New Trial(s) on Antiedema Treatment in Stroke?

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Piracetam for Acute Ischemic Stroke

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People with amyotrophic lateral sclerosis and their caregivers: what matters most?

ObjectivesThe aim of this study is to collect the perspectives and values of people affected by amyotrophic lateral sclerosis (ALS) and their carers to offer clinicians, researchers and policymakers aspects which are precious in prioritising future research questions and reshaping care service organisations in a participatory approach.Design and settingCohort study using ALS Umbria, the electronic database in Italy.ParticipantsEleven patients and 33 carers who agreed to participate in the study were divided into six focus groups by 'status' (patient or carer) and by four severity levels of 'burden of disease'.MethodsA semiquantitative analysis was undertaken. Each recorded group discussion was transcribed into text file and independently read by two psychologists and two ALS specialists to blindly identify needs, emotions and medical issues, which are the key semantic meanings expressed. Any disagreement in interpretation was resolved through consultation among authors.ResultsCarers pronounced significantly more words related to patient's disease burden they cared. 40% of subjects expressed the need for 'assistance', regardless of the disease burden. 'Anger' alone represented more than 1/4 of all expressed emotions and was more common in patients than in carers (73% vs 36%, p=0.077). The most frequent medical issue expressed by 1/3 of participants was 'difficulty in communication'.ConclusionThis study has given voice to the expectations of those affected by the burden of ALS. 'Welfare assistance', 'anger management' and resolution of 'difficulties in communication' represent issues that need to be analysed in a common prioritised research agenda with sensible and shared outcome measures to implement patient-centred medicine

Resonancia magnética versus tomografía computada para la detección de lesiones vasculares agudas en pacientes que consultan por síntomas de accidente cerebrovascular

ResumenAntecedentesLa resonancia magnética (RM) se utiliza cada vez con mayor frecuencia para el diagnóstico del accidente cerebrovascular isquémico agudo aunque ha sido debatida su sensibilidad para la detección precoz de la hemorragia intracerebral. La tomografía computada (TC) se usa ampliamente en el tratamiento clínico del accidente cerebrovascular agudo, especialmente para la exclusión rápida de la hemorragia intracerebral.ObjetivosComparar la precisión diagnóstica de la RM de difusión (RMD) y la CT para el accidente cerebrovascular isquémico agudo, y estimar la precisión diagnóstica de la RMD para el accidente cerebrovascular hemorrágico agudo.Estrategia de búsquedaSe efectuaron búsquedas en MEDLINE y EMBASE (enero de 1995 hasta marzo de 2009) y se examinó la bibliografía de los estudios pertinentes en busca de otras referencias.Criterios de selecciónSe seleccionaron los estudios que compararon RMD y TC en los mismos pacientes para la detección del accidente cerebrovascular isquémico o examinaron la utilidad de la RM para la detección del accidente cerebrovascular hemorrágico, que realizaron la imaginología dentro de las 12 horas de la aparición de los síntomas de accidente cerebrovascular y presentaron datos suficientes como para construir tablas de contingencia.Obtención y análisis de los datosTres autores de forma independiente extrajeron los datos de las características del estudio y las medidas de precisión. Los datos sobre el accidente cerebrovascular isquémico se evaluaron mediante metanálisis de efectos aleatorios y de efectos fijos.Resultados principalesOcho estudios, con un total de 308 participantes, cumplieron los criterios de inclusión. Siete estudios contribuyeron a la evaluación del accidente cerebrovascular isquémico y dos estudios a la evaluación del accidente cerebrovascular hemorrágico. El espectro de pacientes fue relativamente limitado en todos los estudios, los tamaños de las muestras fueron pequeños, hubo un significativo sesgo de incorporación y los procedimientos de cegamiento fueron a menudo incompletos. Entre los pacientes en quienes posteriormente se confirmó el diagnóstico de accidente cerebrovascular isquémico agudo (161/226), las estimaciones de resumen para la RMD fueron: sensibilidad 0,99 (IC del 95%: 0,23 a 1,00), especificidad 0,92 (IC del 95%: 0,83 a 0,97). Las estimaciones de resumen para la TC fueron: sensibilidad 0,39 (IC del 95%: 0,16 a 0,69), especificidad 1,00 (IC del 95%: 0,94 a 1,00).Los dos estudios sobre accidente cerebrovascular hemorrágico informaron estimaciones altas para las secuencias de difusión y ecogradiente pero tenían estándares de referencia inconsistentes. No se calcularon las estimaciones generales para estos dos estudios. No fue posible evaluar la practicidad o los temas relativos a la relación entre costo y efectividad.Conclusiones de los autoresLa RMD parece ser más sensible que la TC para la detección precoz del accidente cerebrovascular isquémico en pacientes sumamente seleccionados. Sin embargo, la variabilidad en la calidad de los estudios incluidos y la presencia de los sesgos de espectro e incorporación tornan dudosa la confiabilidad y la posibilidad de generalizar los resultados observados. Se requieren estudios adicionales bien diseñados, sin sesgos metodológicos, con muestras de pacientes más representativas y estimaciones de la practicidad y los costos, a fin de determinar qué pacientes deben ser sometidos a RM y qué pacientes a TC en el caso de presunto accidente cerebrovascular agudo

