RESUMEN
CONTEXT: To assess the effect of a surgical procedure on a patient, it is conventional to use clinical scores before and after the procedure, but it is increasingly common and recommended to weight the results of these scores with the notion of minimal clinically important difference ("MCID"). This MCID should be determined using either the data distribution method based on score variation, or the anchor method, which uses an external question to categorize the results. MCIDs vary from one population to another, and to our knowledge there has been no investigation in France for total knee arthroplasties (TKAs). We therefore conducted a prospective study on a population of TKAs in order to: 1) Define MCID in France on a population of TKAs for the Oxford score, KOOS (Knee injury and Osteoarthritis Outcome Score) and its derivatives, 2) Determine whether MCID for these scores in France is comparable to results in the literature. HYPOTHESIS: Is the MCID for total knee arthroplasty in France comparable to other results in the literature? MATERIAL AND METHOD: This was a prospective observational study in which 218 patients (85 men, 133 women) with a mean age of 72 years [27-90] who had undergone a primary TKA out of 300 initially included responded, before and after surgery, to the Oxford-12, KOOS and Forgotten Joint Score (FJS) questions (mean follow-up 24 months). MCID was calculated using the distribution method as well as the anchor method ("improvement 1 to 5" and "improvement yes or no"). RESULTS: At a mean follow-up of 24 months [18-36], the Oxford-12 score increased from 16 ± 8 [0-41] to 34 ± 11 [6-48] (p < 0.001), all components of the KOOS score were improved and the FJS at follow-up was 47 ± 32 [0-100]. For the anchor "improvement 1 to 5", there were 14 unimproved patients, 23 patients in identical condition and 179 patients improved by surgery. For the anchor "are you improved yes/no", there were 8 unimproved patients, 22 in identical condition and 187 surgically-improved patients. The mean MCID for all methods (anchor method and distribution) was 10 [7-13] for Oxford-12, 12 [12-12] for KOOS Symptom, 14 [12-17] for KOOS Pain, 12 [11-14] for KOOS Function, 14 [12-16] for KOOS Sport, 15 [15-16] for KOOS Quality of Life (QOL), 11 [10-12] for KOOS 12, 15 [12-18] for KOOS 12 Pa in. 12 [12-13] for KOOS 12 Function, 15 [15-15] for KOOS 12 QOL, 14 [13-14] for KOOS Physical Function Short-form (PS) and 14 [13-16] for KOOS Joint Replacement (JR). DISCUSSION: The MCID for the Oxford-12, KOOS and its derivatives scores in a French population is comparable to that observed in other populations in the literature. LEVEL OF EVIDENCE: IV; prospective study without control group.
RESUMEN
INTRODUCTION: The threshold of a Leg Length Discrepancy (LLD) by clinical examination on a sheet or centimeter paper (CP) is not known precisely whether or not it concerns limbs equipped with a hip prosthesis. We therefore conducted a prospective in silico study in order to: (1) determine the reproducibility and sensitivity of the clinical measurement of the LLD in different ideal and "degraded" clinical situations, (2) determine the threshold from which the human eye is capable of detecting a length inequality in clinic, (3) to determine whether the use of a graduated support (centimeter paper) improves the clinical measurement threshold. HYPOTHESIS: Our hypothesis was that clinical measurement on a centimeter support would improve clinical measurement accuracy. MATERIAL AND METHODS: This was an in silico study, the experiment was conducted on a mannequin. Different inequalities were created on a mannequin and photographed with a total of 30 inequalities from -22 to +22 mm on sheet or centimeter paper (CP). This was a multicenter study, with 40 different readers. We asked the readers to make a second measurement one month later. We evaluated the inter- and intra-observer reproducibility. The error rate at the threshold of 3 mm and 5 mm were calculated versus the gold standard. Finally, we determined at which thresholds respectively 75% and 95% of the measurements were correct. RESULTS: A total of 4140 measurements were performed and compared to the gold standard. With a threshold of 75% accurate measurement, the LLD detection threshold was 2.8 mm on centimeter paper and 4.5 mm on sheet. With a threshold of 95% accurate measurement, the LLD detection threshold was 3.4 mm on centimeter paper and 5.2 mm on sheet. Interobserver agreement (assessed overall on the 40 observers by Krippendorff's generalized Kappa) was 0.86 (95% confidence interval (CI95%) = 0.79 to 0.92) on CP and 0.71 (CI95% = 0.63 to 0.79) on sheet. Intra-observer agreement assessed by the intraclass correlation coefficient among observers who made 2 measurements had a median value (IQR) of 0.96 (0.94 to 0.99) on CP and 0.90 (0.83 to 0.94) on sheet. DISCUSSION: The clinical detection threshold on sheet at the patient's bed appears close to 5 mm. A more precise measurement is possible with graduated centimeter paper. A study in daily practice on patients in real situations would confirm our results. LEVEL OF EVIDENCE: III; prospective diagnostic comparative in Silico study.
