North American Research Committee On Multiple Sclerosis Registry Research Articles

Physical activity as a correlate of symptoms, quality of life, comorbidity, and disability status in Hispanics with multiple sclerosis

BackgroundHispanics with multiple sclerosis (MS) experience disproportionate rates of mobility disability compared to non-Hispanic Whites with MS. Physical activity (PA) is highlighted as a potential adjuvant therapy for improving MS symptoms and disease progression, however less than 30% of Hispanics with MS report sufficient levels of PA. ObjectivesThe current study aimed to examine the correlates of PA behavior among Hispanics with MS in the North American Research Committee on Multiple Sclerosis Registry (NARCOMS). MethodsIn Spring 2015, 136 NARCOMS participants identified as Hispanic and completed the International Physical Activity Questionnaire (IPAQ). IPAQ scores were converted to Health Contribution Scores (HCS) for estimating PA. The association between the HCS scores and MS symptoms (i.e., mobility, cognition, fatigue, spasticity, hand function, bowel/bladder, sensory, tremors, depression, and pain), quality of life (QOL), comorbid conditions, and disability status were evaluated using Pearson or Spearman correlation coefficients with follow-up multivariable regression analyses. ResultsThe mean age among participants was 58 years and 79% identified as female. The mean MS disease duration was 20 years and 68% reported relapsing disease course. The mean HCS score among participants was 15.6 ± 20.9. HCS was moderately associated with disability status (rs = −0.39), mobility (rs = −0.37), bowel/bladder function (rs = −0.33), and physical health related QOL (r = 0.32). There were small associations between HCS and hand function (rs = −0.29), fatigue (rs = −0.20), and tremor (rs = −0.25). Multivariable regression analyses indicated that disability status, mobility, bowel/bladder function, and physical health related QOL were all associated with HCS but did not independently contribute to the models when controlling for age, sex, and employment. ConclusionsThis study highlights correlates of PA behavior among Hispanics with MS. Researchers and clinicians may consider disability status, mobility, and physical health related QOL in future studies examining PA among Hispanics with MS.

Rates and patterns of physical activity among Hispanics with multiple sclerosis in the NARCOMS Registry

BackgroundMultiple sclerosis (MS) is the most common cause of non-traumatic neurological disability among adults with an estimated incidence of 2.9 cases per 100,000 Hispanic adults. Hispanics with MS experience disproportionate rates of mobility disability compared to non-Hispanic Whites with MS. The current study aimed to examine the rates and patterns of physical activity (PA) behavior among Hispanics with MS and compare physical activity behavior to non-Hispanic Whites with MS in the North American Research Committee on Multiple Sclerosis Registry (NARCOMS). MethodsNARCOMS registry participants who completed the physical activity questions in the Spring 2015 semi-annual survey were included in the analyses. Self-identified Hispanic and non-Hispanic Whites were compared. Rates and patterns of physical activity were based on the International Physical Activity Questionnaire. We performed a 2:1 propensity score matching for comparing non-Hispanic White and Hispanic participants. ResultsOf the 6,352 NARCOMS participants in Spring 2015, we included 136 Hispanic and 6,216 non-Hispanic White participants. Among the Hispanic sample, median number of days engaged in vigorous PA was 0 and moderate PA was 1 day. Mean number of minutes sitting per day was 531±266 (approximately 9 hours). Further, a minority of Hispanic participants classified themselves as moderate or heavy active for work (11%), home (24%), and leisure (33%) physical activity. There were no significant differences between participants who identified as Hispanic (n=119) and propensity-matched non-Hispanics White participants (n=238) in demographics, clinical characteristics, or physical activity variables. ConclusionRates of physical activity were low among Hispanics with MS. This highlights an opportunity for examining the impact of physical activity interventions for improving mobility disability.

NARCOMS and Other Registries in Multiple Sclerosis: Issues and Insights.

