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Cost-utility of point-of-care viscoelastic hemostatic assays in the management of bleeding during cardiac surgery: A single-blinded prospective multicenter stepped wedge cluster randomized trial in French context
No full textInternational audienceBackground: The IMOTEC study aims to determine whether a point-of-care viscoelastic hemostatic assay (VHA)-guided algorithm is cost-effective for the management of ongoing bleeding.Methods: Stepped wedge cluster randomized trial, patient blinded, conducted at 16 French academic cardiac surgery centers from 01/2017 to 02/2020. Adults undergoing elective or urgent cardiac surgery with ongoing bleeding were enrolled during 2 successive inclusion periods: 1) transfusion guided on standard hemostasis tests (control period), and 2) transfusion using a VHA-guided algorithm. The primary objective was to estimate the efficiency of VHA based on the 1-year incremental cost-utility ratio (ICUR, primary outcome). Secondary outcomes included transfusion, postoperative complications, duration of stay in-hospital, reintervention, and mortality.Results: 1095 patients were randomized, and 1044 (95.3%) were analyzed. The mean utility was 0.60 (±0.30) in the VHA vs. 0.61 (±0.30) in the control period, adjusted difference, -0.01 [95% CI, -0.09 to 0.07]. The ICUR did not suggest that the VHA-guided algorithm was cost-effective. One-year mortality was 12.0% for VHA and 10.9% for control, Hazard Ratio, 1.69 [95% CI, 0.98-2.89], P = .06. The frequency of plasma and platelet transfusions was significantly lower in the VHA compared to the control period (respectively, 48.8% vs. 72.4%, P < 0.0001 and 52.3% vs. 74.1%, P = .0002), whereas fibrinogen administration was more frequent in the VHA period (58.4% vs. 47.0%, P = .002). The median in-hospital length of stay was significantly shorter in the VHA vs. control period: 11.0 days (8.0-18.0) vs. 14.0 (9.0-22.0), P = .02.Conclusions: The ICUR did not suggest that VHA was cost-effective in cardiac surgery patients with ongoing bleeding, compared with standard tests.Trial registration: Clinical trial submission: November 2, 2016 Registry name: Cost-Utility Analysis of Management of Peri Operative Hemorrhage Following Cardiac Surgery With Cardiopulmonary Bypass (IMOTEC) ClinicalTrials.gov Identifier: NCT02972684 URL registry: https://clinicaltrials.gov/study/NCT02972684
Invasive aspergillosis in liver transplant recipients in France (2007–21): a nationwide, retrospective, matched case–control study
No full textInternational audienceBackgroundInvasive aspergillosis is a rare but severe complication of liver transplantation. Incidence varies from 1·2% to 5·6% and mortality is greater than 50%. Few studies have investigated this complication. We aimed to describe cases of, and identify the factors associated with, invasive aspergillosis occurrence and mortality.MethodsThis nationwide, retrospective, matched case–control study included cases of invasive aspergillosis occurring after liver transplantation between Jan 1, 2007, and Dec 31, 2021, matched 1:1 on centre and transplantation period to control individuals without invasive aspergillosis across 15 liver transplantation centres in France. Cases were patients aged 18 years or older who presented with proven or probable invasive aspergillosis. The matched control was the next patient who received a transplant at the same transplantation centre after the case. Cases were retrospectively identified in each centre using the mycology laboratory database and the French Medicalised Information System Programme. Data were retrieved from hospital charts. The primary outcome was the identification of risk factors associated with the development of invasive aspergillosis following liver transplantation. Multivariable analysis using conditional logistic regression with a random effect for study centres was done to establish risk factors.FindingsAmong 14 332 liver transplantations, 196 recipients with invasive aspergillosis (62 [32%] female and 134 [68%] male) were identified and matched with 196 control individuals (54 [28%] female and 142 [73%] male). Invasive aspergillosis occurred at a median of 29 days (IQR 7–173) after liver transplantation. Risk factors for developing invasive aspergillosis were history of chronic kidney disease (adjusted odds ratio 4·13 [95% CI 2·35–7·24]), liver transplantation for acute liver disease (3·41 [1·44–8·06]), post-liver transplantation renal replacement therapy (3·82 [1·96–7·42]), and post-liver transplantation vasopressor support for longer than 24 h (2·82 [1·70–4·68]).InterpretationThis study identifies three patient populations at risk of invasive aspergillosis after liver transplantation: patients with history of chronic kidney disease, those who have received a transplant for acute liver disease, and those who had a post-operative period marked by organ failure. This identification could lead to new invasive aspergillosis prophylactic strategies
