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Significant advancements have been achieved in delineating the progress of the Global PROMS (PROMS) Initiative. The PROMS Initiative, a collaborative endeavor by the European Charcot Foundation and the Multiple Sclerosis International Federation, strives to amplify the influence of patient input on MS care and establish a cohesive perspective on Patient-Reported Outcomes (PROs) for diverse stakeholders. This initiative has established an expansive, participatory governance framework launching four dedicated working groups that have made substantive contributions to research, clinical management, eHealth, and healthcare system reform. The initiative prioritizes the global integration of patient (For the purposes of the Global PROMS Initiative, the term "patient" refers to the people with the disease (aka People with Multiple Sclerosis - pwMS): any individual with lived experience of the disease. People affected by the disease/Multiple Sclerosis: any individual or group that is affected by the disease: E.g., family members, caregivers will be also engaged as the other stakeholders in the initiative). insights into the management of MS care. It merges subjective PROs with objective clinical metrics, thereby addressing the complex variability of disease presentation and progression. Following the completion of its second phase, the initiative aims to help increasing the uptake of eHealth tools and passive PROs within research and clinical settings, affirming its unwavering dedication to the progressive refinement of MS care. Looking forward, the initiative is poised to continue enhancing global surveys, rethinking to the relevant statistical approaches in clinical trials, and cultivating a unified stance among 'industry', regulatory bodies and health policy making regarding the application of PROs in MS healthcare strategies.
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BACKGROUND: Multiple sclerosis (MS), because of its early age at onset, greatly impacts the working lives of those affected by it in ways linked to different factors, both professional and personal. It has been observed that only a small percentage (20-40%) of workers with MS retain their jobs after the diagnosis. When identifying factors determining job retention or loss in this setting, it is essential to consider the direct perspectives of people with MS (PwMS). METHODS: A qualitative study, based on the conduction of two focus groups, was conducted to explore the personal experiences of PwMS who work. RESULTS: The results show that there are numerous factors, both positive and negative, that can influence these people's ability to retain their jobs. The climate established in the workplace and the relationship between workers with MS and their colleagues were fundamentally important aspects, as was knowledge of the disease at the level of public opinion. CONCLUSIONS: Managing work is a complex undertaking for people with a disabling condition like MS. There needs to be greater awareness of the employment rights of PwMS. Improving these knowledge-based aspects could undoubtedly improve the quality of the working lives of PwM.
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Personas con Discapacidad , Empleo , Grupos Focales , Esclerosis Múltiple , Investigación Cualitativa , Humanos , Esclerosis Múltiple/psicología , Femenino , Masculino , Adulto , Persona de Mediana Edad , Personas con Discapacidad/psicología , Lugar de Trabajo/psicología , Seguridad del EmpleoRESUMEN
BACKGROUND: This study, conducted on a sample of Italian occupational physicians (OPs), aimed to gather data regarding professional activity and their needs in managing workers with multiple sclerosis. METHODS: A convenience sample of OPs recruited by e-mail invitation to the list of Italian Society of Occupational Medicine members was considered. A total of 220 OPs participated between July and October 2022. An ad hoc questionnaire was developed based on previous survey experiences. It investigated, among others, the characteristics of OP respondents, the evaluation of fitness for work issues, and the OP training and updating needs on multiple sclerosis and work. RESULTS: Ninety-one percent of OPs had to assess the fitness for work of workers with multiple sclerosis during their activity. Sixty-four percent experienced particular difficulties in issuing a fitness for work judgment. Regarding the level of knowledge on multiple sclerosis, 54% judged it sufficient. The "Assessment of fitness for work for the specific task" and the "Role of the OPs in identifying reasonable accommodations" were the most interesting training topics regarding MS management in work contexts chosen by the respondents. CONCLUSIONS: The interest in the work inclusion and job retention of people with disability, particularly the aspects linked to the Identification and implementation of reasonable accommodations, will require integration with the occupational safety and health protection system and will undoubtedly impact the OP's activities.
