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BACKGROUND AND OBJECTIVES: The aim of this paper is to analyse the scientific research on multiple sclerosis using a bibliographic analysis of articles published during the period 2003-2012. METHODS: The items under study were obtained from the Science Citation Index-Expanded (SCI-E) database, which was accessed through the Web of Science (WOS) platform. All records with the term 'multiple sclerosis' in the title, plus all articles published in the journals Multiple Sclerosis and Multiple Sclerosis Journal, were analysed. RESULTS: A total of 9778 articles, with 160,966 citations, were retrieved on multiple sclerosis, and the majority of the articles were published in Multiple Sclerosis Journal (n = 1511). The articles were published in journals belonging to 135 different subject areas, with the greatest number of papers falling under the category of clinical neurology. The countries that published the largest numbers of articles were the United States (US) (n = 2786), Italy (n = 1263), the United Kingdom (n = 1147) and Germany (n = 1018). International collaborations produced 20.4% of the papers. CONCLUSIONS: We emphasise the progressive growth of publications worldwide, the publication of articles in a wide variety of journals covering numerous subject areas, and the research leadership of Western countries, most notably European countries, the US and Canada.
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Bibliometría , Bases de Datos Bibliográficas/estadística & datos numéricos , Esclerosis Múltiple , HumanosRESUMEN
OBJECTIVE: The aim of this study is to report the clinical profile and outcome of longitudinally extensive transverse myelitis (LETM). METHODS: We prospectively studied adult patients who presented with LETM from January 2008 to December 2011. Information on demographic, clinical course, magnetic resonance imaging (MRI) and outcome was collected. HLA-DRB1 genotype was compared with those of 225 normal controls and patients with MS (228) and neuromyelitis optica (NMO) (22). RESULTS: In total, 23 patients (16 female) with a median age of 44.5 years (range: 20-77 years) were included. Most (74%) had moderate-severe disability at nadir (48% non-ambulatory), normal/non-multiple sclerosis (MS) brain MRI (96%) and a median MRI cord lesion of 5 vertebral segments (range: 3-19). Laboratory analysis showed cerebrospinal fluid pleocytosis (45%), NMO-IgG (9%), antinuclear antibodies (70%), and genotype HLA-DRB1*13 (57%). The frequency of DRB1*13 genotype was higher compared with controls (p=0.002), MS (p=0.001) and NMO (p=0.003) patients. After a median follow-up of 32 months, one patient converted to MS, two had relapsing LETM with NMO-IgG, and 20 remained as idiopathic with recurrences in four (20%). Twelve (52%) patients recovered with minimal disability (Expanded Disability Status Scale (EDSS) ≤2.5) and three (13%) remained wheelchair dependent. Disability at nadir was associated with the final outcome and extension of the spinal cord lesion with risk of recurrence. Recurrence was not associated with worse outcome. CONCLUSIONS: Inflammatory LETM is mostly idiopathic with a good outcome. It includes a relatively homogenous group of patients with an overrepresentation of the HLA-DRB1*13 genotype. EDSS at nadir is a predictor of the final outcome and extension of the myelitis of the recurrence risk.
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Anticuerpos Antinucleares/líquido cefalorraquídeo , Encéfalo , Cadenas HLA-DRB1/genética , Mielitis Transversa/diagnóstico , Médula Espinal , Adulto , Anciano , Biomarcadores/líquido cefalorraquídeo , Encéfalo/inmunología , Encéfalo/patología , Encéfalo/fisiopatología , Estudios de Casos y Controles , Evaluación de la Discapacidad , Progresión de la Enfermedad , Femenino , Frecuencia de los Genes , Genotipo , Humanos , Leucocitosis/líquido cefalorraquídeo , Leucocitosis/diagnóstico , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Mielitis Transversa/líquido cefalorraquídeo , Mielitis Transversa/genética , Mielitis Transversa/inmunología , Mielitis Transversa/patología , Mielitis Transversa/fisiopatología , Mielitis Transversa/terapia , Fenotipo , Valor Predictivo de las Pruebas , Estudios Prospectivos , Recurrencia , España , Médula Espinal/inmunología , Médula Espinal/patología , Médula Espinal/fisiopatología , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
Experiences of regret associated with caring for patients with multiple sclerosis (MS) can affect medical decisions. A non-interventional study was conducted to assess the dimensionality and item characteristics of a battery including the Regret Intensity Scale (RIS-10) and 15 items evaluating common situations experienced by nurses in MS care. A total of 97 nurses were included. The RIS-10 showed good internal reliability and a unidimensional structure according to Mokken analysis. All-item homogeneity coefficients exceeded 0.30, whereas scalability for the overall RIS-10 was 0.66, indicating a strong scale. This battery showed adequate psychometric properties to evaluate regret among MS nurses.
