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BACKGROUND Being a parent can be demanding and stressful, especially for people with chronic diseases such as multiple sclerosis (MS). Parenting can be disrupted by flareups, disease worsening, and other MS symptoms, including mobility problems, pain, fatigue, and cognitive impairment. Mood disorders, such as depression and anxiety, have been found to occur at much higher rates in people with MS than in the general population. Surprisingly, less is known about which factors may predict mood disorders in parents with MS. This study aims to identify potential demographic, clinical, and self-reported predictors that contribute to mood disorders measured by the Hospital Anxiety and Depression Scale. METHODS A total of 285 parents with MS completed an anonymous online questionnaire combining sociodemographic, clinical, and family characteristics and scales, validated in Italian, related to coping strategies and social support. Associations between each variable and mood disorders were assessed using univariate and multivariate logistic regression analyses. RESULTS Disability level, emotional and dysfunctional coping strategies, and perceived social support were significant predictors of mood disorders in parents with MS. CONCLUSIONS These findings confirm the importance of identifying risk factors for mood disorders in parents with MS so that early intervention can minimize mood disruptions caused by the disease.

Background Comorbid conditions are common in people with multiple sclerosis (pwMS). They can delay diagnosis and negatively impact the disease course, progression of disability, therapeutic management, and adherence to treatment. Objective To quantify the economic impact of comorbidity in multiple sclerosis (MS), based on cost-of-illness estimates made using a bottom-up approach. Methods A retrospective study was carried out in two northern Italian areas. The socio-demographic and clinical information, including comorbidities data, were collected through ad hoc anonymous self-assessment questionnaire while disease costs (direct and indirect costs of disease and loss of productivity) were estimated using a bottom-up approach. Costs were compared between pwMS with and without comorbidity. Adjusted incremental costs associated with comorbidity were reported using generalized linear models with log-link and gamma distributions or two-part models. Results 51.0% of pwMS had at least one comorbid condition. Hypertension (21.0%), depression (15.7%), and anxiety (11.7%) were the most prevalent. PwMS with comorbidity were more likely to use healthcare resources, such as hospitalizations (OR = 1.21, p p p = 0.012), and to incur non-healthcare costs related to investment (OR = 1.32, p p p p = 0.16). Finally, they experienced greater productivity losses (OR = 1.34, p Conclusion Comorbidity has health, social, and economic consequences for pwMS.

Purpose The aim was to carry out a systematic review dedicated to describing the work barriers and the job adjustments that are particularly sensitive to people with Multiple Sclerosis (PwMS). Methods Four electronic databases (PubMed/MEDLINE, Scopus, SciVerse ScienceDirect, and Web of Science) were searched for peer-reviewed original articles reporting the barriers at work and/or the job adjustments used by PwMS. MS must have been diagnosed according to accepted international criteria at the time of the study and/or confirmed by a doctor. No time limits were set for the search. Articles that were published in English, Italian, Spanish, French, and Portuguese were accepted. Each article was screened by three experienced and trained investigators. The protocol was registered in PROSPERO (CRD42022299994). Results The initial systematic search yielded 104,228 results, of which 49 articles provided sufficient information and were considered suitable for inclusion in the study. Overall, the studies included 30283 participants with MS. Thirteen (27.1%) studies reported on barriers to work, 14 (29.2%) addressed reasonable adjustments and 21 (43.7%) assessed both outcomes. Job characteristics are the most important barriers for PwMS. Other reported barriers concern the work environment, social relationships at work, negative work events and lack of information. PwMS are more vulnerable to the need for adjustments at the workplace, being the management of the workload the most commonly used one. Conclusions PwMS are exposed to a wide variety of work barriers and job adjustments. Future studies are still highly encouraged on the topic.

BACKGROUND Balance impairments are common in multiple sclerosis (MS) with reduced ability to maintain position and delayed responses to postural adjustments. Pilates is a popular alternative method for balance training that may reduce the rapid worsening of symptoms and the increased risk of secondary conditions (e.g. depression) frequently associated with physical inactivity. An Italian network of fifteen Centres specialized in MS rehabilitation developed the MS-FIT exergame to autonomously train balance through Pilates exercises. OBJECTIVE Here, we describe the design, development and usability testing of MS-FIT, a Kinect-based tool implementing Pilates exercises customized for MS. METHODS MS-FIT has been developed through a User-Centered Design approach (design, prototype, user feedback and analysis) allowing gaining the target user’s perspective. A team composed of one physical therapist, two game programmers and one game designer provided the first version of MS-FIT that integrated knowledge and experience of the team with MS literature findings related to Pilates exercises and balance interventions based on exergames. MS-FIT, developed by using the Unity 3D game engine software with Kinect Sensor V2 for Windows, implements exercises for breathing, posture and balance. Feedbacks from neurologists, physiatrists, physical therapists and people with MS (PwMS) were collected to customize the tool for a use in MS. The MS-FIT context is the travel around the world to visit some of the most important cities in order to learn aspects of their culture through pictures and stories. At each stay of the travel, the avatar of a teacher of Pilates shows the user the exercises to be performed. Nine PwMS (4 females; mean age: 42.89 ± 11.97 years; mean disease duration 10.19 ± 9.18 years; Expanded Disability Status Scale: 3.17 ± 0.75) were involved in three outpatient user-test sessions of 30 minutes; the MS-FIT usability was assessed through an ad-hoc questionnaire (maximum value = 5; higher the score, higher the usability) evaluating easiness-to-use, playability, enjoyment, satisfaction and acceptance. RESULTS All nine PwMS completed the sessions of user-test and answered the ad-hoc questionnaire. The average score on each item ranged from 3.78 and 4.11, which indicated a high usability level. The feedbacks and suggestions provided by the 9 PwMS and by the 5 therapists involved in the user-test were implemented to refine the first prototype in order to release the MS-FIT 2.0. CONCLUSIONS MS-FIT is a highly usable tool and is a promising system for enhancing motivation and engagement of PwMS in performing exercise with the aim to improve their physical status.

