Multiple Sclerosis Impact Scale Research Articles

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.

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.

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 3mg or 5mg 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 5mg compared to 3mg 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 5mg and two on 3mg) 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 5mg melatonin supplementation group had higher concentrations of urinary 6-SMT and serum melatonin compared to the 3mg 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

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.

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.

Association between sun exposure habits and disease progression in multiple sclerosis.

Higher latitude has been associated with increased occurrence of multiple sclerosis (MS) and with more severe disease. The aim was to study the impact of sun exposure habits on MS disease progression and health-related quality of life. Patients from a population-based case-control study were categorized based on sun exposure habits at diagnosis and were followed up to 15 years post-diagnosis through the Swedish MS registry (n = 3314) with regard to changes in Expanded Disability Status Scale (EDSS). Linear mixed models were used to analyse long-term changes, while Cox regression models, with 95% confidence intervals, were used to investigate outcomes, including 24-week confirmed diasability worsening, EDSS3, EDSS4, and physical worsening as measured by the physical component of the Multiple Sclerosis Impact Scale 29. Compared to average sun exposure (median value), low exposure to sunlight was associated with faster EDSS progression, increased risk of confirmed disability worsening (hazard ratio [HR] 1.48, 95% CI 1.21-1.81), increased risk of reaching EDSS 3 (HR 1.35, 95% CI 1.02-1.79), EDSS 4 (HR 1.47, 95% CI 1.01-2.20) and self-reported physical worsening (HR 1.27, 95% CI 1.00-1.62). Significant trends revealed a lower risk of unfavourable outcomes with increasing sun exposure. Very low levels of sun exposure are associated with worse disease progression and health-related quality of life in patients with MS.

Effects of the powerball® system on muscle strength, coordination, fatigue, functionality and quality of life in people with multiple sclerosis. A randomized clinical trial

IntroductionAlthough clinical and functional impairments in the lower limbs have been extensively studied in patients with MS, the upper limb (UL) are also frequently affected. Clinical impairment of the UL in patients with MS is very common with muscle strength and hand dexterity as critical factors in maintaining functional activities that are the basis for independence and quality of life in people with MS.ObjectiveTo investigate the effects of a training protocol using the Powerball® system in combination with conventional physiotherapy on muscle strength, coordination, fatigue, functionality, and quality of life in persons with MS over an 8-week period.Materials and methodsA double-blind randomized controlled trial was conducted. The control group received conventional treatment, while the experimental group received additional UL training using the Powerball® system. Both groups received the same number of sessions and weeks of intervention. The following outcome measures were used: isometric grip and pinch strength, Box and Block Test (BBT), Nine Hole Peg Test (NHPT), Abilhand scale, Fatigue Severity Scale (FSS), Multiple Sclerosis Impact Scale (MSIS-29), and Likert satisfaction questionnaire for the experimental group. All measures were administered at baseline, after the treatment, and during a 3-week follow-up period.Results25 patients completed the study (12 in the experimental and 13 in the control group). The experimental group showed significant improvements in coordination and manual dexterity of the more affected UL as measured by the BBT comparing pre- to post-treatment (p = 0.048) and pre-treatment to follow-up (p = 0.001), and on the less affected UP comparing pre-treatment to follow-up (p < 0.001) and post-treatment to follow-up (p = 0.034). The Likert-type satisfaction questionnaire obtained a mean score of 89.10 (± 8.54) out of 100 points.ConclusionsUpper limb treatment protocol using the Powerball® system, in combination with conventional physiotherapy for 8 weeks resulted in significant improvements in the intra-group analysis for UL coordination and manual dexterity in favor of the experimental group. The experimental group showed excellent satisfaction to the treatment.

Validity and reliability of the Persian version of Recce stigma scale in people with multiple sclerosis and its impact on quality of life.

