Design and Validation of an Expanded Disability Status Scale Model in Multiple Sclerosis.

INTRODUCTION: We aimed to develop and validate an Expanded Disability Status Scale (EDSS) model through clinical, optical coherence tomography (OCT), and magnetic resonance imaging (MRI) measures. METHODS: Sixty-four multiple sclerosis (MS) patients underwent peripapillary retinal nerve fiber layer and segmented macular layers evaluation through OCT (Spectralis, Heidelberg Engineering). Brain parenchymal fraction was quantified through Freesurfer, while cervical spinal cord (SC) volume was assessed manually guided by Spinal Cord Toolbox software analysis. EDSS, neuroradiological, and OCT assessment were carried out within 3 months. OCT parameters were calculated as the average of both nonoptic neuritis (ON) eyes, and in case the patient had previous ON, the value of the fellow non-ON eye was taken. Brain lesion volume, sex, age, disease duration, and history of disease-modifying treatment (1st or 2nd line disease-modifying treatments) were tested as covariables of the EDSS score. RESULTS: EDSS values correlated with patient's age (r = 0.543, p = 0.001), SC volume (r = -0.301, p = 0.034), and ganglion cell layer (GCL, r = -0.354, p = 0.012). Using these correlations, an ordinal regression model to express probability of diverse EDSS scores were designed, the highest of which was the most probable (Nagelkerke R2 = 43.3%). Using EDSS cutoff point of 4.0 in a dichotomous model, compared to a cutoff of 2.0, permits the inclusion of GCL as a disability predictor, in addition to age and SC. CONCLUSIONS: MS disability measured through EDSS is an age-dependent magnitude that is partly conditioned by SC and GCL. Further studies assessing paraclinical disability predictors are needed.

Dyschromatopsia in multiple sclerosis reflects diffuse chronic neurodegeneration beyond anatomical landmarks.

To formulate and validate a dyschromatopsia linear regression model in patients with multiple sclerosis (MS). 64 MS patients (50 to formulate the model and 14 for its validation) underwent neurological (Expanded Disability Status Scale, EDSS), color vision (Farnsworth D15 test), and peripapillary retinal nerve fiber layer (pRNFL) and retinal evaluation with spectral-domain optical coherence tomography (SD-OCT). Neuroradiological examination permitted to obtain brain parenchymal fraction (BPF) and cervical spinal cord volume (SC). Ophthalmic parameters were calculated as the average of both non-optic neuritis (ON) eyes, and in case the patient had previous ON, the value of the fellow non-ON eye was taken. The influence of sex, age, disease duration, and history of disease-modifying treatment (first- or second-line DMT) was tested as covariables that could influence color perception. Color confusion index (log CCI) correlated with pRNFL (r = - 0.322, p = 0.009), ganglion cell layer (GCL, r = - 0.321, p = 0.01), BPF (r = - 0.287, p = 0.021), SC volume (r = - 0.33, p = 0.008), patients' age (r = 0.417, p = 0.001), disease duration (r = 0.371, p = 0.003), and EDSS (r = 0.44, p = 0.001). The following CCI equation was obtained: log (CCI) = 0.316-0.224 BPF - 0.187 SC volume (mm3) + 0.226 age (years) + 0.012 disease duration (years) - 0.372 GCL (µm). CCI correlates with MS clinical and paraclinical established biomarkers suggesting chronic diffuse neurodegeneration in MS operates at brain, SC, and retina linking all three compartments. Color vision outcome can be calculated through the aforementioned variables for clinical and research purposes.

Magnetic resonance imaging and optical coherence tomography correlations in multiple sclerosis beyond anatomical landmarks.

OBJECTIVE: To investigate multiple sclerosis (MS) optical coherence tomography (OCT) cross-sectional correlations with central nervous system (CNS) magnetic resonance imaging (MRI). MATERIAL AND METHODS: Peripapillary retinal nerve fiber layer (pRNFL), ganglion cell layer (GCL), inner plexiform layer (IPL), inner (INL) and outer nuclear layer (ONL) of 54 relapsing remitting (RRMS) and 38 progressive (PMS, 9 primary and 29 secondary) patients were measured. With less than 3 months brain parenchymal fraction (BPF), spinal cord (SC), total gray matter (GM) and white matter volumes were calculated. Demographical and clinical data was compared according to the history of optic neuritis (HON). Relationships between OCT and MRI data were assessed using multivariable linear regression models, adjusting for age, gender and disease duration, taking into account HON and disease subtype. RESULTS: Cerebellum (p = 0.008), pRNFL (p = 0.001), GCL (p = 0.001) and IPL (p = 0.001) were thinner, while INL was thicker (p = 0.02) if HON. SC correlated better with nasal pRNFL sectors in eyes with HON (all eyes: average pRNFL p = 0.035 η2 = 0.213; N-pRNFL p = 0.04 η2 = 0.36, NI-pRNFL p = 0.0001 η2 = 0.484. RRMS eyes: N-pRNFL p = 0.034 η2 = 0.348; NI-pRNFL p = 0.013 η2 = 0.441), while it correlates with PMB (p = 0.032 η2 = 0.144), GCL (p = 0.03 η2 = 0.147) and IPL (p = 0.028 η2 = 0.151) in eyes without HON regardless of the disease subtype. INL presented no microcystic macular oedema and was inversely associated with BPF (p = 0.029 η2 = 0.363) and cerebellum (p = 0.015 η2 = 0.428) in PMS eyes without HON. CONCLUSIONS: OCT data correlates with different CNS compartments, even with no anatomical or functional linkage, serving as useful neurodegeneration and inflammation surrogate marker.

