What Are the Minimal Detectable Changes in SDMT and Verbal Fluency Tests for Assessing Changes in Cognitive Performance in Persons with Multiple Sclerosis and Non-Multiple Sclerosis Controls?

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Abstract

Introduction: Cognitive impairment is frequent in persons with multiple sclerosis (PwMS) and can impact on activities of daily living. The capacity to differentiate real changes from background statistical noise induced by human, instrumentational, and environmental variations inherent to the evaluation would improve cognitive assessments. Objective: To assess the short-term reproducibility of cognitive tests in non-multiple sclerosis (non-MS) persons and PwMS. Methods: Sixty-two PwMS and 19 non-MS persons performed 2 measurements, 1 week apart, of the Symbol Digit Modalities Test (SDMT) and phonological and semantic verbal fluency. Test-retest reliability was evaluated by the intraclass correlation coefficients (ICC) and agreement by standard error of measurement (SEM) and minimum detectable change (MDC). Results: The reliability of the cognitive variables studied had moderate to high ICC values (ICC > 0.8) in both populations. The threshold to consider a significant cognitive modification evaluated by SEM and MDC was lower in PwMS compared with non-MS persons. Conclusions: SDMT and verbal fluency have good short-term reproducibility in PwMS. Specific SEM and MDC cutoffs based on the same design of evaluation (especially retest timing) and to the targeted pathological population (MS vs. healthy) should systematically be used to consider cognitive modification as significant in research protocol as well as in clinical practice.

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The test-retest reliability of centre of pressure measures in bipedal static task conditions--a systematic review of the literature.

Alexander Ruhe, Bruce Walker, René Fejer (2010)

The analysis of centre of pressure (COP) excursions is used as an index of postural stability in standing. Conflicting data have been reported over the past 20 years regarding the reliability of COP measures and no standard procedure for COP measure use in study design has been established. Six online databases (January 1980 to February 2009) were systematically searched followed by a manual search of retrieved papers. Thirty-two papers met the inclusion criteria. The majority of the papers (26/32, 81.3%) demonstrated acceptable reliability. While COP mean velocity (mVel) demonstrated variable but generally good reliability throughout the different studies (r=0.32-0.94), no single measurement of COP appeared significantly more reliable than the others. Regarding data acquisition duration, a minimum of 90 s is required to reach acceptable reliability for most COP parameters. This review further suggests that while eyes closed readings may show slightly higher reliability coefficients, both eyes open and closed setups allow acceptable readings under the described conditions (r ≥ 0.75). Also averaging the results of three to five repetitions on firm surface is necessary to obtain acceptable reliability. A sampling frequency of 100 Hz with a cut-off frequency of 10 Hz is also recommended. No final conclusion regarding the feet position could be reached. The studies reviewed show that bipedal static COP measures may be used as a reliable tool for investigating general postural stability and balance performance under specific conditions. Recommendations for maximizing the reliability of COP data are provided. Copyright © 2010 Elsevier B.V. All rights reserved.

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Cognitive dysfunction in multiple sclerosis. II. Impact on employment and social functioning.

G Leo, L Ellington, P. Rao … (1991)

We designed a study to assess the specific contribution of cognitive dysfunction to multiple sclerosis patients' problems in daily living. Based on the results of a comprehensive neuropsychological test battery, we classified 100 MS patients as either cognitively intact (N = 52) or cognitively impaired (N = 48). In addition to a neurologic examination, MS patients completed questionnaires on mood and social functioning, underwent a comprehensive in-home occupational therapy evaluation, and were rated by a close relative or friend regarding specific personality characteristics. While there were no significant differences between the two groups on measures of physical disability and illness duration, patients in the cognitively impaired group were less likely to be working, engaged in fewer social and avocational activities, reported more sexual dysfunction, experienced greater difficulty in performing routine household tasks, and exhibited more psychopathology than cognitively intact patients. These findings suggest that cognitive dysfunction is a major factor in determining the quality of life of patients with MS.

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Timed 25-foot walk: direct evidence that improving 20% or greater is clinically meaningful in MS.

Andrew Blight, Andrew Goodman, Norman Putzki … (2013)

In this study, we used data from clinical trials of dalfampridine (fampridine outside the United States) to re-examine the clinical meaningfulness of Timed 25-Foot Walk (T25FW) changes. Pooled data were analyzed from 2 phase III randomized placebo-controlled clinical trials of dalfampridine in multiple sclerosis (MS) (n = 533). Walking speed (T25FW) and patient-reported walking ability (MS Walking Scale-12 [MSWS-12]) were measured, concurrently, multiple times before and during treatment. We examined T25FW speed variability within and between visits, correlations of T25FW speed with MSWS-12 score, and changes in MSWS-12 (mean scores, effect sizes) associated with percent T25FW changes. T25FW speed variability was small (within- and between-visit averages = 7.2%-8.7% and 14.4%-16.3%). Correlations between T25FW and MSWS-12 values were low (-0.20 to -0.30), but relatively stronger between their change values (-0.33 to -0.41). Speed improvements of >20%, and possibly 15%, were associated with clinically meaningful changes in self-reported walking ability using MSWS-12 change score and effect size criteria. This study builds on existing research and provides direct evidence that improvements in T25FW speed of ≥ 20% are meaningful to people with MS. The dalfampridine data enabled examinations previously not possible, including spontaneous and induced speed changes, speed change anchored to change in self-reported walking ability, and a profile of speed changes. Results support the T25FW as a clinically meaningful outcome measure for MS clinical trials.

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Author and article information

Journal

Journal ID (publisher-id): ENE

Journal ID (nlm-ta): Eur Neurol

Journal ID (doi): 10.1159/issn.0014-3022

Title: European Neurology

Publisher: S. Karger AG

ISSN (Print): 0014-3022

ISSN (Electronic): 1421-9913

Publication date Subscription-year: 2020

Publication date (Print): August 2020

Publication date (Electronic): 07 July 2020

Volume: 83

Issue: 3

Pages: 263-270

Affiliations

[_a] _aIntegrative and Clinical Neurosciences EA481, Bourgogne Franche-Comte University, Besançon, France

[_b] _bRegional Memory Centre, Department of Neurology, University Hospital of Besançon, Besançon, France

[_c] _cDepartment of Neurology, University Hospital of Besançon, Besançon, France

[_d] _dLaboratory of Clinical Functional Exploration of Movement, University Hospital of Besançon, Besançon, France

Author notes

*Yoshimasa Sagawa, Integrative and Clinical Neurosciences EA481, Bourgogne Franche-Comte University, FR–25000 Besançon (France), sagawajunior@gmail.com

Article

Publisher ID: 508607 Other ID: Eur Neurol 2020;83:263–270

DOI: 10.1159/000508607

PubMed ID: 32634812

SO-VID: 68c583d7-ac85-4fb6-8768-50ee4387755c

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Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

History

Date received : 17 December 2019

Date accepted : 08 May 2020

Page count

Figures: 1, Tables: 4, Pages: 8

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What Are the Minimal Detectable Changes in SDMT and Verbal Fluency Tests for Assessing Changes in Cognitive Performance in Persons with Multiple Sclerosis and Non-Multiple Sclerosis Controls?

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Karger: Neurology and Neuroscience

Most cited references 35

The test-retest reliability of centre of pressure measures in bipedal static task conditions--a systematic review of the literature.

Cognitive dysfunction in multiple sclerosis. II. Impact on employment and social functioning.

Timed 25-foot walk: direct evidence that improving 20% or greater is clinically meaningful in MS.

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