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BACKGROUND: Sick leave is a common problem among healthcare professionals. Nurses play a critical role in the multidisciplinary management of multiple sclerosis (MS). However, limited information is available on the phenomenon of sick leave among MS nurses. OBJECTIVE: The aim of this study was to assess the presence of sick leave among nurses caring for patients with MS and to identify associated factors. METHODS: We conducted a multicenter, non-interventional, cross-sectional, web-based study. Nurses involved in MS care from across Spain answered a survey composed of demographic characteristics, professional background, questions about their standard practice, and a behavioral battery including the Maslach Burnout Inventory - Human Services Survey (MBI-HSS). A multivariable logistic regression analysis was conducted to determine the association between nurses' characteristics and sick leave. RESULTS: Ninety-six nurses were included in the study. Mean age (SD) was 44.6 (9.8) years, and 91.7% were female. Participants had a median of 6 (IQR 3.0, 11.0) years of expertise in MS managing a median of 15 (5.0, 35.0) patients per week. Sixteen participants (16.7%) had been on sick leave in the last 6 months, with a median absence of 14.5 days (7.0, 30.0). Sixteen nurses (16.7%) reported severe burnout. Participants on sick leave had higher levels of emotional exhaustion (mean MBI-HSS scores of 22.3 and 16.0, p=0.01) and inadequate interactions with their colleagues (mean Practice Environment Scale - Nursing Work Index scores of 11.8 and 13.1, p=0.01) than their counterparts. Burnout was associated with higher risk of sick leave in the multivariable analysis (OR=1.06 [95% CI 1.00, 1.13], p=0.04) after adjustment for confounders. CONCLUSIONS: Occupational burnout is associated with increased risk of sick leave among nurses managing patients with MS. Identifying burnout may be critical for implementing specific intervention strategies to maintain an adequate functioning of MS care units.
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Agotamiento Profesional , Esclerosis Múltiple , Enfermeras y Enfermeros , Adulto , Agotamiento Profesional/epidemiología , Agotamiento Profesional/psicología , Estudios Transversales , Femenino , Humanos , Satisfacción en el Trabajo , Masculino , Atención al Paciente , Ausencia por Enfermedad , Encuestas y CuestionariosRESUMEN
INTRODUCTION: Neuromyelitis optica spectrum disorder (NMOSD) is associated with a reduced health-related quality of life (HRQoL). The purpose of this study was to describe the impact of NMOSD on HRQoL from the patients' perspective and its relationship with other disease factors. METHODS: An observational, cross-sectional study was conducted at 13 neuroimmunology clinics in Spain. Patients with NMOSD diagnosis (2015 Wingerchuk criteria) were included. The 29-item Multiple Sclerosis Impact Scale (MSIS-29) was used to assess the HRQoL. Different questionnaires were used to measure symptom severity, stigma, mood disorders, pain, fatigue, and difficulties in the workplace. Factors that impact HRQoL were identified by Spearman's correlation and multivariate linear regression analysis. RESULTS: Seventy-one patients were included (mean age 47.4 ± 14.9 years, 80.3% female, mean time since disease onset 9.9 ± 8.1 years). The median Expanded Disability Status Scale score was 3.0 (1.5-4.5). The mean (± SD) physical and psychological MSIS-29 sub-scores were 41.9 ± 16.8 and 20.9 ± 8.3, respectively. Fatigue and body pain were the most prevalent symptoms. Depressive symptoms were found in 44.3% (n = 31) of patients. The physical MSIS-29 dimension showed the highest correlation with symptom severity (ρ = 0.85584, p < 0.0001), whereas the highest correlations for psychological MSIS-29 dimension were pain, MSIS-29 physical dimension, and depression (ρ = 0.76487, 0.72779, 0.71380; p < 0.0001, respectively). Pain was a predictor of both dimensions of MSIS-29. CONCLUSION: Fatigue, pain, and depressive symptoms are frequent problems among patients with NMOSD, impacting on their quality of life. Assessment of patient-oriented outcomes may be useful to achieve a holistic approach, allowing early specific interventions.