There is often a fear of social stigma experienced by people with multiple sclerosis (pwMS), which negatively impacts the quality of their lives (QoL). Currently, no Persian-validated questionnaire is available to assess this issue in pwMS. This study aimed to assess the validaty and reliability of the Persian version of Reece Stigma Scale Multiple Sclerosis (RSS-MS) questionnaire for pwMS. This cross-sectional was conducted between January and February 2023 in Isfahan, Iran. The demographic and clinical information and the RSS-MS and Multiple Sclerosis Impact Scale-29 (MSIS-29) questionnaires were recorded from pwMS. The content validity index (CVI) and content validity ratio (CVR) have been used to evaluate validity. To identify the factors supporting the MS-related stigma, an exploratory factor analysis (EFA) was conducted. The present study recruited 194 pwMS. Based on factor analysis, only two factors had eigenvalues ≥ 1.0 and exhibited high internal consistency. The Cronbach's α coefficient for internal consistency of the RSS-MS scale was 0.822. More evidence for the construct validity suggested that having higher levels of stigma is significantly correlated with psychological (r = 0.468, p-value < 0.001) and physical dimensions (r = 0.585, p-value < 0.001) of MSIS-29. Expanded Disability Status Scale, disease duration, and treatment duration did not show a significant correlation with stigma (p-value > 0.05). This study indicated that the modified version of the RSS-MS scale in the Persian language showed acceptable validity and reliability for evaluating the stigma among Persian pwMS. Furthermore, this study emphasizes the cruciality of monitoring and addressing stigma among pwMS, as it can potentially enhance medical, psychological, physical, and QoL outcomes.

Feasibility of a new intervention addressing group-based balance and high-intensity training, physical activity, and employment in individuals with multiple sclerosis: a pilot randomized controlled trial.

Impaired sensorimotor function, reduced physical activity and unemployment are common challenges in persons with multiple sclerosis (pwMS), even when disability is low. CoreDISTparticipation is a new, multidisciplinary intervention delivered across healthcare levels systematically addressing these elements. This study primarily aimed to evaluate the feasibility of CoreDISTparticipation in terms of process, resources, management, and scientific outcomes. The secondary aim was to evaluate initial efficacy in terms of possible short-term effects compared with the usual care on barriers to employment, balance, walking, health-related quality of life (HRQoL), and physical activity. This assessor-blinded prospective pilot randomized controlled trial included 29 pwMS [Expanded Disability Status Scale (EDSS): 0-3.5] randomly allocated to the intervention group (CoreDISTparticipation) (n = 15) or usual care (n = 14). CoreDISTparticipation consists of three phases: (1) hospital outpatient clinic: MS nurse work-focused session and physiotherapist exploring balance; (2) municipality: a digital meeting with pwMS, employer, MS nurse, and physiotherapist addressing employment and physical activity, 4 weeks indoor CoreDIST balance training (60 min × 2/week); and (3) 4 weeks outdoor CoreDIST balance training and high-intensity running/walking (60 min × 2/week). Assessments were undertaken at baseline and at weeks 6 and 11. Primary feasibility metric outcomes were the reporting of process, resources, management, and scientific outcomes. Efficacy measures included evaluation of the Multiple Sclerosis Work Difficulties Questionnaire-23 Norwegian Version (MSWDQ-23NV) and 6 Minute Walk-test as well as the Trunk Impairment Scale-modified Norwegian Version, Mini-Balance Evaluation Systems Test (Mini-BESTest), Multiple Sclerosis Walking Scale-12, Multiple Sclerosis Impact Scale-29 Norwegian Version (MSIS-29NV), ActiGraph wGT3x-BT monitors, and AccuGait Optimized force platform. The statistical analyses included repeated-measures mixed models performed in IBM SPSS Version 29. The primary feasibility metric outcomes demonstrated the need for minor adjustments in regard to the content of the intervention and increasing the number of staff. In regard to the efficacy measures, one person attended no postintervention assessments and was excluded, leaving 28 participants (mean EDSS: 1.8, SD: 1). The mean percentage employment was 46.3 (SD: 35.6) and 65.4 (SD: 39.3) in the CoreDISTparticipation and usual care group, respectively. No between-group differences were found. MSWDQ-23NV demonstrated a within-group difference of 5.7 points from baseline to Week 11 (P = 0.004; confidence interval: 2.2-9.3). Mini-BESTest and MSIS-29NV demonstrated within-group differences. The study is registered in ClinicalTrials.gov (Identifier: NCT05057338). The CoreDISTparticipation intervention is feasible to support pwMS when the identified feasibility metric outcomes in regard to process, resource, management, and scientific outcome metrics are adjusted to improve feasibility. Regarding efficacy measures, no between-group differences were detected; however, within-group differences in barriers to employment, balance, and HRQoL were detected for the CoreDISTparticipation group. A larger comparative trial is needed to explore between-group differences and should accurately and precisely define usual care and address the identified limitations of this study.

