This presentation by Nicki Ward and Jenny Freeman is aimed at novice researchers and based around a real-life case scenario in which many lessons were learnt. It also signposts to practical resources along the way.
3. Session Plan
• Aimed at novice researchers
• Based around a real-life case scenario in which
many lessons were learnt
• Key learning points at each stage
• Ask questions and raise issues along the way
• Sign-posts to practical resources
• Our aim – to prevent you making the same
mistakes!
5. The Beginning
“I’d carried out MS fatigue management courses with an OT
colleague; we had previously travelled to different UK centres
looking at how they managed fatigue”
“We decided to carry out some research on what was the best way
to carry out Fatigue Management courses.
We knew there was some published research on the effectiveness
of these groups but not in the UK. Neither of us had ever carried
out research before although we had both done our Degree”.
How difficult could it be?
Research appeared to be well encouraged so there must
be loads of resources out there/people willing to help....
6. The journey starts……
“We thought to provide a more robust piece of research we
should have a multi centre piece of work…. So who would join
us?”
MS Trust Annual Conference
• information sharing meeting which was mobbed
• those still interested would email us - 7 centres joined in
“Now we had the centres
our next step was writing
the research proposal…”
7. Writing the grant application
• Sought funding from the MS Society “they were bound to accept
us as we were carrying out a good project”. They sent us an
application form.
• I phoned the MS Society convinced they would have someone to
support us ….. “there was none to be had”
• So we grabbed what time we could to write it. Did it in bits n
bobs in the evening…..It took ages to complete….luckily there
was a deadline date
• “Wrote it entirely ourselves, no help”. Funding requested was
for the study days which would prepare all the centres. Some
funding for the analyses
• Submitted it. “Were convinced there would be no issues and we
would be accepted…. Eagerly awaited our funding”
8. The journey continues …. It’s bumpy
We were turned down …… with only vague feedback
“Very upset and disappointed, all that hard work. All those centres who
had agreed to take part! ”
After tears and lots of moaning we approached the MS Trust…. pitched the
research...they agreed to consider it. “I think they did it as a favour to me
really...”
Redesigned as an RCT and submitted. MS Trust liked it but felt it needed to
be tighter in terms of budgeting. Advised to see an experienced researcher.
“I was petrified”, but went to London with the proposal……. She asked me a
series of questions. “I thought I knew what I was doing but……..my
budgeting was naive! ” …….. MS Trust agreed the grant.
Involved the research dep’t at the QE who were very helpful
9. Key Learning Points
• A good research idea is essential
• Be confident there is an evidence gap
• Clinical experience and enthusiasm needs to be
accompanied by support from a research team
• Don’t go it alone - seek advice early on
• Research requires money
• Grant funding is very competitive
10. Developing a grant is like
climbing a mountain
HS&DR
RfPB
HTA
Grant application
HS & DR
EME
i4i
Grant
Charities
PGAR
Submission
11. From the outset you need to consider…
•
•
•
•
•
•
•
The team (clinical and research)
A convincing project plan
Feasibility: supporting audit or pilot data
Access to participants & agreement of other sites
Involvement of other key organisations
Clear management arrangements
Properly costed
12. Collaborate with a range of people
•
•
•
•
•
Research Design Service
Research network
R&D departments of trust (e.g. research nurse manager)
Universities
Finance Departments of collaborating
organisations (e.g. other trusts, universities)
• Clinical trials unit
13. Cost your project effectively
Find someone who knows what they are doing and who:
• understands the forms
• can help you to cost your project
• can help you to complete the forms
• start by listing all research activities
• don’t forget “on-costs”
• don’t underestimate the time this will take
• start early by involving your finance departments
14. Make a clear project plan
• Identify key milestones
• Link with objectives
• Be realistic – things
always take longer than
you think
• Timetable / Gantt chart
linked to milestones /
objectives
15. Develop a Timeline
Bright
idea
Public and
patient
involvement
Circulate
draft for
meeting
Incorporate
comments
from team
Feedback
Costs to
finances
Submit
to
funder
Draft revised
for 10th time!
16. Produce a Gantt Chart
Development of a falls management intervention for people with multiple sclerosis: Building stakeholder consensus
Project Gannt Chart
Month
-3 -2 -1
Ethics Approval
Comprehensive Lit Review
Recruitment
Service User Training
Nominal Group (NG) Meetings
Feedback, Analysis and writing up
Dissemination
1 2
3
4
5
6
7
8
9 10 11 12
12 month funding period requested from the MS Society
Milestones
Recruitment ends month 5
NG Meetings completed month 9
Project written up month 12
and use it to check your progress throughout the project
17. Seek research advice early
Research Design Services
Service covering England ; local access
http://www.ccf.nihr.ac.uk/Pages/RDSMap.aspx
Universities
Universities are keen to
collaborate
18.
