NIHR Grant Programme RP-PG-0707-10012 Executive Team Meeting 28/9 September 2009 Glanville Centre,...
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Transcript of NIHR Grant Programme RP-PG-0707-10012 Executive Team Meeting 28/9 September 2009 Glanville Centre,...
NIHR Grant NIHR Grant ProgrammeProgramme
RP-PG-0707-10012 RP-PG-0707-10012
Executive Team Meeting Executive Team Meeting
28/9 September 2009 28/9 September 2009
Glanville Centre, Salisbury Glanville Centre, Salisbury District Hospital District Hospital
Development of an Development of an integrated service integrated service
model incorporating model incorporating innovative technology innovative technology for the rehabilitation for the rehabilitation
of the upper limb of the upper limb following stroke following stroke
DDevelopment of an evelopment of an IIntegrated ntegrated SService ervice
model incorporating model incorporating innovative innovative
TTechnology for the echnology for the RRehabilitation of the ehabilitation of the UUpper limb following pper limb following
STSTroke roke
DISTRUSTDISTRUST
Working TitleWorking Title
AAssistive ssistive TTechnolgies echnolgies in the in the RRehabilitation ehabilitation of the of the AArm following rm following
SStroketroke
The The ATRASATRAS project project
www.atrasproject.owww.atrasproject.orgrg
Agenda Agenda 1.00 – 1.301.00 – 1.30 LunchLunch
1.30 – 2.001.30 – 2.00 Project to date Project to date overviewoverview
Ian SwainIan Swain
2.00 – 2.402.00 – 2.40 WP1 progress to dateWP1 progress to date Damian Damian Jenkinson/Gabrielle Mc Jenkinson/Gabrielle Mc HughHugh
2.40 – 3.302.40 – 3.30 WP1 discussion WP1 discussion
3.30 – 3.503.30 – 3.50 CoffeeCoffee
3.50 – 4.303.50 – 4.30 WP2 progress to dateWP2 progress to date Anand Pandyan/Sybil Anand Pandyan/Sybil Farmer Farmer
4.30 – 5.004.30 – 5.00 WP2 discussion WP2 discussion
9.00 - 9.409.00 - 9.40 WP3 progress to dateWP3 progress to date Jane Burridge, Anne-Jane Burridge, Anne-Marie Hughes, Sara Marie Hughes, Sara DemainDemain
9.40 – 9.40 – 10.3010.30
WP3 discussionWP3 discussion
10.30 -10.30 -10.50 10.50
Coffee Coffee
10.50 – 10.50 – 11.1511.15
WP4 decision makingWP4 decision making Ian Swain Ian Swain
11.15- 11.15- 12.0012.00
DiscussionDiscussion
Project Overview Project Overview
• 3 year extension to 5 year 3 year extension to 5 year • Aim: Evidence based clinical service for Aim: Evidence based clinical service for
upper limb rehabilitation following stroke upper limb rehabilitation following stroke over the course of the first year over the course of the first year
• Three Work Packages Three Work Packages – Work Package 1: Determine current UL Work Package 1: Determine current UL
rehabilitation for stroke & outcome measures rehabilitation for stroke & outcome measures used used
– Work Package 2: Literature surveyWork Package 2: Literature survey– Work Package 3: User acceptabilityWork Package 3: User acceptability
• Plan clinical trial and write report at 24 - 27 Plan clinical trial and write report at 24 - 27 monthsmonths
Project TeamProject Team
Project ManagementProject ManagementSalisburySalisburyIan Swain
Jo Regan
WP1 BournemouthWP1 BournemouthDamian Jenkinson
Gabrielle McHughEmma Wood
WP2 KeeleWP2 KeeleAnand Pandyan
Sybil Farmer
WP3 SouthamptonWP3 SouthamptonJane Burridge
Anne Marie HughesSara Domain
StatisticsStatisticsSalisburySalisbury
Paul Strike
Health EconomicsHealth EconomicsSouthamptonSouthamptonDavid TurnerJames Raftery
Project Team 2Project Team 2• Salisbury Salisbury
– Duncan Wood, Paul Taylor, Geraldine Mann, (Stef Scott R&D Duncan Wood, Paul Taylor, Geraldine Mann, (Stef Scott R&D advice)advice)
• GloucesterGloucester – Frank HarsentFrank Harsent
• NottinghamNottingham– Hywel Williams, Diane WhithamHywel Williams, Diane Whitham