Does a combination of ≥2 abnormal tests vs. the ERC-ESICM stepwise algorithm improve prediction of poor neurological outcome after cardiac arrest? A post-hoc analysis of the ProNeCA multicentre study.

BACKGROUND Bilaterally absent pupillary light reflexes (PLR) or N20 waves of short-latency evoked potentials (SSEPs) are recommended by the 2015 ERC-ESICM guidelines as robust, first-line predictors of poor neurological outcome after cardiac arrest. However, recent evidence shows that the false positive rates (FPRs) of these tests may be higher than previously reported. We investigated if testing accuracy is improved when combining PLR/SSEPs with malignant electroencephalogram (EEG), oedema on brain computed tomography (CT), or early status myoclonus (SM). METHODS Post-hoc analysis of ProNeCA multicentre prognostication study. We compared the prognostic accuracy of the ERC-ESICM prognostication strategy vs. that of a new strategy combining ≥2 abnormal results from any of PLR, SSEPs, EEG, CT and SM. We also investigated if using alternative classifications for abnormal SSEPs (absent-pathological vs. bilaterally-absent N20) or malignant EEG (ACNS-defined suppression or burst-suppression vs. unreactive burst-suppression or status epilepticus) improved test sensitivity. RESULTS We assessed 210 adult comatose resuscitated patients of whom 164 (78%) had poor neurological outcome (CPC 3-5) at six months. FPRs and sensitivities of the ≥2 abnormal test strategy vs. the ERC-ESICM algorithm were 0[0-8]% vs. 7 [1-18]% and 49[41-57]% vs. 63[56-71]%, respectively (p < .0001). Using alternative SSEP/EEG definitions increased the number of patients with ≥2 concordant test results and the sensitivity of both strategies (67[59-74]% and 54[46-61]% respectively), with no loss of specificity. CONCLUSIONS In comatose resuscitated patients, a prognostication strategy combining ≥2 among PLR, SSEPs, EEG, CT and SM was more specific than the 2015 ERC-ESICM prognostication algorithm for predicting 6-month poor neurological outcome

Riluzole use in presence of contraindications in adults affected by amyotrophic lateral sclerosis and its off-label use in other motor neuron diseases: Findings from an Italian multicentre study (the {CAESAR} project)

Background: This analysis describes the use of riluzole in amyotrophic lateral sclerosis (ALS) individuals with contraindications and off-label use for subjects with other motor neuron diseases (o-MND) in the Italian regions of Latium, Tuscany and Umbria.Methods: A cohort of adults with ALS prescribed with riluzole during the years 2016–2019 was enrolled from administrative healthcare databases, excluding subjects with o-MND in the preceding 5&nbsp;years. Being affected by ALS for more than 5&nbsp;years, presence of tracheostomy, renal or hepatic failure were considered as contraindications to the use of riluzole. A cohort of adults with o-MND was enrolled in 2016–2019 for whom off-label use of riluzole was retrieved up to 4 years, analysing over the time differences related to sex.Results: Among 206 ALS individuals prescribed with riluzole in Latium, 336 in Tuscany and 60 in Umbria, less than 1% were diagnosed with ALS for more than 5&nbsp;years. Less than 2% were tracheotomised or affected by hepatic failure. Renal failure was documented for 1.9%, 2.7%, and 5.0% of ALS individuals in Latium, Tuscany and Umbria. The o-MND cohort comprised 264 subjects in Latium, 222 in Tuscany, and 66 in Umbria. Non-negligible off-label riluzole use was observed: 8.5%, 33.0%, and 4.2% in females, and 19.9%, 26.5% and 2.4% in males in Latium, Tuscany and Umbria.Discussion: Riluzole use in ALS individuals in the presence of contraindications is rare, with slightly higher numbers in presence of renal failure. Off-label use in o-MND was found to be non-negligible, with variations between sexes

Disease-Modifying Therapies and Coronavirus Disease 2019 Severity in Multiple Sclerosis