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Esclerosis Múltiple , Medicina del Trabajo , Humanos , Italia , Esclerosis Múltiple/terapia , Masculino , Femenino , Persona de Mediana Edad , Adulto , Encuestas y Cuestionarios , Evaluación de Capacidad de Trabajo , Médicos LaboralesRESUMEN
BACKGROUND: Mobile health (mHealth) apps have proven useful for people with multiple sclerosis (MS). Thus, easy-to-use digital solutions are now strongly required to assess and monitor cognitive impairment, one of the most disturbing symptoms in MS that is experienced by almost 43% to 70% of people with MS. Therefore, we developed DIGICOG-MS (Digital assessment of Cognitive Impairment in Multiple Sclerosis), a smartphone- and tablet-based mHealth app to self-assess cognitive impairment in MS. OBJECTIVE: This study aimed to test the validity and usability of the novel mHealth app with a sample of people with MS. METHODS: DIGICOG-MS includes 4 digital tests assumed to evaluate the most affected cognitive domains in MS (visuospatial memory [VSM], verbal memory [VM], semantic fluency [SF], and information processing speed [IPS]) and inspired by traditional paper-based tests that assess the same cognitive functions (10/36 Spatial Recall Test, Rey Auditory Verbal Learning Test, Word List Generation, Symbol Digit Modalities Test). Participants were asked to complete both digital and traditional assessments in 2 separate sessions. Convergent validity was analyzed using the Pearson correlation coefficient to determine the strength of the associations between digital and traditional tests. To test the app's reliability, the agreement between 2 repeated measurements was assessed using intraclass correlation coefficients (ICCs). Usability of DIGICOG-MS was evaluated using the System Usability Scale (SUS) and mHealth App Usability Questionnaire (MAUQ) administered at the conclusion of the digital session. RESULTS: The final sample consisted of 92 people with MS (60 women) followed as outpatients at the Italian Multiple Sclerosis Society (AISM) Rehabilitation Service of Genoa (Italy). They had a mean age of 51.38 (SD 11.36) years, education duration of 13.07 (SD 2.74) years, disease duration of 12.91 (SD 9.51) years, and a disability level (Expanded Disability Status Scale) of 3.58 (SD 1.75). Relapsing-remitting MS was most common (68/92, 74%), followed by secondary progressive (15/92, 16%) and primary progressive (9/92, 10%) courses. Pearson correlation analyses indicated significantly strong correlations for VSM, VM, SF, and IPS (all P<.001), with r values ranging from 0.58 to 0.78 for all cognitive domains. Test-retest reliability of the mHealth app was excellent (ICCs>0.90) for VM and IPS and good for VSM and SF (ICCs>0.80). Moreover, the SUS score averaged 84.5 (SD 13.34), and the mean total MAUQ score was 104.02 (SD 17.69), suggesting that DIGICOG-MS was highly usable and well appreciated. CONCLUSIONS: The DIGICOG-MS tests were strongly correlated with traditional paper-based evaluations. Furthermore, people with MS positively evaluated DIGICOG-MS, finding it highly usable. Since cognitive impairment poses major limitations for people with MS, these findings open new paths to deploy digital cognitive tests for MS and further support the use of a novel mHealth app for cognitive self-assessment by people with MS in clinical practice.
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BACKGROUND: The broad implications of caring for a family member with a chronic medical condition, such as MS, can lead caregivers to experience a high burden of care. The aim of the study was to describe profile of MS caregivers and their burden and to explore potential factors influencing this burden. METHODS: 200 family caregivers of a person with MS completed survey questionnaires across a cross-sectional study. Many information were collected: caregiver socio-demographic and health-related data, caregiving activities, knowledge of MS, coping strategies, mood, social support received and care recipient information. Caregiving burden was measured by the ZBI (Zarit Burden Interview). The extent to which the variables explained caregiver burden was analyzed using a hierarchical approach. RESULTS: 68% of the caregivers reported a perceived burden of care (ZBI score > 20). Our results show that physical and mental related-health variables are important predictive factors of the care burden, explaining much of the observed variance (40.9%). CONCLUSION: Family caregivers in MS continue to make up the shortfall produce by national health and welfare systems. We highlighted the importance of good physical and mental health in decreasing perceived burden. Working to alleviate psychological distress through mechanisms focus on reducing worries and perceived burden may be a valid approach.