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Background: The frequency of cognitive impairment (CI) reported in neuromyelitis optica spectrum disorder (NMOSD) is highly variable, and its relationship with demographic and clinical characteristics is poorly understood. We aimed to describe the cognitive profile of NMOSD patients, and to analyse the cognitive differences according to their serostatus; furthermore, we aimed to assess the relationship between cognition, demographic and clinical characteristics, and other aspects linked to health-related quality of life (HRQoL). Methods: This cross-sectional study included 41 patients (median age, 44 years; 85% women) from 13 Spanish centres. Demographic and clinical characteristics were collected along with a cognitive z-score (Rao's Battery) and HRQoL patient-centred measures, and their relationship was explored using linear regression. We used the Akaike information criterion to model which characteristics were associated with cognition. Results: Fourteen patients (34%) had CI, and the most affected cognitive domain was visual memory. Cognition was similar in AQP4-IgG-positive and -negative patients. Gender, mood, fatigue, satisfaction with life, and perception of stigma were associated with cognitive performance (adjusted R2 = 0.396, p < 0.001). Conclusions: The results highlight the presence of CI and its impact on HRQoL in NMOSD patients. Cognitive and psychological assessments may be crucial to achieve a holistic approach in patient care.
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Cognitive impairment (CI) is frequently present in multiple sclerosis patients. Despite ongoing research, the neurological substrates have not been fully elucidated. In this study we investigated the contribution of gray and white matter in the CI observed in mildly disabled relapsing-remitting multiple sclerosis (RRMS) patients. For that purpose, 30 patients with RRMS (median EDSS = 2), and 30 age- and sex-matched healthy controls were studied. CI was assessed using the symbol digit modalities test (SDMT) and the memory alteration test. Brain magnetic resonance imaging, diffusion tensor imaging (DTI), voxel-based morphometry (VBM), brain segmentation, thalamic vertex analysis, and connectivity-based thalamic parcellation analyses were performed. RRMS patients scored significantly lower in both cognitive tests. In the patient group, significant atrophy in the thalami was observed. Multiple regression analyses revealed associations between SDMT scores and GM volume in both hemispheres in the temporal, parietal, frontal, and occipital lobes. The DTI results pointed to white matter damage in all thalamocortical connections, the corpus callosum, and several fasciculi. Multiple regression and correlation analyses suggested that in RRMS patients with mild disease, thalamic atrophy and thalamocortical connection damage may lead to slower cognitive processing. Furthermore, white matter damage at specific fasciculi may be related to episodic memory impairment.
