public and the NHS....”
• Very broad remit:
– Mental Health
– Hospital Medicine
– Primary Care
• But, all of the research is about direct benefit to the patient...
Warwick Arthroplasty Trial
• A Randomised Controlled Trial of Total Hip Arthroplasty Versus
Resurfacing Arthroplasty in the Treatment of Young Patients
with Arthritis of the Hip Joint
•
Design A single-centre, two-arm, parallel group, assessor-blind randomised
controlled trial with 1:1 treatment allocation
•
Participants 126 adult patients with severe arthritis of the hip joint suitable for a
resurfacing arthroplasty of the hip
•
Interventions Total hip arthroplasty – replacement of femoral head and neck. Hip
resurfacing arthroplasty – replacement of the articular surface of femoral head only
i.e. the neck remains intact.
•
Main outcome measures Hip function at 12 months post-operation, assessed using
the Oxford hip score (OHS) and the Harris hip score (HHS).
Why was this application
successful?
• A research question that was obviously relevant to patient care
• A multidisciplinary team – methodology as well as clinical expertise
• Heavy patient involvement
• Simple, pragmatic study design
• Realistic (and limited) goals, within the timescale and budget of
RfPB
Warwick Arthroplasty Trial
• Results
– The hip function of patients following Resurfacing Arthroplasty
was not shown to be better than Total Hip Arthroplasty12 months
after operation.
– Overall complications rates did not differ between the two groups
– Resurfacing may be cost effective in some patients but this
depends upon the long-term survival of the implants
• Conclusions Resurfacing Arthroplasty was not shown to be better
than Total Hip Arthroplasty in the 12 months after surgery.
• Trial registration. Current controlled Trials ISRCTN33354155.
UKCRN 4093.
What have we learnt?
• Don’t be too clever – simple research questions and straightforward
study designs
•
Clinical engagement is key – all of your surgeons and allied health
professionals must be ‘on board’
• No substitute for dedicated research staff – surgeons are rubbish at
recruiting!
• Take your expected rate of recruitment, halve it and then halve it
again...
What we would do
differently next time
• Patients as co-investigators – really important
• Research Design Service input
• What can you afford?
• Qualitative/Mixed Methods, Health Economics etc – may add to the
application but within the budget?
• Talk to someone who has ‘successfully’ delivered an RfPB
project.....
NIHR springboard....
• Track record is important
• NIHR remarkably supportive and willing to give feedback – take their
advice!
• HTA funding:
– Distal Radius Acute Fracture Fixation Trial (DRAFFT)
– Wound Management of Open Fractures of the Lower Limb
(WOLLF)
• Programme Grants for Applied Research:
– Improving the outcome for patients with fracture of the proximal
femur
Thank you
9 February 2012
NIHR-funded Surgical
Research: NIHR HS&DR
Award Holder
Professor Martin Utley
9 February 2012
Outline
• A risk model for paediatric cardiac surgery.
• Building the project and building the team.
• Selling the proposal.
• Getting it done.
Numerology tips from a lottery winner?
The idea
A risk score for paediatric cardiac surgery
that incorporates diagnosis,
is based on national data,
and that can be used for local monitoring
The team
Victor Tsang
Kate Brown
CCAD
UCL CORU
Something for everyone
Experts, expert collaborators, PPI
The idea
Challenge / test / build the idea
Start early!
The team
Something for everyone
Experts, expert collaborators, PPI
The idea
Challenge / test / build the idea
Start early!
The team
The proposal
Value of research to you / patients / NHS
Similar problems / trajectory / spin offs?
Aims – objectives – methods
Roles and responsibilities, Plan B
Realistic timetable
Something for everyone
Experts, expert collaborators, PPI
The idea
Challenge / test / build the idea
Start early!
The team
The proposal
The research
Value of research to you / patients / NHS
Similar problems / trajectory / spin offs?
Aims – objectives – methods
Roles and responsibilities, Plan B
Realistic timetable
Regular and frequent progress meetings
Flag problems / delays
Trouble shooting
Summary
• Benefits made clear
• A competent, well briefed team
• A clear plan
• Risks anticipated and contingency plans in place
• Effective communication
• Start on time and don’t overrun
Sound familiar?
Final lottery tip
You have to buy a ticket.
Thank you
9 February 2012
NIHR-funded Surgical
Research: NIHR PGfPG
Award Holder
Mr Peter McCulloch
9 February 2012
Who are we?
