Multiple Sclerosis Impact Scale Research Articles

Determining the Need for Palliative Care Patients with Multiple Sclerosis-A Cross-Sectional Study.

Multiple sclerosis is characterised by the manifestation of heterogeneous symptoms that affect daily functioning. Patients face physical impairment, psychological problems and socioeconomic changes. Depending on the form of the disease, they may have different needs, which are often unsatisfied and could be overcome by including palliative care in the treatment. Despite the above, not enough is known about this population's needs for palliative care. This cross-sectional study aimed to identify the need for palliative care and assess the functional dependence level in daily living activities in patients with multiple sclerosis. The sample consisted of 120 patients from the Neurology Clinic of the University Clinical Center of Vojvodina, Serbia. The following research instruments were used: a General questionnaire, Sheffield Profile for Assessment and Referral for Care, Multiple Sclerosis Impact Scale and Barthel Index. The need for palliative care was expressed by 36.7% of patients, who expressed the most concern for the physical symptoms, independence and activity domains. Also, it was determined that the disease prevents patients from doing demanding physical tasks and that they are worried about multiple sclerosis. Almost a quarter of patients have had complete/severe dependence on other persons in performing daily activities. The most frequently reported physical symptoms by patients with MS were weakness, bladder problems, fatigue and different levels of dependence, while concerns related to sexual health, low mood and anxiety emerged as key challenges in the psychological domain. These findings underscore the importance of conducting needs assessments to guide the development of an appropriate palliative care model for MS patients.

Middle-range scores from the patient determined disease steps scale reflect varying levels of walking dysfunction in multiple sclerosis

BackgroundMultiple sclerosis (MS) is a leading cause of neurological disability among young and middle-aged adults worldwide, and disability is measured using a variety of approaches, including patient reported outcome measures (PROMs) such as the Patient Determined Disease Steps (PDDS) scale. There is limited evidence for the validity of inferences from the middle-range of scores on the PDDS (i.e., 3 “gait disability” – 6 “bilateral support”), but that range of scores seemingly represents moderate disability characterized by varying levels of walking dysfunction.PurposeThe current study examined whether the middle-range of scores from the PDDS reflect varying levels of walking dysfunction among people with MS.MethodParticipants (N = 374) completed the Patient Determined Disease Steps (PDDS) scale, Multiple Sclerosis Walking Scale-12 (MSWS-12), timed 25-foot walk (T25FW), six-minute walk (6 MW), Modified Fatigue Impact Scale (MFIS), and Multiple Sclerosis Impact Scale-29 (MSIS-29), and underwent a neurological exam for generating an Expanded Disability Status Scale (EDSS) score as part of screening and baseline data collection for a clinical trial of exercise training in MS. We undertook a series of linear trend analyses that examined differences in the outcomes of EDSS, T25FW, 6 MW, MSWS-12, MFIS subscales, and MSIS-29 subscales across the 4 levels of PDDS scores (i.e., 3–6).ResultsThere were statistically significant and strong linear trends for EDSS (F1,370 = 306.1, p < .0001, η2 = 0.48), T25FW (F1,370 = 161.0, p < .0001, η2 = 0.32), 6 MW (F1,370 = 178.9, p < .0001, η2 = 0.34), and MSWS-12 (F1,370 = 97.0, p < .0001, η2 = 0.24). There was a strong correlation between PDDS and EDSS scores (rs = 0.695, 95% CI = 0.643, 0.748). Both PDDS and EDSS scores had strong correlations with walking outcomes, yet weaker correlations with measures of fatigue and QOL.ConclusionThe PDDS could serve as a simple, inexpensive, and rapidly administered PROM for remote screening and early detection of walking dysfunction for initial eligibility into clinical trials and practice for managing mobility-specific disability in MS.RegistrationThe study was registered on ClinicalTrials.gov on March 19, 2018 (NCT03468868).

MyMS: An Interface for Patient-Reported Outcomes for Finnish Individuals With Multiple Sclerosis.

Patient-generated data are a cornerstone of individualized multiple sclerosis (MS) treatment. MyMS, an interface for patient-reported outcomes (PROs) was developed by the Finnish MS Register to enable systematic collection of PROs. MyMS collects data on demographics, lifestyle factors, disease-related factors, and validated questionnaires, including the Quality of Life Questionnaire (15D), the Multiple Sclerosis Impact Scale (MSIS-29), and the Fatigue Severity Scale (FSS). At the end of 2020, the patient-reported Expanded Disability Status Scale (PREDSS), the EuroQOL-5 Dimension (EQ-5D), the Fatigue Scale for Motor and Cognitive Functions (FSMC), and the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) were added. As of January 1, 2023, 1201 individuals with MS (79% female) have added data to MyMS. Of the validated PRO measures (PROMs), the 15D, MSIS-29, and FSS are the most used. The mean PREDSS score is 3.0 and median disease duration is 6.4 years. According to the existing PROMs, patients report mildly compromised quality of life and problems with fatigue and cognition. The patient interface of the Finnish MS Register consists of data from 17 of 21 counties with well-being services. The interface is used by 10% of Finnish individuals with MS. The addition of the PREDSS, EQ-5D, FSMC, and MSNQ to the interface has increased health care professional and patient interest in the use of PROMs. We suggest that PROs should be integrated into electronic health records to improve shared decision-making and diminish documentation burden.

