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Muscle disorders caused by cerebral palsy (CP) can affect oral function. The treatment for masticatory muscle spasticity is important to minimize muscle hyperactivity and preclude oral damages. Objectives: To evaluate the efficacy and safety of non-surgical interventions for the treatment of masticatory muscle spasticity in CP patients. Methods: A comprehensive search was performed in the following databases: MEDLINE, Embase, Cochrane Library, LILACS, BBO, PEDro, Clinicaltrials.gov and WHO/ICTRP, without date and language restrictions. Randomized controlled trials (RCT) evaluating non-surgical interventions were considered. Primary outcomes such as masticatory function and adverse events were planned to be assessed. The risk of bias assessment was performed using the Cochrane risk of bias tool. The certainty of the evidence was assessed using the GRADE approach. Results: Three RCT assessing the effects of botulinum toxin, functional masticatory training and neuromuscular electrostimulation (NMES) were included. Evidence with a very low certainty showed: (i) no difference between botulinum toxin and placebo regarding maximum chewing strength, chewing efficiency and global oral health scale; (ii) improvement in masticatory function in favor of functional masticatory training versus conventional exercises, and (iii) in favor of strengthening exercises plus NMES versus placebo. Conclusions: There was insufficient evidence to support the use of botulinum toxin and masticatory muscle strengthening programs alone and associated with NMES for the treatment of masticatory muscle in patients with PC. The clinical decision must be individualized, and further studies are needed to support or refute the use of different non-surgical interventions for PC. PROSPERO register number CRD42020209761. [ABSTRACT FROM AUTHOR]

Highlights • Patient Information Sheet (PIS) used in MS clinical trials may not be understandable. • User testing (UT) highlighted critical issues in two PIS from clinical trials in MS. • UT is a useful tool for verifying the comprehensibility of PIS. • Developing PIS should involve different stakeholders with specific experience. Abstract The Patient Information Sheet (PIS) is an important aspect of the consent process in a clinical trial that provides potential participants the necessary information for deciding whether to take part in a specific study and for understanding their rights pertaining to participation. User Testing was originally developed to assess how written information about medicinal products performs with its intended users. User testing has been proposed in a small number of clinical trials and has been able to identify subjects' ability or inability to find and understand important information related to providing a valid consent to participate. A 21-item ad hoc user testing questionnaire was applied to 2 PIS used in clinical trials in MS. Sixty subjects were allocated to a group testing an observational study PIS (O-PIS) or to a group testing an intervention study PIS (I-PIS). In the O-PIS group, 19.4% of subjects located all relevant information within the text (21/21) and 3.4% of subjects in the I-PIS group. Overall, 82.1% of subjects testing the O-PIS understood the text and 53.5% of subjects testing the I-PIS understood the text. In the category 'nature and purpose of the trial', one-third of subjects did not understand the text, including the aim of the study. User testing should be considered as a valid tool in evaluating the comprehensibility of PIS in the context of clinical trials MS to assure that subjects provide a valid consent to participate. [ABSTRACT FROM AUTHOR]

The Progressive MS Alliance Industry Forum describes a new approach to address barriers to developing treatments for progressive multiple sclerosis (MS). This innovative model promises to facilitate robust collaboration between industry, academia, and patient organizations and accelerate research towards the overarching goal of developing safe and effective treatments for progressive MS. [ABSTRACT FROM AUTHOR]