Objective: This study was undertaken to assess the impact of immunosuppressive and immunomodulatory therapies on the severity of coronavirus disease 2019 (COVID-19) in people with multiple sclerosis (PwMS). Methods: We retrospectively collected data of PwMS with suspected or confirmed COVID-19. All the patients had complete follow-up to death or recovery. Severe COVID-19 was defined by a 3-level variable: mild disease not requiring hospitalization versus pneumonia or hospitalization versus intensive care unit (ICU) admission or death. We evaluated baseline characteristics and MS therapies associated with severe COVID-19 by multivariate and propensity score (PS)-weighted ordinal logistic models. Sensitivity analyses were run to confirm the results. Results: Of 844 PwMS with suspected (n = 565) or confirmed (n = 279) COVID-19, 13 (1.54%) died; 11 of them were in a progressive MS phase, and 8 were without any therapy. Thirty-eight (4.5%) were admitted to an ICU; 99 (11.7%) had radiologically documented pneumonia; 96 (11.4%) were hospitalized. After adjusting for region, age, sex, progressive MS course, Expanded Disability Status Scale, disease duration, body mass index, comorbidities, and recent methylprednisolone use, therapy with an anti-CD20 agent (ocrelizumab or rituximab) was significantly associated (odds ratio [OR] = 2.37, 95% confidence interval [CI] = 1.18-4.74, p = 0.015) with increased risk of severe COVID-19. Recent use (&lt;1 month) of methylprednisolone was also associated with a worse outcome (OR = 5.24, 95% CI = 2.20-12.53, p = 0.001). Results were confirmed by the PS-weighted analysis and by all the sensitivity analyses. Interpretation: This study showed an acceptable level of safety of therapies with a broad array of mechanisms of action. However, some specific elements of risk emerged. These will need to be considered while the COVID-19 pandemic persists

COVID-19 Severity in Multiple Sclerosis: Putting Data Into Context

Background and objectives: It is unclear how multiple sclerosis (MS) affects the severity of COVID-19. The aim of this study is to compare COVID-19-related outcomes collected in an Italian cohort of patients with MS with the outcomes expected in the age- and sex-matched Italian population. Methods: Hospitalization, intensive care unit (ICU) admission, and death after COVID-19 diagnosis of 1,362 patients with MS were compared with the age- and sex-matched Italian population in a retrospective observational case-cohort study with population-based control. The observed vs the expected events were compared in the whole MS cohort and in different subgroups (higher risk: Expanded Disability Status Scale [EDSS] score &gt; 3 or at least 1 comorbidity, lower risk: EDSS score ≤ 3 and no comorbidities) by the χ2 test, and the risk excess was quantified by risk ratios (RRs). Results: The risk of severe events was about twice the risk in the age- and sex-matched Italian population: RR = 2.12 for hospitalization (p &lt; 0.001), RR = 2.19 for ICU admission (p &lt; 0.001), and RR = 2.43 for death (p &lt; 0.001). The excess of risk was confined to the higher-risk group (n = 553). In lower-risk patients (n = 809), the rate of events was close to that of the Italian age- and sex-matched population (RR = 1.12 for hospitalization, RR = 1.52 for ICU admission, and RR = 1.19 for death). In the lower-risk group, an increased hospitalization risk was detected in patients on anti-CD20 (RR = 3.03, p = 0.005), whereas a decrease was detected in patients on interferon (0 observed vs 4 expected events, p = 0.04). Discussion: Overall, the MS cohort had a risk of severe events that is twice the risk than the age- and sex-matched Italian population. This excess of risk is mainly explained by the EDSS score and comorbidities, whereas a residual increase of hospitalization risk was observed in patients on anti-CD20 therapies and a decrease in people on interferon

DMTs and Covid-19 severity in MS: a pooled analysis from Italy and France

We evaluated the effect of DMTs on Covid-19 severity in patients with MS, with a pooled-analysis of two large cohorts from Italy and France. The association of baseline characteristics and DMTs with Covid-19 severity was assessed by multivariate ordinal-logistic models and pooled by a fixed-effect meta-analysis. 1066 patients with MS from Italy and 721 from France were included. In the multivariate model, anti-CD20 therapies were significantly associated (OR&nbsp;=&nbsp;2.05, 95%CI&nbsp;=&nbsp;1.39–3.02, p&nbsp;&lt;&nbsp;0.001) with Covid-19 severity, whereas interferon indicated a decreased risk (OR&nbsp;=&nbsp;0.42, 95%CI&nbsp;=&nbsp;0.18–0.99, p&nbsp;=&nbsp;0.047). This pooled-analysis confirms an increased risk of severe Covid-19 in patients on anti-CD20 therapies and supports the protective role of interferon