Objective To describe the disruptions in care experienced by persons with Multiple Sclerosis in Italy due to the COVID-19 pandemic and the self-reported impact on their health and wellbeing. Methods A cross-sectional online survey was completed by 2722 persons with Multiple Sclerosis, after Italy instituted a national lockdown in response to the pandemic. Results Persons with Multiple Sclerosis reported that the pandemic caused broad disruptions to usual health and social care services, which impacted on their health and wellbeing. Disruptions in care were consistently associated with negative self-reported impacts on the expected progression of the disease, on out-of-pocket expenditure and on carer’s stress. Psychological consequences were associated with interruption to usual psychological support, and concerns about the safety of care delivered in person. Conclusions The quality of life of persons with Multiple Sclerosis depends greatly on prompt access to a broad range of health and care services. Negative psychological impacts reported by persons with Multiple Sclerosis with less severe disabilities show that accessible integrated services are crucial for maintenance of their wellbeing. Most persons with Multiple Sclerosis with more severe disability experienced negative impacts on perceived health. Their carers compensating for lack of social input resulted in care overburden. As continuity of care is crucial for persons with Multiple Sclerosis, as well as for persons with chronic conditions in general, strategies must be in place to ensure it is included in future pandemic response plans.

Background Multiple sclerosis (MS) is a chronic neuroinflammatory and neurodegenerative disease negatively impacting patients’ physical, psychological and social well-being with a significant economic burden. Objectives The study estimates MS burden and cost of illness in Italy from a societal perspective in 2019. Methods Information on the impact of the disease on daily activities, symptoms, employment, resource utilization and the role of caregivers was collected through questionnaires completed by 944 patients and caregivers. Results were stratified according to both disease severity and payer. Mean costs and overall costs were extrapolated from the sample to the Italian MS population considering published distribution of severity. Results The study showed a great impact of the disease on daily and work activities increasing with the disability. The overwhelming burden of fatigue emerged. Mean annual costs were estimated at €39,307/patient (€29,676, €43,464 and €53,454 in mild, moderate and severe cases, respectively). Direct healthcare costs were the major component (€21,069), followed by indirect costs (€15,004). The overall cost of the disease in Italy was €4.8 billion. The National Healthcare System (NHS) sustained most of the costs (80%), most notably direct healthcare costs, while patients paid almost all non-healthcare expenses. Conclusions This study confirmed that MS carries a substantial burden to patients and society, highlighting the need for awareness of this disease.

Background and ObjectivesSeveral studies have assessed risk factors associated with the severity of COVID-19 outcomes in people with multiple sclerosis (PwMS). The potential role of disease-modifying therapies (DMTs) and demographic and clinical factors on the risk of acquiring SARS-CoV-2 infection has not been evaluated so far. The objective of this study was to assess risk factors of contracting SARS-CoV-2 infection in PwMS by using data collected in the Italian MS Register (IMSR).MethodsA case-control (1:2) study was set up. Cases included PwMS with a confirmed diagnosis of COVID-19, and controls included PwMS without a confirmed diagnosis of COVID-19. Both groups were propensity score–matched by the date of COVID-19 diagnosis, the date of last visit, and the region of residence. No healthy controls were included in this study. COVID-19 risk was estimated by multivariable logistic regression models including demographic and clinical covariates. The impact of DMTs was assessed in 3 independent logistic regression models including one of the following covariates: last administered DMT, previous DMT sequences, or the place where the last treatment was administered.ResultsA total of 779 PwMS with confirmed COVID-19 (cases) were matched to 1,558 PwMS without COVID-19 (controls). In all 3 models, comorbidities, female sex, and a younger age were significantly associated (p < 0.02) with a higher risk of contracting COVID-19. Patients receiving natalizumab as last DMT (OR [95% CI]: 2.38 [1.66–3.42], p < 0.0001) and those who underwent an escalation treatment strategy (1.57 [1.16–2.13], p = 0.003) were at significantly higher COVID-19 risk. Moreover, PwMS receiving their last DMT requiring hospital access (1.65 [1.34–2.04], p < 0.0001) showed a significant higher risk than those taking self-administered DMTs at home.DiscussionThis case-control study embedded in the IMSR showed that PwMS at higher COVID-19 risk are younger, more frequently female individuals, and with comorbidities. Long-lasting escalation approach and last therapies that expose patients to the hospital environment seem to significantly increase the risk of SARS-CoV2 infection in PwMS.Classification of EvidenceThis study provides Class III evidence that among patients with MS, younger age, being female individuals, having more comorbidities, receiving natalizumab, undergoing an escalating treatment strategy, or receiving treatment at a hospital were associated with being infected with COVID-19. Among patients with MS who were infected with COVID-19, a severe course was associated with increasing age and having a progressive form of MS, whereas not being on treatment or receiving an interferon beta agent was protective.

Objective To identify factors that influence the perception parents with multiple sclerosis have of their competence in parenting. Method/design Subjects were parents of a child with a maximum of 18 years of age recruited through a national multiple sclerosis organization’s social media channels. Data on demographic and disease information, mood, coping, quality of life and perceived social support were collected using an anonymous online questionnaire. Univariate and multivariate analyses were performed to assess associations between these variables and subjects’ perception of parenting sense of competence. Results The sample consisted of 285 parents with multiple sclerosis, with a mean age of 41 years and a mean disease duration of 10.4 years. In the multivariate analysis, independent determinants of lower parenting sense of competence were anxiety ( p = 0.012), depression ( p = 0.001) and dysfunctional coping ( p = 0.005). Problem-focused coping ( p = 0.029) and higher physical and mental scores on the SF-12 ( p = 0.006, p < 0.001, respectively) were related to a higher parenting sense of competence. Higher parent age correlated with a lower sense of parenting competence ( p = 0.002). Conclusions The perception parents with multiple sclerosis have of their parenting competence was most strongly correlated with mood, coping strategies and health-related quality of life, factors that are potentially modifiable.

Although mind wandering (MW) is associated with various psychological aspects frequently affected in people with Multiple Sclerosis (PwMS), there is lack of validated tools to assess MW in this clinical population.This psychometric study aimed to assess structural and construct validity and reliability of a brief Italian version of Mind Wandering (MW) Scale that measures two different dimensions of MW, i.e., spontaneous (MW-S) and deliberate (MW-D).Structural validity of the MW Scale was assessed by explorative factor analysis (EFA). To investigate construct validity, mood (Hospital Anxiety Depression Scale) and personality (10-items Big Five Inventory Test) were correlated with MW constructs. Reliability was assessed by Cronbach's α for internal consistency and intraclass correlation coefficients.EFA confirmed two distinct constructs of MW, i.e., MW-S and MW-D, also in PwMS. This tool appropriately fits the graded response model, supporting validity (about 79% of hypotheses for convergent and discriminant constructs confirmed) and internal consistency (MW-S: Cronbach's α = 0.84; MW-D: Cronbach's α = 0.88).MW Scale could be a useful tool to measure MW also in PwMS. As MW seems to be connected to clinical manifestations of MS, a detailed assessment of MW should be encouraged in clinical practice.