RESUMEN
BACKGROUND: Esophageal cancer posed significant global health challenges, particularly due to poor survival rates, especially in advanced stages. Primary endoscopic resection had emerged as an alternative treatment for early esophageal cancer, aiming to preserve organ function and reduce surgical morbidity. METHODS: This retrospective multicenter cohort study included 334 patients with early esophageal cancer (T1a-b, N0) from 30 French-speaking European centers between 2000 and 2010. Patients underwent either primary endoscopic resection followed by esophagectomy (E group, n = 36) or esophagectomy alone (S group, n = 298). Cox proportional hazards models adjusted for TNM stage and propensity score weighting were used to assess the impact of primary endoscopic resection on recurrence-free survival (RFS), overall survival (OS), and postoperative complications. RESULTS: Primary endoscopic resection did not significantly influence RFS (adjusted HR 0.92, 95% CI 0.31 to 2.68, p = 0.88) or OS (adjusted HR 1.06, 95% CI 0.35 to 3.13, p = 0.92) compared to esophagectomy alone. Initial higher thromboembolic complications in the endoscopic resection group were not significant after adjustment (adjusted OR 4.73, 95% CI 0.34 to 64.27, p = 0.24). CONCLUSIONS: Primary endoscopic resection followed by esophagectomy for early esophageal cancer did not alter oncological outcomes or overall survival in this retrospective cohort. These findings supported the role of primary endoscopic resection as a safe initial treatment strategy, warranting validation in larger prospective studies. REGISTRATION: Our study was registered retrospectively on the Clinicaltrials.com website under the identifier NCT01927016. We acknowledge the importance of prospective registration and regret that this was not done before the commencement of the study.
Asunto(s)
Neoplasias Esofágicas , Esofagectomía , Puntaje de Propensión , Humanos , Neoplasias Esofágicas/cirugía , Neoplasias Esofágicas/patología , Neoplasias Esofágicas/mortalidad , Esofagectomía/métodos , Estudios Retrospectivos , Femenino , Masculino , Persona de Mediana Edad , Anciano , Resultado del Tratamiento , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Esofagoscopía/métodosRESUMEN
PURPOSE: To evaluate the quality of lung perfusion imaging obtained with photon-counting-detector CT (PCD-CT) in comparison with dual-source, dual-energy CT (DECT). METHODS: Seventy-one consecutive patients scanned with PCD-CT were compared to a paired population scanned with dual-energy on a 3rd-generation DS-CT scanner using (a) for DS-CT (Group 1): collimation: 64 × 0.6 × 2 mm; pitch: 0.55; (b) for PCD-CT (Group 2): collimation: 144 × 0.4 mm; pitch: 1.5; single-source acquisition. The injection protocol was similar in both groups with the reconstruction of perfusion images by subtraction of high- and low-energy virtual monoenergetic images. RESULTS: Compared to Group 1, Group 2 examinations showed: (a) a shorter duration of data acquisition (0.93 ± 0.1 s vs 3.98 ± 0.35 s; p < 0.0001); (b) a significantly lower dose-length-product (172.6 ± 55.14 vs 339.4 ± 75.64 mGy·cm; p < 0.0001); and (c) a higher level of objective noise (p < 0.0001) on mediastinal images. On perfusion images: (a) the mean level of attenuation did not differ (p = 0.05) with less subjective image noise in Group 2 (p = 0.049); (b) the distribution of scores of fissure visualization differed between the 2 groups (p < 0.0001) with a higher proportion of fissures sharply delineated in Group 2 (n = 60; 84.5% vs n = 26; 26.6%); (c) the rating of cardiac motion artifacts differed between the 2 groups (p < 0.0001) with a predominance of examinations rated with mild artifacts in Group 2 (n = 69; 97.2%) while the most Group 1 examinations showed moderate artifacts (n = 52; 73.2%). CONCLUSION: PCD-CT acquisitions provided similar morphologic image quality and superior perfusion imaging at lower radiation doses. CLINICAL RELEVANCE STATEMENT: The improvement in the overall quality of perfusion images at lower radiation doses opens the door for wider applications of lung perfusion imaging in clinical practice. KEY POINTS: The speed of data acquisition with PCD-CT accounts for mild motion artifacts. Sharply delineated fissures are depicted on PCD-CT perfusion images. High-quality perfusion imaging was obtained with a 52% dose reduction.
RESUMEN
PURPOSE: To compare the diagnostic approach of acute pulmonary embolism (PE) with photon-counting-detector CT (PCD-CT) and energy-integrating-detector CT (EID-CT). MATERIALS AND METHODS: Two cohorts underwent CT angiographic examinations with EID-CT (Group 1; n = 158) and PCD-CT (Group 2; n = 172), (b) with two options in Group 1, dual energy (Group 1a) or single energy (Group 1b) and a single option in Group 2 (spectral imaging with single source). RESULTS: In Group 2, all patients benefited from spectral imaging, only accessible to 105 patients (66.5%) in Group 1, with a mean acquisition time significantly shorter (0.9 ± 0.1 s vs 4.0 ± 0 .3 s; p < 0.001) and mean values of CTDIvol and DLP reduced by 46.3% and 47.7%, respectively. Comparing the quality of 70 keV (Group 2) and averaged (Group 1a) images: (a) the mean attenuation within pulmonary arteries did not differ (p = 0.13); (b) the image noise was significantly higher (p < 0.001) in Group 2 with no difference in subjective image noise (p = 0.29); and (c) 89% of examinations were devoid of artifacts in Group 2 vs 28.6% in Group 1a. The percentage of diagnostic examinations was 95.2% (100/105; Group 1a), 100% (53/53; Group 1b), and 95.3% (164/172; Group 2). There were 4.8% (5/105; Group 1a) and 4.7% (8/172; Group 2) of non-diagnostic examinations, mainly due to the suboptimal quality of vascular opacification with the restoration of a diagnostic image quality on low-energy images. CONCLUSION: Compared to EID-CT, morphology and perfusion imaging were available in all patients scanned with PCD-CT, with the radiation dose reduced by 48%. CLINICAL RELEVANCE STATEMENT: PCD-CT enables scanning patients with the advantages of both spectral imaging, including high-quality morphologic imaging and lung perfusion for all patients, and fast scanning-a combination that is not simultaneously accessible with EID-CT while reducing the radiation dose by almost 50%.