• Quality, Reliability, Safety & Teamwork Unit (QRSTU)
• Research unit focussed on INTERVENTIONS to improve
SAFETY in SURGERY
• Based in Nuffield Dept of Surgical Science, Oxford
University
• Multidisciplinary team includes clinicians, ergonomists,
aviation teamwork experts, specialist in systems
improvement, knowledge translation, statistics and health
economics
Safer Surgical Services
• Programme of studies to evaluate
INTERVENTIONS to improve safety and quality in
surgery
• Looking at SYNERGY between approaches and
effects of CONTEXT and CULTURE on success
• Based on a 3 dimensional model of safety (system,
culture and technology)
• Uses learning from non-medical experience eg
CRM, “Lean”, Ergonomics
• 3 Trusts over 3.5 years, mainly Orthopaedics
Application Process
•
Dates and timelines – 2 years from start to go.
•
•
•
•
•
•
•
•
•
•
5/9/08 Final Draft 1.3
Notes on reviews 28/11/08
Response to review 8/01/09
Response to further reviews 19/01/09
Full application 09/06/09
Resubmission 25/08/09
Final resubmission 22/09/09
Outline, full application & revision so 3 submissions
Further revisions x3 and contract signing 1/11/09
Difficulties around NHS budget holding & sponsorship for
academic partners
Overall Impressions of
Application Process
• Two stage process pointless where HEI
involved, and causes delay
• Review process thorough and professional
(- overly so?)
• CCF staff superb
• Rules a disincentive to career academics
• Online forms not optimal
Pointers for Applicants
• Referees showed strong focus on TEAM
and ENVIRONMENT
• Strong track record with relevant pilot data
essential
• Patience and flexibility required
Setting Up
• Agreeing Contract after award
can take time
• Ethics – vastly improved in last
5 years
• Permissions to enter hospitals –
challenging!!
Achieving permission
Issues
•Difficulty in determining what is
needed – HC, OC, RP ?
•Multiple steps required
• = time and money
• Multiplies chance of delay
•Justification for several steps
unclear
• CRB
• Medical Director sign-off
• Occ Health at each Trust
• Clearance for Letter of
Access
Delays
(n = 24)
Mean 7.8 weeks
Median 8 weeks
Range 3 – 18
weeks
Budgetary control
• Subcontracting awkward – NHS, University
and NIHR accounting systems
• Generally flexible and sensible in day to
day running
• Good interaction with CCF staff –
availability and ability
• Interpretation of rules for funding NHS
support costs seems difficult – and narrow.
Reporting
• Requirements light and not onerous
• Requirement for permission to publish
irritating
• No real feedback on reports
Dealing with NHS R&D Offices
at Trust Level
• Urgent and serious problem which is damaging
research
•
•
•
•
Access
Ethics Amendments
Protocols
Sponsorship
• Perverse incentives
•
•
Staff justify existence by activity not results
No targets or deadlines (? Look at Ethics model)
Patient & Public
Involvement
• Principle not easy to implement
• PALS
• Patients Association
• Special interest groups
• More support needed?
Summary
The Good
• Generous support, vitally needed and
unique
• Very thorough and fair reviewing process
• Superb staff interface at CCF - very helpful
prompt and professional advice
• Financial and Reporting structures effective
and not onerous
Summary
The not so good
• Two stage application process
• Iterations in contract negotiation
• NHS R&D Offices at Trust level a serious
problem
• Dissemination and PPI obligations could do
with more help
• Lack of rigorous mid-stage evaluation
Conclusions
• Vital and important funding for clinically relevant
research
• Innovative on a world scale
• Slow and bureaucratic selection and contracting
• NHS budget holding a problem
• Major problems with Trust research governance
• Effective and helpful day to day management
• Need to put more into PPI and reporting
Thank You NIHR!
Peter McCulloch*
Ken Catchpole*
Lauren Morgan*
Eleanor Robertson*
Julia Matthews*
Beth Bosiak*
Sarah Wills*
Sharon Pickering*
Mohammed Hadi*
Damien Griffin
Steve New*
Trevor Dale*
Alastair Gray*
Oliver Rivera*
Doug Altman*
Gary Collins*
Crispin Jenkinson
Renee Lyons
Alison Kitson
Tony Berendt
Karen Barker*
Thank you
9 February 2012
NIHR Workshop on Surgery
Research
9 February 2012