Streamlined EDSS for use in multiple sclerosis clinical practice: Development and cross-sectional comparison to EDSS.

BACKGROUND: The Expanded Disability Status Scale (EDSS) is the standard measure of disability in multiple sclerosis clinical trials. The EDSS has limited application in the clinical setting due to required completion time and scoring complexity. Systematically recording an objective, simplified, less time-intensive, and neurologist-derived disability score would be beneficial for patient care. OBJECTIVE: To develop and validate a streamlined version of the Expanded Disability Status Scale (sEDSS) for clinical monitoring. METHODS: The EDSS was modified by eliminating maneuvers with no impact on function, consolidating redundancies, and simplifying scoring. This sEDSS was refined and preliminarily validated using a pilot cohort of 102 patients. Subsequently, the sEDSS was retrospectively validated using 968 patients from the CombiRx trial. We evaluated correlation and agreement between each functional system as well as the overall sEDSS and EDSS. RESULTS: The sEDSS correlated strongly with the EDSS, both overall (Spearman's rho = 0.93) and for each functional system (Spearman's rho 0.65-0.97). Correlation was slightly lower for functional systems where scoring was modified for consolidation and simplification. CONCLUSION: The sEDSS had strong agreement and correlation with the existing EDSS and can provide a useful measure of disability in clinical practice.

Long-term follow-up of a randomized study of combination interferon and glatiramer acetate in multiple sclerosis: Efficacy and safety results up to 7 years.

BACKGROUND: To report the long-term results of the blinded extension phase of the randomized, controlled study of the combined use of interferon beta-1a (IFN) 30µg IM weekly and glatiramer acetate (GA) 20mg daily compared to each agent alone in relapsing-remitting multiple sclerosis (RRMS). METHODS: 1008 RRMS patients were followed on protocol until the last participant enrolled completed 3 years, allowing some subjects to be followed for up to 7 years. The primary endpoint was reduction in annualized relapse rate. Secondary outcomes included time to confirmed disability, Multiple Sclerosis Functional Composite (MSFC) score and MRI metrics. RESULTS: Similar to the core study, combination IFN + GA was not superior to the better of the single agents (GA) in risk of relapse. Both the combination therapy and GA were significantly better than IFN in reducing the risk of relapse. The combination was not better than either agent alone in lessening confirmed EDSS worsening or change in MSFC. Also similar to the core result, the combination was superior to either agent alone in reducing new lesion activity, but the 3 year MRI result did not presage a clinical benefit over the extended observation interval. CONCLUSION: Combining GA & IFN did not produce a significant clinical benefit over the entire study duration. The earlier effect on reducing MRI activity did not result in a later clinical advantage. The combination showed a sustained advantage in reducing disease activity free status.

Potentially Modifiable Factors Associated With Physical Activity in Individuals With Multiple Sclerosis.

Physical activity levels among persons with multiple sclerosis (MS) are worryingly low. We aimed to identify the factors associated with physical activity for people with MS, with an emphasis on factors that have not been studied previously (bladder and hand dysfunction) and are potentially modifiable. This study was a secondary analysis of data collected in the spring of 2012 during the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry. NARCOMS participants were surveyed regarding smoking using questions from the Behavioral Risk Factor Surveillance Survey; disability using the Patient Determined Disease Steps; fatigue, cognition, spasticity, sensory, bladder, vision and hand function using self-reported Performance Scales; health literacy using the Medical Term Recognition Test; and physical activity using questions from the Health Information National Trends Survey. We used a forward binary logistic regression to develop a predictive model in which physical activity was the outcome variable. Of 8,755 respondents, 1,707 (19.5%) were classified as active and 7,068 (80.5%) as inactive. In logistic regression, being a current smoker, moderate or severe level of disability, depression, fatigue, hand, or bladder dysfunction and minimal to mild spasticity were associated with lower odds of meeting physical activity guidelines. MS type was not linked to activity level. Several modifiable clinical and lifestyle factors influenced physical activity in MS. Prospective studies are needed to evaluate whether modification of these factors can increase physical activity participation in persons with MS. © 2016 Wiley Periodicals, Inc.

Assessment of Caregiver Inventory for Rett Syndrome.