Association Between Alcohol Consumption and Disability Accumulation in Multiple Sclerosis.

Previous studies have indicated that alcohol consumption is associated with multiple sclerosis (MS) disease progression. We aimed to study the influence of alcohol consumption habits on disease progression and health-related quality of life in MS. We categorized patients from 2 population-based case-control studies by alcohol consumption habits at diagnosis and followed them up to 15 years after diagnosis through the Swedish MS registry regarding changes in the Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Impact Scale 29 (MSIS-29). We used Cox regression models with 95% confidence intervals (CIs) using 24-week confirmed disability worsening, EDSS 3, EDSS 4, and physical and psychological worsening from the patient's perspective as end points. Our study comprised 9,051 patients with MS, with a mean age of 37.5 years at baseline/diagnosis. Compared with nondrinking, low and moderate alcohol consumption was associated with reduced risk of EDSS-related unfavorable outcomes (hazard ratios between 0.81 and 0.90) and with reduced risk of physical worsening. The inverse association was confined to relapsing-remitting MS and was more pronounced among women. High alcohol consumption did not significantly affect disease progression. The inverse relationship between low-moderate alcohol consumption and disability progression became stronger when we only included those who had not changed their alcohol consumption during follow-up (hazard ratios between 0.63 and 0.71). There were no differences in measures of disability at baseline between drinkers who continued drinking alcohol after diagnosis and those who later discontinued. Our findings speak against bias due to reverse causation. Low and moderate alcohol consumption was associated with more favorable outcomes in relapsing-remitting MS, compared with nondrinking, while there was no significant influence of high alcohol consumption on disease outcomes.

Physiological fitness in people with advanced multiple sclerosis

IntroductionPhysiological fitness, encompassing cardiorespiratory fitness (CRF) and body composition, are important markers of overall health, functional capacity, and quality of life in general and clinical populations. Characterizing fitness is important for the development of tailored interventions and strategies to optimize well-being across the spectrum of disability in multiple sclerosis (MS). While existing research has explored fitness in people with mild-to-moderate disability, there is a scarcity of data in people with advanced MS (Expanded Disability Severity Scale, EDSS≥7.0). ObjectiveTo characterize CRF and body composition and their associations with fatigue, quality of life, and function in individuals with advanced MS. MethodsParticipants (n=18, mean age=60.7 years-old, median EDSS=7.5) underwent a cardiopulmonary exercise test and dual-energy X-ray absorptiometry scanning. Main outcomes included peak volume of oxygen uptake (V̇O2peak) and whole and regional body fat, lean mass, bone mineral content, and bone density. Symptoms of fatigue (Modified Fatigue Impact Scale, MFIS), quality of life (29-item MS Impact Scale, MSIS-29), and daily function (Late-Life Function and Disability Instrument, LLFDI) were collected. ResultsParticipants exhibited notably low CRF levels (V̇O2peak=9.8 mL/min/kg) and poor body composition (lower lean mass, bone mineral content and density) compared to previous studies in the general population and in individuals with MS with lower disability. V̇O2peak was most consistently associated with function in daily life (LLFDI scores, rs≥0.637, p≤0.004). ConclusionThese findings reinforce the potential importance of physiological fitness to preserve function in people with advanced MS.

Effects of traditional Chinese exercises on physical and psychological health of patients with multiple sclerosis: A systematic review and meta-analysis

