RESUMO
BACKGROUND: Limited data exist regarding treatment response prediction to oral disease-modifying therapies (DMTs) in multiple sclerosis (MS). OBJECTIVES: We assessed the capacity of available scoring systems to anticipate disease activity parameters in naïve relapsing-remitting MS (RRMS) patients initiating daily oral DMTs, hypothesizing that they exhibit different predictive potentials. METHODS: We conducted a retrospective study and applied the Rio Score (RS), modified Rio Score (mRS), and MAGNIMS Score 12 months after DMT initiation. At 36 months, we examined their ability to predict evidence of disease activity (EDA) components and treatment failure by logistic regression analysis. RESULTS: Notably, 218 patients (62.4% females) initiating dimethyl fumarate, teriflunomide, and fingolimod were included. At 36 months, the RS high-risk group predicted evidence of clinical activity (odds ratio (OR) 10 [2.7-36.9]) and treatment failure (OR 10.6 [3.4-32.5]) but did not predict radiological activity (OR 1.9 [0.7-5]). The mRS non-responders group did not predict EDA and treatment failure. RS, mRS, and MAGNIMS 0 categories showed significantly lower EDA and treatment failure than the remainder. CONCLUSION: Scoring systems present different predictive abilities for disease activity parameters at 36 months in MS patients initiating daily oral therapies, warranting further adjustments (i.e. introduction of fluid biomarkers) to depict disease activity status fully.
Assuntos
Esclerose Múltipla Recidivante-Remitente , Falha de Tratamento , Humanos , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Feminino , Adulto , Masculino , Estudos Retrospectivos , Administração Oral , Pessoa de Meia-Idade , Cloridrato de Fingolimode/administração & dosagem , Fumarato de Dimetilo/administração & dosagem , Crotonatos/administração & dosagem , Hidroxibutiratos , Toluidinas/administração & dosagem , Imunossupressores/administração & dosagem , Nitrilas/administração & dosagem , Prognóstico , Fatores Imunológicos/administração & dosagemRESUMO
PURPOSE: The Comprehensive assessment of Acceptance and Commitment Therapy (CompACT) is a 23-item questionnaire measuring psychological flexibility, a quality of life protective factor. An 18-item version was recently produced. We assessed validity and reliability of CompACT, and equivalence of paper and electronic (eCompACT) versions in people with multiple sclerosis (PwMS) in Italy, Germany and Spain. METHODS: We used confirmatory factor analysis and assessed CompACT-23 and CompACT-18 measurement invariance between the three language versions. We assessed construct validity (Spearman's correlations) and internal consistency (Cronbach's alpha). Test-retest reliability (intraclass correlation coefficient, ICC) and equivalence of paper and eCompACT (ICC and linear regression model for repeated measures) were assessed in subsamples of PwMS. RESULTS: A total of 725 PwMS completed the study. The three-factor structure of the CompACT-23 showed poor fit (RMSEA 0.07; CFI 0.82; SRMR 0.08), while the fit of the CompACT-18 was good (RMSEA 0.05; CFI 0.93; SRMR 0.05). Configural and partial metric invariance were confirmed, as well as partial scalar invariance (reached when five items were allowed to vary freely). The CompACT-18 showed good internal consistency (all alpha ≥ 0.78); and test-retest reliability (all ICCs ≥ 0.86). Equivalence between paper and eCompACT was excellent (all ICCs ≥ 0.86), with no mode, order, or interaction effects. CONCLUSION: Results support using the refined CompACT-18 as a three-factor measure of psychological flexibility in PwMS. Paper and eCompACT-18 versions are equivalent. CompACT-18 can be used cross-culturally, but sub-optimal scalar invariance suggests that direct comparison between the three language versions should be interpreted with caution.