Variability of Multiple Sclerosis Walking Scale and Multiple Sclerosis Impact Scale Scores in People Without Multiple Sclerosis.

Introduction Many people with multiple sclerosis (pwMS) experience problems with mobility at some point in their disease course. The Multiple Sclerosis Impact Scale (MSIS) and Multiple Sclerosis Walking Scale (MSWS) are validated patient-reported outcome measures of physical impairment in pwMS. The range of scores on MSIS and MSWS in people without MS (pwoMS) are not well understood. Methods People over the age of 16 who did not have a diagnosis of multiple sclerosis (MS) were invited to complete an online survey consisting of a general health questionnaire, MSIS and the MSWS. Scores for MSIS and MSWS from pwoMS were compared to those from a cohort of 35 pwMS from a previous study. Scores for MSIS and MSWS were correlated with age, sex and comorbidities in pwoMS. Results One hundred eighty-nine ambulant pwoMS were recruited (52.5% female), aged over 16 years of age. Ninety-nine percent reported no difficulty with walking, 89.4% were non-smokers, and 14% had a physical co-morbidity. None used a walking aid. For pwoMS, the MSIS score was a mean of 39.14±13.75 (range 29-127), compared to a mean of 77.2±24.94 (range 40-126) for pwMS. For pwoMS, the mean MSWS score was 8.46±16.2 (0-87) compared to a mean of 56.9±28.9 (4-100) for pwMS. There was no significant effect of sex or smoking on MSIS or MSWS scores in pwoMS. Presence of a physical co-morbidity was associated with significantly higher MSIS and MSWS scores in pwoMS. There was a significant correlation of increasing age with increasing MSWS score in pwoMS but no correlation of age with MSIS score. Conclusion There is a wide range of MSWS and MSIS scores in pwoMS. The age and presence of comorbidities influence both MSWS and MSIS scores. Our findings have implications for the selection of control groups for clinical studies in pwMS.

Physical activity together for MS (PAT-MS): Secondary outcomes of a randomized controlled feasibility trial

BackgroundCare partners provide essential care to those with multiple sclerosis (MS). Dyadic interventions promoting health behaviours have wide-reaching benefits for individuals with MS and their care partners. However, behavioural interventions to promote physical activity in patient-caregiver dyads have yet to be explored in an MS-specific context. This study examined the secondary outcomes of the “Physical Activity Together for Multiple Sclerosis (PAT-MS)” intervention, including dyadic adjustment, caregiving tasks, caregiver quality of life, coping, and MS impact in MS dyads. MethodsA randomized controlled feasibility trial of the 12-week behavioural PAT-MS intervention. The Dyadic Adjustment Scale, Caregiving Tasks in MS Scale, Caregiver Quality of Life in MS Scale, Coping with MS Caregiving Inventory, and MS Impact Scale measured secondary outcomes of interest. Mixed-model ANOVAs were used to test changes in variables between groups (PAT-MS vs wait-list control) over time. Results20 participants, including 10 people with MS (51.4 ± 10.1 years old; median patient-determined disease steps (PDDS) score= 4, IQR= 1.25) and 10 care partners (48.5 ± 12.1 years old) were recruited and randomized. There was no statistically significant effect of the intervention on any of the secondary outcomes (p= 0.67–1.00). However, large effect sizes and condition-by-time interaction effects indicated improvement in dyadic adjustment (d= 1.03, ηp2= 0.45), the criticism-coercion coping subscale (d= -0.93, ηp2= 0.49), and caregiving tasks (d= 1.05, ηp2= 0.52), specifically within psycho-emotional (d= 1.47, ηp2= 0.38) and socio-practical (d= 1.10, ηp2 =0.37) sub-domains of caregiving tasks after the PAT-MS intervention compared to the wait-list condition. ConclusionWhile this pilot feasibility study was not powered based on the secondary outcomes herein, our findings indicate improvement in dyadic adjustment and emotional and social caregiving tasks, with reduced reliance on criticism-coercion coping in the PAT-MS group compared to controls following the intervention. Findings indicate that PAT-MS may improve dyadic psychosocial well-being of people with moderate-to-severe MS and their care partners, and this should be examined next in a fully-powered study.