Background and purposePhysical exercise improves physical and psychological health. However, information on the quantitative impact of Traditional Chinese Exercise (TCE) on physical and psychological health remains limited. Therefore, this systematic review and meta-analysis aimed to quantitatively explore the effects of TCE on the physical and psychological health of patients with multiple sclerosis (MS). MethodsA comprehensive search was conducted across seven electronic databases (PubMed, SCOPUS, CINAHL, Web of Science, Cochrane Library, China National Knowledge Infrastructure, and Wanfang) from their inception to March 7, 2024 using the terms, Taiji, Tai Chi, Tai Chi Chuan, Qigong, Baduanjin, Wuqinxi, Yijinjing, multiple sclerosis, and disseminated sclerosis. Randomized controlled trials (RCTs) and non-RCTs reporting the effects of TCE on physical function or psychological health outcomes in MS patients were included. A random-effects model and 95 % confidence intervals (95 % CI) were used to compute the effect sizes. ResultsEleven studies, including 461 subjects with MS, were included in this meta-analysis. TCE significantly increased balance (d = 0.88, 95 % CI [0.45, 1.31], p < 0.001, I2 = 39.26 %), activities of daily living (d = 1.17, 95 % CI [0.30, 2.04], p < 0.001, I2 = 89.15 %), Multiple Sclerosis Impact Scale (MSIS) scores (d = 0.53, 95 % CI [0.12, 0.93], p = 0.01, I2 = 0 %), depression (d = 0.66, 95 % CI [0.003, 1.32], p = 0.049, I2 = 62.97 %), and Activities-Specific Balance Confidence (ABC) scores (d = 1.30, 95 % CI [0.41, 2.18], p < 0.001, I2 = 0 %) compared with control conditions. ConclusionsThis meta-analysis suggests the efficacy of TCE in improving balance, activities of daily living, MSIS scores, depression, and ABC scores in MS patients. However, further high-quality research is warranted to investigate these findings.

Outcomes of a Day Wellness Program for People With Multiple Sclerosis Before and During the COVID-19 Pandemic.

The John A. Schafer, MD Multiple Sclerosis Achievement Center (MSAC) conducts wellness programs that include exercise, cognitive stimulation, education, emotional support, and socialization for people with multiple sclerosis and their care partners. Patient-reported outcomes (PROs) are collected annually. Four-year outcomes encompass the COVID-19 pandemic when some of these programs were offered virtually. Beginning in 2017, baseline data were collected for 110 MSAC day wellness program participants through PRO measures. Of those 110, 52 completed PROs annually through 2021. Outcome measures included the Multiple Sclerosis Impact Scale (MSIS-29); Multiple Sclerosis Self-Efficacy Scale (MSSE-10); Godin Leisure-Time Exercise Questionnaire (GLTEQ); and the Neurology Quality of Life domains of Anxiety, Depression, Emotional and Behavioral Dysregulation, Positive Affect, Cognition, Ability to Participate in and Satisfaction with Social Roles and Activities, and Satisfaction with Social Roles and Activities. Analysis using t tests compared baseline with 4-year data. A separate analysis compared outcomes collected in January 2020 and January 2021. Analysis of 4-year data demonstrated statistically significant improvement in MSIS-29 and GLTEQ. Statistically significant improvements noted at years 2 and 3 in the Ability to Participate in Social Roles and Activities were no longer significant at year 4. Other notable changes included significant decreases in MSSE at year 4 when compared with baseline and year 3. Individuals who participated in a weekly, structured day wellness program showed improvements in self-reported disease impact and physical activity at year 4 vs baseline. Decreases in self-efficacy and social domains were seen, corresponding with disruptions caused by the COVID-19 pandemic. Further analysis is needed to understand the effects of the pandemic on program participants.

Associations between fatigue impact and physical and neurobehavioural factors: An exploration in people with progressive multiple sclerosis

BackgroundFatigue is common in people with multiple sclerosis (MS). Understanding the relationship between fatigue, physical and neurobehavioural factors is important to inform future research and practice. Few studies explore this explicitly in people with progressive MS (pwPMS). ObjectiveTo explore relationships between self-reported fatigue, physical and neurobehavioural measures in a large, international progressive MS sample of cognitively impaired people recruited to the CogEx trial. MethodsBaseline assessments of fatigue (Modified Fatigue Impact Scale; MFIS), aerobic capacity (VO2peak), time in moderate-vigorous physical activity (MVPA; accelerometery over seven-days), walking performance (6-minute walk test; 6MWT), self-reported walking difficulty (MS Walking Scale; MSWS-12), anxiety and depression (Hospital Anxiety and Depression Scale; HADS and Beck Depression Inventory-II; BDI-II), and disease impact (MS Impact Scale-29, MSIS-29) were assessed. Participants were categorised as fatigued (MFISTotal >=38) or non-fatigued (MFISTotal ≤38). Statistical AnalysisDifferences in individuals categorised as fatigued or non-fatigued were assessed (t-tests, chi square). Pearson's correlation and partial correlations (adjusted for EDSS score, country, sex, and depressive symptoms) determined associations with MFISTotal, MFISPhysical, MFISCognitive and MFISPsychosocial, and the other measures. Multivariable logistic regression evaluated the independent association of fatigue (categorised MFISTotal) with physical and neurobehavioural measures. ResultsThe sample comprised 308 pwPMS (62 % female, 27 % primary progressive, 73 % secondary progressive), mean age 52.5 ± 7.2 yrs, median EDSS score 6.0 (4.5–6.5), mean MFISTotal 44.1 ± 17.1, with 67.2 % categorised as fatigued. Fatigued participants walked shorter distances (6MWT, p = 0.043), had worse MSWS-12 scores (p < 0.001), and lower average % in MVPA (p = 0.026). The magnitude of associations was mostly weak between MFISTotal and physical measures (r = 0.13 to 0.18), apart from the MSWS-12 where it was strong (r = 0.51). The magnitude of correlations were strong between the MFISTotal and neurobehavioural measures of anxiety (r = 0.56), depression (r = 0.59), and measures of disease impact (MSIS-physical r = 0.67; MSIS-mental r = 0.71). This pattern was broadly similar for the MSIF subscales. The multivariable model indicated a five-point increase in MSWS-12 was associated with a 14 % increase in the odds of being fatigued (OR [95 %CI]: 1.14 [1.07–1.22], p < 0.0001) ConclusionManagement of fatigue should consider both physical and neurobehavioural factors, in cognitively impaired persons with progressive MS.