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Cuidadores , Esclerosis Múltiple , Humanos , Cuidadores/psicología , Estudios Transversales , Esclerosis Múltiple/terapia , Familia/psicología , Salud Mental , Encuestas y CuestionariosRESUMEN
BACKGROUND: The mobile device diffusion has increasingly highlighted the opportunity to collect patient-reported outcomes (PROs) through electronic patient-reported outcomes measurements (ePROMs) during the clinical routine. Despite the ePROMs promises and advantages, the equivalence when a PRO measure is moved from the original paper-and-pencil to the electronic version is still little investigated. This study aims at evaluating equivalence between PROMs and ePROMs self-administration in people with multiple sclerosis (PwMS); in addition, preference of self-administration type was evaluated. METHODS: The Manual Ability Measure-36 (MAM-36) and Fatigue Severity Scale (FSS) were selected for the equivalence test. The app ABOUTCOME was developed through a user-centered design approach to administer the questionnaires on tablet. Both paper-and-pencil and electronic versions were randomly self-administered. Intrarater reliability between both versions was evaluated through the intraclass correlation coefficient (ICC, excellent for values ≥ 0.75). RESULTS: Fifty PwMS (35 females) participated to the study (mean age: 54.7±11.0 years, disease course: 27 relapsing-remitting and 23 progressive; mean EDSS: 4.7±1.9; mean disease duration: 13.3±9.5 years). No statistically significant differences were found for the means total scores of MAM-36 (p = 0.61) and FSS (p = 0.78). The ICC value for MAM-36 and FSS was excellent (0.98 and 0.94, respectively). Most of participants preferred the tablet version (84%). CONCLUSION: The results of the study provide evidence about the equivalence between the paper-and-pencil and electronic versions of PROs administration. In addition, PwMS prefer electronic methods rather than paper because the information can be provided more efficiently and accurately. The results could be easily extended to other MS PROs.
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Esclerosis Múltiple , Femenino , Humanos , Adulto , Persona de Mediana Edad , Anciano , Reproducibilidad de los Resultados , Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple/complicaciones , Encuestas y Cuestionarios , Fatiga/diagnóstico , Fatiga/etiología , ComprimidosRESUMEN
PURPOSE: This study identifies potential predictors of unemployment and describes specific work difficulties and their determinants in a subgroup of employed people with multiple sclerosis (PwMS). The specific work difficulties were evaluated using a validated tool that measures the impact of respondents' symptoms and of workplace features. METHODS: A cross-sectional study was carried out in Italy during 2021-2022. The subjects included were adults (18-65 years) with a diagnosis of MS, currently employed or unemployed. Logistic regression models were used to determine the association between each potential determinant and employment status, while linear regression models were used to determine the association between determinants and specific work difficulties. RESULTS: The main risk factors associated with a higher risk of being unemployed were being older, living in the South of Italy/islands, and having a higher disability level, while protective factors against unemployment were having a high level of education and 'stable' employment (an open-ended contract). Fatigue was found to be associated with all work difficulties analyzed; mood disorders emerged as the main predictors of mental health-related work difficulties; level of disability and comorbidity significantly impacted physical health-related ones, and a good quality of life was found to improve both workplace-related and mental health-related difficulties at work. CONCLUSION: Identifying the most significant difficulties is a crucial step in the development of vocational rehabilitation interventions tailored to maximize the ability of PwMS to handle their job-related duties and demands.
