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Les Potentiels Évoqués Cognitifs (PEC) sont des potentiels endogènes de réalisation non invasive et ancienne. C'est une pratique complémentaire qui n'est pas courante dans le champ psychiatrique. Cette présente description des PEC réalisés dans le centre hospitalier psychiatrique de Limoges est faite autour de deux groupes de pathologies psychiatriques : troubles psychotiques et troubles dépressifs. L'analyse des différentes composantes des PEC permet de mieux cerner les caractéristiques cliniques chez les patients. Le potentiel P300 et la variation contingente négative (VCN) permettent de décrire des indicateurs cliniques comme le retard psychomoteur, les difficultés cognitives, l'anticipation, l'attention, la mémoire et l'intégration des tâches. Le P50 permet de voir la capacité ou non pour un patient à assurer un filtrage de l'information sensorielle. L'association de quatre tests (P300 en moyennage direct, le P300 en rétromoyennage, la VCN et le P50) permet d'obtenir de plus amples informations, ce d'autant plus que des pathologies associées sont fréquentes chez un même patient. Le traitement des patients présente souvent plusieurs molécules associées. Le but de ce travail est de faire un état des lieux de ce complément de bilan des troubles psychiatriques dans une unité de neurophysiologie. Cognitive Evoked Potentials (PEC) are endogenous potentials of non-invasive and ancient realization. It is a complementary practice that is not common in the psychiatric field. The description of the PECs carried out in the Limoges psychiatric hospital center is made around 2 groups of psychiatric pathologies: psychotic disorders, depressive disorders. The analysis of the different components of the PEC allows to better define the clinical characteristics in the patients. P300 and contingent negative variation (CNV) potentials describe clinical indicators such as psychomotor retardation, cognitive difficulties, anticipation, attention, memory and task integration. The P50 allows you to see the ability or not for a patient to filter sensory information. The combination of four tests (P300 in direct averaging, P300 in backward averaging, CNV and P50) provides additional detailed information, especially since associated pathologies are frequent in the same patient. The treatment of patients often presents several associated molecules. The aim of this work is to take stock of this additional assessment of psychiatric disorders in a neurophysiology unit. [ABSTRACT FROM AUTHOR]

Decentralized clinical trial (DCT) approaches are clinical trials in which some or all trial activities take place closer to participants' proximities instead of a traditional investigative site. Data from DCTs may be used for clinical and economic evaluations by health technology assessment (HTA) bodies to support reimbursement decision making. This study aimed to explore the opportunities and challenges for DCT approaches from an HTA perspective by interviewing representatives from European HTA bodies. We conducted semistructured interviews with 25 European HTA representatives between September 2022 and February 2023, and transcripts were analyzed after thematic analysis. Two main themes were identified from the data relating to (1) DCT approaches in HTA and (2) trial-level acceptance and relevance. Experience with assessing DCTs was limited and a variety of knowledge about DCTs was observed. The respondents recognized the opportunity of DCTs to reduce recall bias when participant-reported outcome data can be collected more frequently and conveniently from home. Concerns were expressed about the data quality when participants become responsible for data collection. Despite this challenge, the respondents recognized the potential of DCTs to increase the generalizability of results because data can be collected in a setting reflective of the everyday situation potentially from a more diverse participant group. DCTs could generate relevant results for HTA decision making when data are collected in a real-world setting from a diverse participant group. Increased awareness of the opportunities and challenges could help HTA assessors in their appraisal of DCT approaches. • Decentralized clinical trial (DCT) approaches move trial activities from the investigative site to the participants' surroundings, to render either fully decentralized trials or trials with a combination of at-home and in-clinic activities. These approaches have the potential to reduce participation burden, leverage technologies to collect data, and increase participant representativeness. In Europe, regulators are beginning to explore DCT approaches and have issued guidance documents, but the perspective of health technology assessors has not been studied before. • We identified opportunities and challenges for DCT approaches from a health technology assessment (HTA) perspective. The main opportunities relate to a better reflection of the real-world, for example, because participants feel less observed when participating from home and because of expected increased trial access for underserved groups. Identified challenges include the possibility of reduced data quality—when procedures are moved from sites to less controlled settings—and the limited knowledge of DCTs among HTA assessors. • When evaluating DCT approaches, the different ways trials can be decentralized should be recognized—for example, in terms of recruitment procedures, number and type of included digital health technologies, and related trial complexity and accessibility. DCT approaches should be considered to collect participant-reported outcomes for HTA decision making in a convenient way in a real-world setting. An aligned view from the perspective of HTA assessors and regulators could be communicated through guidance. [ABSTRACT FROM AUTHOR]

Abstract: The aim of the study was to develop an efficient combination antibiotic formulation containing tobramycin and clarithromycin as a dry powder for inhalation. A carrier-free formulation of the two drugs was produced by spray-drying and characterised for its aerodynamic behaviour by impaction tests with an NGI and release profiles. The particle size distribution, morphological evaluation and crystallinity state were determined by laser diffraction, scanning electron microscopy and powder X-ray diffraction, respectively. Drug deposition profiles were similar for the two antibiotics, which has a synergistic effect, allowing them to reach the target simultaneously at the expected dose. The release profiles show that tobramycin and clarithromycin should probably dissolve without any difficulties in vivo in the lung as 95% of tobramycin and 57% of clarithromycin mass dissolved in 10min for the spray-dried formulation. The FPF increased from 35% and 31% for the physical blend for tobramycin and clarithromycin, respectively, to 65% and 63% for the spray-dried formulation. The spray-dried formulation shows particularly high deposition results, even at sub-optimal inspiratory flow rates, and therefore, represents an attractive alternative in the local treatment of lung infection such as in cystic fibrosis. [Copyright &y& Elsevier]