Effects of a Digital Care Pathway for Multiple Sclerosis: Observational Study.

Helsinki University Hospital has developed a digital care pathway (DCP) for people with multiple sclerosis (MS) to improve the care quality. DCP was designed for especially newly diagnosed patients to support adaptation to a chronic disease. This study investigated the MS DCP user behavior and its impact on patient education-mediated changes in health care use, patient-perceived impact of MS on psychological and physical functional health, and patient satisfaction. We collected data from the service launch in March 2020 until the end of 2022 (observation period). The number of users, user logins, and their timing and messages sent were collected. The association of the DCP on health care use was studied in a case-control setting in which patients were allowed to freely select whether they wanted to use the service (DCP group n=63) or not (control group n=112). The number of physical and remote appointments either to a doctor, nurse, or other services were considered in addition to emergency department visits and inpatient days. The follow-up time was 1 year (study period). Furthermore, a subgroup of 36 patients was recruited to fill out surveys on net promoter score (NPS) at 3, 6, and 12 months, and their physical and psychological functional health (Multiple Sclerosis Impact Scale) at 0, 3, 6, and 12 months. During the observation period, a total of 225 patients had the option to use the service, out of whom 79.1% (178/225) logged into the service. On average, a user of the DCP sent 6.8 messages and logged on 7.4 times, with 72.29% (1182/1635) of logins taking place within 1 year of initiating the service. In case-control cohorts, no statistically significant differences between the groups were found for physical doctors' appointments, remote doctors' contacts, physical nurse appointments, remote nurse contacts, emergency department visits, or inpatient days. However, the MS DCP was associated with a 2.05 (SD 0.48) visit increase in other services, within 1 year from diagnosis. In the prospective DCP-cohort, no clinically significant change was observed in the physical functional health between the 0 and 12-month marks, but psychological functional health was improved between 3 and 6 months. Patient satisfaction improved from the NPS index of 21 (favorable) at the 3-month mark to the NPS index of 63 (excellent) at the 12-month mark. The MS DCP has been used by a majority of the people with MS as a complementary service to regular operations, and we find high satisfaction with the service. Psychological health was enhanced during the use of MS DCP. Our results indicate that DCPs hold great promise for managing chronic conditions such as MS. Future studies should explore the potential of DCPs in different health care settings and patient subgroups.

Impact of oral melatonin supplementation on urine and serum melatonin concentrations and quality-of-life measures in persons with relapsing multiple sclerosis

IntroductionMelatonin is an antioxidant and anti-inflammatory agent that modulates the immune system by scavenging free radicals, reducing the upregulation of pro-inflammatory cytokines, and reducing transendothelial cell migration. Therefore, melatonin may play a role in regulating multiple sclerosis (MS) disease activity. However, little is known about how melatonin supplementation effects individuals with MS. ObjectiveDetermine if there was a dose-dependent elevation in urine and serum melatonin concentrations. Determine if melatonin supplementation had an impact on patient reported outcomes. MethodsThis was a randomized, dose-blinded exploratory study. Adults (age 18–65) with relapsing forms of multiple sclerosis (RMS) treated with a stable dose of oral disease modifying therapy for at least 6 months were randomized into melatonin 3 mg or 5 mg daily. Urinary and serum melatonin levels and modified fatigue impact scale (MFIS), multiple sclerosis impact scale (MSIS-29), and Pittsburgh sleep quality index (PSQI), patient determined disease steps (PDDS) and performance scales (PS) were measured at baseline, 3, 6, and 12 months. Urinary and serum melatonin analyses was performed to estimate mean concentrations and their differences between treatment arms over time by a repeated measures linear mixed model. The model included treatment, assessment time, and treatment × time interaction. ResultsThirty patients, randomized 1:1, were analyzed in an intent to treat population. Twenty-three completed the study. The repeated measures linear mixed model analysis of all timepoints revealed higher melatonin concentrations in patients on 5 mg compared to 3 mg melatonin for both urinary 6-SMT (p = 0.03) and serum melatonin (p = 0.04). MFIS, MSIS-29, PSQI, and PDSS-PS scores did not significantly change from baseline to month 12. No significant differences in these measures were seen between the two doses. Five patients stopped melatonin (three on 5 mg and two on 3 mg) due to adverse events, including one patient who developed focal spongiotic dermatitis. One patient experienced three consecutive serious adverse events that were unrelated to melatonin supplementation. ConclusionsThe 5 mg melatonin supplementation group had higher concentrations of urinary 6-SMT and serum melatonin compared to the 3 mg group over 12 months of treatment. There was a correlation between 6-SMT and serum melatonin concentrations. This suggests that measuring serum melatonin is a reliable alternative to measuring urinary 6-SMT. However, no differences in clinical benefit between the two dosage groups were demonstrated in the patient reported outcomes. Trial Registration NumberNCT03498131

