Clinical impact of 20% worsening on Timed 25-foot Walk and 9-hole Peg Test in                 multiple sclerosis

Kragt, J.J.; Linden, F.A.H. van der; Nielsen, Jessica; Uitdehaag, Bernard M. J.; Polman, Chris H.

doi:10.1177/1352458506070768

Cited by 154 publications

(134 citation statements)

References 16 publications

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“…It has been suggested that a 20% change in the 25FTW and 9HPT represents a reliably true change in function, whereas lower levels of change might represent clinically insignificant day-to-day fluctuations. 37 In addition, it has been suggested that an increase of more than 20% in the 25FTW or 9HPT also indicates a clinically significant impact on disability, as perceived by patients with MS. [38][39][40] However, the clinically relevant change in the overall MSFC score has not yet been determined. 41 This limits the usefulness of the MSFC as an outcome measure.…”

Section: Clinical Relevance Of the Multiple Sclerosis Functional Compmentioning

confidence: 99%

“…17 Finally, the clinical interpretation of changes in MSFC z-scores is unclear. Although clinically meaningful scores have been recommended for the components of the MSFC, [37][38][39][40] clinically meaningful scores for overall MSFC scores have not been established. 41 Thus, the MSFC has not been used as a primary outcome measure in clinical trials and is not useful in clinical practice.…”

Section: Multiple Sclerosis Functional Composite Versus Expanded Disamentioning

confidence: 99%

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Measuring Disability Progression with the Multiple Sclerosis Functional Composite

Krysko¹,

O’Connor²

2010

US Neurology

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The multiple sclerosis functional composite (MSFC) is a three-part quantitative objective measure of neurologic function, measuring leg (timed 25-foot walk [25FTW]), arm (nine-hole peg test [9HPT]), and cognitive (three-second paced auditory serial addition test [PASAT3]) function. The MSFC was developed to be a more sensitive measure of disability than the expanded disability status scale (EDSS) and has excellent reliability. Validity is supported by moderately strong correlations with EDSS, brain atrophy, and quality of life. Advantages of the MSFC include its continuous scale and inclusion of several disease dimensions. Limitations include practice effects, the lack of a visual function component, variations in reference populations, and limited understanding of clinically relevant MSFCz-score changes. MSFCz-score change has been used as a secondary end-point in MS trials, but EDSS progression remains the primary disability outcome. A new approach to MSFC data involves defining MSFC progression as worsening in an MSFC component by 15–20% over three months. With further study, this could be used as a primary disability outcome in future clinical trials.

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Section: Clinical Relevance Of the Multiple Sclerosis Functional Compmentioning

confidence: 99%

Section: Multiple Sclerosis Functional Composite Versus Expanded Disamentioning

confidence: 99%

Measuring Disability Progression with the Multiple Sclerosis Functional Composite

Krysko¹,

O’Connor²

2010

US Neurology

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“…Research suggests defining a meaningful cut point may improve the responsiveness and predictive value of the MSFC [Kragt et al 2008]. This has been an ongoing area of research and there have been several explorations of MSFC scoring to define a meaningful change [Rudick et al 2009b;Kragt et al 2006b;Schwid et al 2002].…”

Section: Ms Functional Compositementioning

confidence: 99%

Possible clinical outcome measures for clinical trials in patients with multiple sclerosis

Goldman

Motl

Rudick

2010

Ther Adv Neurol Disord

118

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Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease with both clinical and pathological heterogeneity. The complexity of the MS population has offered challenges to the measurement of MS disease progression in therapeutic trials. The current standard clinical outcome measures are relapse rate, Expanded Disability Severity Scale (EDSS), and the MS Functional Composite (MSFC). These measures each have strengths and some weakness. Two additional measures, the six-minute walk and accelerometry, show promise in augmenting current measures. MS therapeutics is a quickly advancing field which requires sensitive clinical outcome measures that can detect small changes in disability that reliably reflect long-term changes in sustained disease progression in a complex population. A single clinical outcome measure of sustained disease progression may remain elusive. Rather, an integration of current and new outcome measures may be most appropriate and utilization of different measures depending on the MS population and stage of the disease may be preferred.

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“…17 Several investigator groups have worked on the issue of what constitutes a clinically perceptible change in these measures. Some studies 18,19 examined changes in T25FW and 9HPT over time, along with changes in the Guy's Neurological Disability Scale (GNDS), 20 a rating scale evaluating 12 different domains. The comparisons for each test were made in a grouped manner; evaluating the mean GNDS change in patients categorized as: 20% or more improvement, less than 20% change in either direction, or 20% or more worsening.…”

Section: Lessons Learned From Studies Of Motor Function In Msmentioning

confidence: 99%

Evaluating cognitive outcome measures for MS clinical trials: what is a clinically meaningful change?

Benedict

Walton

2012

Mult Scler

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Brief cognitive assessments are increasingly emphasized in MS treatment studies and clinical care. While much is known about the reliability of several widely-used neuropsychological tests, interpretation of the changes in individual patients is inadequate. The FDA offers guidance on the issue, as related to patient-reported outcomes. Unfortunately, cognitive ability is only weakly correlated with the frequency and severity of self-reported cognitive problems. In this review, we critically examined the psychometrics of neuropsychological testing in MS, emphasizing statistical and anchor-based approaches to interpreting clinically meaningful change. We suggest that there are two paths forward that should be currently pursued. First, to employ co-primary outcomes, including a brief cognitive test and a clinician or observer’s impression on a scale of change, where successful treatment would require showing significant improvement in both measures. Secondly, to work toward showing that when reliable brief cognitive tests are employed, increments of statistically-relevant change would correlate with changes in clinically-relevant anchors (such as vocational disability or clinical relapses with cognitive impairment). The latter goal will allow a more parsimonious and scientifically efficient approach of utilizing only the brief cognitive test as a primary outcome. While some progress has been made in this direction, more research is needed. We are of the opinion that data from both the statistical and clinically meaningful approaches will be necessary to develop valid definitions of meaningful change on cognitive outcome measures, and that it would be best to pursue research using tests that already have well-established reliability and validity.

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Clinical impact of 20% worsening on Timed 25-foot Walk and 9-hole Peg Test in multiple sclerosis

Abstract: Worsening on T25FW or 9HPT has a clinical impact on disability, as perceived by MS patients during daily life functioning.

Cited by 154 publications

References 16 publications

Measuring Disability Progression with the Multiple Sclerosis Functional Composite

Measuring Disability Progression with the Multiple Sclerosis Functional Composite

Possible clinical outcome measures for clinical trials in patients with multiple sclerosis

Evaluating cognitive outcome measures for MS clinical trials: what is a clinically meaningful change?

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