The objective of the study was to describe and analyze the stigma, discrimination and the disclosure of the diagnosis of Multiple Sclerosis (MS) in the workplace. The protocol was registered in PROSPERO (CRD42022320437). We systematically searched four scientific databases with key search terms. We included any original peer-reviewed articles reporting the stigma or discrimination experienced at work due to MS or the disclosure of the diagnosis of MS in the workplace. No time limits were set for the search. An appraisal of the individual study quality was performed with the JBI critical appraisal checklist. Overall, 26 studies were deemed to fulfil all the eligibility criteria. The total number of participants in this review was 9571. The prevalence of people with MS who experience some degree of stigma in the workplace can be as high as 79.2%. Those who report greater feelings of discrimination are more likely to be unemployed. The prevalence of employers’ and co-workers’ awareness of the diagnosis varies from 31.7 to 90.2%. The main reason for non-disclosure is the fear of being discriminated against. The psychosocial work environment needs to be taken into consideration as part of public and individual policies to promote the health of patients with MS.

Machine learning (ML) applied to patient-reported (PROs) and clinical-assessed outcomes (CAOs) could favour a more predictive and personalized medicine. Our aim was to confirm the important role of applying ML to PROs and CAOs of people with relapsing-remitting (RR) and secondary progressive (SP) form of multiple sclerosis (MS), to promptly identifying information useful to predict disease progression. For our analysis, a dataset of 3398 evaluations from 810 persons with MS (PwMS) was adopted. Three steps were provided: course classification; extraction of the most relevant predictors at the next time point; prediction if the patient will experience the transition from RR to SP at the next time point. The Current Course Assignment (CCA) step correctly assigned the current MS course with an accuracy of about 86.0%. The MS course at the next time point can be predicted using the predictors selected in CCA. PROs/CAOs Evolution Prediction (PEP) followed by Future Course Assignment (FCA) was able to foresee the course at the next time point with an accuracy of 82.6%. Our results suggest that PROs and CAOs could help the clinician decision-making in their practice.

ObjectivesTo update the knowledge on the occupational outcomes associated with multiple sclerosis (MS), systematically examine the extent, scope and nature of the pre-existing literature and identify research gaps in the existing literature.DesignScoping review.Data sourcesA comprehensive database search of PubMed/MEDLINE, Scopus, SciVerse ScienceDirect and Web of Science was performed. There were no time limits.Eligibility criteriaWe included any peer-reviewed original article reporting the occupational outcomes of people with MS between the ages of 18 and 65 years. We excluded those off-topic and with insufficient information.MethodsThis review was conducted following the Joanna Briggs Institute recommendations and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for scoping review checklist. Screening, reading of full-texts and data extraction was performed in a standardised way by expert reviewers from 14 July 2021 to 31 October 2021. We provided a narrative synthesis and an overview of findings.ResultsThe initial systematic search yielded 104 228 results. After removing duplicates and applying the exclusion criteria, 403 articles were included in the review. In total, the studies evaluated 492 062 subjects with MS. One hundred fifty-four (38.2%) articles were published in the last 5 years, mostly from Europe and North America (50.9% and 33.0%, respectively). Concerning the occupational outcomes, studies mostly addressed unemployment (311, 77.2%), early retirement (120, 29.8%), disability pension (117, 29.0%), sick leave (77, 19.1%), the indirect cost of MS (74, 18.4%) and work characteristics (57, 14.1%). The results were categorised into seven subtopics: ‘Changes in work and occupational status due to MS’, ‘work-related socio-economic consequences of MS’, ‘risk factors for unfavourable occupational outcomes’, ‘reported barriers to employment’, ‘reported job accommodations and vocational rehabilitation strategies’, ‘job satisfaction, stigma, and disclosing the diagnosis in the workplace’ and ‘rating clinical scales’.ConclusionsThere are several issues that deserve further in-depth study by the scientific community in order to improve the occupational outcomes of people with MS.

Background Since combining information from different domains could be useful to increase prediction accuracy over and above what can be achieved at the level of single category of markers, this study aimed to identify distinct and predominant subtypes, i.e., cognitive phenotypes, in people with multiple sclerosis (PwMS) considering both cognitive impairment and mood disorders. Methods A latent class analysis (LCA) was applied on data from 872 PwMS who were tested with Montreal Cognitive Assessment (MoCA), Symbol Digit Modalities Test (SDMT) and Hospital Anxiety and Depression Scale (HADS). Furthermore, the distribution of demographic (i.e., age, gender, years of education) and clinical characteristics (i.e., disease duration, disease course, disability level) was examined amongst the identified phenotypes. Results Based on model fit and parsimony criteria, LCA identified four cognitive phenotypes: 1) only memory difficulties (n = 247; 28.3%); 2) minor memory and language deficits with mood disorders (n = 185; 21.2%); 3) moderate memory, language and attention impairments (n = 164; 18.8%); 4) severe memory, language, attention, information processing and executive functions difficulties (n = 276; 31.7%). Conclusions Since less is known about the progressive deterioration of cognition in PwMS, a taxonomy of distinct subtypes that consider information from different clustered domains (i.e., cognition and mood) represents both a challenge and opportunity for an advanced understanding of cognitive impairments and development of tailored cognitive treatments in MS.