Asunto(s)
Angiografía por Tomografía Computarizada , Fotones , Embolia Pulmonar , Embolia Pulmonar/diagnóstico por imagen , Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Enfermedad Aguda , Angiografía por Tomografía Computarizada/métodos , Adulto , Tomografía Computarizada por Rayos X/métodos , Anciano de 80 o más Años , Arteria Pulmonar/diagnóstico por imagenRESUMEN
BACKGROUND: Evaluation of the residual risk in patient with chronic coronary syndrome is challenging in daily practice. Several types of events (myocardial infarction, ischemic stroke, bleeding, and heart failure [HF]) may occur, and their impact on subsequent mortality is unclear in the era of modern evidence-based pharmacotherapy. METHODS: CORONOR (Suivi d'une cohorte de patients Coronariens stables en région Nord-pas-de-Calais) is a prospective multicenter cohort that enrolled 4184 consecutive unselected outpatients with chronic coronary syndrome. We analyzed the incidence, correlates, and impact of ischemic events (a composite of myocardial infarction and ischemic stroke), major bleeding (Bleeding Academic Research Consortium 3 or higher), and hospitalization for HF on subsequent patient mortality. RESULTS: During follow-up (median, 4.9 years), 677 patients (16.5%) died. The 5-year cumulative incidences (death as competing event) of ischemic events, major bleeding, and HF hospitalization were 6.3% (5.6%-7.1%), 3.1% (2.5%-3.6%), and 8.1% (7.3%-9%), respectively. Ischemic events, major bleeding, and HF hospitalization were each associated with all-cause mortality. Major bleeding and hospitalization for HF were associated with the highest mortality rates in the postevent period (42.4%/y and 34.7%/y, respectively) compared with incident ischemic events (13.1%/y). The age- and sex-adjusted hazard ratios for all-cause mortality were 3.57 (95% CI, 2.77-4.61), 9.88 (95% CI, 7.55-12.93), and 8.60 (95% CI, 7.15-10.35) for ischemic events, major bleeding, and hospitalization for HF, respectively (all P<0.001). CONCLUSIONS: Hospitalization for HF has become both the most frequent and one of the most ominous events among patients with chronic coronary syndrome. Although less frequent, major bleeding is strongly associated with worse patient survival. Secondary prevention should not be limited to preventing ischemic events. Minimizing bleeding and preventing HF may be at least as important.
Asunto(s)
Insuficiencia Cardíaca , Hemorragia , Sistema de Registros , Humanos , Masculino , Femenino , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/mortalidad , Anciano , Hemorragia/epidemiología , Hemorragia/mortalidad , Incidencia , Persona de Mediana Edad , Estudios Prospectivos , Pronóstico , Enfermedad Crónica , Hospitalización , Infarto del Miocardio/epidemiología , Infarto del Miocardio/mortalidad , Infarto del Miocardio/diagnóstico , Factores de Riesgo , Estudios de SeguimientoRESUMEN
INTRODUCTION: The GeneXpert® MRSA/SA SSTI (Methicillin Resistant Staphylococcus aureus/S. aureus skin and soft tissue infection) PCR test allows early detection of methicillin resistance in staphylococci. This test was developed for skin infections and has been evaluated for prosthetic joint infections but, to our knowledge, has not been evaluated for hardware infections outside of arthroplasties. Furthermore, we conducted a retrospective study in patients with non-prosthetic osteosynthesis hardware aiming: (1) to identify the diagnostic values of the PCR test compared to conventional cultures and the resulting rate of appropriate antibiotic therapy; (2) to identify the rate of false negative (FN) results; (3) to identify and compare the rates of failure of infectious treatment (FN versus others); (4) to search for risk factors for FN of the PCR test. HYPOTHESIS: The PCR test allowed early and appropriate targeting of antibiotic therapy. MATERIAL AND METHODS: The results of PCR tests and conventional cultures for osteoarticular infections of non-prosthetic hardware over four years (2012-2016) were compared to identify the diagnostic values of using the results of conventional culture as a reference and the rate of appropriate antibiotic therapies. Infectious management failures between the results of the FN group and the others were compared, and variables associated with a FN of the PCR test were identified. RESULTS: The analysis of 419 PCR tests allowed us to establish a sensitivity of 42.86%, a specificity of 96.82%, a positive predictive value of 60% and a negative predictive value of 93.83%. Using the results of the PCR test for the targeting of postoperative antibiotic therapy, it was suitable for staphylococcal coverage in 90.94% (381/419). The rates of patients for whom infectious treatment failed were not significantly different between the FN group and the other patients (20.8% versus 17.7%, respectively; Hazard Ratio=1.12 (95%CI 0.47-2.69, p=0.79)). A skin opening during the initial trauma (p=0.005) and a polymicrobial infection were significantly associated with a risk of FN from the PCR test (p<0.001). CONCLUSION: The PCR test makes it possible to reduce the duration of empirical broad-spectrum antibiotic therapy during the treatment of an infection of osteosynthesis hardware but causes a lack of antibiotic coverage in 9.06% of cases. LEVEL OF EVIDENCE: III; diagnostic case control study.