• PROMS is a global multi-stakeholder initiative that makes MS patients' change scientifically relevant experiential knowledge. • We envision a PROMs ecosystem in which all stakeholders are co-responsible of the impact of patient engagement, from research to care. • We aim to integrate a PROMs core data set from practice to care, to be included in registries. • We aim to rethink research, trials, and practice via e-PROMs to enable a holistic, comprehensive and personalized care. • We aim to develop a PROMs ecosystem that could be adapted and uptaken to other neurological diseases. On 12 September 2019, the global Patient Reported Outcome for Multiple Sclerosis (PROMS) Initiative was launched at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The multi-stakeholder PROMS Initiative is jointly led by the European Charcot Foundation (ECF) and the Multiple Sclerosis International Federation (MSIF), with the Italian Multiple Sclerosis Society (AISM) acting as the lead agency for and on behalf of the global MSIF movement. The initiative has the ambitious mission to (i) maximize the impact of science with and of patient input on the life of people affected by MS, and (ii) to represent a unified view on Patient-Reported Outcomes for MS to people affected by MS, healthcare providers, regulatory agencies and Health Technologies Assessments agencies. Equipped with an innovative participatory governance of an international and interdisciplinary network of different stakeholders, PROMS has the potential to guide future breakthroughs in MS patient-focused research and care. In this paper we present the progresses of the global PROMS Initiative and discuss the open questions that we aim to address. [ABSTRACT FROM AUTHOR]

• Latent class analysis to identify predominant cognitive phenotypes in PwMS. • Combination of both cognitive and mood information from patient-centered outcomes. • Classification of four phenotypes based on model fit and parsimony criteria. • Taxonomy as a continuum of deterioration of cognition as the disease progresses. Since combining information from different domains could be useful to increase prediction accuracy over and above what can be achieved at the level of single category of markers, this study aimed to identify distinct and predominant subtypes, i.e., cognitive phenotypes, in people with multiple sclerosis (PwMS) considering both cognitive impairment and mood disorders. A latent class analysis (LCA) was applied on data from 872 PwMS who were tested with Montreal Cognitive Assessment (MoCA), Symbol Digit Modalities Test (SDMT) and Hospital Anxiety and Depression Scale (HADS). Furthermore, the distribution of demographic (i.e., age, gender, years of education) and clinical characteristics (i.e., disease duration, disease course, disability level) was examined amongst the identified phenotypes. Based on model fit and parsimony criteria, LCA identified four cognitive phenotypes: 1) only memory difficulties (n = 247; 28.3%); 2) minor memory and language deficits with mood disorders (n = 185; 21.2%); 3) moderate memory, language and attention impairments (n = 164; 18.8%); 4) severe memory, language, attention, information processing and executive functions difficulties (n = 276; 31.7%). Since less is known about the progressive deterioration of cognition in PwMS, a taxonomy of distinct subtypes that consider information from different clustered domains (i.e., cognition and mood) represents both a challenge and opportunity for an advanced understanding of cognitive impairments and development of tailored cognitive treatments in MS. [ABSTRACT FROM AUTHOR]

Abstract: Liposome-encapsulated corticosteroids have shown to exert strong beneficial effects in inflammatory diseases, such as arthritis and cancer. To extend the clinical applicability of these potent nanomedicines, the therapeutic effect of dexamethasone phosphate loaded long-circulating liposomes (LCL-DXP) was evaluated in animal models of multiple sclerosis (MS) and Crohn''s disease (CD). In mice with experimental autoimmune encephalitis (EAE), a model for MS, treatment with LCL-DXP, but not free DXP, resulted in a decrease in disease activity when compared to PBS treated mice. In contrast, in mice with chronic DSS-induced colitis, a model for CD, treatment with LCL-DXP did not induce an improvement, but in fact worsened the fecal blood loss after treatment, indicating an aggravation of the disease. It is hypothesized that modulation of macrophage polarization towards a M2 phenotype underlies the efficacy of corticosteroid-based drug delivery systems, which is supported by the presented data. On the one hand, M1 polarized macrophages are part of the pathogenesis of MS; the modulation to M2-polarization by LCL-DXP is therefore beneficial. On the other hand, M1-polarized intestinal macrophages fulfill a protective and inflammation-suppressing role in intestinal homeostasis; changing their phenotype to M2 causes reduced protection to invading microorganisms, leading to a more severe intestinal inflammation. These findings therefore indicate that the interplay between the specific phenotype of macrophages and the specific inflammatory context of the inflammatory disease in question may be an important determining factor in the therapeutic applicability of liposomal corticosteroids in inflammatory disease. [Copyright &y& Elsevier]