Background Little is known about the economic consequences of living with severe multiple sclerosis (SMS). Aims To assess the cost-effectiveness of a home-based palliative approach (HPA) for people with SMS (pwSMS). To assess direct healthcare costs in this population. Methods PwSMS from three Italian centers received (2:1 ratio) HPA or usual care over six months. Direct healthcare costs were collected on a monthly basis. Incremental cost-effectiveness was gauged from a national healthcare system (NHS) and a personal perspective, considering the Palliative Outcome Scale-Symptoms-MS (POS-S-MS) and the EuroQol five-dimension descriptive system quality-adjusted life years (EQ-5D-3L QALYs), both completed at baseline, after three and six months. Results Of 78 randomized pwSMS, 76 (50 HPA, 26 usual care) were analyzed. Mean QALYs were close to zero, and the mean group difference was -0.006 (95% CI -0.057 to 0.044). The mean baseline-adjusted cost difference was € -394 (95% confidence interval, CI -3,532 to 2,743). POS-S-MS cost-effectiveness showed a slight mean reduction of symptom burden (-1.9; 95% CI -1.1 to 5.0) with unchanged costs. Mean direct costs due to MS were € 23,195/year, almost equally distributed between NHS (€ 13,108) and pwSMS (€ 10,087). Personal care, medications and home rehabilitation accounted for 80% of total expenditures. Most personal care costs were covered by pwSMS, and these costs were 3/4 of pwSMS out-of-pocket. Conclusions The slight reduction of symptom burden produced by the HPA was not associated with an increase in costs. NHS and pwSMS almost equally sustained these costs. Trial registration Current Controlled Trials ISRCTN73082124.

Objective: This study was undertaken to assess the impact of immunosuppressive and immunomodulatory therapies on the severity of coronavirus disease 2019 (COVID-19) in people with multiple sclerosis (PwMS). Methods: We retrospectively collected data of PwMS with suspected or confirmed COVID-19. All the patients had complete follow-up to death or recovery. Severe COVID-19 was defined by a 3-level variable: mild disease not requiring hospitalization versus pneumonia or hospitalization versus intensive care unit (ICU) admission or death. We evaluated baseline characteristics and MS therapies associated with severe COVID-19 by multivariate and propensity score (PS)-weighted ordinal logistic models. Sensitivity analyses were run to confirm the results. Results: Of 844 PwMS with suspected (n = 565) or confirmed (n = 279) COVID-19, 13 (1.54%) died; 11 of them were in a progressive MS phase, and 8 were without any therapy. Thirty-eight (4.5%) were admitted to an ICU; 99 (11.7%) had radiologically documented pneumonia; 96 (11.4%) were hospitalized. After adjusting for region, age, sex, progressive MS course, Expanded Disability Status Scale, disease duration, body mass index, comorbidities, and recent methylprednisolone use, therapy with an anti-CD20 agent (ocrelizumab or rituximab) was significantly associated (odds ratio [OR] = 2.37, 95% confidence interval [CI] = 1.18–4.74, p = 0.015) with increased risk of severe COVID-19. Recent use (

Introduction: Arm and hand function deficits are commonly in people with multiple sclerosis (PwMS). The Arm Function in Multiple Sclerosis Questionnaire (AMSQ) is a novel self-administered instrument specifically developed to evaluate upper limb function in MS. The aim of this study was to translate and adapt the AMSQ into Italian and to assess its psychometric properties in PwMS. Validity (structural, construct, and known-groups) and reliability (internal consistency, test-retest, and measurement error) were assessed. Materials and methods: From June 2017 to February 2018, a prospective cohort of PwMS among those followed as outpatients at the Rehabilitation Services of the Italian Multiple Sclerosis Society (AISM) of Genoa, Padua, and Vicenza was involved in the study. Construct validity of AMSQ was determined by examining correlations with the Italian version of ABILHAND, Modified Fatigue Impact Scale (MFIS), and Functional Independence Measure (FIM). Results: A total of 234 PwMS were enrolled. The mean AMSQ total score was 67.3 (SD = 38.4). Factor analysis results suggested one factor. As expected, moderate to high correlation coefficients were found between AMSQ and ABILHAND (− 0.79), MFIS (0.50) and its subsets, and FIM (− 0.60) and its subsets involving upper limb functioning. PwMS with higher EDSS reported worse total score of AMSQ than patients with low disability. The internal consistency of the 31 items was high (Cronbach’s α, 0.98). Test-retest reliability, as measured with ICC, was 0.96 (95% IC, 0.93–0.98), and measurement error was about 8.3 points showing good reliability. Discussion: AMSQ has been adapted and validated, it is a reliable questionnaire for Italian PwMS.

Background Multiple Sclerosis (MS) is a complex and progressive disease of the central nervous system. In Italy, prevalence of MS ranges from 198 (continental Regions) to 370 (Sardinia) per 100,000. Despite a National Health System, differences among Regions cause inequalities in access to and quality of care, also involving chronic diseases and disabilities, including MS. Methods Interviews and focus groups involving persons with MS, caregivers, institutions, patients association and other stakeholders were conducted in 2019, to evaluate MS policy landscape, existing services, guidelines and care pathways regarding diagnosis, therapy, follow up, strenghts and weaknesses. Results 600 MS specialized neurologists and 350 MS nurses operate in 240 MS Centers located in hospital neurology departments providing clinical care, disease modifying drugs (DMDs), interdisciplinary care. 13 Regions on 20 approved a PDTA (Diagnosis, Therapy, Care Pathway), other are due by 2020. A reference national PDTA has been already discussed by Regional Health Authorities Conference and Ministry of Health. Regional multistakeholder observatories will be organized. A national MS registry started in 2017, at present involving over 140 Centers and including data of 50% (60.000 patients) of estimated prevalence. Discussion MS specialized centers are recognized as the key component of MS care in Italy and the main refererral for 80% of patients, also taking in account that over 60% of patients receive a DMD. Access to rehabilitation is lacking and hospital, community and primary care linkage is needed, also considering transition from early stages to severe disability. Access to psycological support is variable and cost containment strategies restrict drug access and symptomatic care in some areas along with lacking of interdisciplinary management. It is mandatory to integrate health and social care pathways accordingly with the National Plan for Chronicity in which MS has to be included. Key messages MS specialized centers are the backbone care network in Italy. Integrated care pathways (PDTA) stated as National Health System rules define the right for the patients to receive the proper care.