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BACKGROUND: Balance impairments are common in people with 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 (eg, depression) that are frequently associated with physical inactivity. OBJECTIVE: In this paper, we aimed to describe the design, development, and usability testing of MS Fitness Intervention Training (MS-FIT), a Kinect-based tool implementing Pilates exercises customized for MS. METHODS: MS-FIT has been developed using a user-centered design approach (design, prototype, user feedback, and analysis) to gain the target user's perspective. A team composed of 1 physical therapist, 2 game programmers, and 1 game designer developed the first version of MS-FIT that integrated the 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 (Unity Technologies) game engine software with Kinect Sensor V2 for Windows, implements exercises for breathing, posture, and balance. Feedback from an Italian panel of experts in MS rehabilitation (neurologists, physiatrists, physical therapists, 1 statistician, and 1 bioengineer) and people with MS was collected to customize the tool for use in MS. The context of MS-FIT is traveling around the world to visit some of the most important cities to learn the aspects of their culture through pictures and stories. At each stay of the travel, the avatar of a Pilates teacher shows the user the exercises to be performed. Overall, 9 people with MS (n=4, 44% women; mean age 42.89, SD 11.97 years; mean disease duration 10.19, SD 9.18 years; Expanded Disability Status Scale score 3.17, SD 0.75) were involved in 3 outpatient user test sessions of 30 minutes; MS-FIT's 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: A user-centered design approach was used to develop an accessible and challenging tool for balance training. All people with MS (9/9, 100%) completed the user test sessions and answered the ad hoc questionnaire. The average score on each item ranged from 3.78 (SD 0.67) to 4.33 (SD 1.00), which indicated a high usability level. The feedback and suggestions provided by 64% (9/14) of people with MS and 36% (5/14) of therapists involved in the user test were implemented to refine the first prototype to release MS-FIT 2.0. CONCLUSIONS: The participants reported that MS-FIT was a usable tool. It is a promising system for enhancing the motivation and engagement of people with MS in performing exercise with the aim of improving their physical status.
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Priming is a learning process that refers to behavioral changes caused by previous exposure to a similar stimulus. Motor imagery (MI), which involves the mental rehearsal of action representations in working memory without engaging in actual execution, could be a strategy for priming the motor system. This study investigates whether MI primes action execution in Multiple Sclerosis (MS). Here, 17 people with MS (PwMS) and 19 healthy subjects (HS), all right-handed and good imaginers, performed as accurately and quickly as possible, with a pencil, actual or mental pointing movements between targets of small (1.0 × 1.0 cm) or large (1.5 × 1.5 cm) size. In actual trials, they completed five pointing cycles between the left and right targets, whereas in mental trials, the first 4 cycles were imagined while the fifth was actually executed. The fifth cycle was introduced to assess the MI priming effect on actual execution. All conditions, presented randomly, were performed with both dominant (i.e., right) and non-dominant arms. Analysis of the duration of the first 4 cycles in both actual and mental trials confirmed previous findings, showing isochrony in HS with both arms and significantly faster mental than actual movements (anisochrony) in PwMS (p < 0.01) [time (s); HS right: actual: 4.23 ± 0.15, mental: 4.36 ± 0.16; left: actual: 4.32 ± 0.15, mental: 4.43 ± 0.18; PwMS right: actual: 5.85 ± 0.16, mental: 5.99 ± 0.21; left: actual: 6.68 ± 0.20, mental: 5.94 ± 0.23]; anisochrony in PwMS was present when the task was performed with the non-dominant arm. Of note, temporal analysis of the fifth actual cycle showed no differences between actual and mental trials for HS with both arms, whereas in PwMS the fifth actual cycle was significantly faster after the four actual cycles for the non-dominant arm (p < 0.05) [time (s); HS right: actual: 1.03 ± 0.04, mental: 1.03 ± 0.03; left: actual: 1.08 ± 0.04, mental: 1.05 ± 0.03; PwMS right: actual: 1.48 ± 0.04, mental: 1.48 ± 0.06; left: actual: 1.66 ± 0.05, mental: 1.48 ± 0.06]. These results seem to suggest that a few mental repetitions of an action might be sufficient to exert a priming effect on the actual execution of the same action in PwMS. This would indicate further investigation of the potential use of MI as a new motor-cognitive tool for MS neurorehabilitation.