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Background: Decisions based on erroneous assessments may result in unrealistic patient and family expectations, suboptimal advice, incorrect treatment, or costly medical errors. Regret is a common emotion in daily life that involves counterfactual thinking when considering alternative choices. Limited information is available on care-related regret affecting healthcare professionals managing patients with multiple sclerosis (MS). Methods: We reviewed identified gaps in the literature by searching for the combination of the following keywords in Pubmed: "regret and decision," "regret and physicians," and "regret and nurses." An expert panel of neurologists, a nurse, a psychiatrist, a pharmacist, and a psychometrics specialist participated in the study design. Care-related regret will be assessed by a behavioral battery including the standardized questionnaire Regret Intensity Scale (RIS-10) and 15 new specific items. Six items will evaluate regret in the most common social domains affecting individuals (financial, driving, sports-recreation, work, own health, and confidence in people). Another nine items will explore past and recent regret experiences in common situations experienced by healthcare professionals caring for patients with MS. We will also assess concomitant behavioral characteristics of healthcare professionals that could be associated with regret: coping strategies, life satisfaction, mood, positive social behaviors, occupational burnout, and tolerance to uncertainty. Planned Outcomes: This is the first comprehensive and standardized protocol to assess care-related regret and associated behavioral factors among healthcare professionals managing MS. These results will allow to understand and ameliorate regret in healthcare professionals. Spanish National Register (SL42129-20/598-E).
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BACKGROUND: Nurse practitioners (NPs) play a critical role in the multidisciplinary management of patients with multiple sclerosis (MS). Neurologists´ behavioral characteristics have been associated with suboptimal clinical decisions. However, limited information is available on their impact among NPs involved in MS care. The aim of this study was to assess nurses´ therapeutic choices to understand behavioral factors influencing their decision making process. METHODS: A non-interventional, cross-sectional, web-based study was conducted. NPs actively involved in the care of patients with MS were invited to participate in the study by the Spanish Society of Neurology Nursing. Participants answered questions regarding their standard practice and therapeutic management of seven simulated relapsing-remitting MS (RRMS) case scenarios. A behavioral battery was used to measure participants´ life satisfaction, mood, positive social behaviors, feeling of helpfulness, attitudes toward adoption of evidence-based innovations, occupational burnout, and healthcare-related regret. The outcome of interest was therapeutic inertia (TI), defined as the lack of treatment escalation when there is clinical and radiological evidence of disease activity. A score to quantify TI was created based on the number of simulated scenarios where treatment intensification was warranted. RESULTS: Overall, 331 NPs were invited to participate, 130 initiated the study, and 96 (29%) completed the study. The mean age (SD) was 44.6 (9.8) years and 91.7% were female. Seventy-three participants (76.0%) felt their opinions had a significant influence on neurologists´ therapeutic decisions. Sixteen NPs (16.5%) showed severe emotional exhaustion related to work and 13 (13.5%) had depressive symptoms. The mean (SD) TI score was 0.97 (1.1). Fifty-six of NPs showed TI in at least one case scenario. Higher years of nursing experience (p = 0.014), feeling of helpfulness (p = 0.014), positive attitudes toward innovations (p = 0.046), and a higher intensity of care-related regret (p = 0.021) were associated with a lower risk of TI (adjusted R2 = 0.28). Burnout was associated with higher risk of TI (p = 0.001). CONCLUSIONS: Although NPs cannot prescribe MS treatments in Spain, their behavioral characteristics may influence the management of patients with RRMS. Continuing education and specific strategies for reducing occupational burnout may lead to better management skills and improve MS care.
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Agotamiento Profesional/psicología , Esclerosis Múltiple/terapia , Neurólogos/psicología , Enfermeras Practicantes/psicología , Atención al Paciente/normas , Adulto , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Esclerosis Múltiple/epidemiología , Esclerosis Múltiple/psicología , Sistemas en Línea , España/epidemiología , Encuestas y CuestionariosRESUMEN
BACKGROUND: Risk attitude is defined as the willingness to tolerate risk to achieve a greater expected return. Limited information is available on how relapsing-remitting multiple sclerosis people's perceptions about disease trajectory and risk attitude may influence treatment choices. METHODS: A non-interventional study applying principles of behavioral economics was conducted to assess willingness to receive unwarranted high-efficacy disease-modifying therapy (DMT) according to best-practice guidelines. People with relapsing-remitting multiple sclerosis (PwRRMS) according to 2010 McDonald criteria completed a survey on symptom severity, risk preferences, and management of simulated case scenarios mimicking the current treatment landscape. PwRRMS's choice for high-efficacy agents was established as the participant's selection of monoclonal antibodies for case scenarios with at least 2 years of clinical and radiological stability. RESULTS: A total of 211 PwRRMS were studied (mean age 39.1 ± 9.5 years, 70.1% female, mean Expanded Disability Status Scale score 1.8 ± 1.1). Almost 50% (n = 96) opted for a high-efficacy DMT despite the lack of evidence of disease activity. Younger age and risk-seeking behavior were associated with an increased likelihood of selecting unwarranted high-efficacy DMT [odds ratio (OR) 2.00, 95% confidence interval (CI) 1.02-3.93, p = 0.043, and OR 2.17, 95% CI 1.09-4.30, p = 0.027, respectively]. Clinical characteristics or subjective perception of symptom severity had no influence on participants' treatment choices. CONCLUSION: Identifying PwRRMS with risk-seeking behavior would be crucial to implementing specific educational strategies to manage information on disease prognosis, treatment expectations, and safety risk knowledge.