RESUMEN
Gastroesophageal reflux disease (GERD) is frequent and prolonged in esophageal atresia (EA) pediatric patients requiring routine use of proton pump inhibitors (PPIs). However, there are still controversies on the prophylactic use of PPIs and the efficacy of PPIs on GERD and EA complications in this special condition. The aim of the study is to assess the prophylactic use of PPIs in pediatric patients with EA and its complications. We, therefore, performed a systematic review including all reports on the subject from 1980 to 2022. We conducted meta-analysis of the pooled proportion of PPI-and no PPI groups using random effect model, meta-regression, and estimate heterogeneity by heterogeneity index I2 . Thirty-eight reports on the topic met the criteria selection, representing a cumulative 6044 patients with EA. Prophylactic PPI prescription during the first year of life does not appear to prevent GERD persistence at follow-up and is not associated with a significantly reduced rate of antireflux surgical procedures (ARP). PPIs improve peptic esophagitis and induce remission of eosinophilic esophagitis at a rate of 50%. Their effect on other GERD outcomes is uncertain. Evidence suggests that PPIs do not prevent anastomotic stricture, Barrett's esophagus, or respiratory complications. PPI use in EA can improve peptic and eosinophilic esophagitis but is ineffective on the other EA complications. Side effects of PPIs in EA are almost unknown.
Asunto(s)
Atresia Esofágica , Reflujo Gastroesofágico , Inhibidores de la Bomba de Protones , Atresia Esofágica/cirugía , Atresia Esofágica/complicaciones , Inhibidores de la Bomba de Protones/uso terapéutico , Humanos , Reflujo Gastroesofágico/tratamiento farmacológico , NiñoRESUMEN
BACKGROUND & AIMS: The value of non-invasive tests for monitoring the resolution of significant liver fibrosis after treatment is poorly investigated. We compared the performances of six non-invasive tests to predict the resolution of significant fibrosis after bariatric surgery. METHODS: Participants were individuals with obesity submitted to needle liver biopsy at the time of bariatric surgery, and 12 and/or 60 months after surgery. We calculated the fibrosis-4 index (FIB-4), NAFLD fibrosis score (NFS), AST to platelet ratio index (APRI), Hepatic fibrosis score (HFS), Fibrotic NASH index (FNI), and Liver risk score (LRS) at each time point, and compared their performances for predicting significant fibrosis (F ≥ 2) and its resolution following surgery. RESULTS: At baseline, 2436 patients had liver biopsy, including 261 (10.7 %) with significant fibrosis. Overall, 672 patients had pre- and post-operative biopsies (564 at M12 and 328 at M60). The fibrosis stage decreased at M12 and M60 (p < 0.001 vs M0). Resolution of significant fibrosis occurred in 58/121 (47.9 %) at M12 and 32/50 (64 %) at M60. The mean value of all tests decreased after surgery, except for FIB-4. Performances for predicting fibrosis resolution was higher at M60 than at M12 for all tests, and maximal at M60 for FNI and LRS: area under the curve 0.843 (95%CI 0.71-0.95) and 0.92 (95%CI 0.84-1.00); positive likelihood ratio 3.75 (95 % CI 1.33-10.59) and 4.58 (95 % CI 1.65-12.70), respectively. CONCLUSIONS: Results showed the value and limits of non-invasive tests for monitoring the evolution of liver fibrosis after an intervention. Following bariatric surgery, the best performances to predict the resolution of significant fibrosis were observed at M60 with tests combining liver and metabolic traits, namely FNI and LRS.
Asunto(s)
Cirugía Bariátrica , Enfermedad del Hígado Graso no Alcohólico , Humanos , Cirrosis Hepática/diagnóstico , Cirrosis Hepática/cirugía , Cirrosis Hepática/patología , Enfermedad del Hígado Graso no Alcohólico/diagnóstico , Enfermedad del Hígado Graso no Alcohólico/patología , FibrosisRESUMEN
RATIONALE: Mechanical thrombectomy (MT), the standard of care for acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO), is generally not offered to patients with large baseline infarct (core). Recent studies demonstrated MT benefit in patients with anterior circulation stroke and large core (i.e. Alberta Stroke Program Early Computed Tomography Score, ASPECTS 3-5). However, its benefit in patients with the largest core (ASPECTS 0-2) remains unproven. AIM: To compare the efficacy and safety of MT plus best medical treatment (BMT) and of BMT alone in patients with ASPECTS 0-5 (baseline computed tomography (CT) or magnetic resonance imaging (MRI)) and anterior circulation LVO within 7 h of last-seen-well. SAMPLE SIZE ESTIMATE: To detect with a two-sided test at 5% significance level (80% power) a common odds ratio of 1.65 for 1-point reduction in the 90-day modified Rankin Scale (mRS) score in the MT + BMT arm versus BMT arm and to anticipate 10% of patients with missing primary endpoint, 450 patients are planned to be included by 36 centers in France, Spain, and the United States. METHODS AND DESIGN: LArge Stroke Therapy Evaluation (LASTE) is an international, multicenter, Prospectively Randomized into two parallel (1:1) arms, Open-label, with Blinded Endpoint (PROBE design) trial. Eligibility criteria are diagnosis of AIS within 6.5 h of last-seen-well (or negative fluid-attenuated inversion recovery (FLAIR) if unknown stroke onset time), ASPECTS 0-5 (ASPECTS 4-5 for ⩾80-year-old patients), and LVO in the anterior circulation (intracranial internal carotid artery (ICA) and M1 or M1-M2 segment of the middle cerebral artery (MCA)). STUDY OUTCOMES: The primary endpoint is the day-90 mRS score distribution (shift analysis) with mRS categories 5 and 6 coalesced into one category. Secondary endpoints include day-180 mRS score, rates of 90-day and 180-day mRS score = 0-2 and 0-3, rate of decompressive craniectomy, the National Institutes of Health Stroke Scale (NIHSS) score change, revascularization and infarct volume growth at 24 h, and quality of life at day 90 and 180. Safety outcomes (90-day all-cause mortality, procedural complications, symptomatic intracerebral hemorrhage, and early NIHSS score worsening) are recorded. A dynamic balanced randomization (1:1) is used to distribute eligible patients into the experimental arm and control arm, by incorporating the center and these pre-specified factors: baseline ASPECTS (0-3 vs 4-5), age (⩽70 vs >70 years), baseline NIHSS (<20 vs ⩾20), intravenous thrombolysis (no vs yes), admission mode (Drip-and-Ship vs Mothership), occlusion site (intracranial ICA vs MCA-M1 or M1-M2), intravenous fibrinolysis (no vs yes), and last-seen-well to randomization time (0-4.5 vs >4.5-6.5 h). DISCUSSION: The LASTE trial will determine MT efficacy and safety in patients with ASPECTS 0-5 and LVO in the anterior circulation. TRIAL REGISTRATION: LASTE Trial NCT03811769.