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INTRODUCTION: Balance disorders are common in people with Multiple Sclerosis (PwMS) and, together with other impairments and disabilities, often prevent PwMS from performing their daily living activities. Besides clinical scales and performance tests, robotic platforms can provide more sensitive, specific, and objective monitoring. Validated technologies have been adopted as gold standard, but innovative robotic solutions would represent an opportunity to detect balance impairment in PwMS. AIM: Study's aim was to compare postural assessment of 46 PwMS with a relapsing-remitting form during static tasks performed with the novel robotic platform hunova® and the gold standard EquiTest®, METHODS: Pearson's r was run on Center of Pressure (COP)-related parameters and global static balance measures computed from hunova® and EquiTest® in eyes-open (EO) and eyes-closed (EC) conditions. In addition, agreeableness level toward the use of both devices was tested through numeric rating scale. RESULTS: Considering COP-related parameters, correlations were significant for all measures (p < .001). Interestingly, in EO, a strong correlation was shown for sway area (r = .770), while Medio-Lateral (ML) and Anterior-Posterior (AP) oscillation range, path length, ML and AP speed, ML and AP root mean square distance had a relatively strong association (.454 ≤ r ≤ .576). In EC, except for ML oscillation range showing a relatively strong correlation (r = .532), other parameters were strongly associated (.603 ≤ r ≤ .782). Correlations between global balance indexes of hunova® and EquiTest® revealed a relatively strong association between the Somatosensory Score in EquiTest® and the Somatosensory Index in hunova® (r = - .488). While in EO Static Balance Index from hunova® was highly correlated with Equilibrium score of EquiTest® (r = .416), Static Balance Index had a relatively strong association with both the Equilibrium (r = .482) and Strategy Score (r = .583) of EquiTest® in EC. Results from agreeableness rating scale revealed that hunova® was highly appreciated compared to EquiTest® (p = .044). CONCLUSIONS: hunova® represents an innovative adjunct to standard robotic balance evaluation for PwMS. This confirms that combining traditional and robotic assessments can more accurately detect balance impairments in MS.
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Esclerosis Múltiple , Procedimientos Quirúrgicos Robotizados , Humanos , Equilibrio Postural , Actividades CotidianasRESUMEN
OBJECTIVES: Knowledge about multiple sclerosis (MS) is crucial for those who provide care and support as caregivers. However, despite the key benefits of acquiring relevant information to properly assume the caregiving role, caregivers' knowledge of MS is poorly investigated. The aim of this study was to develop and validate the Caregivers' Knowledge of Multiple Sclerosis (CareKoMS), a self-assessed questionnaire, to test MS knowledge in caregivers of people with MS. DESIGN: Cross-sectional study. SETTING: Italy. PARTICIPANTS: Two-hundred caregivers (female: 49%) were asked to self-administer the 32-item CareKoMS questionnaire; they had a median age of 60 years (IQR: 51-68 years) and a medium-high educational level (36.5% primary school and 63.5% high school/university). Item analysis using item difficulty index, item discrimination index, Kuder-Richardson-20 coefficient and item-total correlation were assessed. Once excluding less useful items, reliability, floor and ceiling effects and construct validity were calculated on the 21-item CareKoMS final version. RESULTS: Psychometric evaluation indicates that the 21-item CareKoMS was a good questionnaire with no ceiling or floor effects registered. Internal consistency was satisfactory and acceptable as indicated by the mean value of 0.74 of Kuder-Richardson-20. No ceiling or floor effects have been observed. Interestingly, educational level and disease duration correlated with MS knowledge. CONCLUSION: CareKoMS is a valid self-assessed questionnaire on MS knowledge for caregivers that may be used in clinical practice and research. Assessing knowledge of MS among caregivers is essential to facilitate their caregiving role and thus decrease the burden of disease management.
