Literature DB >> 33464149

A comparison of clinical outcomes in PPMS in the INFORMS original trial data set.

Marcus W Koch1, Jop P Mostert2, Bernard Uitdehaag3, Gary Cutter4.   

Abstract

BACKGROUND: The expanded disability status scale (EDSS) is the standard clinical outcome measure in primary progressive multiple sclerosis (PPMS), even though the timed 25-foot walk (T25FW), nine-hole peg test (NHPT) or combinations of these measures may be more useful. The paced auditory serial addition test (PASAT) is a widely used cognitive measure in MS, but little is known about change in PASAT scores over time in PPMS.
OBJECTIVE: The objective of this study is to compare clinical outcome measures in a large PPMS trial data set.
METHODS: We determined significant worsening events on the EDSS, T25FW and NHPT, and PASAT scores over the course of this 3-year trial. We compared unconfirmed, confirmed and sustained disability worsening and contrasted disability worsening with similarly defined improvement. We examined the association of baseline characteristics with the risk of disability worsening at 12, 24 and 36 months with logistic regression models.
RESULTS: The EDSS and T25FW showed most worsening events, while only few patients worsened on the NHPT. Adding the NHPT to a combined outcome added only few further worsening events. PASAT scores slightly increased over time, possibly due to a practice effect.
CONCLUSION: Both the EDSS and T25FW, but not NHPT or PASAT, appear to be useful outcome measures in PPMS.

Entities:  

Keywords:  Primary progressive multiple sclerosis; clinical trials methodology; outcome measures

Year:  2021        PMID: 33464149     DOI: 10.1177/1352458520987539

Source DB:  PubMed          Journal:  Mult Scler        ISSN: 1352-4585            Impact factor:   6.312


  2 in total

1.  Comparison of the EDSS, Timed 25-Foot Walk, and the 9-Hole Peg Test as Clinical Trial Outcomes in Relapsing-Remitting Multiple Sclerosis.

Authors:  Marcus W Koch; Jop P Mostert; Jerry S Wolinsky; Fred D Lublin; Bernard Uitdehaag; Gary R Cutter
Journal:  Neurology       Date:  2021-08-25       Impact factor: 11.800

2.  The timed 25-foot walk is a more sensitive outcome measure than the EDSS for PPMS trials: an analysis of the PROMISE clinical trial dataset.

Authors:  Marcus W Koch; Jop Mostert; Pavle Repovic; James D Bowen; Jacynthe Comtois; Eva Strijbis; Bernard Uitdehaag; Gary Cutter
Journal:  J Neurol       Date:  2022-05-16       Impact factor: 6.682

  2 in total

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