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Intermediate-Dose Cytarabine as Postinduction AML Therapy
No full textInternational audienceBackground: We conducted a randomized controlled trial to compare intermediate doses (IDAC) with high doses of cytarabine (HDAC) as postinduction therapy in patients 18 to 60 years of age with newly diagnosed acute myeloid leukemia (AML). The main objectives were to evaluate noninferiority in overall survival (OS) after IDAC and safety.Methods: Patients 18 to 60 years of age with newly diagnosed AML, except those with core-binding factor, acute promyelocytic, Philadelphia chromosome-positive, or post-myeloproliferative neoplasm AML, were eligible. After the induction course, we randomly assigned patients to either IDAC (1500 mg/m2/12 hours) or HDAC (3000 mg/m2/12 hours). Patients with intermediate- and adverse-risk AML were eligible for allogeneic hematopoietic stem cell transplantation (HSCT) in first remission. The primary end point was OS in a predefined per-protocol analysis population. The primary analyses were performed in 1132 randomly assigned patients, with a noninferiority outcome adjusted on the European Leukemia Net (ELN) 2022 risk group, the use of induction anthracycline, the response to induction, and HSCT as a function of time following treatment.Results: At 5 years, OS was estimated at 59.3% (95% confidence interval [CI], 55.0 to 63.3) in the IDAC group versus 57.5% (95% CI, 53.3 to 61.5) in the HDAC group (adjusted hazard ratio, 0.96; 95% CI, 0.80 to 1.15; noninferiority test, P=0.0042). A preplanned analysis was unable to detect any interaction between IDAC or HDAC treatment effect and patient subgroups, including those defined by the ELN 2022 risk group or response to induction prior to random assignment. In addition, the severity of chemotherapy-induced myelosuppression and the incidence of related adverse events were lower after IDAC.Conclusions: Our trial shows noninferior outcomes in patients 18 to 60 years of age with newly diagnosed AML treated with low- versus high-dose cytarabine; this occurred with similar or lower toxicities.(Funded by the Regional Clinical Research Office, Angers and others; EudraCT number, 2014-000699-24; ClinicalTrials.gov number, NCT02416388)
Development of a taxonomy mapping dental services integration: a scoping review protocol
No full textInternational audienceIntroduction: The integration of dental services within the broader healthcare landscape is crucial for achieving integrated healthcare delivery. However, we lack a clear representation of the full spectrum of possible dental service integration, which is necessary for policymakers, healthcare system organisers, researchers, professionals and patients themselves to optimise organisations. Our present research aims to establish the foundation for a taxonomy of dental services that is fully integrated into the health domain, while minimising historical, cultural or epistemological biases.Methods and analysis This protocol outlines a scoping review that will adhere to the framework of the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. It has also been registered on the Open Science Framework. The research team, including a patient representative, advocate and transdisciplinary researcher, who has been involved from the inception, describes a two-phase dynamic screening process. An initial search will be conducted in the PubMed database using a Boolean search strategy based on theoretical frameworks that view health through a biopsychosocial continuum. New taxa will be progressively identified, and in the second phase, we will develop a new search strategy based on the results obtained and will explore deeper into certain categories or subcategories of taxa. Iterative strategies may also involve using new databases and even grey literature. This process will be repeated until taxon saturation is achieved and will be updated prior to submission to capture the latest literature, ultimately resulting in a comprehensive taxonomy, at the scale of individual healthcare pathways (micro- and meso-levels of organisation).Ethics and dissemination: This scoping review will analyse published secondary data and does not require ethical review. The findings will be disseminated through publication in scientific journals, presentation at conferences and sharing through professional networks
Pain Intensity after Robotic-assisted Urological Surgery: the PAIROU study An International Prospective Cohort Study
No full textInternational audienceObjective: Despite improvements in perioperative pain management protocols, severe postoperative pain is still a burden for many patients. To improve the prevention and treatment of postoperative pain, it must be accurately assessed for each procedure type. However, there is little data available assessing the pain levels after robot-assisted urological surgeries. This cohort study aimed to estimate the pain scores that can be expected after various types of robotic-assisted urologic procedures.Methods: This was a prospective, multicentre, observational trial in 44 centers in Europe that included patients scheduled for robotic-assisted urological surgery. The primary outcome was pain scores on the first day after surgery assessed using the numeric rating scale (NRS). Secondary outcomes included pain score on the second day after surgery, morphine equivalent consumption in mg 48 hours after the surgery, postoperative nausea and vomiting (PONV), and surgical complications.Results: A total of 965 patients were recruited between November 2022 and June 2023. Median pain score on postoperative day 1 was 2 at rest (IQR, 0-4) (n = 963) and 3 with movement (IQR, 1-5) (n = 921). Morphine equivalent consumption 48 hours after the surgery was 4 mg (IQR 0-20 mg). PONV was experienced by 16 % of the patients (153/963).Conclusion: This large cohort study demonstrates that patients experience low pain scores and require low opioids after robotic-assisted urological surgery when commonly used multimodal analgesia protocols are administered.Trial registration: clinicaltrials.gov No. NCT05575284