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Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológicoRESUMEN
BACKGROUND: The assessment of self-reported outcomes in neuromyelitis optica spectrum disorder (NMOSD) is limited by the lack of validated disease-specific measures. The SymptoMScreen (SyMS) is a patient-reported questionnaire for measuring symptom severity in different domains affected by multiple sclerosis (MS), but has not been thoroughly evaluated in NMOSD. The aim of this study was to assess the psychometric properties of the SyMS in a sample of patients with NMOSD. METHODS: A non-interventional, cross-sectional study in adult subjects with NMOSD (Wingerchuk 2015 criteria) was conducted at 13 neuroimmunology clinics applying the SyMS. A non-parametric item response theory procedure, Mokken analysis, was performed to assess the underlying dimensional structure and scalability of items and overall questionnaire. All analyses were performed with R (v4.0.3) using the mokken library. RESULTS: A total of 70 patients were studied (mean age: 47.5 ± 15 years, 80% female, mean Expanded Disability Status Scale score: 3.0 [interquartile range 1.5, 4.5]). Symptom severity was low (median SyMS score: 19.0 [interquartile range 10.0, 32.0]). The SyMS showed a robust internal reliability (Cronbach's alpha: 0.90 [95% confidence interval 0.86, 0.93]) and behaved as a unidimensional scale with all items showing scalability coefficients > 0.30. The overall SyMS scalability was 0.45 conforming to a medium scale according to Mokken's criteria. Fatigue and body pain were the domains with the highest scalability coefficients. The SyMS was associated with disability (rho: 0.586), and physical and psychological quality of life (rho: 0.856 and 0.696, respectively). CONCLUSIONS: The SyMS shows appropriate psychometric characteristics and may constitute a valuable and easy-to-implement option to measure symptom severity in patients with NMOSD.
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Neuromielitis Óptica , Psicometría , Adulto , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Calidad de Vida , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: Perception of stigma was associated with low self-esteem, psychological problems, and decreased health-seeking behavior among patients with different neurological disorders. The purpose of this study was to assess stigmatization and its impact in patients with neuromyelitis optica spectrum disorder (NMOSD). METHODS: A non-interventional study was conducted at thirteen neuroimmunology clinics in Spain. Patients with a diagnosis of NMOSD (2015 Wingerchuk criteria) were included. The 8-item Stigma Scale for Chronic Illness (SSCI-8), the Expanded Disability Status Scale (EDSS), the 29-item Multiple Sclerosis Impact Scale (MSIS-29), the Beck Depression Inventory-Fast Screen (BDI-FS), the MOS Pain Effects Scale (MOS-PES) and the Fatigue Impact Scale for Daily Use (D-FIS) were used to assess the perception of stigma, disability, quality of life, mood, pain, and fatigue, respectively. Associations between outcome measures were analyzed using Spearman's rank correlation. RESULTS: Seventy-one patients were studied (mean age: 47.4 years ± 14.9, 81.7% female, mean time since disease onset: 9.9 years ± 8.1). The median EDSS score was 3.0 (interquartile range 1.5, 4.5). Stigma prevalence was 61.4% (n=43). Thirty-one patients (43.6%) had depression. The SSCI-8 score showed a significant correlation with both physical (rho=0.576, p<0.0001) and psychological (rho=0.608, p<0.0001) MSIS-29 scales scores, EDSS score (rho=0.349, p=0.0033), BDI-FS score (rho= 0.613, p<0.0001), MOS-PES score (rho= 0.457, p<0.0001), and D-FIS score (rho=0.556, p<0.0001). CONCLUSION: Stigma is a common phenomenon affecting over 6 out of 10 patients with NMOSD. Understanding stigma may be useful to develop educational strategies improving NMOSD knowledge.
