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Priors and decision thresholds in phase 2 and phase 3 randomized controlled trials evaluating drug efficacy using Bayesian methods: a systematic review
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Robotic Assistance in Simultaneous Bilateral Medial Unicompartmental Knee Arthroplasty: A Retrospective Cohort Study of 126 Knees Demonstrating Enhanced Radiographic Accuracy and Comparable Safety to Conventional Methods
No full textInternational audienceBackgroundOne-stage bilateral unicompartmental knee arthroplasty (BUKA) is a promising option for patients with bilateral medial knee osteoarthritis. This study aims to compare the safety, early clinical and functional outcomes, and radiological results of conventional vs robotic-assisted medial BUKA.MethodsA retrospective cohort study was conducted involving patients who underwent medial BUKA as a single-stage procedure between April 2016 and January 2022. The study included both conventional (36 procedures) and robotic-assisted techniques (90 procedures) with a minimum follow-up of 6 months. Conventional procedures were performed either simultaneously by two surgical teams or sequentially by one team. Robotic procedures were exclusively performed sequentially by a single team. Data on surgical outcomes, patient-reported outcome measures (International Knee Society score), and radiographic measurements were collected.ResultsAmong the 63 patients analyzed, robotic-assisted procedures took significantly longer (115 ± 22 minutes) compared to conventional approaches (86.9 ± 12 minutes; P < .0001). No significant differences were observed in complications, length of hospital stay, rehospitalizations, patient-reported outcome measures, or overall clinical outcomes. However, radiographic analysis showed superior joint line restoration in the robotic group (−0.2 ± 0.7 mm vs −1.4 ± 1.35 mm, P = .03) and better tibial implant varus control (0.3° ± 0.6 vs 1° ± 1.8 degrees, P = .03).ConclusionsWhile robotic-assisted BUKA resulted in longer operative times, clinical outcomes were comparable. Radiographic findings indicated improved implant positioning, suggesting potential benefits in implantation accuracy that warrant further research.Level of EvidenceIV
Blood immunophenotyping of multiple sclerosis patients at diagnosis identifies a classical monocyte subset associated to disease evolution
No full textInternational audienceIntroduction: Myeloid cells trafficking from the periphery to the central nervous system are key players in multiple sclerosis (MS) through antigen presentation, cytokine secretion and repair processes.Methods: Combination of mass cytometry on blood cells from 60 MS patients at diagnosis and 29 healthy controls, along with single cell RNA sequencing on paired blood and cerebrospinal fluid (CSF) samples from 5 MS patients were used for myeloid cells detailing.Results: Myeloid compartment study demonstrated an enrichment of a peculiar classical monocyte population in 22% of MS patients at the time of diagnosis. Notably, this patients' subgroup exhibited a more aggressive disease phenotype two years post-diagnosis. This monocytic population, detected in both the CSF and blood, was characterized by CD206, CD209, CCR5 and CCR2 expression, and was found to be more frequent in MS patients carrying the HLA-DRB1*15:01 allele. Furthermore, pathways analysis predicted that these cells had antigen presentation capabilities coupled with pro-inflammatory phenotype.Discussion: Altogether, these results point toward the amplification of a specific and pathogenic myeloid cell subset in MS patients with genetic susceptibilities
Monitoring SARS-CoV-2 variants with complementary surveillance systems: risk evaluation of the Omicron JN.1 variant in France, August 2023 to January 2024
