scholarly journals Validation of the NARCOMS Registry

2011 ◽  
Vol 13 (3) ◽  
pp. 114-120 ◽  
Author(s):  
Ruth Ann Marrie ◽  
Myla Goldman
Keyword(s):  
Multiple Sclerosis ◽  
Construct Validity ◽  
Short Form ◽  
Hand Function ◽  
Functional System ◽  
Research Committee ◽  
The North ◽  
Patient Reported ◽  
And Performance ◽  
Patient Reported Measures

Tremor secondary to multiple sclerosis (MS) can be severely disabling but remains understudied. The development of brief, acceptable patient-reported measures of tremor could facilitate further study. We aimed to assess the criterion and construct validity of the Tremor and Coordination Scale (TACS) used by the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry. Forty-four patients with MS completed the TACS and Performance Scales and underwent a neurologic examination (Expanded Disability Status Scale; EDSS) and evaluation with the Multiple Sclerosis Functional Composite (MSFC). We assessed criterion and construct validity with Spearman rank correlations between the TACS and the following measures: EDSS, Nine-Hole Peg Test (NHPT) of the MSFC, age, body-mass index (BMI), the hand function and mobility domains of the Performance Scales, and the Physical and Mental Composite Scores of the 36-item Short Form Health Status Survey (SF-36). The median (interquartile range; IQR) score on the TACS was 1 (0.5–2.0). The TACS correlated moderately with the cerebellar Functional System Score (FSS) (r = 0.51; 95% confidence interval [CI], 0.24–0.70) and with the NHPT (r = −0.51; 95% CI, −0.70 to −0.29). The TACS correlated with the hand (r = 0.60; 95% CI, 0.36–0.76) and mobility (r = 0.56; 95% CI, 0.31–0.73) domains of the Performance Scales. The TACS did not correlate significantly with age (r = −0.11; 95% CI, −0.40 to 0.19) or BMI (r = 0.15; 95% CI, −0.15 to 0.43). These findings support the criterion and construct validity of the TACS. Further evaluation is needed to establish the test-retest reliability of the scale and its responsiveness to change.

scholarly journals Treatment Discontinuation and Disease Progression with Injectable Disease-Modifying Therapies

2013 ◽  
Vol 15 (4) ◽  
pp. 194-201 ◽  
Author(s):  
Robert J. Fox ◽  
Amber R. Salter ◽  
Tuula Tyry ◽  
Jennifer Sun ◽  
Xiaojun You ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Progression ◽  
Clinical Decision Making ◽  
Medication Compliance ◽  
Clinical Decision ◽  
Research Committee ◽  
The North ◽  
Disease Modifying Therapies ◽  
Patient Reported ◽  
Disease Modifying

Injectable first-line disease-modifying therapies (DMTs) for multiple sclerosis (MS) are generally prescribed for continuous use. Accordingly, the various factors that influence patient persistence with treatment and that can lead some patients to switch medications or discontinue treatment may affect clinical outcomes. Using data from the North American Research Committee on Multiple Sclerosis (NARCOMS) database, this study evaluated participants' reasons for discontinuation of injectable DMTs as well as the relationship between staying on therapy and sustained patient-reported disease progression and annualized relapse rates. Participants selected their reason(s) for discontinuation from among 16 possible options covering the categories of efficacy, safety, tolerability, and burden, with multiple responses permitted. Both unadjusted data and data adjusted for baseline age, disease duration, disability, and sex were evaluated. Discontinuation profiles varied among DMTs. Participants on intramuscular interferon beta-1a (IM IFNβ-1a) and glatiramer acetate (GA) reported the fewest discontinuations based on safety concerns, although GA was associated with reports of higher burden and lower efficacy than other therapies. Difficulties with tolerability were more often reported as a reason for discontinuing subcutaneous (SC) IFNβ-1a than as a reason for discontinuing IM IFNβ-1a, GA, or SC IFNβ-1b. In the persistent therapy cohort, less patient-reported disability progression was reported with IM IFNβ-1a treatment than with SC IFNβ-1a, IFNβ-1b, or GA. These findings have relevance to clinical decision making and medication compliance in MS patient care.

scholarly journals Symptomatic Management of Multiple Sclerosis–Associated Tremor Among Participants in the NARCOMS Registry

2016 ◽  
Vol 18 (3) ◽  
pp. 147-153 ◽  
Author(s):  
William Meador ◽  
Amber R. Salter ◽  
John R. Rinker
Keyword(s):  
Multiple Sclerosis ◽  
Medication Use ◽  
Symptomatic Treatment ◽  
Response To Treatment ◽  
Research Committee ◽  
The North ◽  
Drug Classes ◽  
Symptomatic Medication ◽  
Severity Scores ◽  
Patient Reported

