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Standard formulas and individualised parenteral nutrition preparations in very low birth weight infants
No full textInternational audienceBackground/objectives Optimal nutrition in very low birth weight (VLBW) infants is associated with improved clinical outcomes. When parenteral nutrition (PN) with a marketing authorisation is not appropriate, hospital pharmacies can prepare more suitable PN preparation. This corresponds to standard preparations (i.e., available at any time with a fixed composition) or individualised ones (i.e., available after a period of prescription, preparation, and pharmaceutical control). In France, 12 standard formulas to be compounded were proposed by a national consortium in 2018. The objective of the present study was to evaluate whether individualised PN preparations ordered in our hospital are substitutable by one of the 12 standard formulas. Methods All PN prescriptions for VLBW infants made in 2021 in our hospital were retrospectively extracted. For each prescription, the theoretical intakes that an infant would have received if a standard preparation had been administered were calculated. Standard and individualised preparations were compared using the Mann-Whitney U test for each component. Secondly, the relative difference between the expected intakes and effectively intakes was calculated for each component. Results/Discussion Over the study period, 1708 prescriptions were identified (corresponding to 1708 PN individualised preparations). Most infants were extremely low birth weight infants. Based on the methods of comparison, none of the 12 standard formulas fitted with targeted intakes achieved with individualised PN preparations ordered, whereas prescriptions did fit with international guidelines. Conclusion The study highlights how it is difficult to establish nationally standard PN formulas for VLBW infants; the development of local standard formulas seems therefore relevant
Evaluation of subcutaneous amoxicillin/clavulanic acid pharmacokinetics as an alternative to the intravenous route in older patients -the PhASAge Study
No full textInternational audienceBackground. Amoxicillin/clavulanic acid (AMX/CLV) is commonly prescribed in older adults. Because oral and intravenous (IV) routes may be compromised by swallowing disorders or poor venous access, subcutaneous (SC) administration of AMX/CLV could be an alternative. The main objective of this study was to compare the bioavailability of AMX and CLV after IV and SC administration in older patients.Patients and methods. This prospective multicenter study enrolled patients aged over 65y receiving SC or IV AMX/CLV (1g/0.2g/8h). At steady-state, AMX and CLV concentrations were measured just before and after the infusion, at 2 h (in the SC group only), and at 5 h using Liquid Chromatography coupled to tandem Mass Spectrometry. Population PK analysis estimated SC AMX/CLV bioavailability in comparison to IV administration and tolerance was assessed.Results. Seventeen patients (mean age 85.1±4.8y) were enrolled (14 in the IV group and 3 in the SC group). SC bioavailability of AMX and CLV was estimated at 78% and 82%, respectively.Although Cmax values were approximately 45% lower with SC administration, unbound AMX concentrations remained above thresholds for common pathogens (i.e. Streptococcus pneumoniae, Enterococci and Enterobacterales) and trough concentrations were close to those observed after IV administration. Based on safety assessment after 122 IV and SC infusions, no serious adverse event related to the treatment occurred and local SC adverse events were transient edema, erythema and pain.Conclusions. The present study provides data supporting the use of SC administration of AMX/CLV in the older population
A narrative review of strategies for discontinuing long-term benzodiazepine use and methodological recommendations: Is a success rate of only one in three patients sufficient?