Asunto(s)
Isquemia Encefálica , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Humanos , Anciano , Anciano de 80 o más Años , Accidente Cerebrovascular/cirugía , Calidad de Vida , Resultado del Tratamiento , Trombectomía/métodos , Infarto , Isquemia Encefálica/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
OBJECTIVES: To describe the characteristics of patients admitted to Pediatric Intermediate Care Units (PImCU) and to assess their illness severity trajectories. METHODS: This prospective, observational, multicentre cohort study was conducted in seven French PImCUs between September 2012 and January 2014. All consecutive patients aged under 18 were included. The severity of illness was evaluated through the Paediatric Advanced Warning Score (PAWS), measured every 8 h for each patient. A latent class mixed model was used to identify severity trajectory classes. RESULTS: A total of 2868 patients were included. The median [interquartile range] age was 29 [5-103] mo and the median length of stay was 1 [1-3] d. The primary indication for admission was respiratory (44%). Almost 3% of the patients were subsequently transferred to a pediatric intensive care unit. Three severity trajectory classes were identified. In one class, comprising the largest proportion of patients, the PAWS was low on admission and did not change markedly over time. In this class, patients were older and had a shorter length of stay. The other two classes were characterized by a higher PAWS on admission and rapid or slow improvement. These patients were more severely ill, mostly due to respiratory failure. CONCLUSIONS: A large proportion of patients had a stable profile and no signs of severity which suggests that the stay in PImCU was not indicated but a part of these patients have remained stable perhaps because of the advanced monitoring and intensive nursing in these units. CLINICAL TRIAL REGISTRATION: The study was registered with ClinicalTrials.gov Protocol, Identifier: NCT02304341, ClinicalTrials.gov .
RESUMEN
PURPOSE: Patients presenting the most severe form of coronavirus disease 2019 (COVID-19) pneumonia, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), have a prolonged intensive care unit (ICU) stay and are exposed to broad-spectrum antibiotics, but the impact of COVID-19 on antimicrobial resistance is unknown. METHODS: Observational prospective before-after study in 7 ICUs in France. All consecutive patients with an ICU stay > 48 h and a confirmed SARS-CoV-2 infection were included prospectively and followed for 28 days. Patients underwent systematic screening for colonization with multidrug-resistant (MDR) bacteria upon admission and every week subsequently. COVID-19 patients were compared to a recent prospective cohort of control patients from the same ICUs. The primary objective was to investigate the association of COVID-19 with the cumulative incidence of a composite outcome including ICU-acquired colonization and/or infection related to MDR bacteria (ICU-MDR-col and ICU-MDR-inf, respectively). RESULTS: From February 27th, 2020 to June 2nd, 2021, 367 COVID-19 patients were included, and compared to 680 controls. After adjustment for prespecified baseline confounders, the cumulative incidence of ICU-MDR-col and/or ICU-MDR-inf was not significantly different between groups (adjusted sub-hazard ratio [sHR] 1.39, 95% confidence interval [CI] 0.91-2.09). When considering both outcomes separately, COVID-19 patients had a higher incidence of ICU-MDR-inf than controls (adjusted sHR 2.50, 95% CI 1.90-3.28), but the incidence of ICU-MDR-col was not significantly different between groups (adjusted sHR 1.27, 95% CI 0.85-1.88). CONCLUSION: COVID-19 patients had an increased incidence of ICU-MDR-inf compared to controls, but the difference was not significant when considering a composite outcome including ICU-MDR-col and/or ICU-MDR-inf.
Asunto(s)
COVID-19 , Humanos , COVID-19/epidemiología , Estudios Prospectivos , Estudios Controlados Antes y Después , SARS-CoV-2 , Factores de Riesgo , Unidades de Cuidados Intensivos , BacteriasRESUMEN
BACKGROUND: The identification of patients at high risk of a disabling disease course would be invaluable in guiding initial therapy in Crohn's disease (CD). Our objective was to evaluate a combination of clinical, serological, and genetic factors to predict complicated disease course in pediatric-onset CD. METHODS: Data for pediatric-onset CD patients, diagnosed before 17 years of age between 1988 and 2004 and followed more than 5 years, were extracted from the population-based EPIMAD registry. The main outcome was defined by the occurrence of complicated behavior (stricturing or penetrating) and/or intestinal resection within the 5 years following diagnosis. Lasso logistic regression models were used to build a predictive model based on clinical data at diagnosis, serological data (ASCA, pANCA, anti-OmpC, anti-Cbir1, anti-Fla2, anti-Flax), and 369 candidate single nucleotide polymorphisms. RESULTS: In total, 156 children with an inflammatory (B1) disease at diagnosis were included. Among them, 35% (nâ =â 54) progressed to a complicated behavior or an intestinal resection within the 5 years following diagnosis. The best predictive model (PREDICT-EPIMAD) included the location at diagnosis, pANCA, and 6 single nucleotide polymorphisms. This model showed good discrimination and good calibration, with an area under the curve of 0.80 after correction for optimism bias (sensitivity, 79%, specificity, 74%, positive predictive value, 61%, negative predictive value, 87%). Decision curve analysis confirmed the clinical utility of the model. CONCLUSIONS: A combination of clinical, serotypic, and genotypic variables can predict disease progression in this population-based pediatric-onset CD cohort. Independent validation is needed before it can be used in clinical practice.