Rett syndrome (RTT) requires total caregiver attention and leads to potential difficulties throughout life. The Caregiver Burden Inventory, designed for Alzheimer disease, was modified to a RTT Caregiver Inventory Assessment (RTT CIA). Reliability and face, construct, and concurrent validity were assessed in caregivers of individuals with RTT. Chi square or Fisher's exact test for categorical variables and t tests or Wilcoxon two-sample tests for continuous variables were utilized. Survey completed by 198 caregivers; 70 caregivers completed follow-up assessment. Exploratory factor analysis revealed good agreement for physical burden, emotional burden, and social burden. Internal reliability was high (Cronbach's alpha 0.898). RTT CIA represents a reliable and valid measure, providing a needed metric of caregiver burden in this disorder.

Disability Progression After Switching from Natalizumab to Fingolimod or Interferon Beta/Glatiramer Acetate Therapies: A NARCOMS Analysis.

Background: Physicians must weigh the benefits against the risk of progressive multifocal leukoencephalopathy (PML) in patients treated with natalizumab, especially beyond 2 years. However, disability progression associated with switching therapies versus continuing natalizumab therapy after 2 years has not been fully evaluated. Methods: In this retrospective analysis using the NARCOMS Registry, disability progression (Patient-Determined Disease Steps [PDDS] scale) and physical health-related quality of life (HRQOL) worsening (12-item Short Form Health Status Survey Physical Component Score [SF-12 PCS]) were compared between participants switching to fingolimod (n = 50) or interferon beta (IFNß)/glatiramer acetate (GA) (n = 71) therapy and those continuing natalizumab (n = 406) after 2 years or more of treatment (median follow-up: natalizumab, 4 years; fingolimod, 4.5 years; IFNß/GA, 5 years). Results: Participants continuing to take natalizumab had less disability progression (mean PDDS change: natalizumab, 0.3; fingolimod, 0.6; IFNß/GA, 0.7; P = .0036), were less likely to report disability progression (proportion with PDDS increase: natalizumab, 31%; fingolimod, 46%; IFNß/GA, 42%; P = .0296), and had less worsening in physical HRQOL (mean SF-12 PCS change: natalizumab, -1.4; fingolimod, -2.8; IFNß/GA, -4.6; P = .0476) than those switching treatment. Conclusions: Although all medication groups exhibited some level of worsening, switching from natalizumab treatment after 2 years was associated with increased disability progression and worsening physical HRQOL. The risk of disability progression from disease activity and the risk of PML should be considered when making natalizumab treatment decisions.

Health insurance affects the use of disease-modifying therapy in multiple sclerosis.

OBJECTIVE: To evaluate the association between health insurance coverage and disease-modifying therapy (DMT) use for multiple sclerosis (MS). METHODS: In 2014, we surveyed participants in the North American Research Committee on MS registry regarding health insurance coverage. We investigated associations between negative insurance change and (1) the type of insurance, (2) DMT use, (3) use of free/discounted drug programs, and (4) insurance challenges using multivariable logistic regressions. RESULTS: Of 6,662 respondents included in the analysis, 6,562 (98.5%) had health insurance, but 1,472 (22.1%) reported negative insurance change compared with 12 months earlier. Respondents with private insurance were more likely to report negative insurance change than any other insurance. Among respondents not taking DMTs, 6.1% cited insurance/financial concerns as the sole reason. Of respondents taking DMTs, 24.7% partially or completely relied on support from free/discounted drug programs. Of respondents obtaining DMTs through insurance, 3.3% experienced initial insurance denial of DMT use, 2.3% encountered insurance denial of DMT switches, and 1.6% skipped or split doses because of increased copay. For respondents with relapsing-remitting MS, negative insurance change increased their odds of not taking DMTs (odds ratio [OR] 1.50; 1.16-1.93), using free/discounted drug programs for DMTs (OR 1.89; 1.40-2.57), and encountering insurance challenges (OR 2.48; 1.64-3.76). CONCLUSIONS: Insurance coverage affects DMT use for persons with MS, and use of free/discounted drug programs is substantial and makes economic analysis that ignores these supplements potentially inaccurate. The rising costs of drugs and changing insurance coverage adversely affect access to treatment for persons with MS.

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

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.

Relationship between symptom change, relapse activity and disability progression in multiple sclerosis.