No full textInternational audienceBenzodiazepines (BZs) are psychotropic medications mainly prescribed for insomnia and anxiety. They can cause dependence, leading to decades of use. As such, there is debate grounded in confusion between substance abuse and fear of dependence in some patients. Clinical practice and evidence-based reviews agree that BZ dependence is difficult to treat: without support, only 7% of misusers manage to stop taking them. Analyzing randomized control trials (RCTs), this review examines three main interventions for BZ withdrawal: brief intervention (BI), substitution medication (SM) and cognitive-behavioral therapy (CBT). Post-intervention abstinence rates suggest that BIs can be compared to a simple taper program (TP), requiring low patient involvement, and may enable one in three patients to discontinue BZ use. However, this strategy should be considered with caution: outcomes could be adversely affected by the presence of a psychiatric disorder, a factor not controlled in these studies, nor are long-term results evaluated. Furthermore, can we consider that treating one in three patients is sufficient? CBT proved highly effective, enabling three in four patients attempting to abstain to successfully discontinue use, including patients with insomnia or anxiety. The SM approach showed no superiority over placebo effects. Moreover, abstinence rates being only measured over the very short term, no recommendations can be made regarding their use. This review concludes that there is a major methodological discrepancy between these approaches, BI and SM studies presenting substantially lower methodological quality in comparison to CBT studies. The present article proposes methodological recommendations for the study of BZ withdrawal methods
Integrative exploration of bio-psycho-social determinants of DSM-5 severity levels of opioid use disorder: the BEBOP cohort study protocol
No full textInternational audienceIntroduction: Opioid use disorder (OUD) is a chronic and severe psychiatric condition defined by a level of opioid use which significantly impairs interpersonal and social functioning. In the biopsychosocial model of addiction, research has shown that psychiatric, sociological and neurobiological factors individually affect OUD severity. However, how these factors interact in the determination of OUD severity remains poorly understood.Method and analysis: The Epigenetic Bonds of Opioid Use Profiles are a multidisciplinary project whose primary objective is to characterise psychiatric and social factors of OUD in a large cohort of patients. The secondary objectives are, first, to correlate psychosocial severity with blood-derived epigenetic biomarkers to provide a deeper understanding of determinants of OUD and, second, to examine over a 2 year follow-up the correlation between the evolution of OUD and psychosocial severity with epigenetic biomarkers at inclusion. An additional objective is to analyse the impact of drug consumption rooms on access to care for most severely affected patients with OUD. In total, 300 opioid users will be recruited at supervised injection sites in Strasbourg and Paris and at addiction care centres in Strasbourg and Lyon to explore four psychiatric (substance use disorders beyond opioids, depression, anxiety, post-traumatic stress disorder) and five social (social support and status, traumatic experiences, housing, imprisonment, access to care) factors. Opioid users will be followed for 24 months and reassessed for psychosocial factors at 3, 6, 12, 18 and 24 months. Opioid consumption will be measured in all subjects using questionnaires, complemented by toxicological screenings (mass spectrometry). Finally, DNA methylation and gene expression will be characterised in capillary blood using next-generation sequencing. Mixed models will be used to model the primary and secondary outcomes
SUN-490 Real Word Incidence Of Adrenal Insufficiency After Long-terme Use Of Systemic And Inhaled Corticosteroids
No full textInternational audienceDisclosure: P. Vaduva: None. F. Bonnet: None. G. Fauchier: None. G. Raverot: None. J.Y. Bertherat: None. L. Fauchier: None.Aim: The incidence of adrenal insufficiency following chronic use of both systemic and inhaled corticosteroids remains poorly known. The aim of our study was to assess the incidence of hospitalization for adrenal insufficiency (AI) after long-term use of systemic and inhaled corticosteroids in a large population-based cohort. Methods: We used TriNetx Research Collaborative network, with access to electronic medical records from a number of participating health care organizations, to identify participants. Diagnosis was done using the International Classification of Diseases codes, and data on medications were studied. We included individuals who were treated with long-term systemic or inhaled only corticosteroids. We excluded those with a past history of causes of primary and secondary adrenocortical insufficiency. We used a 1:1 propensity-score to compare matched subjects treated by long term systemic (n=243,430) or inhaled (n=315,237) steroid to subjects treated by NSAID only. Results: Mean age of the population studied was 56.5 ± 18 years, with 40% of men. Over a mean follow-up of 2.4 ± 1.9 years, long-term systemic corticosteroids use was associated with a more frequent diagnosis of AI (0.20% vs 0.04% per year; HR: 6.32, 95%CI [5.50-7.26], p<0.001) and a greater incidence of hospitalization for AI (0.02% vs 