Comparing the Pathology, Clinical, and Demographic Characteristics of Younger and Older-Onset Multiple Sclerosis.

Older people with multiple sclerosis (MS) have a less active radiological and clinical presentation, but many still attain significant levels of disability; but what drives worsening disability in this group? We used data from the UK MS Register to characterize demographics and clinical features of late-onset multiple sclerosis (LOMS; symptom onset at ≥50 years), compared with adult-onset MS (AOMS; onset 18-49 years). We performed a pathology study of a separate MS cohort with a later onset (n = 18, mean age of onset 54 years) versus AOMS (n = 23, mean age of onset 29 years). In the Register cohort, there were 1,608 (9.4%) with LOMS. When compared with AOMS, there was a lower proportion of women, a higher proportion of primary progressive MS, a higher level of disability at diagnosis (median MS impact scale 36.7 vs. 28.3, p < 0.001), and a higher proportion of gait-related initial symptoms. People with LOMS were less likely to receive a high efficacy disease-modifying treatment and attained substantial disability sooner. Controlling for age of death and sex, neuron density in the thalamus and pons decreased with onset-age, whereas actively demyelinating lesions and compartmentalized inflammation was greatest in AOMS. Only neuron density, and not demyelination or the extent of compartmentalized inflammation, correlated with disability outcomes in older-onset MS patients. The more progressive nature of older-onset MS is associated with significant neurodegeneration, but infrequent inflammatory demyelination. These findings have implications for the assessment and treatment of MS in older people. ANN NEUROL 2024;95:471-486.

Patient-reported outcome parameters and disability worsening in progressive multiple sclerosis

ObjectivesDetection and prediction of disability progression is a significant unmet need in people with progressive multiple sclerosis (PwPMS). Government and health agencies have deemed the use of patient-reported outcomes measurements (PROMs) in clinical practice and clinical trials a major strategic priority. Nevertheless, data documenting the clinical utility of PROMs in neurological diseases is scarce. This study evaluates if assessment of PROMs could track progression in PwPMS. MethodsEmerging blood Biomarkers in Progressive Multiple Sclerosis (EmBioProMS) investigated PROMs (Beck depression inventory-II (BDI-II), multiple sclerosis impact scale-29 (MSIS-29), fatigue scale for motor and cognition (FSMC)) in PwPMS (primary [PPMS] and secondary progressive MS [SPMS]). PROMs were evaluated longitudinally and compared between participants with disability progression (at baseline; retrospective evidence of disability progression (EDP), and during follow up (FU); prospective evidence of confirmed disability progression (CDP)) and those without progression. In an independent cohort of placebo participants of the phase III ORATORIO trial in PPMS, the diagnostic and prognostic value of another PROMs score (36-Item Short Form Survey [SF-36]) regarding CDP was evaluated. ResultsEmBioProMS participants with EDP in the two years prior to inclusion (n = 136/227), or who suffered from CDP during FU (number of events= 88) had worse BDI-II, MSIS-29, and FSMC scores compared to PwPMS without progression. In addition, baseline MSIS29physical above 70th, 80th, and 90th percentiles predicted future CDP/ progression independent of relapse activity in EmBioProMS PPMS participants (HR of 3.7, 6.9, 6.7, p = 0.002, <0.001, and 0.001, respectively). In the placebo arm of ORATORIO (n = 137), the physical component score (PCS) of SF-36 worsened at week 120 compared to baseline, in cases who experienced progression over the preceding trial period (P = 0.018). Worse PCS at baseline was associated with higher hazard ratios of disability accumulation over the subsequent 120 weeks (HR: 2.01 [30th-], 2.11 [20th-], and 2.8 [10th percentile], P = 0.007, 0.012 and 0.005, respectively). ConclusionsPROMs could provide additional, practical, cost-efficient, and remotely accessible insight about disability progression in PMS through standardized, structured, and quantifiable patient feedback.

