Disability assessment: can we combine responsiveness and clinical - - PowerPoint PPT Presentation

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Disability assessment: can we combine responsiveness and clinical - - PowerPoint PPT Presentation

Disability assessment: can we combine responsiveness and clinical relevance? Prof. Bernard Uitdehaag, MD PhD neurologist / epidemiologist chair of the dept. of Neurology VU University Medical Center Amsterdam The Netherlands Disclosures


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Disability assessment: can we combine responsiveness and clinical relevance?

  • Prof. Bernard Uitdehaag, MD PhD

neurologist / epidemiologist chair of the dept. of Neurology VU University Medical Center Amsterdam The Netherlands

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SLIDE 2

Disclosures

consultation fees from Novartis, Merck Serono, Biogen Idec, and Danone Research.

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SLIDE 3

Bottom line

Functional assessments are promising tools for measuring disability in multiple sclerosis (MS) trials. * multidimensional * valid * reliable * responsive * meaningful to the patient

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SLIDE 4

MS is a multidimensional disease

  • Mobility
  • Manual dexterity
  • Vision
  • Cognition
  • Bladder problems
  • etc
  • Motor function
  • Sensory function
  • Coordination
  • Brain stem function
  • Visual function
  • Higher cortical

functions

  • etc
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SLIDE 5

EDSS

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SLIDE 6

EDSS

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SLIDE 7

EDSS

  • Dimensionality
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SLIDE 8

EDSS

  • Dimensionality
  • Reliability
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SLIDE 9

EDSS

  • Dimensionality
  • Reliability
  • Responsiveness
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SLIDE 10

EDSS

  • Dimensionality
  • Reliability
  • Responsiveness
  • Ordinal scale

≠ ≠

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SLIDE 11

Functional walking test

Kieseier and Pozzilli MSJ 2012

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SLIDE 12

Timed 25 foot walk test (TWT)

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TWT - reliability

Schwid et al. Neurology 2002

Repeated TWT assessment in stable patients n=63 (single center: n = 27, multicenter: n = 36) variability single center: 16% multicenter: 24%

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SLIDE 14

TWT - reliability

Kieseier and Pozzilli MSJ 2012

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TWT - validity

vs Guy’s Neurological Disability Scale (GNDS); n=527

Kragt et al. Mult. Scler. 2006

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SLIDE 16

TWT - validity

Kaufman et al. Mult. Scler. 2000

Perceived changes in walking during exacerbation; n=49

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TWT - validity

Coleman et al. Curr. Med. Res. Opin. 2012

vs Clinician Global Impression (CGI); n=296

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SLIDE 18

TWT - validity

Hobart et al. Neurology 2013

vs MS Walking Scale-12 (MSWS-12); n=533

1 = > 20% slower 2 = 10-20% slower 3 = -10 - + 10 change 4 = 10-15% faster 5 = 15-20% faster 6 = 20-15% faster

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SLIDE 19

Timed 25 foot walk test (TWT)

Predicting PRO’s in progressive MS; n=134

Bosma et al. MSJ 2012

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Timed 25 foot walk test (TWT)

Bosma et al. MSJ 2012

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SLIDE 21

Timed 25 foot walk test (TWT)

Bosma et al. MSJ 2012

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TWT

  • Reliable
  • Responsive
  • Clinically meaningful

– Concurrent validity – Predictive validity

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TWT

  • Seconds or speed
  • Group vs individuals
  • Worsening vs improvement
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TWT

  • Functional assessment tool for mobility
  • Part of a spectrum to cover

multidimensionality

  • Easy to perform, well accepted
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Bottom line

Functional assessments are promising tools for measuring disability in multiple sclerosis (MS) trials.