Asunto(s)
Enfermedad de Crohn , Niño , Humanos , Enfermedad de Crohn/complicaciones , Biomarcadores , Progresión de la Enfermedad , Constricción PatológicaRESUMEN
RATIONALE: Mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke secondary to large vessel occlusion (LVO) of the anterior circulation. Conversely, its benefit in patients with National Institutes of Health Stroke Scale (NIHSS) score ⩽ 5 is unproven. AIM: To demonstrate the superiority of immediate MT plus best medical treatment (BMT) compared to BMT (with secondary MT in case of deterioration) for increasing the rate of modified Rankin Scale (mRS) score ⩽ 1 at 90 days after minor stroke (NIHSS score ⩽ 5) and anterior circulation LVO. SAMPLE SIZE ESTIMATES: To detect an absolute increase of 10% (80% power) in the 90-day mRS score = 0-1 rate in the MT + BMT group, by assuming an mRS score = 0-1 rate of 60% in the BMT group and by considering two interim efficacy/futility analyses (after study completion by 274 and 548 patients), 824 patients must be included by 36 centers in France, Spain, and the USA. METHODS AND DESIGN: MOSTE is an international, multicenter, prospectively randomized into two parallel (1:1) arms, open-label, with blinded endpoint trial. Eligibility criteria are diagnosis of acute ischemic stroke within 23 h of last-seen-well, NIHSS score ⩽ 5, and LVO in the anterior circulation (intracranial internal carotid artery, M1 or M1-M2 segment of the middle cerebral artery). STUDY OUTCOMES: The primary endpoint is the rate of excellent outcome at day 90 (mRS score = 0-1). Secondary endpoints include the rates of 90-day mRS score = 0-2 and score = 0, NIHSS score change, secondary MT, revascularization and infarct volume growth at 24 h, and quality of life and cognitive function at day 90. Safety outcomes (90-day all-cause mortality, procedural complications, symptomatic intracerebral hemorrhage, and rapid NIHSS score worsening) are recorded. DISCUSSION: The MOSTE trial will determine MT efficacy and safety in patients with minor stroke and LVO in the anterior circulation. TRIAL REGISTRATION: MOSTE Trial. NCT03796468.
Asunto(s)
Isquemia Encefálica , Procedimientos Endovasculares , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Humanos , Accidente Cerebrovascular/cirugía , Isquemia Encefálica/cirugía , Calidad de Vida , Trombectomía/métodos , Resultado del Tratamiento , Procedimientos Endovasculares/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
OBJECTIVES: To evaluate the frequency and pattern of pulmonary vascular abnormalities in the year following COVID-19. METHODS: The study population included 79 patients remaining symptomatic more than 6 months after hospitalization for SARS-CoV-2 pneumonia who had been evaluated with dual-energy CT angiography. RESULTS: Morphologic images showed CT features of (a) acute (2/79; 2.5%) and focal chronic (4/79; 5%) PE; and (b) residual post COVID-19 lung infiltration (67/79; 85%). Lung perfusion was abnormal in 69 patients (87.4%). Perfusion abnormalities included (a) perfusion defects of 3 types: patchy defects (n = 60; 76%); areas of non-systematized hypoperfusion (n = 27; 34.2%); and/or PE-type defects (n = 14; 17.7%) seen with (2/14) and without (12/14) endoluminal filling defects; and (b) areas of increased perfusion in 59 patients (74.9%), superimposed on ground-glass opacities (58/59) and vascular tree-in-bud (5/59). PFTs were available in 10 patients with normal perfusion and in 55 patients with abnormal perfusion. The mean values of functional variables did not differ between the two subgroups with a trend toward lower DLCO in patients with abnormal perfusion (74.8 ± 16.7% vs 85.0 ± 8.1). CONCLUSION: Delayed follow-up showed CT features of acute and chronic PE but also two types of perfusion abnormalities suggestive of persistent hypercoagulability as well as unresolved/sequelae of microangiopathy. CLINICAL RELEVANCE STATEMENT: Despite dramatic resolution of lung abnormalities seen during the acute phase of the disease, acute pulmonary embolism and alterations at the level of lung microcirculation can be identified in patients remaining symptomatic in the year following COVID-19. KEY POINTS: ⢠This study demonstrates newly developed proximal acute PE/thrombosis in the year following SARS-CoV-2 pneumonia. ⢠Dual-energy CT lung perfusion identified perfusion defects and areas of increased iodine uptake abnormalities, suggestive of unresolved damage to lung microcirculation. ⢠This study suggests a complementarity between HRCT and spectral imaging for proper understanding of post COVID-19 lung sequelae.