Assuntos
Terapia de Aceitação e Compromisso , Comparação Transcultural , Esclerose Múltipla , Psicometria , Humanos , Esclerose Múltipla/psicologia , Esclerose Múltipla/terapia , Feminino , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Inquéritos e Questionários/normas , Adulto , Análise Fatorial , Qualidade de Vida/psicologia , Alemanha , Espanha , Itália , IdosoRESUMO
BACKGROUND AND OBJECTIVES: We aimed to assess the presence of retinal neurodegeneration independent of optic neuritis (ON) in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and to investigate the development of trans-synaptic anterograde degeneration in these patients after ON. METHODS: Cross-sectional, retrospective study of 34 adult patients with MOGAD and 23 healthy controls (HC). Clinical, optical coherence tomography (OCT), and MRI data were collected. Peripapillary retinal nerve fiber layer (pRNFL) and ganglion cell inner plexiform layer (GCIPL) were obtained using Heidelberg Spectralis. FreeSurfer7 was used to obtain the lateral geniculate nucleus (LGN), occipital volume fractions (to total estimated intracranial volume), and occipital cortical thickness. For the anterior visual pathway, the analysis was conducted using eyes, classified based on the history of ON (Eye-ON and Eye-NON) and compared with Eye-HC. The analysis of OCT and brain volumetric measures was conducted comparing MOGAD-ON, MOGAD-NON, and HC groups. The analysis of covariance with a Bonferroni-adjusted post hoc test was used to test differences between groups and linear regression analysis to evaluate OCT/MRI associations; age and sex were considered as covariates. RESULTS: 24 (70.5%) patients had a prior ON. Median pRNFL and GCIPL thickness (um) was significantly reduced in Eye-ON vs EyeNON and HC (pRNFL: 69.4 (17.3), 89.6 (13.7), 98.2 (11.7), p < 0.001; GCIPL: 55.8 (8.7), 67.39 (8.7), 72.6 (4.5), p < 0.001). pRNFL and GCIPL thickness had a negative correlation with the number of ON episodes (p = 0.025 and p = 0.031, respectively). LGN volume fraction was significantly lower in patients with MOGAD-ON than in HC (0.33 (0.05) vs 0.39 (0.04), p = 0.002). The occipital cortical thickness was lower in MOGAD-ON compared with MOGAD-NON and HC (p = 0.010). In patients with MOGAD-ON, pRNFL correlated with LGN volume (p = 0.006), occipital thickness (p = 0.002), and the medial occipital cortex (p = 0.002), but not the lateral occipital lobe. DISCUSSION: Compared with HC, MOGAD-ON exhibits reduced retinal thickness, primarily influenced by the presence and the number of prior ON episodes. Moreover, MOGAD-ON demonstrates significant atrophy in the retinal, subcortical, and cortical regions of the visual pathway, distinguishing them from MOGAD-NON and HC. These findings suggest that in patients with MOGAD neurodegeneration is tightly correlated with damage to the involved pathway.
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Neurite Óptica , Vias Visuais , Adulto , Humanos , Glicoproteína Mielina-Oligodendrócito , Vias Visuais/diagnóstico por imagem , Estudos Transversais , Degeneração Retrógrada , Estudos Retrospectivos , Neurite Óptica/diagnóstico por imagem , RetinaRESUMO
Importance: Vaccination in patients with highly active multiple sclerosis (MS) requiring prompt treatment initiation may result in impaired vaccine responses and/or treatment delay. Objective: To assess the immunogenicity and safety of inactivated vaccines administered during natalizumab treatment. Design, Setting, and Participants: This self-controlled, prospective cohort study followed adult patients with MS from 1 study center in Spain from September 2016 to February 2022. Eligible participants included adults with MS who completed immunization for hepatitis B virus (HBV), hepatitis A virus (HAV), and COVID-19 during natalizumab therapy. Data analysis was conducted from November 2022 to February 2023. Exposures: Patients were categorized according to their time receiving natalizumab treatment at the time of vaccine administration as short-term (≤1 year) or long-term (>1 year). Main Outcomes and Measures: Demographic, clinical, and radiological characteristics were collected during the year before vaccination (prevaccination period) and the year after vaccination (postvaccination period). Seroprotection rates and postvaccination immunoglobulin G titers were determined for each vaccine within both