No full textInternational audienceBackground Early detection and characterisation of SARS-CoV-2 variants have been and continue to be essential for assessing their public health impact. In August 2023, Santé publique France implemented enhanced surveillance for BA.2.86 and sub-lineage JN.1 because of their genetic divergence from other variants and increased prevalence. Aim To detail how combining epidemiological and laboratory data sources, targeted investigations and modelling enabled comprehensive characterisation of sub-lineage JN.1. Methods Data were collected from epidemiological investigations using a standardised questionnaire and from routine and novel (RELAB network) surveillance systems. JN.1 cases were compared with cases infected with previously circulating variants, such as EG.5, BA.4/BA.5 and other BA.2.86 sub-lineages. The growth rate and doubling time of JN.1 were estimated. Results JN.1 was first detected in September 2023 in the Île-de-France region, France, and spread widely across the country. By late November, doubling time was estimated to be 8.6 to 26.4 days depending on the region. For all data sources, cases infected by JN.1 showed similar demographics, rates of hospitalisation and RT-PCR cycle threshold values compared with those infected by previous variants. JN.1 cases also had older median age (54 years; 40–71 vs 47 years; 30–59), more frequent reports of feverish feeling and less frequent cough or nausea compared with BA.4/BA.5 cases. JN.1 cases had significantly higher frequency of anosmia compared with other BA.2.86 cases. Conclusion Combining different data sources played a key role in detecting emerging variant JN.1, for which no evidence of increased public health impact was found despite its genetic divergence
Applying positive end-expiratory pressure before and during endotracheal tube removal versus extubation with concomitant aspiration: protocol for the randomised controlled multicentre EXSUPEEP trial
No full textInternational audienceIntroduction The optimal method for removing the endotracheal tube (ETT) during extubation in the intensive care unit (ICU) remains uncertain. Two methods are described for removing the ETT in ICU, namely the ‘Traditional technique’ with continuous aspiration during cuff deflation and ETT removal; and the ‘PEEP’ method, which consists in applying positive end-expiratory pressure (PEEP) before and during cuff deflation and ETT removal. Our hypothesis is that applying PEEP during extubation in the ICU would improve clinical outcome. Methods and analysis This is a prospective, multicentre, randomised, open-label, controlled, superiority trial, analysed by intention-to-treat, comparing ETT removal with concomitant suction vs application of PEEP before and during ETT removal. In total, 424 patients will be recruited and randomly assigned in a 1:1 ratio to one of two groups, according to the strategy of ETT removal. The primary outcome is the number of days free from any mechanical ventilation within 28 days following extubation. Secondary outcomes include the reintubation rate up to 7 days after ETT removal, the cumulative duration of non-invasive ventilation up to 7 days following extubation, the rate of acute respiratory failure, the rate of acquired pneumonia during the first 7 days following ETT removal, the length of stay in ICU and in hospital and all-cause mortality at 28 days following ETT removal. Ethics and dissemination The study was approved by the Ethics Committee ‘CPP Ile de France II’. Patients will be included after providing written informed consent. The results will be submitted for publication in peer-reviewed journals, and in national and international congresses. Trial registration number NCT05147636
Screening for Metabolic Dysfunction–Associated Steatotic Liver Disease–Related Advanced Fibrosis in Diabetology: A Prospective Multicenter Study
No full textInternational audienceOBJECTIVE Screening for advanced fibrosis (AF) resulting from metabolic dysfunction–associated steatotic liver disease (MASLD) is recommended in diabetology. This study aimed to compare the performance of noninvasive tests (NITs) with that of two-step algorithms for detecting patients at high risk of AF requiring referral to hepatologists. RESEARCH DESIGN AND METHODS We conducted a planned interim analysis of a prospective multicenter study including participants with type 2 diabetes and/or obesity and MASLD with comprehensive liver assessment comprising blood-based NITs, vibration-controlled transient elastography (VCTE), and two-dimensional shear-wave elastography (2D-SWE). AF risk stratification was determined by a composite criterion of liver biopsy, magnetic resonance elastography, or VCTE ≥12 kPa depending on availability. RESULTS Of 654 patients (87% with type 2 diabetes, 56% male, 74% with obesity), 17.6% had an intermediate/high risk of AF, and 9.3% had a high risk of AF. The area under the empirical receiver operating characteristic curves of NITs for detection of high risk of AF were as follows: Fibrosis-4 (FIB-4) score, 0.78 (95% CI 0.72–0.84); FibroMeter, 0.74 (0.66–0.83); Fibrotest, 0.78 (0.72–0.85); Enhanced Liver Fibrosis (ELF) test, 0.82 (0.76–0.87); and SWE, 0.84 (0.78–0.89). Algorithms with FIB-4 score/VCTE showed good diagnostic performance for referral of patients at intermediate/high risk of AF to specialized care in hepatology. An alternative FIB-4 score/ELF test strategy showed a high negative predictive value (NPV; 88–89%) and a lower positive predictive value (PPV; 39–46%) at a threshold of 9.8. The FIB-4 score/2D-SWE strategy had an NPV of 91% and a PPV of 58–62%. The age-adapted FIB-4 score threshold resulted in lower NPVs and PPVs in all algorithms. CONCLUSIONS The FIB-4 score/VCTE algorithm showed excellent diagnostic performance, demonstrating its applicability for routine screening in diabetology. The ELF test using an adapted low threshold at 9.8 may be used as an alternative to VCTE
Association between treatment center volume and survival of endometrial cancer patients: A multicenter study: A Francogyn group study
No full textInternational audienceIntroduction: Endometrial cancer (EC) is the fourth most common cancer in women worldwide. The quality of care for EC patients may vary depending on the treatment center volume. The present study aimed to investigate the impact of center volume on the survival of EC patients.Methods: This multicenter retrospective study analyzed a large cohort of EC patients with type 1 and type 2 tumors treated between 2001 and 2020 in France. The study analyzed the impact of center volume on overall survival, as well as the impact of other factors such as age, FIGO stage, lymph node involvement, laparoscopic surgery, and overall recurrence.Results: The study found that treatment center volume had a significant impact on the overall survival of type 1 EC patients but not on type 2 EC patients. Other factors such as age, FIGO stage, lymph node involvement, laparoscopic surgery, and overall recurrence also impacted survival.Conclusion: Our study provides important insights into the quality of care for EC patients in France. The study's results highlight the impact of treatment center volume and other factors on survival and underscore the importance of high-quality care for all EC patients
Mycoplasma pneumoniae infection in adult inpatients during the 2023–24 outbreak in France (MYCADO): a national, retrospective, observational study
No full textInternational audienceBackground. An epidemic of Mycoplasma pneumoniae infection has been observed in France since the fall of 2023. We aimed to: i) describe the characteristics of adults hospitalized for M. pneumoniae infection and ii) identify factors associated with severe outcomes of infection (i.e., intensive care unit [ICU)] admission or in-hospital death).Methods. MYCADO is a retrospective observational study including adults hospitalized for ≥24 hours in 76 French hospitals for a M. pneumoniae infection between 1 September 2023 and 29 February 2024. Clinical, laboratory and imaging data were collected from medical records.We identified factors associated with severe outcomes of infection, defined as need for ICU or in-hospital death, using multivariable logistic regression.Findings. Overall, 1309 patients with M. pneumoniae infection were included: 718 (54.9%) males; median age 43 years (IQR 31-63); 288 (22.0%) with chronic respiratory failure; 423 (32.3%) with cardiovascular comorbidities; 95 (7.3%) with immunosuppression. The most common symptoms were: cough (n=1098, 83.9%), fever (n=1023, 78.2%), dyspnoea (n=948, 72.4%), fatigue (n=550, 42.0%), headache (n=211, 16.1%), arthromyalgia (n=253, 19.3%), vomiting (n=132, 10.1%); 156 (11.9%) patients had extra-respiratory manifestations, including 36 (2.8%) erythema multiforme, 19 (1.5%) meningoencephalitis, 44 (3.4%) autoimmune haemolytic anaemia and 17 (1.3%) myocarditis. The median hospital stay duration was 8 days (IQR 6-11); 415 (31.7%) patients were admitted to ICU and 28 (2.1%) died at hospital. Men, patients with hypertension, obesity, respiratory or liver chronic failure, extra-respiratory manifestations, bilateral lung damage or consolidation on computed tomography scan, elevated inflammatory syndrome, lymphopenia, and those who did not receive any active antibiotic against M. pneumoniae prior to admission, were more likely to present with severe outcomes of infection.Interpretation. This national, observational study highlights unexpected, atypical radiologic presentations, a high proportion of transfers to ICU, and an association between severity and delayed administration of effective antibiotics