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Cuidadores , Esclerosis Múltiple , Humanos , Femenino , Persona de Mediana Edad , Anciano , Estudios Transversales , Psicometría , Reproducibilidad de los Resultados , Encuestas y CuestionariosRESUMEN
INTRODUCTION: Over the years, disease registers have been increasingly considered a source of reliable and valuable population studies. However, the validity and reliability of data from registers may be limited by missing data, selection bias or data quality not adequately evaluated or checked. This study reports the analysis of the consistency and completeness of the data in the Italian Multiple Sclerosis and Related Disorders Register. METHODS: The Register collects, through a standardized Web-based Application, unique patients. Data are exported bimonthly and evaluated to assess the updating and completeness, and to check the quality and consistency. Eight clinical indicators are evaluated. RESULTS: The Register counts 77,628 patients registered by 126 centres. The number of centres has increased over time, as their capacity to collect patients. The percentages of updated patients (with at least one visit in the last 24 months) have increased from 33% (enrolment period 2000-2015) to 60% (enrolment period 2016-2022). In the cohort of patients registered after 2016, there were ≥ 75% updated patients in 30% of the small centres (33), in 9% of the medium centres (11), and in all the large centres (2). Clinical indicators show significant improvement for the active patients, expanded disability status scale every 6 months or once every 12 months, visits every 6 months, first visit within 1 year and MRI every 12 months. CONCLUSIONS: Data from disease registers provide guidance for evidence-based health policies and research, so methods and strategies ensuring their quality and reliability are crucial and have several potential applications.
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Esclerosis Múltiple , Humanos , Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple/epidemiología , Reproducibilidad de los Resultados , Italia/epidemiologíaRESUMEN
BACKGROUND: Regulatory agencies have been responsive to public demand for inclusion of the patient experience in evaluating and approving therapies. Over the years, patient-reported outcome measures (PROMs) have become increasingly prevalent in clinical trial protocols; however, their influence on regulators, payers, clinicians, and patients' decision-making is not always clear. We recently conducted a cross-sectional study aimed at investigating the use of PROMs in new regulatory approvals of drugs for neurological conditions between 2017 and 2022 in Europe. METHODS: We reviewed European Public Assessment Reports (EPARs) and recorded on a predefined data extraction form whether they considered PROMs, their characteristics (e.g., primary/secondary endpoint, generic/specific instrument) and other relevant information (e.g., therapeutic area, generic/biosimilar, orphan status). Results were tabulated and summarized by means of descriptive statistics. RESULTS: Of the 500 EPARs related to authorized medicines between January 2017 and December 2022, 42 (8%) concerned neurological indications. Among the EPARs of these products, 24 (57%) reported any use of PROMs, typically considered as secondary (38%) endpoints. In total, 100 PROMs were identified, of which the most common were the EQ-5D (9%), the SF-36 (6%), or its shorter adaptation SF-12, the PedsQL (4%). CONCLUSIONS: Compared to other disease areas, neurology is one where the use of patient-reported outcomes evidence is inherently part of the clinical evaluation and for which core outcome sets exist. Better harmonization of the instruments recommended for use would facilitate the consideration of PROMs at all stages in the drug development process.
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Aprobación de Drogas , Medición de Resultados Informados por el Paciente , Humanos , Aprobación de Drogas/métodos , Europa (Continente) , Estudios TransversalesRESUMEN
BACKGROUND: In the general population, maternal SARS-CoV-2 infection during pregnancy is associated with worse maternal outcomes; however, only one study so far has evaluated COVID-19 clinical outcomes in pregnant and postpartum women with multiple sclerosis, showing no higher risk for poor COVID-19 outcomes in these patients. OBJECTIVE: In this multicenter study, we aimed to evaluate COVID-19 clinical outcomes in pregnant patients with multiple sclerosis. METHODS: We recruited 85 pregnant patients with multiple sclerosis who contracted COVID-19 after conception and were prospectively followed-up in Italian and Turkish Centers, in the period 2020-2022. A control group of 1354 women was extracted from the database of the Multiple Sclerosis and COVID-19 (MuSC-19). Univariate and subsequent logistic regression models were fitted to search for risk factors associated with severe COVID-19 course (at least one outcome among hospitalization, intensive care unit [ICU] admission and death). RESULTS: In the multivariable analysis, independent predictors of severe COVID-19 were age, body mass index ⩾ 30, treatment with anti-CD20 and recent use of methylprednisolone. Vaccination before infection was a protective factor. Vaccination before infection was a protective factor. Pregnancy was not a risk nor a protective factor for severe COVID-19 course. CONCLUSION: Our data show no significant increase of severe COVID-19 outcomes in patients with multiple sclerosis who contracted the infection during pregnancy.