19.
20. Useful Websites: Research Process
For information re:
• developing research question
• deciding on research design and methods
• writing your research proposal
• collecting the data
• disseminating the findings
http://www.rddirect.org.uk
http://www.rdinfo.org.uk
http://www.csp.org.uk
Up to here 45 minutes
21. Grant successful:
The next stage of the journey
• Organised 2 study days for the 7 centres to attend.
• Supported by local Research dep’t who were able to answer
specific ethics and research design questions
• CD given to each team with all the teaching resources on it and
various issues and potential problems ironed out and
addressed
Drop out of 1 centre – who felt unable to recruit adequate
participants for both control and experiment group
22. …..onto national ethics
“it was turned down 4 times”
• I had to keep re-applying “it took months and months”
• “I wish I had submitted it nearer to me …to attend the ethics
committee meeting and listen to the issues”
• “I felt sure I was addressing everything that I read on the
feedback, but obviously not” In the end I phoned the MREC at
Southampton go through the issues
– Engaged help from Uni to change randomisation method
– Why didn’t I do that earlier??? It was so straightforward!
Drop-out of another centre as lead person left employment
and no-one else willing to take on the research
23. …. and then to local ethics
“….
I thought that approval at national level meant local
ethics approval would be a mere formality”
But no, issues at every remaining centre
–
–
–
–
who employed the individual carrying out the research?
problems with venues
Issues with documents
further delays
But finally accepted
Lost another centre due to loss of funding for fatigue
classes. Only 4 centres left!!
24. Useful Websites: Ethics application
NRES:
http://www.nres.npsa.nhs.uk/applications/guidance
Finding your local REC and R & D Organisation
Detailed Guidance sheets
Procedure Flowcharts
IRAS:
https://www.myresearchproject.org.uk
Tutorials on application
Detailed Guidance sheets
www.swpctresearch.nhs.uk:
Up-to-date information on latest changes involved with NHS
ethics application process - click on the 'ethical information'
link
25. Key Learning Points
• Use the resources IRAS
provides
• Talk to people
• Seek advice and help
• Be realistic re timeframe
• “Buy-in” from partners
• Leadership is essential
• And most importantly
…………………
26. What am I doing???
• General feeling of loss of interest, even me.
• Research partner moved…… I was left on my own. I lost motivation, it
all seemed too much.
• Updates required by MS Trust but…
“I was really embarrassed as little was going on!!
I couldn’t face them sometimes”
Lost another centre “no patients met the eligibility criteria in terms of anxiety
and depression”. Now 3 centres left
•
60 mins
29. Finally……doing the research!
1st tranche
• 1st centre - no problems
• 2nd centre - didn’t use the outcome measures for the control
group; not informed until too late .
• 3rd centre: people started to drop out of the course, which had
never happened before ! The control group all attended
everything they were asked to!
2nd tranche
• 1st and 2nd centre - OK although struggled to recruit 16 patients
• 3rd centre recruited 16, all paperwork completed, course due to
start the following week……” I was diagnosed with breast cancer
and had to cancel the course”. Off for 12 months!!!
30. Key learning points
• Involve people with MS early on
• Be realistic about the numbers of potential
participants / centres
• If you involve other centres, there is a need for
regular communication to ensure everyone is
doing what is required!
31. Useful resources:
involving people in research
• MS Trust
– http://www.mstrust.org.uk/research/gettinginvolved
• MS Society Research Network:
– http://www.mssociety.org.uk/research/research_net
work
• INVOLVE
– http://www.invo.org.uk
32. Participant / Centre numbers
• How many patients of this group enter
theTrust / are seen in your practice?
• How many of these fulfil the inclusion criteria?
• What is your predicted recruitment rate
(be pessimistic)?
• What is your predicted attrition?
• What are these estimates based on?
33. “How many of these patients do
you see, say, per month?”
Thousands!
35. Can you just check how many it is over
the coming month?
Hundreds!
36. And how many would be willing to
participate?
It was a quiet month!
37. And how many will you follow up?
OK – I’ll ask another site…
38. I’m almost there……
but what do I do with the data?
• All information
collected
• “just found a guy to
help me make sense of
the data”
• Hoping it will be
analysed early next year
• Then the write up!!
39. Key learning points
•
•
•
•
Decide how you analyse data from the outset
Seek advice from statistician at the beginning
Cost in statistical support
Allow enough time for analyses and write-up
…….and dissemination