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OBJECTIVE: Pivotal trial have shown that patients with multiple sclerosis (MS) receiving ocrelizumab had better outcomes. However, data on ocrelizumab in clinical practice are limited. The aim of this study was to evaluate the preliminary safety profile and effectiveness of ocrelizumab treatment for multiple sclerosis (MS) in a real-world clinical setting. METHODS: We conducted a retrospective study including consecutive patients from nine public hospitals in south-eastern Spain who received ocrelizumab after it was approved. RESULTS: A total of 228 MS patients were included (144 with relapsing-remitting MS [RRMS], 25 secondary progressive MS [SPMS], and 59 primary progressive MS [PPMS]). Median follow-up period was 12 months (range, 1-32). No evidence of disease activity (NEDA) status at year 1 was achieved in 91.2% of the relapsing MS (RMS) population, while disability progression was detected in 37.5% of the PPMS patients (median follow-up period, 19 months). The most common adverse events reported were infusion-related reactions and infections, with the most common infections being urinary tract infections followed by upper respiratory infections and COVID-19. INTERPRETATION: The preliminary results in our real-world setting show that ocrelizumab presented excellent results in suppressing disease activity with a favorable and consistent safety profile.
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Anticuerpos Monoclonales Humanizados/uso terapéutico , Factores Inmunológicos/uso terapéutico , Esclerosis Múltiple Crónica Progresiva/tratamiento farmacológico , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Adulto , Encéfalo/diagnóstico por imagen , Progresión de la Enfermedad , Femenino , Humanos , Reacción en el Punto de Inyección , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Esclerosis Múltiple Crónica Progresiva/diagnóstico por imagen , Esclerosis Múltiple Crónica Progresiva/fisiopatología , Esclerosis Múltiple Recurrente-Remitente/diagnóstico por imagen , Esclerosis Múltiple Recurrente-Remitente/fisiopatología , Estudios Retrospectivos , España , Médula Espinal/diagnóstico por imagen , Resultado del TratamientoRESUMEN
BACKGROUND: Status quo (SQ) bias is defined as patient´s tendency to continue taking a previously selected but inferior therapeutic option. OBJECTIVE: To assess the presence of SQ bias and its associated factors in patients with relapsing-remitting multiple sclerosis (RRMS). METHODS: A multicenter, non-interventional study involving 211 patients with RRMS was conducted. Participants answered questions regarding risk preferences and management of simulated MS case-scenarios. The SymptoMScreen (SMSS) questionnaire was used to assess the perception of severity from the patients´ perspective. SQ bias was defined as patients' preference to maintain the current treatment despite evidence of disease activity. Mixed linear models adjusting for clustering assessed the association of candidate predictors with the outcome of interest. RESULTS: The mean age (SD) was 39.1 (9.5) years and 70.6% were women. SQ bias was observed in 74.4% (n=161) participants. Univariate analysis showed that SMSS score was associated with SQ bias (OR 1.04; 95% CI 1.01-1.07). Mixed linear regression models suggest that for every point increase in SMSS, there was a 4% increase in the likelihood of SQ bias (ß 0.04; 95%CI 0.015-0.06; p<0.002). Among the different symptomatic dimensions included in the SMSS, only vision impairment (ß 0.32; 95%CI 0.05-0.50) and depression (ß 0.29; 95%CI 0.006-0.58) remained associated with SQ bias in the multivariate analysis. There was no association between participants' risk preferences and SQ bias. CONCLUSIONS: Unwillingness to pursue treatments that are more effective is a common phenomenon affecting over 7 out of 10 patients with RRMS. This phenomenon appears to be driven by patients' negative self-perception of their clinical status.