• OswestryOswestry– Neil PostansNeil Postans
• SouthamptonSouthampton– Caroline Ellis-Hill, Paul Chappell, Lucy YardleyCaroline Ellis-Hill, Paul Chappell, Lucy Yardley
• NewcastleNewcastle– Garth Johnson, Paul CharltonGarth Johnson, Paul Charlton
• Stoke Stoke – Tony Ward, Alexandra BallTony Ward, Alexandra Ball
• Birmingham (WP4)Birmingham (WP4)– Christine Singleton Christine Singleton
Overview Overview
• How each package contributes to the end result… How each package contributes to the end result… • Key Question 1Key Question 1
– How do we decide which ATs to How do we decide which ATs to incorporate in the clinical trialincorporate in the clinical trial ??
• Key Question 2Key Question 2
– How soon can we submit the Interim How soon can we submit the Interim report?report?
• Key Question 3Key Question 3
– How quickly do we get an answer from How quickly do we get an answer from NIHR after submitting the interim NIHR after submitting the interim report?report?
NIHR PROGRAMME GRANT v3 09 10 11
Version 2 if trial not funded
Start date 1/3/09 (Q1) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Task
WP1 - Review of existing services
Identification of centres
Qualitative design phase workshop
Drafting of questionnaire
Piloting of questionnaire
Analysis of pilot results
Modification of questionnaire
Main questionnaire and follow up
Analysis of results
Producing review for publication
Updating existing services review
Reports 20/11/
09 20/11/
1001/03/
11 20/11/
10
WP2 - Literature review09Q1 Q2 Q3 Q4
10Q1 Q2 Q3 Q4
11Q1 Q2 Q3 Q4
Planning the review
Conducting the searches
Selection of articles
Review process
Peer review by management team
Audit of article selection
Audit of reviewed articles
Updating of reviews
Publication of systematic reviews
Reports 20/11/2009
20/11/2010
01/03/2011
20/11/2010
WP3 - Acceptability of ATs09Q1 Q2 Q3 Q4
10Q1 Q2 Q3 Q4
11Q1 Q2 Q3 Q4
Ethical application and approval
Design, running and evaluating the interactive exhibition
Focus groups
Focus group analysis
Questionnaire design
Questionnaire validation
Questionnaire data collection
Questionnaire analysis
Field trials design
Dissemination
Reports 20/11/2009
20/11/2010
01/03/2011
20/11/2010
WP4 - Clinical Trials09Q1 Q2 Q3 Q4
10Q1 Q2 Q3 Q4
11Q1 Q2 Q3
Q4/Q1 2012
WP4 Phase 1
AT selection procedure and consultation
Decision on what ATs to include in Phase 2
Trial design
WP4 Phase 2
JDs and advert for therapists
WP6 - Dissemination
Annual/Financial Report 01/03/2010
01/09/2010
01/03/2011
01/03/2012
Trial design report (major report) 15/03/2
011
Presenting at key meetings
Writing final report
Publishing book/special edition
International conference
Definition of ATsDefinition of ATsAn AT is a mechanical or electrical device An AT is a mechanical or electrical device
used in a functional task orientated used in a functional task orientated training process which will have a training process which will have a
systemic or rehabilitative effect on the systemic or rehabilitative effect on the person. This specifically excludes devices person. This specifically excludes devices used to improve a single function such as a used to improve a single function such as a
modified spoon, dressing aid etc.modified spoon, dressing aid etc.It is possible that the evidence will be It is possible that the evidence will be stronger for an AT which his used in stronger for an AT which his used in
conjunction with another treatment such conjunction with another treatment such as a drug treatment eg Botulinum or as a drug treatment eg Botulinum or physiotherapy. If so that combined physiotherapy. If so that combined
package will be considered as ‘The AT’ to package will be considered as ‘The AT’ to go forward as one arm of the clinical trial. go forward as one arm of the clinical trial.