Does development of submucosal dissection models influence quality of training? Comparison of existing models
No full textInternational audienceUse of endoscopic submucosal dissection (ESD) is growing, but access to it remains limited. The aim of this study was to compare the performance of various existing models and the progress made by students on them. Four training models (bovine colon (ex-vivo), ex vivo porcine model, live porcine model, and an artificial model (Endogel)) were evaluated during a 1-week training course. Each participant was evaluated at the beginning (D1) and at the end of the training (D5). Learners performed a standardized ESD of 2 cm on the four models in a randomized order. Experts evaluated the ability of participants to perform ESD using the objective structured assessment of technical skill score (OSATS). Sixteen students were involved, the average age was 35.6 years (+/- 4.6) and they practiced endoscopy for 10 years (+/-5.3). The OSATS significantly increased in each model during the week, with mean scores increasing from 8.6 to 23.3, from 10.7 to 12.9, from 8.8 to 21.3 and from 8.2 to 12.5 for the bovine colon, ex vivo porcine model, live porcine model, and Endogel models, respectively. Ex-vivo models are good models for learning ESD skills. The bovine colon model seems to be the most discriminating. Synthetic models should be reserved for novices
Risk factors and outcomes of not having a preferred doctor: a cross-sectional study based on data from the French main health insurance scheme
No full textInternational audienceAbstract Background In France, 90.1% of the population was registered with a preferred doctor in 2019. Objectives To explore the risk factors and healthcare utilization associated with not being registered with a preferred doctor. Design and Setting Population-based cross-sectional study conducted among insured individuals aged 16 years or above in the Lyon metropolitan area. Methods Data was extracted from the French health insurance information system for the year 2019. Univariate and multivariate models were used to analyse the risk factors and healthcare utilization associated with not being registered with a preferred doctor. Results Among 878 030 individuals, 12.2% were not registered with a preferred doctor. In multivariate analysis, individuals not registered with a preferred doctor were younger (OR up to 18.2 between 16 and 30 years, compared to those aged ≥ 75 years), more often male (OR = 1.13), lived more often in a high medical accessibility area (OR up to 1.13 in the fourth quartile, compared to the first quartile), had less often a low income (OR = 0.64) or a long-term condition status (OR = 0.30), than those registered. Individuals without a preferred doctor had fewer visits to a GP (OR = 0.09), to a specialist (OR = 0.15), and to an emergency department (OR = 0.35), fewer hospitalizations (OR for no hospitalization = 4.54), and fewer selected prevention procedures (OR as low as 0.06 for breast cancer screening). Conclusions Not having a preferred doctor may limit access to primary and secondary care. Strategies to enhance registration should be considered, particularly for individuals with a long-term condition and those living in medically underserved areas
Multicentre, double-blind, randomised controlled clinical trial comparing intermittent cefoxitin administration versus loading bolus followed by continuous infusion for the prevention of surgical site infection in colorectal surgery: the PROPHYLOXITIN study protocol
No full textInternational audienceIntroduction Surgical site infections (SSIs) are the second leading cause of healthcare-associated infections in Europe with the highest rates being reported in colorectal surgery (ranging from 9% to 30%). Surgical antibiotic prophylaxis (SAP) is one of the most efficient measures for SSI prevention and should be started before surgical incision. Cefoxitin is an antibiotic widely used as SAP for colorectal surgery, but its continuous administration is currently the subject of debate due to its potential pharmacokinetic advantages. Therefore, the aim of the PROPHYLOXITIN study is to demonstrate that a loading dose followed by continuous infusion of cefoxitin during colorectal surgery (intervention group) decreases the rate of SSI compared to an intermittent bolus administration (control group).Methods and analysis The PROPHYLOXITIN study is a superiority, prospective, double-blind, randomised and multicentre study of 2000 patients undergoing colorectal surgery. The primary objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over intermittent bolus administration in reducing the proportion of SSIs within 30 days after colorectal surgery. Subjects will be randomised 1:1 using a secure web-based random-number generator to one of two study groups. Randomised allocation of treatment will be done by minimisation and stratified according to the centre, the localisation of surgery (colon or rectum) and the type of surgical procedure (laparoscopy or laparotomy).Ethics and dissemination This research has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.Trial registration number EudraCT 2022-003262-20 and Clinical trial NCT05755789
Dental needs in patients with Sjögren's disease compared to the general population: A cross-sectional study