BACKGROUND: Symptom changes may serve as a risk factor for relapse activity (RA) and disability progression (DP), which could facilitate multiple sclerosis (MS) treatment decisions. OBJECTIVE: To assess the relationship of symptom change with RA and DP. METHODS: We evaluated the relationship of symptom change with subsequent RA and DP using NARCOMS registry data reported over a five-year period. Symptom change was evaluated using both symptom worsening (SW) and average of Performance Scales (APS) scores. Disability progression was defined as a one-point or more increase in Patient-Determined Disease Steps (PDDS) score between two consecutive updates. Repeated measures logistic regression was used to investigate the relationship between symptom change and RA and DP. RESULTS: SW and APS were both significant predictors of subsequent RA and DP. Both SW and APS have a significant interaction with levels of disability (Mildly Impaired versus Highly Impaired) for the prediction of the subsequent RA or DP. For Mildly Impaired MS subjects, both SW and APS were significant predictors of both RA and DP. However, for Highly Impaired MS subjects, SW did not significantly predict future RA and neither SW nor APS predicted disability progression. CONCLUSION: Changes in self-reported overall symptomatology may precede and predict clinical relapse and future disability progression. The predictive power of symptom changes may only be present at lower levels of disability.

Prevalence of multiple sclerosis symptoms across lifespan: data from the NARCOMS Registry.

The North American Research Committee on Multiple Sclerosis is a voluntary patient registry with more than 38,000 registrants as of 2015. In a recent collaborative project, longitudinal data on patient-perceived impairment in 11 domains commonly affected by multiple sclerosis were examined and tabulated as a function of disease duration. The patterns of disability accumulation differed by domain. Certain symptoms (sensory, fatigue) were particularly prevalent early in the disease. Other symptoms (mobility, hand function, fatigue, bowel/bladder dysfunction, spasticity) were progressively more common with longer disease duration. Some symptoms (vision, cognition, sensory, pain, depression) were relatively common early on in multiple sclerosis, but did not appear to be more frequent with longer disease duration. Ongoing research includes studies of the impact of disease-modifying therapy and symptomatic treatment on patient-perceived impairment over the disease course.

Causes of death among persons with multiple sclerosis.

BACKGROUND: Multiple Sclerosis (MS) is a leading cause of disability among young Americans. Reports suggest that life expectancy (i.e., average age at death) remains reduced as compared to the general population, but underlying causes of death (UCOD) are less well-characterized. OBJECTIVE: To describe the cause-specific mortality among participants enrolled in the North American Research Committee on Multiple Sclerosis (NARCOMS) registry and to compare the profile of these causes by age, sex, race and disability status at entry into NARCOMS, with U.S. mortality data. METHODS: The underlying cause of death (UCOD), any mention cause of death and proportionate mortality were compared among U.S. NARCOMS participants by age, sex, race and disability status. RESULTS: Of the 32,445 participants to be considered for this study, 2,927 had died. Compared to survivors, decedents were older at enrollment and MS diagnosis, more likely to be male, and had less education. UCOD differed markedly by age group. In both sexes, MS as the UCOD was proportionately lower by 20% or more in those aged 25-39 compared to those aged 75 or older. Cancer and cardiovascular causes were more frequent as causes of death with increasing age, but were less than expected at older ages. The effect of disability on mortality was roughly equivalent to the effect of aging on mortality. CONCLUSIONS: Among NARCOMS participants older age at enrollment, male sex and greater disability were associated with increased mortality risk. This cohort of MS subjects had a lower proportionate mortality from cardiovascular disease and cancer compared to the U.S. population.

Impact of multiple sclerosis relapse: The NARCOMS participant perspective.

Acute relapses continue to be a significant aspect of multiple sclerosis (MS) on both the epidemiologic level and the individual patient level. Past work demonstrates residual disability from relapses as well as high patient-reported rates of ineffective relapse treatment. To better characterize the impact of MS relapses on the patient, a relapse-specific survey was administered through the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry to 1000 registry participants who had reported at least one relapse in the past 12 months. Thirty percent of respondents confirmed lack of relapse treatment efficacy at one month and at three months. Relapses also impacted socioeconomic measures; for individuals still going to school or working, more than half missed days and their average loss of school or work was 12.7 days. An impact on household tasks was reported by 68% of respondents. A healthcare facility such as a hospital, emergency room or urgent care center was utilized by 20.4% of respondents. The most common relapse symptoms were fatigue, weakness of the lower extremity, sensory symptoms, problems walking, and weakness of the upper extremity. Of the respondents who reported receiving corticosteroid treatment (53.3%), over half reported an adverse event. However, this was not a significant factor in dictating whether or not respondents would seek a different treatment on their next relapse, although 31% would choose a different treatment for their next relapse. Relapses continue to be an impactful experience that requires continued clinical attention. Improved follow-up from relapses and relapse treatment might be beneficial.