0.008% per year; HR: 3.52, 95%CI [2.57-4.84], p<0.001) as compared to individuals treated with NSAID. Long-term inhaled corticosteroids use was associated with a more common diagnosis of AI (0.05% vs 0.04% per year; HR: 1.55, 95%CI [1.34-1.80], p<0.001), without increased risk of hospitalization for AI (0.01% vs 0.01% per year). Conclusions: Long-term use of systemic corticosteroids was associated with an increased risk of diagnosed AI with a greater incidence of hospitalization for AI over a 2.4-year follow-up. Inhaled corticosteroids use was associated with an increased incidence of diagnosed AI. These findings from a large real world-based cohort underscore the importance of preventing the onset of corticotropic insufficiency among individuals with long-term corticosteroids treatment. Presentation: Sunday, July 13, 202
Caractérisation de sarcomes traités à la chimiothérapie par le coefficient de rétrodiffusion et des statistiques d'enveloppe
No full textUltrasons biomédicaux - Tissus osseux; GAPSUS - Acoustique Physique, Sous-Marine et Ultra-SonoreNational audienceActuellement, pour certains types de tumeurs, la réponse au traitement est évaluée sur la pièce opératoire après chirurgie. Une évaluation précoce de l'effet du traitement permettrait de confirmer rapidement son efficacité pour éventuellement le modifier. Pour cela, notre projet vise à évaluer les changements de la microstructure tissulaire par ultrasons (coefficient de rétrodiffusion BSC et statistiques d'enveloppe) dans les sarcomes osseux traités par chimiothérapie conventionnelle (doxorubicine). Des mesures ultrasonores ont été effectuées sur 23 ostéosarcomes et 24 chondrosarcomes ex vivo à 40 MHz (Vevo 770, RMV704). Les animaux ont été divisés en deux groupes (contrôle et traité) et ont reçu un traitement sur 1, 2 ou 2.5 semaine(s). Le volume tumoral relatif a été mesuré pour déterminer si les tumeurs répondaient au traitement. Les paramètres dérivés du BSC de Lizzi- Feleppa et avec le modèle Gaussien ainsi que les paramètres d'enveloppes avec les distributions Homodyned-K et Nakagami ont été calculés sur des régions homogènes dans le premier millimètre des tumeurs. Ensuite, les échantillons ont été préparés pour analyses histologique et de séquençage ARN (5 échantillons) : pour estimer des paramètres morphologiques cellulaires et pour mettre en avant les différences d'expression différentielles de gènes dans les groupes contrôle et traité. Au final, toutes les tumeurs se sont avérées non-répondantes. Certains paramètres ultrasonores ont montré des différences significatives entre les tumeurs contrôles et traitées à différents temps de traitement. Cela est également observé sur les courbes moyennes des BSCs où des différences entre les tumeurs contrôles et traitées sont observées après 2 et 4 traitements notamment. Les analyses biologiques mettent en avant une diminution de la condensation de la chromatine et du collagène pour les tumeurs traitées qui pourraient être à l'origine des tendances observées sur les mesures ultrasonores
Behavioral Profiles and Sociodemographic Predictors of Planetary Health Diet Engagement Among Health Care Professionals to Inform Public Health Promotion: Cross-Sectional Study
No full textInternational audienceThe planetary health diet (PHD) promotes dietary habits that are beneficial to human health and environmental sustainability, two closely related goals of modern public health. Health care professionals are expected to lead by example and use their position to encourage their patients and communities to adopt healthier and more sustainable behaviors. However, little is known about health care professionals’ knowledge, attitudes, and behaviors (KAB) related to the PHD, which limits the ability to design targeted interventions for this key population. Objective This study aimed to analyze KAB profiles related to the PHD among French health care professionals and assess associations with individual characteristics. Methods This cross-sectional study was conducted from April 2024 to June 2024 among health care professionals. Participants were recruited using a nonprobabilistic convenience sampling method. Inclusion criteria were to be aged ≥18 years, fluent in French, and working as a health care professional at Hospices Civils de Lyon. Data were collected through an online questionnaire including sociodemographic and geographic variables, KAB items related to the PHD, and dietary intake. Adherence to the PHD was calculated using a validated scoring system. KAB items were analyzed using k-means clustering to identify distinct profiles. Associations with sociodemographic and geographic variables were explored using chi-square tests and ANOVA. Results Among 1104 respondents (n=927, 83.97% women and n=882, 79.89% aged between 30 and 59 years), 3 KAB clusters were identified: cluster 1 (“knowledge-attitude gap”; n=481, 43.57%) included professionals with good knowledge but moderate attitudes and partially consistent behaviors; cluster 2 (“high intent, low action”; n=318, 28.8 included those with strong knowledge and positive attitudes but limited behavioral change, and cluster 3 (“behavior-driven alignment”; n=305, 27.63%) included participants who reported pro-PHD behaviors despite lower knowledge and less favorable attitudes. PHD adherence was significantly associated with being female, having a vegetarian or flexitarian diet, and reporting environmental concerns (P<.01 in all cases). Conclusions Distinct KAB profiles among health care professionals suggest differing levels of engagement regarding the PHD. Findings suggest that tailored interventions addressing knowledge, attitudes, or behaviors could improve health care professionals’ alignment with planetary health goals within similar institutional contexts
