Early MRI results and odds of attaining 'no evidence of disease activity' status in MS patients treated with interferon β-1a in the EVIDENCE study

Abstract Introduction 'No evidence of disease activity' (NEDA) is increasingly used as a treatment target with disease-modifying drugs for relapsing multiple sclerosis. Methods This post-hoc analysis of the randomised EVIDENCE trial compared interferon beta-1a injected subcutaneously three times weekly (IFN β-1a SC tiw) with interferon β-1a injected intramuscularly once weekly (IFN β-1a IM qw) on NEDA and clinical activity-free (CAF) status. The influence of the frequency of magnetic resonance imaging (MRI) scanning on NEDA and the effect of baseline T1 gadolinium-enhancing (Gd +) lesions on NEDA and CAF were also investigated. Results More patients in the IFN β-1a SC tiw group achieved NEDA compared with the IFN β-1a IM qw group, although rates were lower when monthly MRI scans through 24 weeks were included (35.0% vs. 21.6%, respectively; p p p = 0.022), and CAF through Week 48 in patients receiving IFN β-1a SC tiw ( p = 0.024). Conclusions IFN β-1a SC tiw was associated with significantly higher rate of NEDA status compared with IFN β-1a IM qw. Baseline Gd + lesions augured less frequent CAF or NEDA status. Inclusion of more MRI scans in the analysis reduced rates of NEDA status

Deeper Learning and Assessment in Drama-based CLIL Learning Spaces - A Conceptual Framework

This article draws on a European collaborative initiative between four countries involved in the Erasmus+ project Playing beyond CLIL (PbC, 2018–2021). In the following, we propose a conceptual framework for dynamic assessment in CLIL classrooms. Building our framework on a pluriliteracies approach to deeper learning (PTDL; Meyer, Coyle, Halbach, Schuck & Ting, 2015) merged with pedagogies of drama-based learning, we argue that dynamic assessment needs to be conceptually and pedagogically congruent with the fundamental principles and aims of both approaches. The PbC Framework for Assessment is the outcome of our collaborative work in the PbC project. The key issues this proposal raises are addressed and discussed.Peer reviewe

Deeper Learning and Assessment in Drama-based CLIL Learning Spaces

This article draws on a European collaborative initiative between four countries involved in the Erasmus+ project Playing beyond CLIL (PbC, 2018–2021). In the following, we propose a conceptual framework for dynamic assessment in CLIL classrooms. Building our framework on a pluriliteracies approach to deeper learning (PTDL; Meyer, Coyle, Halbach, Schuck & Ting, 2015) merged with peda-gogies of drama-based learning, we argue that dynamic assessment needs to be conceptually and pedagogically congruent with the fundamental principles and aims of both approaches. The PbC Framework for Assessment is the outcome of our collaborative work in the PbC project. The key issues this proposal raises are addressed and discussed.Este artículo recoge parte del trabajo llevado a cabo por investigadores de cuatro países participantes en el proyecto Erasmus+ denominado Playing beyond CLIL (PbC, 2018–2021). Concretamente, presen¬ta un marco conceptual para la evaluación dinámica en el aula AICLE basado en el enfoque de las pluriliteracidades para el aprendizaje profundo (PTDL en inglés; Meyer, Coyle, Halbach, Schuck & Ting, 2015) y en la pedagogía de la dramatización. En consecuencia, tal y como se justifica a lo largo del trabajo, la evaluación dinámica debe ser conceptual y pedagógicamente congruente con los principios fundamentales y los objetivos de ambos enfoques. Los aspectos clave de esta propuesta son descritos en detalle.Peer Reviewe

No evidence of disease activity status in patients treated with early vs. delayed subcutaneous interferon β-1a.