Validation of Visual Analogue Scales to Assess Occupational Stress Compared to the Karasek Questionnaire: A Cross Sectional Study
No full textInternational audienceBACKGROUND: The Job Demand-Control-Support (JDCS) model is one of the most important tools for assessing work-related stress. However, its complexity highlights the need for simpler instruments, such as the Visual Analog Scale (VAS), for rapid assessment in occupational medicine.OBJECTIVES: To validate three VAS corresponding to the main JDCS dimensions: job demand, job control, and social support. METHOD: We conducted an observational cross-sectional validation study using a self-administered questionnaire completed twice, a week apart, at the participants' convenience, to perform test-retest.RESULTS: We analysed 155 participants (60 for test and retest), mostly women around 40 years. Acceptability was excellent, with high response rates. Internal consistency analysis revealed moderate correlations between VAS and JDCS model main dimensions. Reliability assessed by Lin's concordance correlation coefficient was acceptable for the VAS and higher for the JDCS. Mean VAS scores indicated significant differences between low and high demand, control, and social support, with cut-off values of 58, 71.5 and 63.5 respectively. For external validity, we mainly found high agreement between VAS and JDCS. CONCLUSIONS: VAS are valid, quick, easy to use, and reliable tools for the assessment of job demand, job control and social support in daily clinical practice for primary prevention and diagnosis. Based on our findings, easier-to-remember cut-offs could be proposed at 60, 70, and 60 for VAS job demand, VAS job control, and VAS social support, respectively. However, when results are over the determined cut-off, we encourage the use of JDCS questionnaire. TRIAL REGISTRATION: ClinicalTrials.gov NCT05871411
Muscle Retracting Sign in Colorectal Macronodular Lesions: Prevalence, ESD Outcomes, and Submucosal Cancer Predictors
No full textInternational audienc
Non-Aspergillus invasive mould infections in liver transplant recipients : a French national retrospective case-control study, 2007 to 2021
No full textInternational audienceBACKGROUND: Non-Aspergillus invasive mould infections (IMIs) are emerging in immunocompromised patients and liver is the second most commonly organ transplanted worldwide. METHODS: We conducted a multicenter retrospective case-control (1:1) study of liver transplant recipients diagnosed with non-Aspergillus IMIs in France between January 2007 and December 2021. RESULTS: We identified 27/14,332 (0.18%) LT recipients with non-Aspergillus IMIs. Mucorales spp. (48%) were the most common pathogens, followed by Scedosporium spp. (14%), Fusarium spp. (14%), and other IMIs (25%). Lungs were the primary infection site, followed by soft tissues, abdomen, brain, sinuses, heart, and bone. Multivariate analysis showed that a MELD score > 20 prior to transplantation and primary antifungal prophylaxis (with echinocandins or fluconazole) tended to increase the risk of non-Aspergillus IMIs by nearly threefold ((aOR: 3.73, 95% CI [0.90-15.45], p = 0.07) and (aOR: 3.93; 95% CI [0.94-16.42], p = 0.06) respectively). The 6-month mortality rate was 55%. In a Cox survival model, non-Aspergillus IMIs were associated with a threefold increase in mortality risk ((HR: 3.82 [2.01-7.26] p<0.001). CONCLUSION: Non-Aspergillus IMIs are rare but highly fatal infections whose early diagnosis in high-risk liver-transplanted patients is essential. Whether or not recently available molecular tools for diagnosing non-Aspergillus IMIs will improve their prognosis in the liver transplantation setting remains to be studied
A nationwide 12‐month observatory of automated insulin delivery shows improved glucose control, sustained adoption, and reduced acute severe events