Analysis of the influence of clinical and demographic factors on the understanding of cataract informed consent / Análisis de la influencia de factores clínicos y demográficos en la comprensión del consentimiento informado de cataratas / Análise da influência de fatores clínicos e demográficos na compreensão do consentimento informado para cirurgia de catarata

PURPOSE: To estimate the influence of clinical and demographical information in the understanding of cataract surgery informed consent, identifying less understandable areas. To assess informed consent document concept. METHODS: Multiple-choice questionnaire was designed to collect information and to evaluate the understanding of cataract surgery and informed consent. An ordinary regression model was adjusted to express the effect of clinical and demographic variables to the questionnaire score. RESULTS: The study comprised 180 patients. Sex (female, p=0.404), non-ophthalmologist source of information (p=0.397), previous surgical history (p=0.571), not having a companion (p=0.396) nor the days since the signing of informed consent form (p=0.535) had no influence in the understanding of cataract surgery informed consent. Age (r=-0.083, p<0.001) and educational level (secondary studies r=1.845, p<0.001; tertiary studies r=4.289, p<0.001) showed statistical significance with greater strength of association educational level (OR secondary studies = 6.33, OR tertiary studies = 72.86) than age had (OR = 0.92). CONCLUSION: Patient's knowledge about cataract informed consent is influenced by age and educational level. The purpose and the risks, consequences of not performing surgery and postoperative indications are the least understood topics. Informed consent is seen as a forced legal obligation.

OBJETIVOS: estimar la influencia de la información clínica y demográfica en la comprensión del consentimiento informado de la cirugía de cataratas, identificando áreas menos comprensibles. Evaluar el concepto de "documento de consentimiento informad". MÉTODOS: el cuestionario de opción múltiple se diseñó para reunir información y evaluar la comprensión de la cirugía de cataratas y el consentimiento informado. Se ajustó un modelo de regresión ordinario para expresar el efecto de las variables clínicas y demográficas en la puntuación del cuestionario. RESULTADOS: El estudio abarcó 180 pacientes. Sexo (femenino, p = 0.404); fuente de información no oftalmológica (p = 0.397); historial quirúrgico previo (p = 0.571); no tener acompañante (p = 0.396), y los días desde la firma del formulario de consentimiento informado (p = 0,535), que no tuvo influencia en la comprensión del consentimiento informado en la cirugía de cataratas. La edad (r = -0.083, p <0.001) y el nivel educativo (estudios secundarios r = 1.845, p <0.001; estudios terciarios r = 4.289, p <0.001) mostraron significación estadística con una mayor fuerza del nivel educativo de asociación (OR estudios secundarios = 6.33, OR estudios terciarios = 72.86) que la edad (OR = 0.92). CONCLUSIÓN: El conocimiento del paciente sobre el consentimiento informado en cirugía de cataratas está influenciado por la edad y el nivel educativo. Los temas menos entendidos son el propósito y los riesgos, las consecuencias de no realizar la cirugía y las indicaciones postoperatorias. El consentimiento informado se considera una obligación legal forzada.

OBJETIVO: Estimar a influência de informações clínicas e demográficas na compreensão do consentimento informado para cirurgia de catarata, identificando áreas menos compreensíveis. Avaliar o conceito do documento de consentimento informado. MÉTODOS: Um questionário de múltipla escolha foi desenvolvido para coletar informações e avaliar a compreensão sobre cirurgia de catarata e de consentimento informado. Um modelo de regressão ordinária foi ajustado para expressar o efeito das variáveis clínicas e demográficas no escore do questionário. RESULTADOS: O estudo envolveu 180 pacientes. Sexo (feminino, p=0,404), fonte de informações não oftalmológica (p=0,397), história cirúrgica prévia (p=0,571), não ter um/a companheiro/a (p=0,396) nem os dias desde a assinatura do formulário de consentimento informado (p=0,535) tiveram influência na compreensão do consentimento informado para cirurgia de catarata. Idade (r=-0,083, p<0,001) e nível educacional (estudos secundários r=1,845, p<0,001; estudos terciários r=4,289, p<0,001) mostraram significância estatística, com maior força de associação para o nível educacional (OR estudos secundários = 6,33, OR estudos terciários = 72,86) que para a idade (OR = 0,92). CONCLUSÃO: O conhecimento do paciente sobre o consentimento informado para cirurgia de catarata é influenciado pela idade e nível educacional. O objetivo e os riscos, consequências, de não fazer a cirurgia e as indicações pós-operatórias são os tópicos menos compreensíveis. O consentimento informado é visto como uma obrigação legal compulsória.