Background: Tremor affects 25% to 58% of patients with multiple sclerosis (MS) and is associated with poor prognosis and increased disability. MS-related tremor is difficult to treat, and data regarding patient-reported characterization and response to treatment are limited. We describe the symptomatic treatment of tremor in 508 enrollees in the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry who self-reported tremor. Methods: From 777 surveys sent to NARCOMS participants who indicated mild or greater tremor using the Tremor and Coordination Scale, we compiled data regarding disability, tremor severity, symptomatic medication use, and reported response to medications. Results: Symptomatic medications reported to reduce tremor were used by 238 respondents (46.9%). Symptomatic medication use was associated with increased rates of unemployment and disability, and many other characteristics were similar between groups. Symptomatic drug use was more likely in participants reporting moderate (53.9%) or severe (51.3%) tremor than in those with mild (36.6%) or totally disabling (35.0%) tremor. This disparity held true across multiple tremor severity scores. The most commonly used drug classes were anticonvulsants (50.8%) and benzodiazepines (46.2%), with gabapentin and clonazepam used most often in their respective classes. Conclusions: Tremor in MS remains poorly treated; less than half of the participants reported benefit from symptomatic medications. Patients with moderate-to-severe tremor are more likely to report tremor benefit than are those with mild or disabling tremor. γ-Aminobutyric acid–active medications were most commonly reported as beneficial.

Validity of performance scales for disability assessment in multiple sclerosis

2007 ◽  
Vol 13 (9) ◽  
pp. 1176-1182 ◽  
Author(s):  
R.A. Marrie ◽  
M. Goldman
Keyword(s):  
Multiple Sclerosis ◽  
Construct Validity ◽  
Hand Function ◽  
Functional System ◽  
Criterion Validity ◽  
Self Report ◽  
Quality Of Life Inventory ◽  
Cognitive Subscale ◽  
Self Reported Health Status ◽  
The Individual

Researchers increasingly use self-reported health status assessments, but these require validation. Performance Scales (PS) is a self-report measure for multiple sclerosis (MS)-associated disability, assessing mobility, bowel/bladder, fatigue, sensory, vision, cognition, spasticity and hand function. The criterion validity of the total PS score was established using the Expanded Disability Status Scale (EDSS), but the construct and criterion validity of the individual subscales have not been established. We assessed the criterion and construct validity of the PS subscales. Forty-four patients with MS completed PS, and these criterion measurements: neurological examination (EDSS), the Multiple Sclerosis Functional Composite (MSFC), contrast acuity testing, and the Multiple Sclerosis Quality of Life Inventory. We assessed criterion and construct validity with Spearman rank correlations between PS subscales and the other measurements. PS correlated with the MSFC ( r = -0.58, P < 0.0001). The mobility, hand, vision, fatigue and bladder subscales correlated with their criterion measures ( r = 0.59—0.77, P < 0.0001). The sensory subscale correlated weakly with the sensory functional system score ( r = 0.39, P = 0.01 ), and the cognitive subscale did not correlate with the PASAT ( r = -0.17, P = 0.26). This study supports the criterion and construct validity of PS overall, and its mobility, hand, vision, fatigue, and bladder subscales. Further assessment of the cognitive, sensory and spasticity subscales is needed. Multiple Sclerosis 2007; 13: 1176—1182. http://msj.sagepub.com

scholarly journals Development of the Arm Function in Multiple Sclerosis Questionnaire-Short Form (AMSQ-SF): A static 10-item version

2018 ◽  
Vol 24 (14) ◽  
pp. 1892-1901 ◽  
Author(s):  
Michiel AJ Luijten ◽  
Iris Eekhout ◽  
Marie D’Hooghe ◽  
Bernard MJ Uitdehaag ◽  
Lidwine B Mokkink
Keyword(s):  
Multiple Sclerosis ◽  
Short Form ◽  
Hand Function ◽  
Patient Reported Outcome ◽  
Full Length ◽  
Optimal Test ◽  
Computerized Adaptive Test ◽  
Graded Response ◽  
Patient Reported ◽  
Arm Function

Background: Assessing arm and hand function of multiple sclerosis (MS) patients is important as impaired functioning may impact daily activities and reduce quality of life. Objective: A short-form of the Arm Function in Multiple Sclerosis Questionnaire (AMSQ), a recently developed patient-reported outcome measure containing 31 items, is developed to allow non-adaptive application. Methods: Complete data from 690 patients with MS, recruited via outpatient clinics, a residential center or via a Dutch website aimed at MS patients, were included in the analyses. A graded response model was fit to these data to estimate item response theory (IRT) parameters, which were used to perform post hoc computerized adaptive test (CAT) simulations with a cutoff standard error of measurement (SEM) of 0.32. The optimal test length was determined by the correlation between the static short-form and full-length theta, the mean SEM, and the amount of patients reaching a satisfactory SEM in CAT simulations. Results and Conclusion: Based on five selection criteria (i.e. discrimination parameters, total information, times selected in CAT simulations, raw item means, and item content), 10 items were selected for inclusion in the short-form. The score on the final 10-item short-form correlated strongly with the full-length AMSQ and provided reliable ability estimations, indicating its usefulness instrument in research and clinical settings.

