1. mRS & NIHSS Training and Certification Procedure

2. Training in Assessment Tools
Why?
wide variation in perception of deficits and in application of scales
mRS – functional/disability (outcome)
inconsistency confounds outcome assessment
NIHSS - neurological (severity)
consistent approach gives better measure of severity for comparative purposes & interpretation of outcomes such as SAE
consistent approach will better identify deterioration

3. Inter-rater variability for mRS
In multi-center setting: overall agreement between pairs of raters: 43%
Adequate … but room for improvement
Wilson et al., 2005, Stroke; 36;777-81

4. Impact of misclassification
reduced effect from 7.5% to 6%
20% misclassification:
reduced effect from 7.5% to 4%
Certification as means to reduce variability
Quinn et al., 2007, Stroke; 38:
Choi et al., 2002, J Neurotrauma; 2002;19:17–22

5. Modified Rankin Scale (mRS)
0 No symptoms at all
1 No significant disability despite symptoms; able to carry out all usual duties and activities
2 Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance
3 Moderate disability; requiring some help, but able to walk without assistance
4 Moderately severe disability; unable to walk without assistance, and unable to attend to own bodily needs without assistance
Severe disability: bedridden, incontinent, and requiring constant nursing care and attention
Dead

6. mRS - Rating conventions
When in doubt, stick to the key discriminators of the scale, thus if:
remaining symptoms  1, not 0
inability to do all previous activities  2, not 1
dependence on others in ADL  3, not 2
inability to walk without assistance  4, not 3
bedridden, requiring constant nursing care 5, not 4
If still in doubt between two alternatives, choose the worse grade

7. NIHSS Level of Consciousness Eye movements Vision Facial movements
Motor power in limbs (strength)
Coordination of movement
Sensation
Language (understanding, speech, naming)
Articulation (clarity of speech versus slurring)
Inattention (diminution of usual awareness)

8. NIHSS: Level of consciousness (1)

9. NIHSS: Facial Palsy / Motor Arm

10. NIHSS: Motor Leg / Limb Ataxia
Ataxia (from Greek α- [used as a negative prefix] + -τάξις [order], meaning "lack of order") is a neurological sign and symptom consisting of gross lack of coordination of muscle movements.

11. NIHSS - Rating conventions
Score actual response, not what you think patient can do
Language may still be testable in anarthria, by Q&A
When assessing limb power, remember that some initial movement after releasing the limb is normal: record drift only if it persists
Ataxia is assessable only if reasonable power is present, otherwise score normal: 0
Ataxia scores 1 if one limb is affected and 2 if two or more limbs are affected: do not add sub-items to the total
An unassessable item (e.g.dysarthria due to intubation),scores a 9, but do not include this in the total

12. NIHSS/mRS lessons learned
When item 1a scored 3 further items like 5 and 6 scoring motor function will always be 4
UNK =9 can only be scored in case e.g. a limb is amputated
Exactly following mRS scoring definitions is crucial: difference between 2 and 3
mRS score of 3 or 4 should not be based on being sick and therefore in bed. There should always be a motor deficit or ataxia

13. NIHSS – Version in DIAS 4 NIHSS booklets
English or local language version: to be decided before site initiation
Word lists in local language
Use the booklets for examining the patients and rate the NIHSS
Booklets considered source data
Signed and dated
Transcribe the scores into the NIHSS scoring sheet on the eCRF

14. mRS & NIHSS - Online Training and Certification
A single website for both scales!

15. mRS & NIHSS - Online Training and Certification
Invitation to register on TrainingCampus sent by to each rater
Certification for each scale completed or updated prior to enrolling the first patient
Certification for each scale to be updated annually
Printed copy of certificates filed in the site Trial Master File

16. mRS – Certification scoring system
Certification based on several thousand raters
Correct answer
consistent with scoring instructions; and
> 50% of raters
Acceptable answer
> 10% of raters (+ consistent with instructions)
Unacceptable answer
< 10% of raters
Certificate awarded if all ‘correct’ or ‘acceptable’

17. NIHSS - Online Certification
Composed of 6 sections
1 single patient interview per section
All 6 patient interviews must be scored
At least 84 of 90 items must be scored correctly (you can try as often as needed to successfully pass!)
One-year validity form the first certification and two-year validity ever after

18. Protocol Section
The NIHSS will be provided in the form of user-friendly booklets. Sites will be requested to use these booklets as primary source-data. After rating a subject, the scores must be transferred into the eCRF scoring sheet.

19. ”FAQ”
What if I have a valid certificate? No need to certify
When do I need to certify? – This will be indicated on the invitation (taking into account expected FPFV)
Can you accept my local society’s certificate for NIHSS? Yes, if accepted ASA

20. Questions ?