mRS & NIHSS Training and Certification Procedure

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

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

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; 38:2257-61 Choi et al., 2002, J Neurotrauma; 2002;19:17–22

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

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

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)

NIHSS: Level of consciousness (1)

NIHSS: Facial Palsy / Motor Arm

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.

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

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

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

mRS & NIHSS - Online Training and Certification A single website for both scales! http://desmo.trainingcampus.net

mRS & NIHSS - Online Training and Certification Invitation to register on TrainingCampus sent by email 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 http://desmo.trainingcampus.net

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’

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

Protocol Section 5.3.2.2. 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.

”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 email (taking into account expected FPFV) Can you accept my local society’s certificate for NIHSS? Yes, if accepted ASA

Questions ?