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COVID-19 , Esclerosis Múltiple , Complicaciones Infecciosas del Embarazo , Embarazo , Humanos , Femenino , ARN Viral , Mujeres Embarazadas , SARS-CoV-2 , Esclerosis Múltiple/epidemiología , Complicaciones Infecciosas del Embarazo/epidemiología , Resultado del EmbarazoRESUMEN
BACKGROUND AND PURPOSE: Although two doses of COVID-19 vaccine elicited a protective humoral response in most persons with multiple sclerosis (pwMS), a significant group of them treated with immunosuppressive disease-modifying therapies (DMTs) showed less efficient responses. METHODS: This prospective multicenter observational study evaluates differences in immune response after a third vaccine dose in pwMS. RESULTS: Four hundred seventy-three pwMS were analyzed. Compared to untreated patients, there was a 50-fold decrease (95% confidence interval [CI] = 14.3-100.0, p < 0.001) in serum SARS-CoV-2 antibody levels in those on rituximab, a 20-fold decrease (95% CI = 8.3-50.0, p < 0.001) in those on ocrelizumab, and a 2.3-fold decrease (95% CI = 1.2-4.6, p = 0.015) in those on fingolimod. As compared to the antibody levels after the second vaccine dose, patients on the anti-CD20 drugs rituximab and ocrelizumab showed a 2.3-fold lower gain (95% CI = 1.4-3.8, p = 0.001), whereas those on fingolimod showed a 1.7-fold higher gain (95% CI = 1.1-2.7, p = 0.012), compared to patients treated with other DMTs. CONCLUSIONS: All pwMS increased their serum SARS-CoV-2 antibody levels after the third vaccine dose. The mean antibody values of patients treated with ocrelizumab/rituximab remained well below the empirical "protective threshold" for risk of infection identified in the CovaXiMS study (>659 binding antibody units/mL), whereas for patients treated with fingolimod this value was significantly closer to the cutoff.
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COVID-19 , Esclerosis Múltiple , Humanos , Vacunas contra la COVID-19 , Formación de Anticuerpos , Clorhidrato de Fingolimod , Esclerosis Múltiple/tratamiento farmacológico , Estudios Prospectivos , Rituximab/uso terapéutico , COVID-19/prevención & control , SARS-CoV-2 , Anticuerpos Antivirales , VacunaciónRESUMEN
Innovative pro-regenerative treatment strategies for progressive multiple sclerosis (PMS), combining neuroprotection and immunomodulation, represent an unmet need. Neural precursor cells (NPCs) transplanted in animal models of multiple sclerosis have shown preclinical efficacy by promoting neuroprotection and remyelination by releasing molecules sustaining trophic support and neural plasticity. Here we present the results of STEMS, a prospective, therapeutic exploratory, non-randomized, open-label, single-dose-finding phase 1 clinical trial ( NCT03269071 , EudraCT 2016-002020-86), performed at San Raffaele Hospital in Milan, Italy, evaluating the feasibility, safety and tolerability of intrathecally transplanted human fetal NPCs (hfNPCs) in 12 patients with PMS (with evidence of disease progression, Expanded Disability Status Scale ≥6.5, age 18-55 years, disease duration 2-20 years, without any alternative approved therapy). The safety primary outcome was reached, with no severe adverse reactions related to hfNPCs at 2-year follow-up, clearly demonstrating that hfNPC therapy in PMS is feasible, safe and tolerable. Exploratory secondary analyses showed a lower rate of brain atrophy in patients receiving the highest dosage of hfNPCs and increased cerebrospinal fluid levels of anti-inflammatory and neuroprotective molecules. Although preliminary, these results support the rationale and value of future clinical studies with the highest dose of hfNPCs in a larger cohort of patients.