Observational studies and registries can play a critical role in elucidating the natural and treated history of multiple sclerosis (MS) and identifying factors associated with outcomes such as disability and health-related quality of life. The North American Research Committee on Multiple Sclerosis (NARCOMS) Registry is one of multiple registries worldwide that focuses on people with MS, but one of the very few patient-driven MS registries. On the 25th anniversary of the first data collection for the NARCOMS Registry, we discuss the importance of disease registries in the MS field, describe key concepts related to registry design and management, and highlight findings from MS registries relevant to clinical care or health policy.

A Survey of Cannabis Use in a Large US-Based Cohort of People with Multiple Sclerosis.

As cannabis products become increasingly accessible across the United States, it is important to understand the contemporary use of cannabis for managing multiple sclerosis (MS) symptoms. We invited participants with MS from the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry (aged 18 years or older) to complete a supplemental survey on cannabis use between March and April 2020. Participants reported cannabis use, treated symptoms, patterns, preferences, methods of use, and the factors limiting use. Findings are reported using descriptive statistics. Of the 6934 participants invited, 3249 responded. Of the respondents, 31% reported having ever used cannabis to treat MS symptoms, with 20% currently using cannabis. The remaining 69% had never used cannabis for MS symptoms, for reasons including not enough data about efficacy (40%) and safety (27%), and concerns about legality (25%) and cost (18%). The most common symptoms current users were attempting to treat were spasticity (80%), pain (69%), and sleep problems (61%). Ever users (vs never users) were more likely to be younger, be non-White, have lower education, reside in the Northeast and West, be unemployed, be younger at symptom onset, be currently smoking, and have higher levels of disability and MS-related symptoms (all P < .001). Despite concerns about insufficient safety and efficacy data, legality, and cost, almost one-third of NARCOMS Registry respondents report having tried nonprescription cannabis products in an attempt to alleviate their symptoms. Given the lack of efficacy and safety data on such products, future research in this area is warranted.

Characterizing Long-term Disability Progression and Employment in NARCOMS Registry Participants with Multiple Sclerosis Taking Dimethyl Fumarate.

Delayed-release dimethyl fumarate (DMF) is effective in relapsing-remitting multiple sclerosis (RRMS), but long-term effects of DMF on disability and disease progression in clinical settings are unknown. We evaluated disability and employment outcomes in persons with RRMS treated with DMF for up to 5 years. This longitudinal study included US North American Research Committee on Multiple Sclerosis (NARCOMS) Registry participants with RRMS reporting DMF initiation in fall 2013 through spring 2018 with 1 year or more of follow-up. Time to 6-month confirmed disability progression (≥1-point increase in Patient-Determined Disease Steps [PDDS] score) and change in employment status were evaluated using Kaplan-Meier analysis. Participants were censored at last follow-up or at DMF discontinuation, whichever came first. During the study, 725 US participants with RRMS had at least 1 year of DMF follow-up data, of whom most were female and White. At year 5, 69.9% (95% CI, 65.4%-73.9%) of these participants were free from 6-month confirmed disability progression, and 84.7% (95% CI, 78.6%-89.2%) were free from conversion to secondary progressive MS. Of 116 participants with data at baseline and year 5, most had stable or improved PDDS and Performance Scales scores over 5 years. Of 322 participants 62 years and younger and employed at the index survey, 66.0% (95% CI, 57.6%-73.1%) were free from a negative change in employment type over 5 years. Most US NARCOMS Registry participants treated up to 5 years with DMF remained free from 6-month confirmed disability progression and conversion to secondary progressive MS and had stable disability and employment status. These results support the long-term stability of disability and work-related outcomes with disease-modifying therapy.

A propensity-matched comparison of long-term disability worsening in patients with multiple sclerosis treated with dimethyl fumarate or fingolimod.