Clinical characteristics and impact on patient-reported outcomes and quality of life of people with ambulatory secondary progressive multiple sclerosis: DISCOVER study

BackgroundPeople with secondary progressive multiple sclerosis (pwSPMS) experience increasing disability, which impacts negatively on their health-related quality of life (HRQoL). Our aims were to assess the impact of secondary progressive multiple sclerosis (SPMS) on functional status and HRQoL and describe the clinical profile in this population. MethodsDISCOVER is an observational, cross-sectional, multicenter study with retrospective data collection in real-world clinical practice in Spain. Sociodemographic and clinical variables, functional and cognitive scales, patient-reported outcomes (PROs), and direct healthcare, and non-healthcare and indirect costs were collected. ResultsA total of 297 evaluable pwSPMS with a EDSS score between 3-6.5 participated: 62.3 % were female and 18.9 % had active SPMS. At the study visit, 77 % of them presented an Expanded Disability Scale Score (EDSS) of 6–6.5. Nearly 40 % did not receive any disease-modifying treatment. Regarding the working situation, 61.6 % were inactive due to disability. PROs: 99.3 % showed mobility impairment in EuroQoL-5 Dimensions-5 Levels, and about 60 % reported physical impact on the Multiple Sclerosis Impact Scale-29. Fatigue was present in 76.1 %, and almost 40 % reported anxiety or depression. The Symbol Digit Modalities Test was used to assess cognitive impairment; 80 % of the patients were below the mean score.Participants who presented relapses two years before and had high EDSS scores had a more negative impact on HRQoL. PwSPMS with a negative impact on HRQoL presented a higher cost burden, primarily due to indirect costs. ConclusionsPwSPMS experience a negative impact on their HRQoL, with a high physical impact, fatigue, cognitive impairment, and a high burden of indirect costs.

A machine learning approach to determine the risk factors for fall in multiple sclerosis

BackgroundFalls in multiple sclerosis can result in numerous problems, including injuries and functional loss. Therefore, determining the factors contributing to falls in people with Multiple Sclerosis (PwMS) is crucial. This study aims to investigate the contributing factors to falls in multiple sclerosis using a machine learning approach.MethodsThis cross-sectional study was conducted with 253 PwMS admitted to the outpatient clinic of a university hospital between February and August 2023. A sociodemographic data collection form, Fall Efficacy Scale (FES-I), Berg Balance Scale (BBS), Fatigue Severity Scale (FSS), Expanded Disability Status Scale (EDSS), Multiple Sclerosis Impact Scale (MSIS-29), and Timed 25 Foot Walk Test (T25-FW) were used for data collection. Gradient-boosting algorithms were employed to predict the important variables for falls in PwMS. The XGBoost algorithm emerged as the best performed model in this study.ResultsMost of the participants (70.0%) were female, with a mean age of 40.44 ± 10.88 years. Among the participants, 40.7% reported a fall history in the last year. The area under the curve value of the model was 0.713. Risk factors of falls in PwMS included MSIS-29 (0.424), EDSS (0.406), marital status (0.297), education level (0.240), disease duration (0.185), age (0.130), family type (0.119), smoking (0.031), income level (0.031), and regular exercise habit (0.026).ConclusionsIn this study, smoking and regular exercise were the modifiable factors contributing to falls in PwMS. We recommend that clinicians facilitate the modification of these factors in PwMS. Age and disease duration were non-modifiable factors. These should be considered as risk increasing factors and used to identify PwMS at risk. Interventions aimed at reducing MSIS-29 and EDSS scores will help to prevent falls in PwMS. Education of individuals to increase knowledge and awareness is recommended. Financial support policies for those with low income will help to reduce the risk of falls.