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 and severity of tremor in a subset of registrants and (3) to compare several measures of tremor severity for strength of agreement. SETTING: The North American Research Committee on MS (NARCOMS) registry. PARTICIPANTS: Registrants of NARCOMS reporting mild or greater tremor severity. OUTCOME MEASURES: We determined the cross-sectional prevalence of tremor in the NARCOMS registry over three semiannual updates between fall 2010 and fall 2011. A subset of registrants (n=552) completed a supplemental survey providing detailed descriptions of their tremor. Outcomes included descriptive characteristics of their tremors and correlations between outcome measures to determine the strength of agreement in assessing tremor severity. RESULTS: The estimated prevalence of tremor in NARCOMS ranged from 45% to 46.8%, with severe tremor affecting 5.5-5.9% of respondents. In the subset completing the supplemental survey, mild tremor severity was associated with younger age of MS diagnosis and tremor onset than those with moderate or severe tremor. However, tremor severity did not differ by duration of disease or tremor. Respondents provided descriptions of tremor symptoms on the Clinical Ataxia Rating Scale, which had a moderate to good (ρ=0.595) correlation with the Tremor Related Activities of Daily Living (TRADL) scale. Objectively scored Archimedes' spirals had a weaker (ρ=0.358) correlation with the TRADL. Rates of unemployment, disability and symptomatic medication use increased with tremor severity, but were high even among those with mild tremor. CONCLUSIONS: Tremor is common among NARCOMS registrants and severely disabling for some. Both ADL-based and symptom-descriptive measures of tremor severity can be used to stratify patients.

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

INTRODUCTION: The 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. PURPOSE: To investigate the reasons patients switch DMTs and identify characteristics associated with the decision to switch. METHOD: The 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. RESULTS: Of 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%). CONCLUSION: Participants 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.

Improvement of multiple sclerosis-associated tremor as a treatment effect of natalizumab.

BACKGROUND: Tremor is among the most physically disabling symptoms associated with MS. The effect of MS disease modifying therapies (DMTs) on the severity of MS tremor is unclear. OBJECTIVE: To compare the change over time in scores reflecting tremor severity between subjects treated with natalizumab and other disease modifying drugs. METHODS: Questionnaires were sent to North American Research Committee on MS registrants reporting mild or greater tremor on semiannual updates. Respondents on natalizumab and other MS therapies completed a survey which included tremor-specific scales to indicate tremor severity both currently and when the current therapy was initiated. Differences between natalizumab and non-natalizumab groups were compared using ANOVA. RESULTS: Surveys were returned by 567 registrants, including 202 taking natalizumab. Subjects on natalizumab were more likely to report tremor improvement (29.6%) than those never (15.2%) or previously (14.8%, p=0.0002) on natalizumab. Over a mean recall period of 6.2+4.6 years, the Tremor Related Activities of Daily Living score worsened by 1.8 points among natalizumab-treated subjects, 3.3 points among those previously on natalizumab, and 5.3 points among those who never took natalizumab (p=0.009). CONCLUSION: Respondents taking natalizumab were more likely to experience tremor improvement than those taking other MS disease modifying therapies.

Preferred sources of health information in persons with multiple sclerosis: degree of trust and information sought.

BACKGROUND: Effective health communication is important for informed decision-making, yet little is known about the range of information sources used by persons with multiple sclerosis (MS), the perceived trust in those information sources, or how this might vary according to patient characteristics. OBJECTIVE: We aimed to investigate the sources of health information used by persons with MS, their preferences for the source of health information, and levels of trust in those information sources. We also aimed to evaluate how these findings varied according to participant characteristics. METHODS: In 2011, participants in the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry were asked about their sources of health information using selected questions adapted from the 2007 Health Information National Trends (HINTS) survey. RESULTS: Of 12,974 eligible participants, 66.18% (8586/12,974) completed the questionnaire. Mass media sources, rather than interpersonal information sources, were the first sources used by 83.22% (5953/7153) of participants for general health topics and by 68.31% (5026/7357) of participants for MS concerns. Specifically, the Internet was the first source of health information for general health issues (5332/7267, 73.40%) and MS (4369/7376, 59.23%). In a logistic regression model, younger age, less disability, and higher annual income were independently associated with increased odds of use of mass media rather than interpersonal sources of information first. The most trusted information source was a physician, with 97.94% (8318/8493) reporting that they trusted a physician some or a lot. Information sought included treatment for MS (4470/5663, 78.93%), general information about MS (3378/5405, 62.50%), paying for medical care (1096/4282, 25.59%), where to get medical care (787/4282, 18.38%), and supports for coping with MS (2775/5031, 55.16%). Nearly 40% (2998/7521) of participants had concerns about the quality of the information they gathered. CONCLUSIONS: Although physicians remain the most trusted source of health information for people with MS, the Internet is the first source of health information for most of them. This has important implications for the dissemination of health information.