A new bleeding risk score specifically developed for direct oral anticoagulants in a geriatric population
No full textInternational audienceAbstract Although the use of direct oral anticoagulants increases in parallel with the increase in atrial fibrillation (AF) with age, none of the bleeding risk scores (HAS-BLED, HEMORR2HAGES, ATRIA nor RE-LY) have been developed in a geriatric population. Our study aimed to develop a bleeding risk score adapted to this specific population and this therapeutic class. Multicentre, longitudinal, prospective, observational, pharmacoepidemiologic study conducted in 60 French cardiologic and geriatric centres included consecutive patients aged ≥80 years with AF, treated with rivaroxaban and followed for at least 1 year. All thromboembolic, bleeding and clinical events, including falls, hospitalisations or deaths, were recorded every 3 months for 1 year. A predictive risk score based on the clinical variables most associated with bleeding events was developed from the total sample, randomly divided into a training sample and a validation sample. Among the 839 patients included (mean age = 86 year old, 62% women), there were 78 (9.3%) major haemorrhagic events. Variables associated with bleeding were age, anaemia, low albuminemia, amiodarone use and low creatinine clearance estimated with Cockcroft formula, grouped together as the A4C score. The A4C score better identifies bleeding risk in subjects ≥80 years than the scores already validated in younger populations, as its area under the curve in the training sample and in the validation sample was 0.73 and 0.66, respectively, whereas it was 0.49/0.55 for the HAS-BLED score, 0.53/0.50 for the HEMORR2HAGES score, 0.58/0.61 for the ATRIA score and 0.57/0.54 for the RE-LY score. A threshold of the A4C score ≥ 2 identifies subjects ≥80 years at high risk of bleeding
A French multicenter randomized-controlled trial of hypothermic oxygenated perfusion in extended criteria donor liver transplantation (HOPExt)
No full textInternational audienceThe aim of this study was to assess the efficacy of end-ischemic hypothermic oxygenated perfusion (HOPE) used before liver transplantation (LT) with extended criteria donor (ECD) organs from donation after brain death (DBD) in reducing early allograft dysfunction (EAD) compared with static cold storage (SCS). Between 2019 and 2023, 262 ECD-DBD grafts from 8 French centers were randomly assigned for LT either after SCS (control group, n = 131) or after SCS and subsequent 1-4 h single portal HOPE before implantation (HOPE group, n = 131). The primary endpoint was the incidence of EAD. HOPE resulted in a significantly lower rate of EAD (17.6% vs 30.5%, P = .01). Severe complication rate (61.5% vs 52.4%, P = .15), comprehensive complication index (49 [34-65] vs 46 [35-65], P = .78), and 90-day mortality (5.3% vs 2.3%, P = .20) did not differ significantly between the control and HOPE groups, respectively. Four patients (4.9%) in the control group and 3 patients (3.3%) in the HOPE group experienced ischemic cholangiopathy at 1 year after LT (P = .71). In older patients receiving grafts with more than 6 hours of cold ischemia, HOPE was associated with a lower severe complication rate (26% vs72%, P = .005). HOPE in ECD grafts from DBD for LT reduces EAD with little clinical impact on morbidity and survival in recipients with low model for end-stage liver disease scores. Older recipients with long cold ischemia time might benefit the most. Clinical trial number: NCT03929523
Intervention mapping for the development of a new model of care for people with cystic fibrosis in the era of highly effective modulator therapy
No full textInternational audienceHighly effective modulator therapy (HEMT) is available to a broader range of people with cystic fibrosis (pwCF). It has significantly improved short-term clinical outcomes and has the potential to alter the natural history of this fatal genetic disease. If long-term follow-up observational data is required to ensure clinical benefits, it is obvious that it will also change the needs of pwCF and the roles and missions of healthcare professionals (HCPs) in CF centers and beyond. We will conduct a nationwide research program called 'HORIZON' to support the changes in the organization of CF care in the coming years. It has received the financial support of the French Ministry of Health in 2022. Our primary objective is to design a new model of care that respond to the new needs and missions of pwCF and HCPs in this era of rapid and profound changes due to HEMT. This research program is based on the intervention mapping method, in which we will conduct the first four steps to design and plan the implementation of a new model of care. The program will involve all stakeholders of the CF care network, including HCPs from CF care centers and outside, pwCF, their families, patient organizations, and experts in CF. It will combine quantitative and qualitative research approaches and rely on an 'action research' method. Anticipating and supporting the reorganization of CF care in France requires a robust research program to find the best model that meets the expectations of all key stakeholders