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!
Freeman&Thain/MSTrust/2015
4. Jenny T’s research story:
A well planned journey?
Or a series of unknown
barriers eventually
overcome?
Freeman&Thain/MSTrust/2015
5. The Beginning
“I’d done research projects previously including an
MPhil, but this was in a much more supported
situation ie registered with University and was
working in a research post therefore had time.”
“Subsequent research projects were within my
clinical practice and proved more challenging….”
How difficult could it be?
As a clinical specialist research was written
into my job description and job plan……..
Freeman&Thain/MSTrust/2015
6. The journey starts……
• Trust’s RD & I committee keen on influencing
changing perceptions of AHP RD & I capability and on
promoting a ‘World Class Service’”
• Non –medic research award – 1 page application
• 3 shortlisted
• 10 page application form…….
Freeman&Thain/MSTrust/2015
7. Writing the application
• Consultant Lead supportive
• Therapy Manager – staff costs
• Trust’s RD & I team support in writing application and
design
• Literature search – Library services
• Critical analysis and concluding what evidence tells us
• Design – how to access a statistician – links to University
• Patient and Public Involvement
• Not funded /resourced for this time
Freeman&Thain/MSTrust/2015
8. 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
• If you don’t have appropriate skills “go and get it!”
• Don’t go it alone - seek advice early on
• Research requires money and time
• Grant funding is very competitive ……..so you need
a good research question
Freeman&Thain/MSTrust/2015
9. Why are “good” research
questions important?
“Well-crafted questions guide the systematic
planning of research. Formulating your
question precisely enables you to design a
study with a good chance of answering
them.”
Light, Singer, Willett, By Design (1990)
Freeman&Thain/MSTrust/2015
10. What are the characteristics of a
“good” research question?
• Feasible - it can be answered
• Interesting – to you and others
• Novel - it breaks new ground
• Ethical - no harm to subjects
• Relevant - the “So What” test
(F-I-N-E-R)
Hulley, Newman & Cummings, 1988
Freeman&Thain/MSTrust/2015
11. Formulating an answerable
research question
opulation or participants
ntervention
omparator or Control
utcome
Freeman&Thain/MSTrust/2015
12. PICO
• What are your questions?
• Can you fit them into the PICO frame?
• Please discuss with your neighbour (5 min)…
Freeman&Thain/MSTrust/2015
13. Developing a grant is like
climbing a mountain
Grant
Submission
HS&DRRfPB
HTA
Charities
EME
i4i
HS & DR PGAR
Grant application
Freeman&Thain/MSTrust/2015
14. 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
Freeman&Thain/MSTrust/2015
15. Collaborate with a range of people
• Research Design Service
• Clinical Research Network
• R&D departments of trust (e.g. research nurse manager)
• Universities
• Statisticians
• Clinical Trials Unit
• Finance Departments
Freeman&Thain/MSTrust/2015
16. Involve people with MS from the start
• The research topic
• The research question
• Study design
• Outcomes to measure
• Methods of recruitment
• Methods of retention
• Dissemination
Freeman&Thain/MSTrust/2015
18. 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 underestimate the time this will take
• start early by involving your finance departments
Freeman&Thain/MSTrust/2015
19. 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
Freeman&Thain/MSTrust/2015
21. 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 1 2 3 4 5 6 7 8 9 10 11 12
Ethics Approval
Comprehensive Lit Review
Recruitment
Service User Training
Nominal Group (NG) Meetings
Feedback, Analysis and writing up
Dissemination
Milestones
Recruitment ends month 5
NG Meetings completed month 9
Project written up month 12
12 month funding period requested from the MS Society
and use it to check your progress throughout the project
Freeman&Thain/MSTrust/2015
22. Seek research advice early
Research Design Services Universities
http://www.ccf.nihr.ac.uk/Pages/RDSMap.aspx
Service covering England ; local access Universities are keen to
collaborate
Freeman&Thain/MSTrust/2015
25. 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
Freeman&Thain/MSTrust/2015
26. Award successful:
The next stage of the journey
• Ethics
• R & D approval
• Venues
• Staff / training / log / costs
• Availability of staff and Departments ie R & D and
Neurophysiology
• Recruitment procedures
• Site File
• Storage of data
Freeman&Thain/MSTrust/2015
27. 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
Freeman&Thain/MSTrust/2015
28. What am I doing???
• General feeling of loss of interest, even me.
• R & D link person left – felt “starting from scratch
again”
• Updates required by Trust but…
“I was really embarrassed as little was going on!!
I couldn’t face them sometimes”
Freeman&Thain/MSTrust/2015
29. 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
…………………
Freeman&Thain/MSTrust/2015
30. Be prepared for the rollercoaster ride
Freeman&Thain/MSTrust/2015
32. Finally……doing the research!
• Slow to identify participants
• Recruitment procedure seemed complex for one
control group
• Room availability change as R& D moved
• Changes of staff
• Declines
• DNA’s
• Time to chase up above…..
Freeman&Thain/MSTrust/2015
33. Key learning points
• 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!
Freeman&Thain/MSTrust/2015
34. Undertaking a “virtual investigation”
To help ensure the
research process
runs smoothly,
carry out the study in
your mind….undertake a
“virtual investigation”
Freeman&Thain/MSTrust/2015
35. Participant / Centre numbers
• How many patients of this group enter the
Trust / 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?
Freeman&Thain/MSTrust/2015
36. I’m almost there……
but what do I do with the data?
• All information collected
• Ensure it is recorded in
right place from start
• Do ‘adding up’ as you go
along
• Statistician
• SPSS
• What to do with the
data?
• Then the write up!!
Freeman&Thain/MSTrust/2015
37. Key learning points
• Don’t put “your head in the
sand”
• Decide how you analyse
data from the outset
• Seek advice from
statistician at the beginning
• Sample size calculations
• Cost in statistical support
• Allow enough time for
analyses and write-up
…….and dissemination
Freeman&Thain/MSTrust/2015
38. Reflection
Positives
• Study now complete and written up (2 .5
years for a ‘pilot’)
• Results not what we expected but still able to
suggest future study from what we did find
• Have been able to use this as an example ‘in-
house’ whilst working on increasing AHP
Research interest & activity in Trust as ‘live’ so
validates
Freeman&Thain/MSTrust/2015
39. Reflection
Negatives
• Monkey on my back - has been a long haul
• Frustrating with slow recruitment
• Had to change protocol as other clinicians not
fully supporting recruitment
• Participants agreeing to attend then DNA
• Difficulties re access to stats / SPSS – tenacity
• Need to disseminate results
Freeman&Thain/MSTrust/2015
46. Moving forwards in the real world:
START SIMPLE
Perhaps…..
• Be involved as an assessor in someone else’s study
• A Masters project is a great starter
• Supported schemes can help (e.g. CATP)
• Case reports / Single case studies / Routine Data
collection / Audit are manageable
• Incorporate research with your own appraisal
process
• Be a collaborator in another research project
• Recognise your own strengths – a great idea ? A
good head for design? A data collector? A proof
reader? A disseminator?Freeman&Thain/MSTrust/2015
47. Training pathway with four levels of award
(Masters, Doctoral, Clinical Lectureship (post-
doc) and Senior Clinical LectureshipFreeman&Thain/MSTrust/2015