Cladribine effects on patient-reported outcomes and their clinical and biometric correlates in highly active relapsing multiple sclerosis at first switch: the observational, multicenter, prospective, phase IV CLADFIT-MS study.

Patient-reported outcomes (PROs) are essential for understanding the effects of MS and its treatments on patients' lives; they play an important role in multiple sclerosis (MS) research and practice. We present the protocol for an observational study to prospectively assess the effect of cladribine tablets on PROs and their correlation to disability and physical activity in adults with highly active relapsing MS switching from a first disease modifying drug (DMD) to cladribine tablets in routine clinical practice at study sites in Italy. The primary objective will be to evaluate changes from baseline in the impact of highly active MS on self-assessed physical functioning 52 weeks after the switch to cladribine tablets using the Multiple Sclerosis Impact Scale-29 (MSIS-29). Secondary objectives will include self-assessed psychological impact of highly active MS in daily life and general health after the switch to cladribine tablets as well as changes in cognitive function, anxiety, and depression symptoms. Additional PRO measures will include the Hospital Anxiety and Depression Scale (HADS), the EuroQoL 5-Dimension 5-Level (EQ-5D-5L), the Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis (WPAI:MS), and the Patient-Reported Outcomes Measurement Information System (PROMIS). Wearable devices will acquire activity data (step counts, walking speed, time asleep, and energy expenditure). Additional clinical, radiological, and laboratory data will be collected when available during routine management. The findings will complement data from controlled trials by providing insight from daily clinical practice into the effect of cladribine tablets on the patient's experience and self-assessed impact of treatment on daily life.

COMBAT-MS: A Population-Based Observational Cohort Study Addressing the Benefit-Risk Balance of Multiple Sclerosis Therapies Compared with Rituximab.

To assess comparative effectiveness, safety, and tolerability of off-label rituximab, compared with frequently used therapies approved for multiple sclerosis (MS). A Swedish cohort study of persons with relapsing-remitting MS, age 18 to 75 years at inclusion and with a first therapy start or a first therapy switch between 2011 and 2018. Low-dose rituximab was compared with MS-approved therapies. Primary outcomes were proportions with 12 months confirmed disability worsening and change in MS Impact Scale-29 (MSIS-29) scores, respectively. Secondary endpoints included relapses, therapy discontinuation, and serious adverse events. Analyses used an intention-to-treat approach and were adjusted for demographics, MS features, and health characteristics. We included 2,449 participants as first therapy start and 2,463 as first therapy switch. Proportions with disability worsening at 3 years were 9.1% for rituximab as first therapy and 5.1% after therapy switch, with no differences to MS-approved comparators. Worsening on rituximab was mostly independent of relapses. MSIS-29 with rituximab at 3 years improved by 1.3/8.4 points (physical/psychological) for first disease-modifying therapy (DMT) and 0.4/3.6 for DMT switch, and was mostly similar across therapies. Rituximab had lower relapse rates and higher therapy persistence in both groups. The rate of hospital-treated infections was higher with rituximab after a therapy switch, but not as a first therapy. This population-based real-world cohort study found low rates of disability progression, mostly independent of relapses, and without significant differences between rituximab and MS-approved comparators. Rituximab led to lower rates of inflammatory activity and higher treatment persistence, but was associated with an increased rate of serious infections. ANN NEUROL 2024.

Validation of scores from a telephone administered multiple sclerosis walking scale-12 in persons with multiple sclerosis

BackgroundThe Multiple Sclerosis Walking Scale-12 (MSWS-12) has typically been delivered through paper-and-pencil or computer-based administration. PurposeThis study examined the validity of inferences from scores derived via a telephone administration of the MSWS-12 applied as part of screening of participants with walking dysfunction into a clinical trial of exercise training in MS. MethodThe MSWS-12 was administered on two occasions separated by approximately 2 weeks through the telephone and then in-person (i.e., computer-based administration). Participants further completed the Patient Determined Disease Steps (PDDS) scale, timed 25-foot walk (T25FW), six-minute walk (6MW), Modified Fatigue Impact Scale (MFIS), and Multiple Sclerosis Impact Scale-29 (MSIS-29), and underwent a neurological exam for generating an expanded disability status scale (EDSS) score. The primary set of data (Full Sample) for analyses included all persons who passed the telephone screening for inclusion with MSWS-12 scores between 25 and 75 (N = 374). The secondary set of data (Truncated Sample) included only persons with MSWS-12 scores between 25 and 75 for both the telephone and computer administrations of the MSWS-12 (N = 248). ResultsThe results in the Full Sample indicated a difference in overall and item levels scores between the telephone and computer data collections, and the computer version had higher internal consistency and stronger unidimensionality. Nevertheless, MSWS-12 scores from both modes of administration had comparable correlations with the T25FW, 6MW, EDSS, PDDS, MFIS, and MSIS-29, but the correlation between the two MSWS-12 administrations did not approach unity. There was a systematic difference in scores between telephone and computer administrations across levels of walking dysfunction based on a Bland-Altman plot, and the difference was predicted by MFIS physical, 6MW, and EDSS scores. The comparison of results between the Full and Truncated Samples suggested that the primary analysis might have been influenced by the larger range of scores on the computer than telephone administrations of the MSWS-12. ConclusionThe telephone administration of the MSWS-12 provides an efficient and cost-effective measure of walking dysfunction in persons with MS.