While the safety and efficacy of Disease Modifying Therapy (DMT) in multiple sclerosis (MS) are assessed in clinical trials, these are of relatively short duration and always confined to highly selected patient groups. The evaluation of real-world data such as patient registries, is vital as it offers long-term data collection and is patient rather than product-focused during the lifetime of MS, and allows to document a patient's treatment history throughout the disease course. Patient registries can play an important role in monitoring the safety of drus. Regulators and the pharmaceutical industry have shown interest in complementing or even replacing phase 4 clinical studies with data from MS registries. The Italian MS Register (IMSR), in collaboration with the Big MS Data initiative, that also includes the national MS registries of Denmark, France, and Sweden and the international database network MSBase, came together with industry to conduct studies on post-authorization safety (PASS) and treatment effectiveness. The IMSR includes the clinical history of approximately 55,000 patients, or approximatively 45% of the estimated cases of MS in Italy. More than 10,000 patients have a follow-up duration of over 10 years. A Core Protocol outlining principles of PASS projects was created in which aggregated results made available to sponsors and health authorities. The Core Protocol specifies variables, emphasizes improved capture of adverse events, in particular cancer, non-melanoma skin cancers and immunosuppression-related infections, all MedDRA-coded. EUROCAT codes for pregnancy outcomes are also documented. Regulators, the pharmaceutical industry and national-level registries have jointly identified a format of collaboration on PASS for DMT in MS to benefit patients and the larger society. In this way, we hope to contribute to a framework that will include emerging and existing registries with the common goal of contributing to the advancement of knowledge in MS. Key messages The real-world data can contribute to understanding of the impact of disease-modifying therapy on long term. A format of collaboration among clinical research, regulators and pharmaceutical industry could be a winning framework to improve the knowledge on safety and treatment effectiveness in MS.

Introduction Lower urinary tract symptoms (LUTS) are common in individuals with multiple sclerosis (MS), and can have a significant impact on quality of life (QoL). Prevalence of LUTS in MS ranges from 32% to 96.8%, including storage or voiding symptoms or a combination of these. Post-void residual (PVR) is a very well-tolerated, non-invasive test for evaluating voiding dysfunction. The aim of the current study was to describe the distribution of PVR volumes across MS subjects with and without LUTS and to examine relationships between storage symptoms, voiding symptoms, and PVR. Methods A large group of subjects (N = 501) completed a questionnaire on LUTS (current bladder management, number of urinary tract infections in the last year and urological investigations). A bladder ultrasound for PVR was performed and data were collected. We used Chi-Square and the Mann-Whitney non-parametric tests respectively for categorical and continuous variables in order to assess differences between symptomatic and asymptomatic groups. The differences of PVR by LUTS status were explored using the Mann-Whitney non-parametric test for independent samples. Results Overall mean PVR was 132.4 mL (PVR>100 ml was considered an abnormal residual urine volume). Based on the LUTS questionnaire, 43 subjects (8.6%) were asymptomatic, while 458 subjects (91.4%) reported at least one LUTS. Storage-related symptoms were reported by 87.2% of subjects (437) and 65.1% (326) reported at least one voiding-related symptom. Two-third of subjects (66.5%) reported three or more LUTS. There was a statistically significant association between the presence of LUTS and the number of infections reported (p = 0.0015). The symptomatic group had significantly higher PVR than the asymptomatic group (p = 0.011). PVR significantly correlated with male gender, disability level and a progressive disease course. Conclusion Results showed a high prevalence of LUTS in subjects with MS and that storage symptoms are predominant. There was an association between the presence of LUTS and a progressive disease course. The relationship between LUTS, higher PVR and the severity of disease course indicates that a comprehensive clinical evaluation should include an assessment of both neurological and micturition disorders and, importantly, PVR should be measured at every clinical assessment, despite the presence or absence of LUTS.

Background Mood disorders, such as depression and anxiety, are frequent in people with Multiple Sclerosis (PwMS). Although anxiety has a well-recognized negative influence on family, work and social life, it has received less attention than depression. Thus, it is still under debate which risk factors can predict anxiety, its evolution over time and the extent of its effect on disability progression. Objective The aim of this retrospective study was to identify potential demographic, clinical and self-reported predictors that contribute to clinically significant anxiety at one-year follow up, measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). Methods Data was acquired from a cohort of 608 subjects with MS, and included domains potentially meaningful for clinically significant anxiety. Associations between each variable and clinically significant anxiety at one-year follow-up were assessed with univariate and multivariate logistic regression analyses. Results Lower educational level, relapsing-remitting disease course, presence of clinically significant anxiety at baseline, higher depression and fatigue perception were significant predictors for clinically significant anxiety at one-year follow up. Conclusion Findings confirm the importance of identifying risk factors for clinically significant anxiety in predicting prognosis and planning early intervention.

The Patient Information Sheet (PIS) is an important aspect of the consent process in a clinical trial that provides potential participants the necessary information for deciding whether to take part in a specific study and for understanding their rights pertaining to participation. User Testing was originally developed to assess how written information about medicinal products performs with its intended users. User testing has been proposed in a small number of clinical trials and has been able to identify subjects' ability or inability to find and understand important information related to providing a valid consent to participate. A 21-item ad hoc user testing questionnaire was applied to 2 PIS used in clinical trials in MS. Sixty subjects were allocated to a group testing an observational study PIS (O-PIS) or to a group testing an intervention study PIS (I-PIS). In the O-PIS group, 19.4% of subjects located all relevant information within the text (21/21) and 3.4% of subjects in the I-PIS group. Overall, 82.1% of subjects testing the O-PIS understood the text and 53.5% of subjects testing the I-PIS understood the text. In the category 'nature and purpose of the trial', one-third of subjects did not understand the text, including the aim of the study. User testing should be considered as a valid tool in evaluating the comprehensibility of PIS in the context of clinical trials MS to assure that subjects provide a valid consent to participate.

Purpose: This cross-sectional study aims to identify the predictors of work-related difficulties in a sample of employed persons with multiple sclerosis as addressed with the Multiple Sclerosis Questionnaire for Job Difficulties. Materials and methods: Hierarchical linear regression analysis was conducted to identify predictors of work difficulties: predictors included demographic variables (age, formal education), disease duration and severity, perceived disability and psychological variables (cognitive dysfunction, depression and anxiety). The targets were the questionnaire’s overall score and its six subscales. Results: A total of 177 participants (108 females, aged 21–63) were recruited. Age, perceived disability and depression were direct and significant predictors of the questionnaire total score, and the final model explained 43.7% of its variation. The models built on the questionnaire’s subscales show that perceived disability and depression were direct and significant predictors of most of its subscales. Conclusions: Our results show that, among patients with multiple sclerosis, those who were older, with higher perceived disability and higher depression symptoms have more and more severe work-related difficulties. The Multiple Sclerosis Questionnaire for Job Difficulties can be fruitfully exploited to plan tailored actions to limit the likelihood of near-future job loss in persons of working age with multiple sclerosis.Implications for rehabilitationDifficulties with work are common among people with multiple sclerosis and are usually addressed in terms of unemployment or job loss. The Multiple Sclerosis Questionnaire for Job Difficulties is a disease-specific questionnaire developed to address the amount and severity of work-related difficulties.We found that work-related difficulties were associated to older age, higher perceived disability and depressive symptoms.Mental health issues and perceived disability should be consistently included in future research targeting work-related difficulties. Difficulties with work are common among people with multiple sclerosis and are usually addressed in terms of unemployment or job loss. The Multiple Sclerosis Questionnaire for Job Difficulties is a disease-specific questionnaire developed to address the amount and severity of work-related difficulties. We found that work-related difficulties were associated to older age, higher perceived disability and depressive symptoms. Mental health issues and perceived disability should be consistently included in future research targeting work-related difficulties.