periods. Additionally, differences in annualized relapse rate (ARR), new T2 lesions (NT2L), Expanded Disability Status Scale (EDSS) scores, and John Cunningham virus (JCV) serostatus between the 2 periods were assessed. Results: Sixty patients with MS (mean [SD] age, 43.2 [9.4] years; 44 female [73.3%]; 16 male [26.7%]; mean [SD] disease duration, 17.0 [8.7] years) completed HBV, HAV, and mRNA COVID-19 immunization during natalizumab treatment, with 12 patients in the short-term group and 48 patients in the long-term group. The global seroprotection rate was 93% (95% CI, 86%-98%), with individual vaccine rates of 92% for HAV (95% CI, 73%-99%), 93% for HBV (95% CI, 76%-99%), and 100% for the COVID-19 messenger RNA vaccine (95% CI, 84%-100%). Between the prevaccination and postvaccination periods there was a significant reduction in the mean (SD) ARR (0.28 [0.66] vs 0.01 [0.12]; P = .004) and median (IQR) NT2L (5.00 [2.00-10.00] vs 0.81 [0.00-0.50]; P = .01). No changes in disability accumulation were detected (median [IQR] EDSS score 3.5 [2.0-6.0] vs 3.5 [2.0-6.0]; P = .62). No differences in safety and immunogenicity were observed for all vaccines concerning the duration of natalizumab treatment. Conclusions and Relevance: The findings of this cohort study suggest that immunization with inactivated vaccines during natalizumab therapy was both safe and immunogenic, regardless of the treatment duration. Natalizumab may be a valuable option for proper immunization, averting treatment delays in patients with highly active MS; however, this strategy needs to be formally evaluated.
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Imunogenicidade da Vacina , Esclerose Múltipla , Natalizumab , Vacinas de Produtos Inativados , Adulto , Feminino , Humanos , Masculino , Estudos de Coortes , Esclerose Múltipla/tratamento farmacológico , Natalizumab/administração & dosagem , Estudos Prospectivos , Vacinas de Produtos Inativados/imunologia , Pessoa de Meia-IdadeRESUMO
Se realiza una panorámica del desarrollo de la actividad científica informativa en Cuba desde sus orígenes hasta años recientes. Se caracteriza el Sistema Nacional de Información, como el mecanismo que articula esta actividad en el país, y la labor del Instituto de Documentación e Información Científica y Tecnológica (IDICT), como órgano rector del sistema desde su creación en el año 1963.
A panoramically view of the development of the informational scientific activity, from its origin, to recent years is done. The informational national system is characterized like the mechanism that joins this activity in the country and the job of the Technological scientific information and documentation institute (IDICT) like the head organ of the system since it was created in the year 1963.
RESUMO
Se exponen ciertos elementos teóricos generales relacionados con las políticas nacionales de información, necesarios para su comprensión: definición, fases, características, propósitos, evolución histórica; así como su desarrollo en América Latina.
Some general theoretical elements related to the national policy of information which are necessary for their comprehension are stated: definition, phases, characteristics, purpose, historical evolution, as well as its development in Latin America.
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Formulação de Políticas , Política Organizacional , Sistemas de InformaçãoRESUMO
Se pretende analizar, sobre la base de las opiniones de destacados especialistas de información en Cuba, la trayectoria de la formulación e implementación de la política nacional de información en el país, así como los aciertos y desaciertos de este proceso y los factores que los condicionaron. Se esbozan también los elementos, que, desde el punto de vista de los entrevistados, podrían incidir favorablemente en el renacer de esta política, tan necesaria en las condiciones actuales del país.
This work is aimed at analyzing the trajectory of the formulation and implementation of the national information policy, as well as the do's and don'ts of this process and the factors that conditioned it, using as a basis the opinions of outstanding information specialists. This study also takes into consideration the elements which, from the point of view of those interviewed, could favorably influence on the rebirth of this policy, which is so necessary in the current conditions of the country.