Disability in multiple sclerosis: a reference for patients and clinicians.

OBJECTIVE: To create a reference table of disability outcomes in multiple sclerosis (MS) that would enable patients to rank their disability relative to others' with similar disease duration and to develop a cost-effective research tool for comparing MS severity across patient populations and time periods. METHODS: The North American Research Committee on Multiple Sclerosis (NARCOMS) Registry collects disability data from patients with MS on a validated, 9-point Patient-Determined Disease Steps (PDDS) scale. We compiled the Disability Expectancy Table, which displays cumulative frequencies of PDDS scores for each year of disease duration, from 0 to 45 years. We also tabulated disease duration-adjusted mean ranks of PDDS scores, referred to as Patient-derived MS Severity Scores (P-MSSS). RESULTS: The cohort consisted of 27,918 NARCOMS enrollees, 72.7% of whom were female and 90.1% of whom were white. Mean age at symptom onset was 30.1 ± 10.1 years, and age at enrollment was 47.1 ± 11.0 years. The Disability Expectancy Table and P-MSSS afford a detailed overview of disability outcomes in a large MS cohort over a 45-year period. In the first year of disease, 15% of patients reported need of ambulatory aid, and 4% needed bilateral assistance or worse; after 45 years of disease, 76% of patients required ambulatory aid, and 52% bilateral assistance or worse. Proportion of patients who reported minimal or no interference in daily activities (PDDS ≤ 1) declined from 63% in the first year to 8% after 45 years of disease. CONCLUSION: The Disability Expectancy Table allows individual patients to determine how their disability ranks relative to NARCOMS enrollees with the same disease duration. P-MSSS may be used to compare disability across patient populations and to track disease progression in patient cohorts. P-MSSS does not require a formal neurologic examination and may therefore find wide applicability as a practical and cost-effective outcome measure in epidemiologic studies.

Randomized study combining interferon and glatiramer acetate in multiple sclerosis.

OBJECTIVE: A double-blind, randomized, controlled study was undertaken to determine whether combined use of interferon ß-1a (IFN) 30 µg intramuscularly weekly and glatiramer acetate (GA) 20 mg daily is more efficacious than either agent alone in relapsing-remitting multiple sclerosis. METHODS: A total of 1,008 participants were randomized and followed until the last participant enrolled completed 3 years. The primary endpoint was reduction in annualized relapse rate utilizing a strict definition of relapse. Secondary outcomes included time to confirmed disability, Multiple Sclerosis Functional Composite (MSFC) score, and magnetic resonance imaging (MRI) metrics. RESULTS: Combination IFN+GA was not superior to the better of the single agents (GA) in risk of relapse. Both the combination therapy and GA were significantly better than IFN in reducing the risk of relapse. The combination was not better than either agent alone in lessening confirmed Expanded Disability Status Scale progression or change in MSFC over 36 months. The combination was superior to either agent alone in reducing new lesion activity and accumulation of total lesion volumes. In a post hoc analysis, combination therapy resulted in a higher proportion of participants attaining disease activity-free status (DAFS) compared to either single arm, driven by the MRI results. INTERPRETATION: Combining the 2 most commonly prescribed therapies for multiple sclerosis did not produce a significant clinical benefit over 3 years. An effect was seen on some MRI metrics. In a test of comparative efficacy, GA was superior to IFN in reducing the risk of exacerbation. The extension phase for CombiRx will address whether the observed differences in MRI and DAFS findings predict later clinical differences.

"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.

Natural history of multiple sclerosis symptoms.

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.

Treatment discontinuation and disease progression with injectable disease-modifying therapies: findings from the north american research committee on multiple sclerosis database.

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 IFNß-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) IFNß-1a than as a reason for discontinuing IM IFNß-1a, GA, or SC IFNß-1b. In the persistent therapy cohort, less patient-reported disability progression was reported with IM IFNß-1a treatment than with SC IFNß-1a, IFNß-1b, or GA. These findings have relevance to clinical decision making and medication compliance in MS patient care.