Asunto(s)
COVID-19 , Embolia Pulmonar , Enfermedades Vasculares , Humanos , Angiografía por Tomografía Computarizada , Circulación Pulmonar , Síndrome Post Agudo de COVID-19 , SARS-CoV-2 , Tomografía Computarizada por Rayos X/métodos , Pulmón/diagnóstico por imagen , Pulmón/irrigación sanguínea , Embolia Pulmonar/diagnóstico por imagenRESUMEN
Importance: The benefits of prophylactic antibiotics for hospitalized patients with severe alcohol-related hepatitis are unclear. Objective: To determine the efficacy of amoxicillin-clavulanate, compared with placebo, on mortality in patients hospitalized with severe alcohol-related hepatitis and treated with prednisolone. Design, Setting, and Participants: Multicenter, randomized, double-blind clinical trial among patients with biopsy-proven severe alcohol-related hepatitis (Maddrey function score ≥32 and Model for End-stage Liver Disease [MELD] score ≥21) from June 13, 2015, to May 24, 2019, in 25 centers in France and Belgium. All patients were followed up for 180 days. Final follow-up occurred on November 19, 2019. Intervention: Patients were randomly assigned (1:1 allocation) to receive prednisolone combined with amoxicillin-clavulanate (n = 145) or prednisolone combined with placebo (n = 147). Main Outcome and Measures: The primary outcome was all-cause mortality at 60 days. Secondary outcomes were all-cause mortality at 90 and 180 days; incidence of infection, incidence of hepatorenal syndrome, and proportion of participants with a MELD score less than 17 at 60 days; and proportion of patients with a Lille score less than 0.45 at 7 days. Results: Among 292 randomized patients (mean age, 52.8 [SD, 9.2] years; 80 [27.4%] women) 284 (97%) were analyzed. There was no significant difference in 60-day mortality between participants randomized to amoxicillin-clavulanate and those randomized to placebo (17.3% in the amoxicillin-clavulanate group and 21.3% in the placebo group [P = .33]; between-group difference, -4.7% [95% CI, -14.0% to 4.7%]; hazard ratio, 0.77 [95% CI, 0.45-1.31]). Infection rates at 60 days were significantly lower in the amoxicillin-clavulanate group (29.7% vs 41.5%; mean difference, -11.8% [95% CI, -23.0% to -0.7%]; subhazard ratio, 0.62; [95% CI, 0.41-0.91]; P = .02). There were no significant differences in any of the remaining 3 secondary outcomes. The most common serious adverse events were related to liver failure (25 in the amoxicillin-clavulanate group and 20 in the placebo group), infections (23 in the amoxicillin-clavulanate group and 46 in the placebo group), and gastrointestinal disorders (15 in the amoxicillin-clavulanate group and 21 in the placebo group). Conclusion and Relevance: In patients hospitalized with severe alcohol-related hepatitis, amoxicillin-clavulanate combined with prednisolone did not improve 2-month survival compared with prednisolone alone. These results do not support prophylactic antibiotics to improve survival in patients hospitalized with severe alcohol-related hepatitis. Trial Registration: ClinicalTrials.gov Identifier: NCT02281929.
Asunto(s)
Combinación Amoxicilina-Clavulanato de Potasio , Antibacterianos , Profilaxis Antibiótica , Hepatitis Alcohólica , Femenino , Humanos , Masculino , Persona de Mediana Edad , Combinación Amoxicilina-Clavulanato de Potasio/administración & dosificación , Combinación Amoxicilina-Clavulanato de Potasio/efectos adversos , Combinación Amoxicilina-Clavulanato de Potasio/uso terapéutico , Antibacterianos/administración & dosificación , Antibacterianos/efectos adversos , Antibacterianos/uso terapéutico , Enfermedad Hepática en Estado Terminal/tratamiento farmacológico , Enfermedad Hepática en Estado Terminal/etiología , Enfermedad Hepática en Estado Terminal/mortalidad , Hepatitis/tratamiento farmacológico , Hepatitis/etiología , Hepatitis/mortalidad , Prednisolona/efectos adversos , Prednisolona/uso terapéutico , Índice de Severidad de la Enfermedad , Profilaxis Antibiótica/efectos adversos , Profilaxis Antibiótica/métodos , Profilaxis Antibiótica/mortalidad , Hepatitis Alcohólica/tratamiento farmacológico , Hepatitis Alcohólica/etiología , Hepatitis Alcohólica/mortalidad , Hospitalización , Antiinflamatorios/efectos adversos , Antiinflamatorios/uso terapéutico , Glucocorticoides/efectos adversos , Glucocorticoides/uso terapéutico , AdultoRESUMEN
OBJECTIVES: To compare lung parenchyma analysis on ultra-high resolution (UHR) images of a photon-counting CT (PCCT) scanner with that of high-resolution (HR) images of an energy-integrating detector CT (EID-CT). METHODS: A total of 112 patients with stable interstitial lung disease (ILD) were investigated (a) at T0 with HRCT on a 3rd-generation dual-source CT scanner; (b) at T1 with UHR on a PCCT scanner; (c) with a comparison of 1-mm-thick lung images. RESULTS: Despite a higher level of objective noise at T1 (74.1 ± 14.1 UH vs 38.1 ± 8.7 UH; p < 0.0001), higher qualitative scores were observed at T1 with (a) visualization of more distal bronchial divisions (median order; Q1-Q3) (T1: 10th division [9-10]; T0: 9th division [8-9]; p < 0.0001); (b) greater scores of sharpness of bronchial walls (p < 0.0001) and right major fissure (p < 0.0001). The scores of visualization of CT features of ILD were significantly superior at T1 (micronodules: p = 0.03; linear opacities, intralobular reticulation, bronchiectasis, bronchiolectasis, and honeycombing: p < 0.0001), leading to the reclassification of 4 patients with non-fibrotic ILD at T0, recognized with fibrotic ILD at T1. At T1, the mean (± SD) radiation dose (CTDI vol: 2.7 ± 0.5 mGy; DLP: 88.5 ± 21 mGy.cm) was significantly lower than that delivered at T0 (CTDI vol: 3.6 ± 0.9 mGy; DLP: 129.8 ± 31.7 mGy.cm) (p < 0.0001), corresponding to a mean reduction of 27% and 32% for the CTDIvol and DLP, respectively. CONCLUSIONS: The UHR scanning mode of PCCT allowed a more precise depiction of CT features of ILDs and reclassification of ILD patterns with significant radiation dose reduction. CLINICAL RELEVANCE STATEMENT: Evaluation of lung parenchymal structures with ultra-high-resolution makes subtle changes at the level of the secondary pulmonary lobules and lung microcirculation becoming visually accessible, opening new options for synergistic collaborations between highly-detailed morphology and artificial intelligence. KEY POINTS: ⢠Photon-counting CT (PCCT) provides a more precise analysis of lung parenchymal structures and CT features of interstitial lung diseases (ILDs). ⢠The UHR mode ensures a more precise delineation of fine fibrotic abnormalities with the potential of modifying the categorization of ILD patterns. ⢠Better image quality at a lower radiation dose with PCCT opens new horizons for further dose reduction in noncontrast UHR examinations.