Randomized Controlled Trial of Occupational Performance Coaching for Adults With Multiple Sclerosis

ObjectiveTo determine if the receipt of occupational performance coaching (OPC) by adults living with multiple sclerosis (MS) improves participants’ satisfaction with performance in daily activities (primary outcome); improves perceived performance in daily activities, resilience, autonomy, and participation; and reduces illness intrusiveness and effect of MS (secondary outcomes). DesignTwo-group randomized clinical trial with a waitlist control. SettingCommunity. ParticipantsConvenience sample of adults with MS were recruited through a research registry. Eighty-three individuals were approached; 35 were assessed for eligibility and 31 were enrolled and 30 completed baseline assessment (Final sample size, N=30). Participants were English-speaking, were without serious cognitive impairment or severe depression, and were not receiving other coaching interventions. InterventionsSix telephone sessions of OPC were delivered by a trained facilitator over 10 weeks. Initial sessions focused on goal setting, prioritization, and action planning. Subsequent sessions involved goal and action plan review, discussion of facilitators and barriers, and goal and plan refinement. Main Outcome MeasuresPrimary outcome was participants’ satisfaction with performance in daily activities, as measured by the Canadian Occupational Performance Measure (COPM). Secondary outcome measures included the COPM performance rating, Connor-Davidson Resilience Scale, Impact on Participation and Autonomy Questionnaire, Adapted Illness Intrusiveness Rating Scale, and MS Impact Scale. Measures were administered by a blinded assessor at baseline, 10 weeks, and 2 months. ResultsParticipants in the intervention and waitlist control groups were equivalent on demographic and outcome measures at baseline. At 10 weeks, the intervention group had significantly higher COPM ratings for both satisfaction (P<.001) and performance (P=.002). No other outcomes were significantly different. For the intervention group, the benefits of OPC were maintained at 2 months. ConclusionsOPC led to improved satisfaction with performance and performance in daily activities. Future research with a larger sample is needed to determine other effects and who benefits most from OPC.

The Cognitive Reserve May Influence Fatigue after Rehabilitation in Progressive Multiple Sclerosis: A Secondary Analysis of the RAGTIME Trial

Cognitive reserve (CR) seems to be an ability to adapt cognitive processes in response to brain disease and may influence rehabilitation outcomes. This is a secondary analysis of the “Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressive MultiplE sclerosis patients” (RAGTIME) trial to investigate the influence of CR on the outcomes after gait rehabilitation in people with multiple sclerosis (PwMS). We included 53 PwMS and severe gait disability (EDSS 6–7). The participants were randomized into two groups to receive either robot-assisted gait training or overground walking (three times/week over four weeks). CR was evaluated by the Cognitive Reserve Index questionnaire (CRIq), which encompasses three sections (CRI Education, CRI Working Activity, and CRI Leisure Time). We stratified the patients using the 115 cut-off CRIq total score of at least a medium-high CR. The outcome measures were Timed 25-Foot Walk, 6 min walking test, Berg Balance Scale, Multiple Sclerosis Impact Scale—29, Multiple Sclerosis Walking Scale—12, Patient Health Questionnaire—9, and Fatigue Severity Scale (FSS). After gait rehabilitation, the FSS was significantly improved in those patients with higher CR compared with the others (F = 4.757, p = 0.015). In our study, CR did not affect the gait, balance, disability perception, and depression. Conversely, it positively influenced the fatigue after gait rehabilitation.