No full textInternational audienceObjectives: To describe the dental health status of patients with Sjögren’s disease (SD), particularly as concerns care needs, coronal restoration quality, the prevalence of caries and wear lesions, relative to the general population from the RESTO DATA study.Materials and methods: Thirty-eight patients with SD were recruited during specialist consultations at Brest University Hospital and Charles Foix Hospital in Paris between December 2020 and December 2021. A questionnaire was used to record data for dental risk factors. Dental health status was assessed with the DMF-T index, ICDAS score, and the BEWE coding system, and oral health-related quality of life was assessed with the OHIP-14. The Xerostomia Inventory was used to evaluate xerostomia symptoms. Unstimulated and stimulated salivary flows were measured, together with saliva pH and buffering capacity.Results: The SD patients had more visible heavy dental plaque on teeth, a high prevalence of non-cavitated carious lesions, a large number of restored teeth, a high prevalence of cervical lesions, secondary caries, restoration failure, and a high percentage of wear lesions, despite regular attendance and correct eating habits. In the SD population, the characteristics of carious and wear lesions and the status of restorations were influenced by salivary flows. The SD population had a significantly poorer oral quality of life.Conclusions: These results confirm that SD is associated with oral health issues, with increases in the risks of carious lesions, wear lesions, and restoration failures. These findings could serve as early warning signs for oral healthcare professionals in the context of Sjögren's disease diagnosis
Assessment of neuronal and glial serum biomarkers in myelin oligodendrocyte glycoprotein antibody-associated disease: the MULTIMOGAD study
No full textInternational audienceBackground Serum neurofilament light chain (sNfL) and serum glial fibrillary acidic protein (sGFAP) have emerged as important biomarkers in multiple sclerosis (MS) and aquaporin-4 seropositive neuromyelitis optica spectrum disorder (AQP4-NMOSD). However, their interest in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) remains unclear. Our aim was to characterise sNfL and sGFAP profile and analyse their usefulness in predicting relapses and disability in MOGAD. Methods Retrospective study of adult MOGAD patients with serum samples collected at baseline (=3 months from disease onset) and follow-up (>6 months from baseline sample). sNfL and sGFAP were analysed using Simoa HD-1, and values were compared across time-points. The association between biomarkers and clinical variables and their predictive value for disability and relapses were analysed. Results Eighty-nine MOGAD patients were included. Baseline sNfL and sGFAP values were high at baseline and decreased over time (p<0.001, p=0.027, respectively). sNfL and sGFAP values were associated with Expanded Disability Status Scale (EDSS) at attacks (ß 0.15 (0.06; 0.25), p=0.002; ß 0.14 (0.07; 0.21), p<0.001, respectively) and were lower in optic neuritis presentations (ß -0.69 (-1.18; -0.19), p=0.007; ß -0.42 (-0.76; -0.08), p=0.016). Biomarker deltas[?] (baseline values – second samples values) were associated with ?EDSS (initial EDSS - final EDSS) (?sNfL ß 0.52 (0.01; 1.04), p=0.046; ?sGFAP ß 1.07 (0.38; 1.75), p=0.003). Finally, sNfL values independently predicted the risk of relapses (HR 2.06 (1.41; 3.01), p<0.001). Conclusions Our results on sNfL and sGFAP suggest initial neuro-axonal and astrocytic damage in MOGAD and the utility of these biomarkers at onset and follow-up in predicting clinical recovery and relapses
Spectrum of Phenotypes in SMA Patients With 4 SMN2 Copies in the French Population
No full textInternational audienceClinical phenotype and course of individuals with 4 copies of the SMN2 gene are insufficiently described, and presymptomatic treatment remains controversial. This is a cohort study that analyzed data from SMA patients with zero SMN1 and 4 SMN2 copies collected in the "Registre SMA France" to describe epidemiology, clinical presentation, and course. A total of 140 of 1,112 patients with SMA carried 4 SMN2 copies (16% of those with available SMN2 copy number). The median age at onset was 3.5 years (6 months-20 years), and the median follow-up was 32 years. Twelve patients (8.6%) did not walk independently (SMA2). Of them, most were able to stand or walk with support (72%). Independent walking was acquired in 91% (123 SMA3, 5 SMA4), and one-third of them lost this ability (median 16 years). Loss of ambulation was significantly earlier in children with onset before 3 years (SMA3a). There was a significant predominance of male participants in the whole cohort (63%) and in subcohorts (SMA2, 83%; SMA3, 61%; adult population, 68%). There was a significant lower risk for female participants to lose ambulation (p = 0.01). Sixty-five percent of patients used a wheelchair. Scoliosis surgery and ventilation were required in less than 15%. Most SMA patients with 4 SMN2 copies in the French population show an onset during childhood and a progressive course with absence or loss of ambulation before adulthood. Presymptomatic treatment seems an acceptable option to consider, although identification of individual pejorative markers of early or severe phenotypes would allow more targeted approaches. Our results and literature suggest a gender effect in this population. NCT04177134
Management of peritoneal gastric metastasis: An update
No full textInternational audienceImportancePeritoneal metastases from gastric cancer (PMGC) are associated with poorer median survival and systemic chemotherapy remains the standard of care. This narrative review summarizes the current evidence for medical and surgical treatment of PMGC.ObservationsTreatment is moving to local ways of administering chemotherapy, either intraperitoneal normothermic chemotherapy, laparoscopic hyperthermic intraperitoneal chemotherapy (HIPEC) or even pressurized intraperitoneal aerosol chemotherapy. Furthermore, cytoreductive surgery±HIPEC could also be an alternative in specific situations.Conclusions and relevance: This review provides an updated summary of existing strategies that can be discussed in the management of patients with PMGC