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Trasplante de Células Madre Hematopoyéticas , Esclerosis Múltiple , Células-Madre Neurales , Adolescente , Adulto , Humanos , Persona de Mediana Edad , Adulto Joven , Esclerosis Múltiple/terapia , Estudios Prospectivos , Trasplante de Células Madre/métodosRESUMEN
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.
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Esclerosis Múltiple , Humanos , Lugar de TrabajoRESUMEN
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.
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BACKGROUND AND PURPOSE: Clinical outcomes of multiple sclerosis (MS) patients affected by coronavirus disease 2019 (COVID-19) have been thoroughly investigated, but a further analysis on main signs and symptoms and their risk factors still needs attention. The objective of this study was to group together and describe based on similarity the most common signs and symptoms of COVID-19 in MS patients and identify all factors associated with their manifestation. METHOD: Logistic and linear regression models were run to recognize factors associated with each pooled group of symptoms and their total number. RESULTS: From March 2020 to November 2021, data were collected from 1354 MS patients with confirmed infection of COVID-19. Ageusia and anosmia was less frequent in older people (odds ratio [OR] 0.98; p = 0.005) and more in smoker patients (OR 1.39; p = 0.049). Smoke was also associated with an incremental number of symptoms (OR 1.24; p = 0.031), substance abuse (drugs or alcohol), conjunctivitis and rash (OR 5.20; p = 0.042) and the presence of at least one comorbidity with shortness of breath, tachycardia or chest pain (OR 1.24; p = 0.008). Some disease-modifying therapies were associated with greater frequencies of certain COVID-19 symptoms (association between anti-CD20 therapies and increment in the number of concomitant symptoms: OR 1.29; p = 0.05). Differences in frequencies between the three waves were found for flu-like symptoms (G1, p = 0.024), joint or muscle pain (G2, p = 0.013) and ageusia and anosmia (G5, p < 0.001). All cases should be referred to variants up to Delta. CONCLUSION: Several factors along with the choice of specific therapeutic approaches might have a different impact on the occurrence of some COVID-19 symptoms.
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Ageusia , COVID-19 , Esclerosis Múltiple , Humanos , Anciano , Ageusia/epidemiología , Ageusia/etiología , SARS-CoV-2 , Anosmia , Esclerosis Múltiple/complicacionesRESUMEN
OBJECTIVE: Chronic comorbidities are common in people with multiple sclerosis (PwMS), thus worsening their prognosis and quality of life, and increasing disease burden. The aim of the present study was to evaluate the prevalence of common comorbidities in PwMS in Tuscany (Central Italy) and to compare it with the general population. METHODS: The prevalence of comorbidities, including diabetes, chronic obstructive pulmonary disease (COPD), hypertension, stroke, heart failure (HF), cardiac infarction and ischemic heart disease (IHD), was assessed in PwMS and in general population resident in Tuscany, aged > 20 years, using administrative data. RESULTS: In total, we identified 8,274 PwMS. Among them, 34% had at least one comorbidity, with hypertension being the most common (28.5%). Comparing PwMS with the general population, PwMS had a higher frequency of hypertension and stroke when considering the whole group, and of diabetes, COPD, and IHD when considering sex and age subgroups. This increased risk was especially evident in the young and intermediate age groups, where multiple sclerosis may play an important role as risk factor for some comorbidities. In PwMS, as well as in the general population, prevalence of chronic diseases was higher in males and increased with age. CONCLUSIONS: Comorbidities frequently coexist with multiple sclerosis and they may have an impact on this complex disease, from the health, clinical, and socioeconomic points of view. Therefore, a routine screening of chronic comorbidities should be a crucial step in clinical practice, as well as the promotion of healthy lifestyles to prevent the onset and to reduce their burden.