Abstract Background Clinically isolated syndrome (CIS) is defined as a monophasic clinical episode highly suggestive of multiple sclerosis (MS). Regardless, studies have shown that treatment at this early stage of MS can delay a second event and prolong the transition to clinically diagnosed MS. The objective of this post-hoc analysis was to determine the effect of early CIS treatment with once weekly (qw) or three times weekly (tiw) subcutaneous interferon (scIFN) β-1a vs. delayed treatment (DT) on the composite endpoint of no evidence of disease activity (NEDA)-3. Methods In REFLEX, patients with CIS were randomized to double-blind scIFN β-1a 44 µg tiw, qw, or placebo for 24 months. Upon clinically-definite MS, patients switched to open-label scIFN β-1a tiw. Patients who completed REFLEX entered an extension (REFLEXION). Patients initially randomized to placebo switched to tiw (DT); scIFN β-1a patients continued their initial qw/tiw regimen for up to 60-months post-randomization. This post-hoc analysis was conducted in the integrated intent-to-treat REFLEX plus REFLEXION population (tiw, n = =171; qw, n = =175; DT, n = =171). All p values are nominal. CIS was defined using the McDonald 2010 criteria. Results Patients receiving early treatment (ET) with scIFN β-1a tiw and qw were more likely to achieve NEDA-3 than DT at year 2 (tiw vs. DT: OR 4.26, 95% CI 2.02–8.98, p = =0.0001; qw vs. DT: OR 2.99, 95% CI 1.39–6.43, p = =0.005). Compared with DT, ET with scIFN β-1a tiw was more likely to achieve NEDA-3 at year 3 (OR 3.73, 95% CI 1.63–8.55, p = =0.002) and year 5 (OR 12.96, 95% CI 1.66–101.04, p = =0.015). Between ET regimens, the odds of achieving NEDA-3 were not significantly improved by scIFN β-1a 44 µg tiw at year 2 (OR 1.42, 95% CI 0.81–2.50, p = =0.22) but were at year 3 (OR 2.26, 95% CI 1.11–4.60, p = =0.024) and year 5 (OR 3.22, 95% CI 1.01–10.22, p = =0.048), indicating that the beneficial effects of more frequent scIFN β-1a dosing become more apparent over time in patients with CIS. In the subgroup of patients with Gd+ lesions at baseline the odds for achieving NEDA-3 were higher for ET up to year 2 compared with DT (tiw: OR 10.21, 95% CI 1.23–84.82, p = =0.03; qw: OR 8.97, 95% CI 1.08–74.28, p = =0.04). In patients without Gd+ lesions at baseline, those receiving ET were more likely to achieve NEDA-3 at year 2 (OR 3.56, 95% CI 1.56–8.10, p = =0.003), year 3 (OR 2.54, 95% CI 1.05–6.18, p = =0.04) and year 5 (OR 9.63, 95% CI 1.19–77.79, p = =0.034) than patients who received DT. Conclusions ET with scIFN β-1a tiw was associated with a higher likelihood of achieving NEDA-3 not only at 2 but also at 3 and 5 years

Therapy optimization in multiple sclerosis: a prospective observational study of therapy compliance and outcomes.

BACKGROUND: Data sources for MS research are numerous but rarely provide an objective measure of drug therapy compliance coupled with patient-reported health outcomes. The objective of this paper is to describe the methods and baseline characteristics of the Therapy Optimization in MS (TOP MS) study designed to investigate the relationship between disease-modifying therapy compliance and health outcomes. METHODS: TOP MS was designed as a prospective, observational, nationwide patient-focused study using an internet portal for data entry. The protocol was reviewed and approved by Sterling IRB. The study was registered with ClinicalTrials.gov. It captured structured survey data monthly from MS patients recruited by specialty pharmacies. Data collection included the clinical characteristics of MS such as MS relapses. Disability, quality of life and work productivity and activity impairment were assessed quarterly with well-validated scales. When events like severe fatigue or new or worsening depression were reported, feedback was provided to treating physicians. The therapy compliance measure was derived from pharmacy drug shipment records uploaded to the study database. The data presented in this paper use descriptive statistics. RESULTS: The TOP MS Study enrolled 2966 participants receiving their disease-modifying therapy (DMT) from specialty pharmacies. The mean age of the sample was 49 years, 80.4% were female, 89.9% were Caucasian and 55.7% were employed full or part time. Mean time since first symptoms was 11.5 years; mean duration since diagnosis was 9.5 years. Patient-reported EDSS was 3.5; 72.2% had a relapsing-remitting disease course. The most commonly reported symptoms at the time of enrollment were fatigue (74.7%), impaired coordination or balance (61.8%) and numbness and tingling (61.2%). Half of the sample was using glatiramer acetate and half was using beta-interferons. CONCLUSION: Demographic and clinical characteristics of the TOP MS sample at enrollment are consistent with other community-based MS samples, and the sample appears to be representative of DMT users in the US. TOP MS data can be used to explore the associations between disease-modifying therapy compliance and health outcomes. TRIAL REGISTRATION: ClinicalTrials.gov (NCT00819000)

An investigation of mismatch negativity in current and ex-cannabis users using a feature controlled method

Abstract presented at the 23rd Australasian Society for Psychophysiology Conference, 20-22 Nov 2013, Wollongong, Australi

Spectrum of Illness in International Migrants Seen at GeoSentinel Clinics in 1997-2009, Part 2: Migrants Resettled Internationally and Evaluated for Specific Health Concerns

Of 7629 migrants, one third were infected with tuberculosis (22% active, 10% latent), one quarter with a variety of parasites (malaria 7%, schistosomes 6%, Strongyloides 5%, miscellaneous 5%), and 17% with chronic viral hepatitis (12% hepatitis B, 5% hepatitis C