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Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Adulto , Femenino , Humanos , Masculino , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , AutoimagenRESUMEN
Crucial elements for achieving optimal long-term outcomes in multiple sclerosis (MS) are patient confidence and effective physician-patient communication. Patient-reported instruments may provide the means to fill the gap in currently available clinician-rated measures. The SymptoMScreen (SMSS) is a brief self-assessment tool for measuring symptom severity in 12 neurologic domains commonly affected by MS. We conducted a non-interventional study to assess the dimensional structure and item characteristics of the SMSS. A total of 218 patients with relapsing-remitting MS and mild disability (median Expanded Disability Status Scale score 2.0) were studied. Symptom severity was low (SMSS score 13.5, interquartile range 4.2-27), fatigue being the domain with the highest impact. A non-parametric item response theory, i.e., Mokken analysis, found that the SMSS is a robust one-dimensional scale (overall scalability index H 0.60) with high reliability (Cronbach's alpha 0.94). The confirmatory factor analysis model confirmed the unidimensional structure (comparative fit index 1.0, root-mean-square error of approximation 0.001). Samejima's model fitted well an unconstrained model with different item difficulties. The SMSS shows appropriate psychometric characteristics and may constitute a valuable and easy-to-implement addition to measure the symptom severity in clinical practice.
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Objectives: The aim of this study was to describe the tolerability, safety, and effectiveness of ocrelizumab for primary progressive multiple sclerosis (PPMS) and relapsing multiple sclerosis (RMS) in a clinical practice setting. Methods: In this retrospective observational study, we analyzed clinical and MRI data in all patients with PPMS and RMS who had received at least one infusion of ocrelizumab in two health areas in south-eastern Spain. Patients involved in any ocrelizumab trial and those patients with a follow-up shorter than 6 months were excluded. Results: The cohort included 70 patients (42 women) who had received ocrelizumab; 30% had PPMS and 70%, RMS. At baseline, patients' mean age was 47.1 years in the PPMS group and 39.2 years in the RMS group, while the median EDSS was 3.0 and 2.5, respectively. Median follow-up was 13.6 months. The median number of treatment cycles was three. Most patients remained free from clinical and MRI activity after ocrelizumab initiation. Baseline MRI showed T1 Gd-enhancing lesions in 57% of the patients; by the first MRI control at 4-6 months, all patients except one were free of T1 Gd-enhancing lesions (69/70, 98.6% P < 0.001). The proportion of patients with NEDA was 94% in the group of RMS patients who were followed for at least 1 year. Ocrelizumab was generally well-tolerated; the most common adverse events were infusion-related reactions and infections, none of which were serious. Conclusions: Our real-world study supports the tolerability, safety, and effectiveness of ocrelizumab in clinical practice.
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The objective in this paper is to compare the cumulative incidence and incidence density of therapy-related acute myeloid leukaemia in two cohorts of patients with multiple sclerosis treated with mitoxantrone, and with previously reported data in the literature. Six new cases of acute myeloid leukaemia were observed by prospectively following two Spanish series of 142 and 88 patients with worsening relapsing multiple sclerosis and secondary-progressive disease treated with mitoxantrone. A literature review shows 32 further cases of acute myeloid leukaemia reported, 65.6% of which are therapy-related acute promyelocytic leukaemia. Five cases in the cohorts fulfilled the diagnostic criteria for acute promyelocytic leukaemia, and one patient was diagnosed with pre-B-acute lymphoblastic leukaemia. Acute myeloid leukaemia latency after mitoxantrone discontinuation was 1 to 45 months. The accumulated incidence and incidence density was 2.82% and 0.62%, respectively, in the Valencian cohort, and 2.27% and 0.44% in the Catalonian cohort. In the only seven previously reported series, the accumulated incidence varied from 0.15% to 0.80%. The real incidence of acute myeloid leukaemia after mitoxantrone therapy in the multiple sclerosis population could be higher as evidenced by the growing number of cases reported. Haematological monitoring should continue for at least 5 years after the last dose of mitoxantrone. These data stress the necessity of re-evaluating this risk.