Background:Although the aggregate of data among patients with multiple sclerosis (MS) have shown similar efficacy between dimethyl fumarate (DMF) and fingolimod (FTY), most studies have not assessed long-term worsening of disability. We compared long-term disability worsening over 5 years, as assessed by the Patient-Determined Disease Steps (PDDS), among participants with MS treated with DMF or FTY.Methods:We identified individuals in the North American Research Committee on Multiple Sclerosis (NARCOMS) registry who had relapsing-remitting MS (RRMS), residing in the United States (Spring 2011 to Spring 2018), who initiated treatment with DMF (n = 689) or FTY (n = 565) and had ⩾1 year follow-up on index treatment. Participants receiving DMF who were previously treated with FTY and those on FTY previously treated with DMF were excluded. Propensity score matching at baseline was used to match FTY-treated to DMF-treated participants. Time to 6-month confirmed disability worsening (⩾1-point increase on PDDS, sustained for ⩾6 months) was estimated using Cox regression. A sensitivity analysis was conducted to account for differences in the duration of index exposure between DMF and FTY groups.Results:After propensity score matching, 468 DMF-treated participants were matched with 468 FTY-treated participants. Median treatment duration was 3.0 years for DMF and 4.0 years for FTY. At 5 years, 68.3% [95% confidence interval (CI): 62.4–73.5] of DMF-treated participants and 63.3% (95% CI: 59.6–70.1) treated with FTY were free from 6-month confirmed PDDS worsening [hazard ratio (HR) 1.01 (95% CI: 0.79–1.28); p = 0.95]. Results were similar in the sensitivity analysis: 70.5% (95% CI: 61.8–77.6) of DMF-treated participants and 72.7% (95% CI: 65.4–78.6) of FTY-treated participants were free from 6-month confirmed PDDS worsening [HR: 1.04 (95% CI: 0.71–1.51); p = 0.84].Conclusions:In participants with MS from the NARCOMS registry, there was no significant difference in confirmed disability (PDDS) worsening over 5 years between those treated with DMF versus FTY.

Shared Decision Making and Autonomy Among US Participants with Multiple Sclerosis in the NARCOMS Registry.

Treatment decisions in multiple sclerosis (MS) are affected by many factors and are made by the patient, doctor, or both. With new disease-modifying therapies (DMTs) emerging, the complexity surrounding treatment decisions is increasing, further emphasizing the importance of understanding decision-making preferences. North American Research Committee on Multiple Sclerosis (NARCOMS) Registry participants completed the Fall 2014 Update survey, which included the Control Preferences Scale (CPS). The CPS consists of five images showing different patient/doctor roles in treatment decision making. The images were collapsed to three categories: patient-centered, shared, and physician-centered decision-making preferences. Associations between decision-making preferences and demographic and clinical factors were evaluated using multivariable logistic regression. Of 7009 participants, 79.3% were women and 93.5% were white (mean [SD] age, 57.6 [10.3] years); 56.7% reported a history of relapses. Patient-centered decision making was most commonly preferred by participants (47.9%), followed by shared decision making (SDM; 42.8%). SDM preference was higher for women and those taking DMTs and increased with age and disease duration (all P < .05). Patient-centered decisions were most common for respondents not taking a DMT at the time of the survey and were preferred by those who had no DMT history compared with those who had previously taken a DMT (P < .0001). There was no difference in SDM preference by current MS disease course after adjusting for other disease-related factors. Responders reported most commonly considering their doctor's opinion before making a treatment decision and making decisions jointly with their doctor. DMT use, gender, and age were associated with decision-making preference.

A contemporary profile of primary progressive multiple sclerosis participants from the NARCOMS Registry