People with MS are a heterogeneous population with varying difficulties and needs that are influenced by the individual experience of the disease, symptoms and disease course. The aim of the present study was to identify factors that influence health-related quality of life in a sample of subjects with MS, specifically health and social care-related needs and demographic and disease characteristics.Individuals with a definite diagnosis of MS were identified through MS out-patient clinics and local branches of the Italian MS Society. The EQ-5D-3L utility index was used to describe health profiles and as an overall measure of perceived HRQoL. The number of unmet health and social care-related needs was used to describe the impact of unmet needs on HRQoL. Multiple regression analyses were performed using a hierarchical approach.Data was analyzed from 1013 subjects. Overall, 83% of subjects reported at least one health or social care-related need as being unmet and subjects with a higher number of unmet needs had lower HRQoL (p 0.001). The number of unmet needs was entered at the first step with a statistically significant effect (Cox-Snell RThe study demonstrated that a higher number of both health and social care-related unmet needs predicted lower HRQoL. The health profile of the sample identified all domains of the EQ-5D-3L as being important in determining HRQoL. Data confirms that unmet needs alone are significantly related to reduced HRQoL, although the multifactorial and complex nature of MS makes it a challenge to identify the combination of aspects that fully predict variability in quality of life.

Several multiple sclerosis studies matching self- and physician assessment of disease course and disability show moderate and high agreement respectively. However, the role played by socio-demographic, clinical, and quality of life (QoL) factors was not much investigated. The study aims at exploring how self-/physician agreement could depend on these variables. Participants were asked to report own disease course and disability according to preset categories. Kappa-value and confidence interval (CI) for disease course and two-way random interclass correlation coefficient (ICC) and CI for disability were calculated to evaluate self-/physician agreement. Χ2 was applied to examine whether other factors (gender, age, education, civil status, disease duration, fatigue, quality of life) had systematic effects. Data analysis on 203 participants indicated fair agreement (Kappa-value = 0.30; 95% CI 0.23–0.38) and no dependency on the categories of each variable for disease course. Satisfactory correlation was found for disability (ICC = 0.74; 95% IC 0.67–0.80), good agreement was found for almost all variable categories, and significant differences were observed for education (better agreement for higher levels), disease duration, fatigue and QoL (better agreement for worse conditions). Results seem to suggest that higher education and worse clinical and QoL conditions could engage the patient in developing more disease awareness and realistic self-perception and self-evaluation.

Assessing the coverage by public or private resources in meeting health-related and social-related needs may be useful for service planning and guide optimization of care, important especially in view of an increase in the prevalence of multiple sclerosis (MS). An ad hoc questionnaire assessed satisfaction of health-related and social care–related needs in a cross-sectional study of 1014 people with MS identified through MS outpatient clinics and local branches and social media channels of the Italian MS Society. 87.1% and 79.8% of the responders had experienced at least one health-related or social-related need, respectively. The study demonstrated significant gaps between perceived needs and service provision. Rehabilitation, residential care, and psychological support were most frequently unsatisfied health-related needs, while the more commonly unmet social-related needs were financial support, elimination of architectural barriers, workplace adaptations, and career guidance. The multivariate analysis highlighted that the satisfaction of health-related needs was primarily associated with geographic area of residence. Social-related needs correlated with both clinical and sociodemographic aspects. The results provide insight into the range of interventions, care, and support people with MS report to be important to them at different points in their disease trajectory. More emphasis should be put on the inequitable distribution of NHS services in different geographic areas of Italy as well as on particularly fragile subgroups of the MS population (older individuals, and those with higher levels of disability) because the care of these individuals continues to be assumed by the family.

Background Everyday-life activities often require performing dual tasks (DT), with consequent possible occurrence of motor-cognitive or motor-motor interference. This could reduce quality of life, in particular in people with neurological diseases. However, there is lack of validated tools to assess the patients’ perspective on DT difficulties in this population. Therefore, we developed the Dual-task Impact on Daily-living Activities-Questionnaire (DIDA-Q) and tested its psychometric properties in people with multiple sclerosis (PwMS). Methods Items were generated based on existing scales, DT paradigms used in previous studies and the opinion of a multi-stakeholder group, including both experts and PwMS. Twenty DT constituted the preliminary version of the DIDA-Q which was administered to 230 PwMS. The psychometric properties of the scale were evaluated including internal consistency, validity and reliability. Results Nineteen items survived after exploratory factor analysis, showing a three-factor solution which identifies the components mostly contributing to DT perceived difficulty (i.e., balance and mobility, cognition and upper-limb ability). The DIDA-Q appropriately fits the graded response model, with first evaluations supporting internal consistency (Cronbach's alpha=0.95), validity (70% of the hypotheses for convergent and discriminant constructs confirmed) and reliability (intraclass correlation coefficients=0.95) of this tool. Conclusion The DIDA-Q could be used in research and clinical settings to discriminate individuals with low vs. high cognitive-motor or motor-motor interference, and to develop and evaluate the efficacy of personalized DT rehabilitative treatments in PwMS.