We will not consider treatments that do We will not consider treatments that do not include a device. not include a device.
What can be usedWhat can be used
• Rehabilitation RobotsRehabilitation Robots• Functional Electrical StimulationFunctional Electrical Stimulation• EMG BiofeedbackEMG Biofeedback• Active OrthoticsActive Orthotics• Constraint Induced Movement Constraint Induced Movement
TherapyTherapy• Combinations of the above Combinations of the above
– Including use of current treatments Including use of current treatments • Physio, passive splinting, botulinum toxinPhysio, passive splinting, botulinum toxin
Key Deadlines Key Deadlines
• 3 months delay by DOH 3 months delay by DOH – Start date 1/3/09Start date 1/3/09
• 12 months: Financial Reporting 12 months: Financial Reporting – 1/3/101/3/10
• 18 months: Progress Report to NIHR18 months: Progress Report to NIHR– 1/9/101/9/10
• 24 months: Interim Project report24 months: Interim Project report– 1/3/111/3/11
• Determines whether clinical trial continues Determines whether clinical trial continues • Submitted to NIHR at the end of Year 2 Submitted to NIHR at the end of Year 2
ATRAS Web siteATRAS Web site
• https://portal.nihr.ac.uk/sites/nihr-ccf/ATRAS/Pages/Description.aspx
Steering CommitteeSteering Committee
• Rhodda Alison – Devon PCTRhodda Alison – Devon PCT• Prof Anne Ashburn – Southampton UniversityProf Anne Ashburn – Southampton University• Stephen Little/Debbie Wilson – Different Stephen Little/Debbie Wilson – Different
StrokesStrokes• Dr. John Chae – Cleveland OhioDr. John Chae – Cleveland Ohio• Prof Herme Hermans – Het Roessingh NEProf Herme Hermans – Het Roessingh NE• Stephanie Armstrong - Stroke AssociationStephanie Armstrong - Stroke Association• Dr Chris Price – Newcastle NHSDr Chris Price – Newcastle NHS• Dr. Paulette van Vliet – Nottingham Dr. Paulette van Vliet – Nottingham
University University
Suggestions/Comments Suggestions/Comments from the Steering from the Steering
CommitteeCommittee• Contact Val Pomeroy to utilise her work on Contact Val Pomeroy to utilise her work on
current treatmentscurrent treatments• ICF Guidelines should be used for classifying ICF Guidelines should be used for classifying
evidence in WP2evidence in WP2• Revise project plan to allow sufficient time for Revise project plan to allow sufficient time for
producing the Trial Design Report (1/3/11)producing the Trial Design Report (1/3/11)• Employ Prof Maarten Ijzerman as a consultant Employ Prof Maarten Ijzerman as a consultant
to help with decision making for WP4to help with decision making for WP4• Is 2 years going to be long enough for the Is 2 years going to be long enough for the
clinical trial?clinical trial?
To do in near futureTo do in near future
• WP3 interactive exhibition 7-9 WP3 interactive exhibition 7-9 October, Southampton University October, Southampton University
• Stroke Forum – workshop and posterStroke Forum – workshop and poster• Financial report 1/3/10Financial report 1/3/10• Project progress form 1/9/10Project progress form 1/9/10• DONM end of March 2010DONM end of March 2010
www.atrasprojewww.atrasproject.orgct.org