Multiple sclerosis and quality of life: The role of cognitive impairment on quality of life in people with multiple sclerosis.

Multiple Sclerosis (MS), a chronic disease of the central nervous system (CNS), affects functional ability and quality of life (QoL). Depression, fatigue, and disability status are among the many factors that have been shown to impact QoL in people with MS, but the extent to which MS-related cognitive impairment is related to QoL is understudied in the literature. The purpose of this study was to determine relevant predictors of QoL from a wide list of symptoms including physical disability, and a multi-dimensional computerized cognitive assessment battery (CAB), depression, fatigue, and demographic variables (including employment status). In addition, the unique predictive power of cognitive impairment on QoL was explored in relation to other common factors of disease impact. 171 people with MS (PwMS) were evaluated with a computerized assessment battery (CAB), EDSS examination, and validated Patient Reported Outcome (PRO) measures (Multiple Sclerosis Impact Scale, MSIS-29;Beck Depression Inventory - Second Edition BDI-2; and the Modified Fatigue Impact Scale, MFIS). 171 PwMS were included [Age: 46.02 years ± 9.85, 124 (72.5%) female]. Depression and fatigue scores were highly correlated with MSIS-29. EDSS, unemployment, memory, executive functioning, and motor skills were moderately correlated with MSIS-29. Predictors of QoL were EDSS, depression, fatigue, executive functioning, and attention. Attention and executive functioning were predictive of QoL even after controlling for demographic variables, fatigue, depression, and physical disability status. Findings indicate the need for comprehensive and quantified evaluation of all factors associated with disease burden, which will ultimately serve to improve the QoL in PwMS through more targeted and patient-centered care.

The effect of saffron and corrective exercises on depression and quality of life in women with multiple sclerosis: A randomized controlled clinical trial.

Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system which causes various complications such as reduced ability to do daily activities, depression and early death of patients. The present study aimed to compare the effect of saffron and corrective exercises on depression and quality of life in women with MS. This randomized controlled clinical trial was conducted on 80 MS women for 12 weeks. Participants were selected through convenience sampling and allocated into four study groups (three intervention groups and one control group) using the stratified block randomization. The Expanded Disability Status Scale, Beck Depression Inventory and The Multiple Sclerosis Impact Scale were used to collect data at the start of the study and also at the end of the sixth and the twelfth weeks. At the end of the twelfth week, the depression mean scores in all experimental groups (saffron group, corrective exercises group, corrective exercises+saffron group) were significantly different compared to the control group (P<0.05), and this difference in corrective exercises+saffron group was more than the others. Also, at the end of the twelfth week, the mean scores of the quality of life (both physical and mental dimensions) in all experimental groups were significantly different from the control group (P<0.05). The saffron group in physical dimension and the corrective exercises+saffron group in psychological dimension showed a significant difference with other groups. Although each of the corrective exercises program and saffron consumption alone were effective in reducing depression and enhancing the quality of life in MS patients, the consequences will be more beneficial in case these two interventions are used together. Therefore, it is necessary to encourage MS patients to consume saffron supplement along with doing physical activities in caring and rehabilitation programs.