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Efficacy of esketamine nasal spray over quetiapine extended release over the short and long term: sensitivity analyses of ESCAPE-TRD, a randomised phase IIIb clinical trial
No full textInternational audienceBackground In patients with treatment resistant depression (TRD), the ESCAPE-TRD study showed esketamine nasal spray was superior to quetiapine extended release. Aims To determine the robustness of the ESCAPE-TRD results and confirm the superiority of esketamine nasal spray over quetiapine extended release. Method ESCAPE-TRD was a randomised, open-label, rater-blinded, active-controlled phase IIIb trial. Patients had TRD (i.e. non-response to two or more antidepressive treatments within a major depressive episode). Patients were randomised 1:1 to flexibly dosed esketamine nasal spray or quetiapine extended release, while continuing an ongoing selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor. The primary end-point was achieving a Montgomery–Åsberg Depression Rating Scale score of ≤10 at Week 8, while the key secondary end-point was remaining relapse free through Week 32 after achieving remission at Week 8. Sensitivity analyses were performed on these end-points by varying the definition of remission based on timepoint, threshold and scale. Results Of 676 patients, 336 were randomised to esketamine nasal spray and 340 to quetiapine extended release. All sensitivity analyses on the primary and key secondary end-point favoured esketamine nasal spray over quetiapine extended release, with relative risks ranging from 1.462 to 1.737 and from 1.417 to 1.838, respectively (all p < 0.05). Treatment with esketamine nasal spray shortened time to first and confirmed remission (hazard ratio: 1.711 [95% confidence interval 1.402, 2.087], p < 0.001; 1.658 [1.337, 2.055], p < 0.001). Conclusion Esketamine nasal spray consistently demonstrated significant superiority over quetiapine extended release using all pre-specified definitions for remission and relapse. Sensitivity analyses supported the conclusions of the primary ESCAPE-TRD analysis and demonstrated robustness of the results
Nonischemic Cardiac Manifestations in VEXAS Syndrome
No full textInternational audienceThis case series reports on the clinical presentation, laboratory findings, imaging characteristics, treatments, and outcomes of nonischemic cardiac manifestations in patients with VEXAS syndrome with confirmed pathogenic UBA1 alterations
A.B. Sexo ETP : une mallette pédagogique pour accompagner les professionnels de santé à aborder la santé sexuelle dans le champ de maladies rares: 4. Acquisition d'aptitudes individuelles et collectives
No full textInternational audience1. IntroductionFace aux impacts des maladies auto-immunes et auto-inflammatoires rares (MAIR) sur leur santé sexuelle (SS), les patients expriment le besoin de communiquer sur le sujet avec les professionnels de santé (PS). Ils considèrent que cette initiative doit venir des PS. De leur côté, les PS se sentent illégitimes pour aborder la SS par manque de connaissance et d’outils et par crainte d’être intrusifs. L’éducationthérapeutique du patient (ETP) est l’occasion d’aborder cette thématique mais il existe peu de ressources visant à soutenir les PS dans cette démarche. L’Unité Transversale d’Education du Patient de Clermont-Ferrand, le centre de référence pour les maladies auto immunes et auto inflammatoire d’Auvergne (CERAINAUV), du CHU de Clermont Ferrand et l’Instance Régionale d’Education etde Promotion de la Santé du Puy de Dôme, avec la Filière de santé des maladies Auto-Immunes et Auto-Inflammatoires Rares (FAI2R) élaborent la mallette pédagogique en SS : A.B. Sexo ETP : « Aborder la santé Sexuelle en ETP en Maladies Rares »*.2. MéthodeUn comité pluridisciplinaire a été constitué pour construire la mallette. Une revue de littérature ciblée sur les impacts des MAIR sur la SS a été réalisée. L’inventaire des ressources disponibles dans le champ de la SS a été effectué. Un état des lieux des actions en SS menées par des associations de patients concernés par les MAIR est actuellement en cours sous forme d’entretiens semidirectifs.Il est prévu de tester la mallette auprès de plusieurs équipes d’ETP en MAIR. 3. Résultats - discussionLes impacts des MAIR sur la SS se traduisent par une prévalence des troubles sexuels plus élevée qu’en population générale et des conséquences plus lourdes sur le plan émotionnel, psychique, relationnel et sur la qualité de vie. Les actions menées par les associations de patients dans le champ des MAIR sont hétérogènes. Il existe des ressources disponibles pouvant être utilisées dans l’élaboration de la