Background: Primary progressive multiple sclerosis (PPMS) represents 10%–15% of all multiple sclerosis (MS) diagnoses. Information regarding socio-demographic and clinical characteristics of persons with PPMS is limited. Objective: To characterize persons with PPMS in the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry. Methods: We compared demographic and health-related characteristics of NARCOMS Registry participants reporting PPMS in the spring 2015 update survey with those reporting relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS), with characteristics of published PPMS cohorts. Results: Of 8004 responders, 6774 self-reported a clinical course of PPMS, SPMS, or RRMS. The PPMS cohort (n = 632, 9.3%) reported a mean (standard deviation (SD)) age of 64.3 (8.9) years; 62.7% were female; the SPMS and RRMS cohorts were younger and had a higher proportion of females. The NARCOMS PPMS cohort differed in age, time from onset and diagnosis, and proportion of females compared to population-based and clinical trial cohorts. Median (25%, 75%) number of comorbidities was 2 (1, 2) for each cohort with vascular comorbidities being most frequently reported. Conclusion: The NARCOMS population provides a different perspective on persons with PPMS than clinical trials. A better understanding of the characteristics of persons with PPMS may help address unmet needs in this population.

Symptomatic Management of Multiple Sclerosis-Associated Tremor Among Participants in the NARCOMS Registry.

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. 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. 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. 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.

Risk tolerance to MS therapies: Survey results from the NARCOMS registry

BackgroundThere is little information about risk acceptance of multiple sclerosis (MS) patients to various MS therapies. ObjectiveTo determine MS patients׳ tolerance to risky therapies and identify associated characteristics. MethodsMS patients from the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry׳s online cohort were invited to complete questionnaires on decision making and risk tolerance (RT) to two therapeutic scenarios: a theoretical cure for MS [CureMS], with permanent reversal of all MS symptoms but a risk of immediate painless death; and natalizumab [NAT], a real-life scenario with benefits and risks as defined by Phase III trial results. ResultsThe median RT for both scenarios was 1:10,000; 15–23% of respondents were not willing to take any risk for their MS therapy. Participants with greater disability or not taking any MS therapy showed a greater RT, while females and those caring for dependents had a lower RT. Females and older age were predictors of lower RT, while increasing disability and greater blunting attitude with respect to information seeking behavior were predictors of higher RT. ConclusionMS patients displayed a wide range of RT for MS therapies. Our study identified gender, age, disability and information seeking behavior to be associated with RT.

Prevalence and characteristics of tremor in the NARCOMS multiple sclerosis registry: a cross-sectional survey

Objectives(1)To describe the prevalence and severity of tremor in patients with multiple sclerosis (MS) registered within a large North American MS registry; (2) to provide detailed descriptions on the characteristics...

Patient perspectives on switching disease-modifying therapies in the NARCOMS registry.

IntroductionThe evolving landscape of disease-modifying therapies (DMTs) for multiple sclerosis raises important questions about why patients change DMTs. Physicians and patients could benefit from a better understanding of the reasons for switching therapy.PurposeTo investigate the reasons patients switch DMTs and identify characteristics associated with the decision to switch.MethodThe North American Research Committee on Multiple Sclerosis (NARCOMS) Registry conducted a supplemental survey among registry participants responding to the 2011 update survey. The supplemental survey investigated reasons for switching DMT, origin of the discussion of DMT change, and which factors influenced the decision. Chi-square tests, Fisher’s exact tests, and logistic regression were used for the analyses.ResultsOf the 691 eligible candidates, 308 responded and met the inclusion criteria (relapsing disease course, switched DMT after September 2010). The responders were 83.4% female, on average 52 years old, with a median (interquartile range) Patient-Determined Disease Steps score of 4 (2–5). The most recent prior therapy included first-line injectables (74.5%), infusions (18.1%), an oral DMT (3.4%), and other DMTs (4.0%). The discussion to switch DMT was initiated almost equally by physicians and participants. The primary reason for choosing the new DMT was based most frequently on physician’s recommendation (24.5%) and patient perception of efficacy (13.7%).ConclusionParticipants frequently initiated the discussion regarding changing DMT, although physician recommendations regarding the specific therapy were still weighed highly. Long-term follow-up of these participants will provide valuable information on their disease trajectory, satisfaction with, and effectiveness of their new medication.