Depression, anxiety, disease severity, and cognitive functions impact on the quality of life of people with MS. However, the majority of studies were not based on multivariate models and did not target employed patients. The aim of this study was to investigate predictors of HRQoL in persons with MS in the workforce considering cognitive, psychological, disease severity, and disability-related variables.Cross-sectional study. Hierarchical block regression analyses were conducted to identify predictors of physical and mental components of HRQoL, measured with the MSQOL-54. Candidate predictors included cognitive functioning (a selection of Rao's BRB-NT), sample features (age, education, MS duration), depressive symptoms (BDI-II), anxiety (STAI-Y), disability (WHODAS 2.0), and MS severity (EDSS): those that correlated with PCS and MCS with p .250 and those that correlated with other predictors with coefficients.800 were excluded from regression analyses.In total, 181 patients (60.8% females, mean age 39.6, median EDSS 1.5) were included. In both models, cognitive variables had a poor explicative power. The models improved significantly when psychological, as well as, disease severity and disability variables were added. R(2) of complete models was 0.732 for the physical component, 0.697 for the mental one: BDI-II, STAI-State and, some WHODAS 2.0 scales were significant predictors of HRQoL.Monitoring anxiety, depressive symptoms, and level of disability through self-reported questionnaires may provide useful suggestions to improve the HRQoL of persons with MS in the workforce, permitting to address possible problems in the work context and plan corrective actions.

Multiple Sclerosis (MS) mainly affects people of working age. The Multiple Sclerosis Questionnaire for Job Difficulties (MSQ-Job) was designed to measure difficulties in work-related tasks. Our aim is to define cut-off score of MSQ-Job to identify potential critical situations that might require specific attention. A sample of patients with MS completed the MSQ-Job, WHODAS 2.0 and MSQOL-54 respectively for work difficulties, disability and health-related quality of life (HRQoL) evaluation. K-means Cluster Analysis was used to divide the sample in three groups on the basis of HRQoL and disability. ANOVA test was performed to compare the response pattern between these groups. The cut-off score was defined using the receiver operating characteristic (ROC) curve analyses for MSQ-Job total and count of MSQ-Job items scores ≥3: a score value corresponding to the maximum of the sensitivity-to-specificity ratio was chosen as the cut-off. Out of 180 patients enrolled, twenty were clustered in the higher severity group. The area under the ROC curve was 0.845 for the MSQ-Job total and 0.859 for the count of MSQ-Job items scores ≥3 while the cut-off score was 15.8 for MSQ-Job total and 8 for count of items scored ≥3. We recommend the use of MSQ-Job with this calculation as cut-off for identifying critical situations, e.g. in vocational rehabilitation services, where work-related difficulties have a significant impact in terms of lower quality of life and higher disability.

OBJECTIVE To assess the parenting sense of competence in mothers and fathers with MS compared to a matched group of healthy parents and to evaluate whether illness features, mood, coping and social support influence parenting sense of competence in mothers and fathers with MS. METHOD/DESIGN Participants in both groups were parents with at least 1 child under 18 years of age. They completed an anonymous online questionnaire of scales on parenting sense of competence, health-related quality of life, coping, depression and anxiety, and perceived social support. Univariate and multivariate analyses were performed to evaluate associations between parents with MS and study outcomes. RESULTS Eighty parents with MS and 80 healthy parents participated in the study. The mean age of the MS group was 41.5 years and 42.8 years in the control group. Both groups were 83.8% female and 16.7% male. A comparison between groups on parenting sense of competence did not highlight a significant difference. Higher scores on the 12-Item Short Form Health Survey, both physical (p < .001) and mental (p = .001) components, contributed to a higher score on the Parenting Sense of Competence scale in the MS group. CONCLUSIONS/IMPLICATIONS Parents with MS in the current study maintained a sense of competence in their parenting role, similar to the healthy control group and quality of life correlated with parenting sense of competence. (PsycINFO Database Record

The impact of the multiple sclerosis (MS) on the individual’s ability to work is important especially because the onset of the disease occurs mainly between 20 and 30 years of age. This study evaluated different factors associated with job maintenance using a questionnaire that defined what factors are considered obstacle or help in work management. A cross-sectional study of people with MS was carried out in Italy. A total of 1016 individuals with MS were enrolled in the study. Our results showed that negative item related to job maintenance as ‘attitudes of other in the workplace’ was associated with a lower likelihood of being employed (OR 0.65, 95 % CI 0.57–0.76), while ‘your attitudes toward work’ (OR 1.37, 95 % CI 1.19–1.59), ‘attitudes of other in the workplace’ (OR 1.41, 95 % CI 1.17–1.69) and ‘personal considerations’ (OR 1.54, 95 % CI 1.23–1.93), positive items related to job maintenance, were associated with a higher likelihood of being employed. In addition, a poor quality of life and severity disease as well same demographic characteristics (i.e. to be resident in South Italy or in the Islands, living in own original family, have lower educational level) inhibited significantly the job maintenance together with a heavy job and a fixed-term contract. In conclusion, a complex set of variables contribute to the barriers faced by PwMS who are employed suggesting that different stakeholders may play an important role in difficult management of the work for people with MS.

Background: Community-based studies are required to accurately describe the supportive services needed by people with multiple sclerosis (MS). Methods: A total of 1205 people with MS participated in a cross-sectional study evaluating their unmet health and social care needs through a questionnaire collecting information used in the study. It was specifically developed by a multi-disciplinary team. Results: Overall, 79% of the responders declared at least one health or social care needs. The most prevalent health care need was the psychological support (27.5%), whereas the transport was the social care need more frequent (over 41%) in our sample. The multivariate analysis highlighted that unmet health care needs depended mainly on clinical factors such as disease stage, influenced by disease duration, and disability degree, whereas the social care needs were related to both clinical and socio-demographic factors. Conclusion: These findings suggest that MS needs significantly change over time during the disease development and to find the best way to personalize PwMS management is crucial. Moreover, more public funding directed at improving the health-related quality of life of people with MS is needed. For this reason, we think that these results will provide important information and baseline data on how to build the national service strategies thereby making healthcare planning more efficient.