scholarly journals Natural History of Multiple Sclerosis Symptoms

2013 ◽  
Vol 15 (3) ◽  
pp. 146-156 ◽  
Author(s):  
Ilya Kister ◽  
Tamar E. Bacon ◽  
Eric Chamot ◽  
Amber R. Salter ◽  
Gary R. Cutter ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Duration ◽  
Hand Function ◽  
Unmet Need ◽  
Bladder Function ◽  
Research Committee ◽  
Domain Specific ◽  
The North ◽  
Symptomatic Management ◽  
Symptom Prevalence

The North American Research Committee on Multiple Sclerosis (NARCOMS) Registry is a database that contains information from over 35,000 patient volunteers on symptom severity in 11 domains commonly affected in multiple sclerosis (MS): mobility, hand function, vision, fatigue, cognition, bowel/bladder function, sensory, spasticity, pain, depression, and tremor/coordination. The Registry affords a unique opportunity to study the frequency and severity of domain-specific impairment in a contemporary, mostly treated MS cohort over the course of the disease. The objective of this work was to calculate symptom prevalence in each of the 11 domains for years 0 to 30 from symptom onset. The resulting “symptom prevalence tables” demonstrate that a majority of participants perceive at least some degree of impairment in most domains as early as the first year of disease. The severity of impairment increases with disease duration across all domains, but the patterns of disability accumulation differ. The symptom prevalence tables illustrate the magnitude of perceived impact of the disease and highlight the extent of unmet need in symptomatic management. The tables are easy to use and allow MS patients and their clinicians to compare an individual's own impairment in any of the 11 domains to that of NARCOMS participants with the same disease duration.

scholarly journals Disease-modifying therapy prescription patterns in people with multiple sclerosis by age

2021 ◽  
Vol 14 ◽  
pp. 175628642110064
Author(s):  
Yinan Zhang ◽  
Amber Salter ◽  
Shan Jin ◽  
William J. Culpepper ◽  
Gary R. Cutter ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Activity ◽  
Age Groups ◽  
The Elderly ◽  
Department Of Veterans Affairs ◽  
Real World Data ◽  
Research Committee ◽  
The North ◽  
Disease Modifying ◽  
Magnetic Resonance Imaging Mri

Background: Disease-modifying therapies (DMTs) for multiple sclerosis (MS) are approved for their ability to reduce disease activity, namely clinical relapses and signal changes on magnetic resonance imaging (MRI). Disease activity appears age dependent. Thus, the greatest benefit would be expected in younger people with MS (PwMS) whereas benefits in the elderly are uncertain. Methods: Real-world data were obtained from PwMS from the North American Research Committee on Multiple Sclerosis (NARCOMS) registry and the US Department of Veterans Affairs Multiple Sclerosis Surveillance Registry (MSSR). Results: 6948 PwMS were surveyed from NARCOMS, and the MSSR had 1719 participants. In younger adult PwMS 40-years old or less, 183 (61.4%) in NARCOMS and 179 (70.5%) in the MSSR were prescribed DMTs. Among PwMS over age 60, 1575 (40.1%) in NARCOMS and 239 (36.3%) in the MSSR were prescribed DMTs. More PwMS in the age group of 31–40 ( p = 0.035) and 41–50 ( p = 0.001) in the MSSR were using DMTs compared with PwMS of the same age groups in NARCOMS. Conclusion: These findings suggest that DMTs are under-utilized in the younger population and continue to be commonly prescribed in the elderly. Broader access may explain the higher prescription rate of DMTs in US veterans.

Assessment of computer adaptive testing version of the Neuro-QOL for people with multiple sclerosis

2018 ◽  
Vol 25 (13) ◽  
pp. 1791-1799 ◽  
Author(s):  
Brian C Healy ◽  
Jonathan Zurawski ◽  
Cindy T Gonzalez ◽  
Tanuja Chitnis ◽  
Howard L Weiner ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measures ◽  
Computerized Adaptive Testing ◽  
Short Form ◽  
Patient Reported Outcome Measures ◽  
Adaptive Testing ◽  
Patient Reported Outcome ◽  
Longitudinal Change ◽  
Sf 36 ◽  
Patient Reported