“Seeing” in NARCOMS: a look at vision-related quality of life in the NARCOMS registry

Background: Research on vision-related quality of life (QOL) in multiple sclerosis (MS) is still limited. Tools such as the Visual Functioning Questionnaire-25 (VFQ-25) and the Vision Performance Scale (VPS) facilitate assessments of the severity of visual impairment and its impact on daily life. Objective: The objective of this paper is to examine vision-related QOL, comorbid eye conditions, use of visual aids and utilization of eye-care providers in the North American Research Committee on Multiple Sclerosis (NARCOMS) population, and to explore these issues in those with a history of optic neuritis (ON) and diplopia. Methods: In 2008, NARCOMS registrants reported on their use of visual aids, the VFQ-25, VPS, history of ON, diplopia, refractive error conditions (REC) and comorbid eye diseases (CED). We conducted regression analyses and correlations between select variables. Results: The response rate for the survey was 60.4%. Of the 9107 responders, 66.7% reported visual disability measured by VPS. Of respondents, 43.1% had a history of ON and 38.6% reported prior diplopia. Frequencies of myopia (51.8%), hyperopia (26.6%), and uveitis (3.4%) exceeded those expected for the general population. Mean (SD) VFQ-25 composite score was 82.0 (14.2). A history of ON or diplopia accounted for 9.7% of the variance in the VFQ-25; 90.6% of respondents used glasses or contact lenses. Rates of utilizations of eye-care providers were lower than expected. Conclusion: Prior ON, diplopia, REC and CED adversely impact vision-related QOL in MS. Increased utilization of eye-care providers and use of visual aids could improve vision-related QOL in people with MS.

Validation of the NARCOMS Registry

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.

Disparities in the management of multiple sclerosis–related bladder symptoms

Participants enrolled in the North American Research Committee on Multiple Sclerosis (NARCOMS) registry report disability status using Performance Scales (PS), a self-report measure. The bladder/bowel subscale (PSB) of PS has not been validated. It is also unknown whether ethnic or socioeconomic disparities exist in bladder care. We aimed to validate the bladder/bowel subscale used by the NARCOMS registry and to describe urologic symptoms, investigations, and treatments received by registry participants. In the Fall 2005 update questionnaire, we collected the Bowel Control Scale (BWCS) and Urogenital Distress Inventory-6 (UDI-6) as criterion measures and urologic investigations and treatments. We measured associations between investigations, treatments, and symptoms with clinical and sociodemographic variables using chi(2) tests for categorical variables and Kruskal-Wallis tests for continuous variables, followed by multivariable logistic regression. Nine thousand six hundred eighty-eight participants completed the survey. For the UDI-6, the median (interquartile range) score was 33.3 (16.7 to 50.0), for the BWCS 3 (1 to 6), and for the PSB 1 (1 to 3). The correlation between the PSB and the UDI-6 was r = 0.67 and between the PSB and the BWCS r = 0.53 (both p < 0.0001). Participants had increased odds of receiving medication for bladder symptoms if they had health insurance (odds ratio [OR] 1.90; 1.07 to 3.35). Participants who were white (OR 1.5; 1.16 to 1.94) and had health insurance (OR 2.0; 1.3 to 3.07) had increased odds of undergoing urologic investigations. The Performance Scales bladder question has adequate criterion and construct validity in multiple sclerosis (MS). There are ethnic and socioeconomic disparities in bladder management in MS.

Validation of the NARCOMS Registry: fatigue assessment

Participants in the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry report disability using Performance Scales (PS), which assess eight domains. We aimed to validate the PS fatigue subscale (PSF) using the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS) as external criteria. We measured correlations between the PSF and age, disease duration and PS subscales to assess construct validity. The PSF correlated strongly with the MFIS (r =0.72, P <0.0001) and FSS (r =0.75, P <0.0001). Correlations between the PSF and age, disease duration were low, indicating divergent validity. Correlations between the PSF and spasticity, sensory and mobility PS scales were moderate, indicating convergent validity. The PSF has adequate criterion and construct validity in MS.

Validation of the NARCOMS Registry: pain assessment

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 enrollment, 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.