Objective: Multiple sclerosis (MS) affects young adults of working age. Difficulties in work-related activities are usually ascribed to MS symptoms, while the impact of workplace features is underestimated. This article presents the Multiple Sclerosis Questionnaire for Job Difficulties (MSQ-Job), designed to assess working difficulties due to MS symptoms and workplace features. Methods: A sample of employed MS patients completed the MSQ-Job, the WHO-Disability Assessment Schedule (WHODAS 2.0) and the 54-items MS Quality of Life Questionnaires (MSQOL-54); the expanded disability status scale (EDSS) was used to define MS severity. Factor structure was evaluated using principal component extraction and Oblimin rotation; internal consistency was assessed with Cronbach's alpha; construct and discriminant validity using t-test (EDSS 0-2 vs >2; patients self-reporting need for support vs patients reporting no needs; full-time vs part-time employees); and Pearson's correlation with WHODAS 2.0 and MSQOL-54. Results: The MSQ-Job is a 42-item questionnaire with six scales and an overall factor. Scores range on a 0-100 scale (higher scores indicate more and more severe difficulties); patients with EDSS>2 and self-reporting support needs had worse scores than those with EDSS 0-2 and without needs. Correlations with WHODAS 2.0 and MSQOL-54 were generally significant (P < 0.0007) and below 0.70. Conclusions: The MSQ-Job jointly measures the impact of respondents' symptoms and workplace features on work activities and enables to assess the effects of clinical and occupational interventions and better describe the impact of MS indirect costs.

Objective: To assess multiple sclerosis (MS) incidence from 1998 to 2007, and MS prevalence on 31 December 2007, in the province of Genoa, Italy. Methods: We identified MS cases diagnosed before 31 December 2007 by analyzing archives of hospitals with neurological or rehabilitation wards, the local Italian MS society, family doctor records and requests for oligoclonal band analysis on cerebrospinal fluid (CSF). Results: A total of 1312 MS patients were residing in the province of Genoa on the prevalence day; 431 (32.85%) were men and 881 (67.15%) were women; mean age was 50.6 (± 13.9). The overall crude MS prevalence rate was 148.5/100,000; 103.1/100,000 in men and 189.1/100,000 in women. The crude mean annual MS incidence rate was 6.6 cases/100,000 (4.4/100,000 men; 8.6/100,000 women). Mean age at diagnosis was 39.5 ± 12.3 (men: 39.9 ± 13.0; women: 39.3 ± 11.9). A mean annual incidence of 4 MS patients ≥ 60 was observed. Conclusions: We observed an increased MS prevalence in the province of Genoa, compared to 1997. The mean age at diagnosis was relatively high (39 years old), 18% of our MS patients were over 65, and a notable incidence increase was seen in patients over 60. This has important implications, in terms of the need to organize the health system to better serve elderly MS patients, especially considering comorbidities and different medical needs of elderly MS patients; and to increase awareness within the medical community about the increasing risk of newly-presenting MS in the older population.

To date, a lack of accurate information about how the different rehabilitation settings are actually delivered to people with multiple sclerosis (PwMS) is still present. Here, we described how PwMS use the different rehabilitation settings in Italy. An observational retrospective study was designed and data collected through an anonymous questionnaire distributed attending MS clinical centers, rehabilitation units, or among PwMS affiliated to the Italian MS Society. We considered as settings: out-patient ambulatory therapy (OUT), hospitalized therapy (HOSP, in-patient and out-patient hospitalized therapy), and home-based therapy (HOME). One thousand six hundred eighty-six subjects at all disability levels were included in the analysis. A high number (53%, n = 890) did not receive rehabilitation care in the last 3 months before the interview. Main causes were probably due to organizational aspects and poor transports and road networks especially in Center and the Islands. The rehabilitation setting profile of the 796 subjects obtaining rehabilitation care consisted in 58.3% (n = 464) receiving only OUT setting, 9.4% (n = 75) only HOSP setting, and 21.7% (n = 173) only HOME setting. We observed a percentage of overlap among different rehabilitation settings: 3.9% (n = 31) OUT-HOME, 3.6% (n = 29) OUT-HOSP, 2.6% (n = 21) HOSP-HOME, and 0.4% (n = 3) OUT-HOME-HOSP. The physiotherapy was the treatment more common among different rehabilitation settings. Only in the in-patient hospitalized therapy setting, the patient received more frequently diversified treatment. Considering the results, the admission to rehabilitation care in Italy is still far from the standards outlined by the recent guidelines that hypothesize a multidisciplinary evaluation and a more individualized rehabilitation plan.

Introduction:In order to estimate the value of interventions in multiple sclerosis (MS) – where lifetime costs and outcomes cannot be observed – outcome data have to be combined with costs. This requires that cost data be regularly updated.Objectives and methods:This study is part of a cross-sectional retrospective study in 16 countries collecting data on resource consumption and work capacity, health-related quality of life (HRQoL) and prevalent symptoms for patients with MS. Descriptive analyses are presented by level of severity, from the societal perspective, in EUR 2015.Results:A total of 1010 patients (mean age = 45 years) participated in Italy. In total, 94% were below retirement age, and of these, 56% were employed. Employment was related to disability, and MS affected productivity at work in 77% of the patients. Overall, 96% and 65% of the patients experienced fatigue and cognitive difficulties as a problem, respectively. Mean utility and total annual costs were 0.735 and €22,900 at Expanded Disability Status Scale (EDSS) of 0–3, 0.534 and €40,100 at EDSS of 4–6.5, and 0.135 and €53,300 at EDSS of 7–9. The mean cost of a relapse was estimated to be €2600.Conclusion:This study illustrates the burden of MS on Italian patients and provides current data on MS that are important for the development of health policies.

Background Studies have shown that people with multiple sclerosis (MS) report low levels of self-efficacy and self-esteem, high levels of anxiety and depression and reduced quality of life. The study aims to assess self-esteem, self-efficacy, mood and quality of life in young adults with MS and to compare them to a healthy control group. Methods The age range for inclusion in the study was between 18 and 35 years of age for both groups. Subjects with MS were recruited through the Italian MS Society. Healthy controls were recruited through social media and from a university undergraduate program. Subjects completed an anonymous online questionnaire combining various scales. Group differences on demographic data were assessed using parametric and non-parametric tests. Analyses of covariance (ANCOVA) were performed to evaluate differences between the two groups on scales of self-perception, mood and quality of life, adjusting for potentially confounding factors. Results Eighty-nine subjects with MS and 109 HC were included in the analysis. ANCOVA failed to demonstrate statistically significant differences between groups on self-esteem (F = 0.11, p = 0.743), self-efficacy (F = 2.22, p = 0.138), mood (anxiety F = 0.03, p = 0.855; depression F = 0.06, p = 0.812) and quality of life (F = 0.08, p = 0.772). Conclusions This study demonstrated that young adults with MS and healthy controls have similar levels of self-esteem and self-efficacy and that they do not differ significantly on measures of mood and quality of life, as previously reported.