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Antineoplásicos/efectos adversos , Leucemia Mieloide Aguda/inducido químicamente , Leucemia Mieloide Aguda/epidemiología , Mitoxantrona/efectos adversos , Esclerosis Múltiple/complicaciones , Adolescente , Adulto , Anciano , Antiinflamatorios/uso terapéutico , Antineoplásicos/uso terapéutico , Niño , Estudios de Cohortes , Femenino , Humanos , Interferón Tipo I/uso terapéutico , Masculino , Región Mediterránea/epidemiología , Metilprednisolona/uso terapéutico , Persona de Mediana Edad , Mitoxantrona/uso terapéutico , Esclerosis Múltiple/tratamiento farmacológico , Esclerosis Múltiple Crónica Progresiva/complicaciones , Esclerosis Múltiple Crónica Progresiva/tratamiento farmacológico , Esclerosis Múltiple Recurrente-Remitente/complicaciones , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Estudios Prospectivos , Proteínas Recombinantes , Medición de Riesgo , Adulto JovenRESUMEN
BACKGROUND: Changes in the demographic epidemiology of multiple sclerosis (MS) may challenge the view of a latitudinal gradient in the distribution of MS. The objective of this study was to assess the incidence and prevalence of MS in addition to information on MS phenotypes and the use of disease modifying therapies (DMTs) in San Vicente del Raspeig in south eastern Spain. METHODS: This was a prospective epidemiological study of MS in San Vicente del Raspeig (population of 57,175 inhabitants based on the 2017 census) from 2005 to 2018. Multiple sources were used to identify MS cases. We considered as prevalent and incident cases all patients who satisfied either the criteria of Poser for clinically or laboratory-supported definite MS, or McDonald criteria. MS phenotypes were defined according to the 2013 revisions. RESULTS: For the prevalence data, 64 patients were identified. The non-adjusted prevalence was 111.9 (95% CI: 87.7-142.9) cases per 100,000 inhabitants; the prevalence was 159.3 cases per 100,000 inhabitants for women and 63.6 cases per 100,000 inhabitants for men. The female-to-male ratio was 2.6:1. The age-adjusted prevalence for the European standard population was 107 cases per 100,000 inhabitants. During the study period, the incidence was 5 cases per 100,000 inhabitants per year. Most patients were being treated with DMTs (81.3%). MS was active in at least 12.5% of patients. CONCLUSIONS: The results are consistent with the increased risk of MS in Spain observed over the last three decades, with growing prevalence rates that place the country in the high-risk prevalence zone.
Asunto(s)
Esclerosis Múltiple/epidemiología , Adolescente , Adulto , Anciano , Femenino , Humanos , Inmunosupresores/uso terapéutico , Incidencia , Masculino , Persona de Mediana Edad , Esclerosis Múltiple/tratamiento farmacológico , Prevalencia , España/epidemiología , Adulto JovenRESUMEN
Conferences traditionally play an important role in the ongoing medical education of healthcare professionals. We assessed the influence of attending the ECTRIMS congress on therapeutic decision-making in multiple sclerosis (MS) care. A non-interventional, cross-sectional study involving 96 neurologists was conducted. Treatment escalation when therapeutic goals were unmet and management errors related to tolerability and safety scenarios of MS therapies were tested using different case-scenarios. Attendance at ECTRIMS was associated with an increase likelihood of treatment escalation in the presence of clinical progression (cognitive decline) and radiological activity (OR 2.44; 95% CI 1.06-5.82) and lower number of management errors (OR 0.26; 95% CI 0.07-0.98). Attendance at ECTRIMS may facilitate therapeutic decisions and reduction in management errors in MS care.