Background: To date, the computerized adaptive testing (CAT) version of the Neuro-quality of life (QOL) has not been assessed in a large sample of people with multiple sclerosis (MS). Objective: The aim of this study was to assess the associations between the CAT version of Neuro-QOL and other clinical and patient-reported outcome measures. Methods: Subjects ( n = 364) enrolled in SysteMS completed the CAT version of the Neuro-QOL and the 36-Item Short Form Survey (SF-36) within 4 weeks of a clinical exam that included the Multiple Sclerosis Functional Composite-4 (MSFC-4). The correlations between the Neuro-QOL domains and the MSFC-4 subscores and the SF-36 scores were calculated. The changes over time in the Neuro-QOL and other measures were also examined. Results: The lower extremity functioning score of the Neuro-QOL showed the highest correlations with MSFC-4 components including Timed 25-Foot Walk, 9-Hole Peg Test, and cognitive score. The expected domains of the Neuro-QOL showed high correlations with the SF-36 subscores, and some Neuro-QOL domains were associated with many SF-36 subscores. There was limited longitudinal change on the Neuro-QOL domains over 12 months, and the change was not associated with change on other measures. Conclusion: The CAT version of the Neuro-QOL shows many of the expected associations with clinical and patient-reported outcome measures.

Validation of the NARCOMS Registry: pain assessment

2005 ◽  
Vol 11 (3) ◽  
pp. 338-342 ◽  
Author(s):  
Ruth Ann Marrie ◽  
Gary Cutter ◽  
Tuula Tyry ◽  
Olympia Hadjimichael ◽  
Timothy Vollmer
Keyword(s):  
Multiple Sclerosis ◽  
Convergent Validity ◽  
Disease Duration ◽  
Self Report ◽  
Research Committee ◽  
Retest Reliability ◽  
The North ◽  
Disability Status ◽  
Pain Question ◽  
Test Retest Reliability

The North American Research Committee on Multiple Sclerosis (NARCOMS) Registry is a multiple sclerosis (MS) self-report registry with more than 24 000 participants. Participants report disability status upon enrolment, and semi-annually using Performance Scales (PS), Patient Determined Disease Steps (PDDS) and a pain question. In November 2000 and 2001, we also collected the Pain Effects Scale (PES). Our aim was to validate the NARCOMS pain question using the PES as our criterion measure. We measured correlations between the pain question and age, disease duration, various PS subscales and PDDS to assess construct validity. We correlated pain question responses in participants who reported no change in PDSS or the PS subscales between questionnaires to determine test—retest reliability. We measured responsiveness in participants who reported a substantial change in the sensory, spasticity PS subscales. The correlation between the pain question and PES was r=0.61 in November 2000, and r=0.64 in November 2001 (both P<0.0001). Correlations between the pain question and age, and disease duration were low, indicating divergent validity. Correlations between the pain question and spasticity, sensory PS subscales and PDSS were moderate, indicating convergent validity. Test—retest reliability was r=0.84 (P<0.0001). Responsiveness was 70.7%. The pain question is a valid self-report measure of pain in MS.

PATIENT-REPORTED OUTCOMES AND DISABILITY IN MULTIPLE SCLEROSIS

2015 ◽  
Vol 86 (11) ◽  
pp. e4.32-e4
Author(s):  
Neil Scolding ◽  
Hongwei Wang ◽  
Yan Liu ◽  
Lawrence Steinman
Keyword(s):  
Multiple Sclerosis ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Minimum Important Difference ◽  
Point Change ◽  
Clinical Difference ◽  
Sf 36 ◽  
Patient Reported ◽  
Edss Score ◽  
Multiple Sclerosis Patients

In the 2-year, phase 3 CARE-MS II study (NCT00548405), alemtuzumab demonstrated superior clinical and patient-reported outcomes (PROs) over subcutaneous interferon beta-1a in relapsing-remitting multiple sclerosis patients who had inadequate efficacy response to prior therapy. To further evaluate the relationship between PROs and disability, Short-Form 36-Item (SF-36) survey physical component summary (PCS) and mental component summary (MCS), and Functional Assessment of Multiple Sclerosis (FAMS) scores were analysed against Expanded Disability Status Scale (EDSS) outcomes, adjusted for baseline characteristics and randomisation arm. A 1.0-point difference in baseline EDSS score was associated with 2.0-point PCS, 0.8-point MCS, and 4.0-point FAMS worsening over 12 months (all P<0.001). A 1.0-point annualised EDSS score worsening corresponded to a 2.2-point PCS, 1.6-point MCS, and 6.0-point FAMS worsening (all P<0.001). For baseline EDSS score <4.0, 1.0-point annualised worsening was associated with 7.2-point FAMS and 2.0-point MCS worsening (both P<0.001). For baseline EDSS score ≥4.0, 1.0-point worsening corresponded to worsening on FAMS (2.4 points; P=0.04), but not MCS (P=0.82). Given that a half-point EDSS change is considered the minimum reliably measurable clinical difference, a 1.0-point change in SF-36 PCS and MCS or 3.0-point change in FAMS may represent a minimum important difference in PRO for multiple sclerosis patients.

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