Cross-cultural adaptation and validation of the Arabic version of the Multiple Sclerosis Impact Scale-29

Purpose The Multiple Sclerosis Impact Scale-29 (MSIS-29) is a patient self-reported outcome (PRO) that measures patients’ quality of life, and it is divided into two sub-scales for the physical (PHYS) and psychological (PSYCH) domains. This study aimed to translate the MSIS-29 into Arabic, cross-culturally adapt it, and examine its psychometric properties. Materials and Methods One hundred fifty patients with MS completed the MSIS-29-Ar, the Functional Assessment of Multiple Sclerosis (FAMS), and the Short-Form Health Survey (SF-36). After one week, 60 participants were asked to complete the MSIS-29-Ar again to examine test-retest reliability. Results The MSIS-29-Ar was clear and understandable among patients with MS in Saudi Arabia. The internal consistency for the MSIS-29-Ar-PHYS was excellent, with a Cronbach’s alpha of 0.955, and was good for the MSIS-29-Ar-PSYCH, with a Cronbach’s alpha of 0.891. The test-retest reliability for MSIS-29-Ar-PHYS was ICC2,1 = 0.97; 95% confidence interval (0.93, 0.99) and ICC2,1 = 0.95.; 95% confidence interval (0.897, 0.976) for MSIS-29-Ar-PSYCH domains. The minimal detectable change with 95% confidence (MDC95) was 10.28 and 13.37 for the MSIS-29-Ar-PHYS and MSIS-29-Ar-PSYCH, respectively. No floor and ceiling effects were observed. Convergent and divergent validity was supported by 75% of the predefined hypotheses and correlated with the other health-related quality-of-life measures, SF-36 and FAMS. Conclusion The MSIS-29-Ar questionnaire is a valid and reliable outcome measure among Saudi patients with MS. IMPLICATION FOR REHABILITATION Rehabilitation specialists can confidently interpret patient scores in the MSIS-29-Ar to measure physical and psychological factors impacting patients’ quality of life with Multiple Sclerosis (MS). Patients with unchanged clinical status will have similar scores in the MSIS-29-Ar with repeated scale administrations over time. The MSIS-29-Ar can be used in clinical practice and research studies to measure factors that impact the quality of life in Arabic-speaking patients with MS.

Smoking and Health-Related Quality of Life in Patients With Multiple Sclerosis From Latin America.

Tobacco smoking is an important, modifiable, environmental risk factor for multiple sclerosis (MS) with a relevant impact on health-related quality of life (HRQOL). We aimed to assess the use of tobacco in individuals with MS from Latin America (LATAM), and its impact on HRQOL. We conducted a cross-sectional study based on a LATAM web-based survey. Demographics, social and clinical data, information on physical disability, and HRQOL scores were collected using the MS Impact Scale-29 (MSIS-29), the Fatigue Severity Scale (FSS), and the Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Individuals with MS were classified at the time of the survey as follows: never-smokers (ie, patients who reported they had never smoked), past smokers (those who had smoked tobacco but not during the past year), or current smokers. For the analysis, groups were compared. 425 patients (74.6% female) from 17 LATAM countries were included, mean age 43.6 ± 11 years and median Expanded Disability Status Scale score 2. There were 122 (28.7%) current smokers, 178 (41.9%) past smokers, and 125 (30.4%) never-smokers. Current smokers had significantly higher MSIS-29 physical (physical worsening), FSS (fatigue), and HADS-A (anxiety) scores compared with past and never-smokers after being adjusted for covariables. No significant differences were observed in any of the other analyzed demographic, clinical, and therapeutic variables. Thirty percent of the current and past smokers groups had never had their neurologists discuss smoking cessation with them. Individuals with MS who were current smokers had higher fatigue and anxiety scores and worse HRQOL compared with past and never-smokers.

Physical activity as a mediator in the relationship between health locus of control and health-related quality of life in multiple sclerosis patients with different disease duration

BackgroundThe importance of undertaking physical activity for functioning of patients with multiple sclerosis (MS) has been repeatedly highlighted. However, the research on the role of physical activity in shaping the quality of life of patients with different disease duration is scarce. ObjectiveThe aim of this study was to identify the mediating role of physical activity in the relationship between health locus of control (HLoC) and health-related quality of life in MS patients with varying disease duration. MethodsThe study included 339 patients with MS from rehabilitation centers. The Multiple Sclerosis Impact Scale (MSIS-29) was used to measure health-related quality of life, physical activity was assessed by the Godin Leisure Time Exercise Questionnaire (GLTEQ) and the Health Locus of Control Questionnaire was used to measure HLoC. ResultsPhysical activity has been shown to be a mediator in the relationship between intrinsic HLoC and health-related quality of life particularly in patients with longer disease duration. Intrinsic HLoC was positively associated with engaging in physical activity, which in turn was positively associated with the physical component of quality of life in patients with longer (indirect effect: β = −0.077, p < 0.05) and moderate (β = −0.040, p < 0.05) duration of illness. ConclusionThe results highlight the importance of psychological resources for undertaking quality-of-life-related physical activity by MS patients with long disease duration. Particularly important here is the internal HLoC, which promotes physical activity that increases the chance of a high quality of life.