Download - WORK PACKAGE 2
WORK PACKAGE 2Sybil Farmer
Venugopal DurairajAnand Pandyan
September 2010
Where are the Gaps?
A framework for development and evaluation of RCTs for complex interventions to improve health MRC 2000
WP2 Activity
• Completion of van Tulder Scoring
• Meeting re Data Extraction
Data Extraction Form• Ref Works ID• Form number• Treatment Regime
– Duration = of course of tx—number FT and unit drop down
– Session duration– Session frequency
• Joint (listed)—yes /no
• Technology --select from drop down list
• TX Comparisons– AT/AT, – Routine TX/AT,– NoTx/AT, – Sham/AT, other
• Time from end of Tx to last assessment
• Time after Stroke– Under 1 month– 1-6 months ( inclusive of month 6)– Over 6 months – Other
• Odds ratio data • Effect size data • Study design
Effect Size'Effect size' is simply a way of quantifying the size of the difference between two groups.
Odds Ratio
Compares the proportion of those who benefitted from treatment with the proportion of those in the control group who improved
WP2 Activity
• Completion of van Tulder Scoring
• Meeting re Data Extraction– Webform designed– Level 4 & 3 papers allocated– Data Extracted
• Meeting re Extracted Data
Study DesignsLevel Type of Study Number of
Studies
3Quasi-controlled studies (independent sample design) 33
4
Randomised controlled study design (not powered or powered below 80% and 0.05 significance level)
78
110
Data from78 papers
Effect size 768 lines
Odds Ratio 40 lines
No data from 22 papers
Level 3 & 4 papers
Data Extraction
Data Lines
Selecting Papers
Van Tulder Questions
– Randomisation
– Similar Prognosis
– Assessor Blinded
Gold
Standard
High Quality Papers
52 papersLevel 3&4
38 papersData extracted 32 papers
No data 6 papers
Not Identified as RCTs14 papers
Data extracted 4 papers
Duplicates 3 papers
No data 1 paper
Rejected after checking 6 papers
Yes to Key Questions
Paper Classification
Data Extraction
Papers with Extractable Data
Bio feed-back
CIMT ES Robotics TMS VR0
2
4
6
8
10
12
14
AT Papers
Series1
Shoul
der
Elbo
wS&
E
Wris
t
Hand
Elbo
w, W
rist an
d Han
d
Wris
t & H
and
Arm
Arm&Han
d
0
1
2
3
4
5
6
7
8
Bio feedbackCIMTESRoboticsTMSVR
Joints Treated and ATs
Outcome Measures
• Fugl Myer• ARAT • WMFT• FIM• BPI• Ashworth• Bartel• 9 Hole Peg Test• MAL • Stroke Impact Score• Jebson Taylor Hand
Function
• Force• Distance• ROM
– Active– Passive
• Movement Time
• Repetition• Drawing• Tracking
Outcome Measure, Maximum Effect Size and
ATs
ARAT
Fugl-M
yer
Peak
For
ceMAL
WMFT FI
M
0
0.5
1
1.5
2
2.5
3
Bio feedbackCIMTESRobotics
Where are the Gaps?
A framework for development and evaluation of RCTs for complex interventions to improve health MRC 2000
Timing of Intervention
Bio feed-back
CIMT ES Robotics TMS0
1
2
3
4
5
Mean Time After Stroke
Under 1 Month1-6 MonthsOver 6 Months
Over 6 months ----- mean range 15 -98 months
WP2 Activity
• Completion of van Tulder Scoring
• Meeting re Data Extraction– Webform designed– Level 4 & 3 papers allocated– Data Extracted
• Meeting re Extracted Data
• Papers Cross-checked with Cochrane Reviews
Cochrane Reviews• Electromechanical and robot-assisted arm training for improving arm function
and activities of daily living after stroke
• Electrostimulation for promoting recovery of movement or functional ability after stroke
• Electrical stimulation for preventing and treating post-stroke shoulder pain
• Supportive devices for preventing and treating subluxation of the shoulder after stroke
• Constraint-induced movement therapy for upper extremities in stroke patients
• EMG biofeedback for the recovery of motor function after stroke
• Interventions for sensory impairment in the upper limb after stroke
• Orthotic devices after stroke and other non-progressive brain lesions -Withdrawn
Cochrane Reviews
Bio fe
edba
ckCIM
T ES
Robot
ics TMS VR
0
5
10
15
20
25
30
35
2
129 9
1
4 8
2
3
10
16
2
Cochrane Status
New RejectedIncluded
Papers
Cochrane Protocols• Virtual reality for stroke rehabilitation
• Botulinum toxin for adult spasticity after stroke or non-progressive brain lesion
• Home-based therapy programmes for upper limb functional recovery following stroke
• Hands-on therapy interventions for upper limb motor dysfunction following stroke
• Mental practice for treating upper extremity deficits in individuals with hemiparesis after stroke
• Mirror therapy for improving motor function after stroke• Interventions for maintaining soft tissue length in the stroke –
affected shoulder
WP2 Activity
• Completion of van Tulder Scoring
• Meeting re Data Extraction– Webform designed– Level 4 & 3 papers allocated– Data Extracted
• Meeting re Extracted Data
• Papers Cross-checked with Cochrane Reviews
• Contact with NIHR re development of website
Next Stage
• Write up– Systematic Review Method
• Refine and Test– Quality Assessment Method
• Update– All searches
• Contact Cochrane Stroke Team• Further data exploration and Analysis
More data explorationFOR DISCUSSION
• Improvement maintained at Follow-up?
• How long after 6 Months?
Further Questions?