mallette. Ce travail va permettre de structurer notre mallette en deux parties : La première à destination des PS vise leur formation au concept de santé sexuelle et aux impacts des MAIR sur la SS des patients. La seconde est constituée d’ateliers basées sur des cas cliniques permettant d’aborder les thématiques clés de la SS en MAIR et combinables entre eux. 4. ConclusionCette mallette pédagogique sera distribuée via la Filière de santé des maladies Auto-Immunes et Auto-Inflammatoires Rares (FAI2R) aux centres de références et de compétence qui souhaiteraient l’utiliser auprès des patients suivis pour des MAIR. Cette mallette pédagogique devra être évaluée ultérieurement tant du point de vue des patients que des PS
Vécu de l’accouchement des femmes selon le type de poussée utilisé lors du 2ème stade du travail : Etude EOLE
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Environmental impact of single-use versus reusable gastroscopes
No full textInternational audienceAbstract Introduction The environmental impact of endoscopy is a topic of growing interest. This study aimed to compare the carbon footprint of performing an esogastroduodenoscopy (EGD) with a reusable (RU) or with a single-use (SU) disposable gastroscope. Methods SU (Ambu aScope Gastro) and RU gastroscopes (Olympus, H190) were evaluated using life cycle assessment methodology (ISO 14040) including the manufacture, distribution, usage, reprocessing and disposal of the endoscope. Data were obtained from Edouard Herriot Hospital (Lyon, France) from April 2023 to February 2024. Primary outcome was the carbon footprint (measured in Kg CO 2 equivalent) for both gastroscopes per examination. Secondary outcomes included other environmental impacts. A sensitivity analysis was performed to examine the impact of varying scenarios. Results Carbon footprint of SU and RU gastroscopes were 10.9 kg CO 2 eq and 4.7 kg CO 2 eq, respectively. The difference in carbon footprint equals one conventional car drive of 28 km or 6 days of CO 2 emission of an average European household. Based on environmentally-extended input-output life cycle assessment, the estimated per-use carbon footprint of the endoscope stack and washer was 0.18 kg CO 2 eq in SU strategy versus 0.56 kg CO 2 eq in RU strategy. According to secondary outcomes, fossil eq depletion was 130 MJ (SU) and 60.9 MJ (RU) and water depletion for 6.2 m 3 (SU) and 9.5 m 3 (RU), respectively. Conclusion For one examination, SU gastroscope have a 2.5 times higher carbon footprint than RU ones. These data will help with the logistics and planning of an endoscopic service in relation to other economic and environmental factors
Effects of a sedentary behaviour intervention in emergency dispatch centre phone operators: a study protocol for the SECODIS randomised controlled cross-over trial
No full textInternational audienceIntroduction Sedentary behaviour is a public health problem. We mainly have sedentary behaviour at work, transforming them into occupational risk. To our knowledge, there is no intervention study on the reduction of occupational sedentary behaviour in a real work situation and its impact on health and biomarkers of stress. The main objective is to study changes in sedentary behaviour following a behavioural intervention (sit-and-stand desk and cycle ergometer). Methods and analysis This is a randomised controlled trial in cross-over design conducted in a single centre. The study will be proposed to emergency medical dispatchers of Clermont-Ferrand. Each volunteer will be followed during three cycles of 1 week (3 weeks in total). Each 1-week cycle is made up of 12 hours of work (three conditions: a control and two interventions), 12 hours of successive rest and 6 days of follow-up. For each condition, the measurements will be identical: questionnaire, measure of heart rate variability, electrodermal activity and level of physical activity, saliva and blood sampling. The primary outcome is sedentary behaviour at work (ie, number of minutes per day standing/active). Data will be analysed with both intention-to-treat and per protocol analysis. A p<0.05 will be considered as indicating statistical significance. Ethics and dissemination The study protocol has been approved by the Ethics Committee Ouest IV, FRANCE. The study is registered in ClinicalTrials.gov. All patients will be informed about the details of the study and sign written informed consent before enrolment in the study. Results from this study will be published in a peer-reviewed journal. This study involves human participants and was approved by Comité de protection des personnes Ouest IVCPP reference: 23/132-2National number: 2022-A02730-43. Trial registration number NCT05931406