No full textInternational audienceAims: A nationwide observational study was conducted to assess the 12-month effectiveness of AID systems in the routine care of people with Type 1 diabetes (PwT1D).Methods: All PwT1D, adults, and children, who initiated AID between January 1, 2022, and December 31, 2022, were included across 79 centres. Clinical data, continuous glucose monitoring (CGM) parameters, acute severe events in the last year, and HbA1c levels were collected at AID initiation, and after 3, 6, and 12 months of AID treatment. Median values [interquartile range, IQR] and % PwT1D with acute severe events were reported. The primary outcome was the change in time in range (TIR; 3.9-10 mmol/L) after 1 year with AID.Results: A total of 2741 PwT1D were included: 44.4% male, age 38 years [29], BMI 24.5 kg/m2 [6.7], diabetes duration 19 years [20]. AID systems were MiniMed 780G in 49.7%, Tandem Control-IQ in 49.3%, others in 1%. After 12 months, TIR increased from 58.0 [21] to 70.1% [14] while HbA1c levels decreased from 7.6 [1.2] to 7.0% [0.8]. Percent PwT1D experiencing severe hypoglycaemia (SH) decreased from 4.1 to 0.9%, and ketoacidosis from 1.2 to 0.6%. All improvements were observed after 3 months, sustained through 12 months, and statistically significant (p < 0.05). Only 2.8% of PwT1D discontinued AID.Conclusions: Twelve months of AID use in routine care improved glucose control in PwT1D, among whom there was less experienced SH and a minor discontinuation
Uncovering the dynamics of mucosa-associated microbiota in post-operative recurrence of Crohn’s disease
No full textInternational audienceBackgroundAbout 50 to 75% of Crohn’s Disease patients (CD) need bowel resection. Postoperative recurrence of Crohn’s disease is frequent. Here, we investigate the evolution of the mucosa-associated microbiota along the Rutgeerts score measuring endoscopic recurrence after surgery.MethodsWe used 16S rRNA and ITS2 sequencing to profile the mucosa-associated microbiota of biopsies from CD patients at the time of surgery (M0, n=139) and later, at the time of endoscopic assessment of recurrence (M6, n=125).ResultsWhile the effect of surgery and recurrence were moderate on the overall microbiota composition, we identified specific microbial signatures displaying differential relative abundance when accounting for clinical covariates. The relative abundance of certain species, notably a decrease of Faecalibacterium prausnitzii, or increase of Akkermansia muciniphila, was differentially associated with a whole range of Rutgeerts score or with more specific scores characterizing the inflammation of the anastomosis or the ileum. In addition, machine learning performances were impacted by the consideration of the Rutgeerts score as a multilevel prediction instead of a binary classification, further confirming the need to consider its full range. Finally, we investigated the community dynamics, which highlighted a denser network organisation after surgery and in the absence of recurrence, along with changes in keystone species.ConclusionAltogether, these results provide further understanding of the effects of ileal resection patients with CD and show that disease recurrence is a dynamic process characterized by several waves of changes in the microbiota composition
DOP029 One-Year Effectiveness and Safety of Upadacitinib in 261 Patients With Crohn’s Disease: A Multicenter Real-World Cohort Study
No full textDigital Oral PresentationInternational audienc
Santé environnementale et transition écologique du système de santé
No full textInternational audienceFace à l’urgence climatique et aux effets de l’environnement sur la santé, la transition écologique du système de santé est devenue un enjeu majeur. Cet ouvrage propose une synthèse structurée et opérationnelle des fondements de la santé environnementale et de leur application au champ sanitaire et médico-social.Il réunit les définitions essentielles des notions clés (santé environnementale, transition écologique, décarbonation des activités…), un état des lieux du cadre juridique, des politiques publiques et des connaissances actuelles (PNSE 4, feuille de route de planification écologique du système de santé), ainsi que des exemples concrets de démarches de transition mises en œuvre dans les établissements de santé et médico-sociaux.Une annexe méthodologique dédiée aux concours administratifs complète l’ouvrage, avec des conseils pratiques et des exemples de sujets.Initialement conçu pour les candidats aux concours d’entrée à l’EHESP, ce livre s’adresse également aux professionnels du système de santé souhaitant intégrer les enjeux environnementaux dans leurs pratiques, leurs décisions et leurs engagements, ainsi qu’à toutes celles et ceux désireux de concilier expertise sanitaire et responsabilité écologique