Oral resveratrol in adults with knee osteoarthritis: A randomized placebo-controlled trial (ARTHROL)
No full textInternational audienceBackground Resveratrol is a natural compound found in red wine. It has demonstrated anti-inflammatory properties in preclinical models. We compared the effect of oral resveratrol in a new patented formulation to oral placebo for individuals with painful knee osteoarthritis. Methods and findings ARTHROL was a double-blind, randomized, placebo-controlled, Phase 3 trial conducted in 3 tertiary care centers in France. We recruited adults who fulfilled the 1986 American College of Rheumatology criteria for knee osteoarthritis and reported a pain intensity score of at least 40 on an 11-point numeric rating scale (NRS) in 10-point increments (0, no pain, to 100, maximal pain). Participants were randomly assigned (1:1) by using a computer-generated randomization list with permuted blocks of variable size (2, 4, or 6) to receive oral resveratrol (40 mg [2 caplets] twice a day for 1 week, then 20 mg [1 caplet] twice a day; resveratrol group) or matched oral placebo (placebo group) for 6 months. The primary outcome was the mean change from baseline in knee pain on a self-administered 11-point pain NRS at 3 months. The trial was registered at ClinicalTrials.gov : (NCT02905799). Between October 20, 2017 and November 8, 2021, we assessed 649 individuals for eligibility, and from November 9, 2017, we recruited 142 (22%) participants (mean age 61.4 years [standard deviation (SD) 9.6] and 101 [71%] women); 71 (50%) were randomly assigned to the resveratrol group and 71 (50%) to the placebo group. At baseline, the mean knee pain score was 56.2/100 (SD 13.5). At 3 months, the mean reduction in knee pain was −15.7 (95% confidence interval (CI), −21.1 to −10.3) in the resveratrol group and −15.2 (95% CI, −20.5 to −9.8) in the placebo group (absolute difference −0.6 [95% CI, −8.0 to 6.9]; p = 0.88). Serious adverse events (not related to the interventions) occurred in 3 (4%) in the resveratrol group and 2 (3%) in the placebo group. Our study has limitations in that it was underpowered and the effect size, estimated to be 0.55, was optimistically estimated. Conclusions In this study, we observed that compared with placebo, oral resveratrol did not reduce knee pain in people with painful knee osteoarthritis. Trial registration ClinicalTrials.gov ID: NCT02905799
Comment apprivoiser l’intelligence artificielle (IA) quand on est formateur en IFSI ?
No full textOver the past two years, AI has come to occupy an important place in society, and this is particularly questioning within higher education. Nursing training institutes (IFSI) are not immune to this phenomenon. In addition, it raises questions about the practice of trainers and how to integrate it into the training of nursing students in a practical and ethical way. The aim of this article is to identify the levers that can be used by nursing trainers in the field of artificial intelligence.Depuis deux ans, l'IA occupe une place importante dans la société et celle-ci interroge particulièrement au sein de l'enseignement supérieur. Les Instituts de formation en soins infirmiers (IFSI) ne sont pas épargnés par ce phénomène. En outre, elle questionne la pratique des formateurs et la manière de l'intégrer dans la formation des étudiants infirmiers de façon pratique et éthique. Cet article a pour objectif d'identifier des leviers utilisables par les formateurs en soins infirmiers en matière d'intelligence artificielle
Will Endoscopic-Ultrasound-Guided Choledocoduodenostomy with Electrocautery-Enhanced Lumen-Apposing Metal Stent Placement Replace Endoscopic Retrograde Cholangiopancreatography When Treating Distal Malignant Biliary Obstructions?
No full textInternational audienceMalignant distal biliary obstructions are becoming increasingly common, especially in patients with cancers of the pancreatic head, despite progress in medical oncology research. ERCP is the current gold standard for management of such strictures, but the emergence of EC-LAMS has rendered EUS-CDS both safe and efficient. It is a “game changer”; originally intended for ERCP failure, two randomised clinical trials recently proposed EUS-CDS as a first-intent procedure in palliative settings. For resectable diseases, the absence of iatrogenic pancreatitis associated with a lower rate of postsurgical adverse events (compared with ERCP) leads us to believe that EUS-CDS might be used in first-intent as a pre-operative endoscopic biliary drainage
Caries management in France – Evolution between 2002 and 2023-2024.
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