Asunto(s)
Enfermedades Pulmonares Intersticiales , Pulmón , Tomografía Computarizada por Rayos X , Humanos , Enfermedades Pulmonares Intersticiales/diagnóstico por imagen , Fotones , Pulmón/diagnóstico por imagen , Inteligencia ArtificialRESUMEN
OBJECTIVES: We investigated serum neutralizing activity against BA.1 and BA.2 Omicron sublineages and T cell response before and 3 months after administration of the booster vaccine in healthcare workers (HCWs). METHODS: HCWs aged 18-65 years who were vaccinated and received booster doses of the BNT162b2 vaccine were included. Anti-SARS coronavirus 2 IgG levels and cellular response (through interferon γ ELISpot assay) were evaluated in all participants, and neutralizing antibodies against Delta, BA.1, and BA.2 were evaluated in participants with at least one follow-up visit 1 or 3 months after the administration of the booster dose. RESULTS: Among 118 HCWs who received the booster dose, 102 and 84 participants attended the 1-month and 3-month visits, respectively. Before the booster vaccine dose, a low serum neutralizing activity against Delta, BA.1, and BA.2 was detectable in only 39/102 (38.2%), 8/102 (7.8%), and 12/102 (11.8%) participants, respectively. At 3 months, neutralizing antibodies against Delta, BA.1, and BA.2 were detected in 84/84 (100%), 79/84 (94%), and 77/84 (92%) participants, respectively. Geometric mean titres of neutralizing antibodies against BA.1 and BA.2 were 2.2-fold and 2.8-fold reduced compared with those for Delta. From 1 to 3 months after the administration of the booster dose, participants with a recent history of SARS coronavirus 2 infection (n = 21/84) had persistent levels of S1 reactive specific T cells and neutralizing antibodies against Delta and BA.2 and 2.2-fold increase in neutralizing antibodies against BA.1 (p 0.014). Conversely, neutralizing antibody titres against Delta (2.5-fold decrease, p < 0.0001), BA.1 (1.5-fold, p 0.02), and BA.2 (2-fold, p < 0.0001) declined from 1 to 3 months after the administration of the booster dose in individuals without any recent infection. DISCUSSION: The booster vaccine dose provided significant and similar response against BA.1 and BA.2 Omicron sublineages; however, the immune response declined in the absence of recent infection.
Asunto(s)
COVID-19 , SARS-CoV-2 , Humanos , COVID-19/prevención & control , Vacuna BNT162 , Anticuerpos Neutralizantes , Inmunidad Celular , Vacunación , Anticuerpos AntiviralesRESUMEN
Diabetes mellitus (DM) is a common comorbidity among cancer patients, but its impact on chemotherapy tolerance has not been widely studied. We aimed to compare the occurrence of severe grade 3/4 adverse events (G3/4 AEs) within 90 days of starting chemotherapy between patients with and without diabetes. We conducted a retrospective single-center study in Lille University Hospital Oncology Department, France. Patients who received the first cycle of chemotherapy for gastrointestinal, gynecological or cancer of unknown primary source between 1 May 2013 and 1 May 2016, were included. Overall, 609 patients were enrolled: 490 patients without diabetes (80.5%) and 119 patients with diabetes (19.5%). Within 90 days of starting chemotherapy, patients with diabetes had a significantly higher occurrence of AEs G3/4 compared to those with no diabetes (multivariate odds ratio [OR]: 1.57 [1.02-2.42], P = .04). More frequent G3/4 AEs in patients with diabetes were infection (26%), hematological disorders (13%), endocrine disorders (13%) and deterioration of the general condition (13%). In the year following the beginning of chemotherapy, patients with diabetes were twice as likely to be hospitalized as those without diabetes (univariate OR: 2.1 [1.40-3.15], P = .0003). After multivariate adjustment, diabetes was no longer significantly associated with the risk of hospitalization (P = .051). There were no differences between patients with and without diabetes regarding dose reduction and chemotherapy treatment delays (P = .61 and P = .30, respectively). Our study suggests the need for better consideration of DM in the personalized care plan to improve chemotherapy tolerance and quality of life of patients with DM.
Asunto(s)
Diabetes Mellitus , Neoplasias , Humanos , Estudios Retrospectivos , Calidad de Vida , Diabetes Mellitus/epidemiología , Neoplasias/tratamiento farmacológico , HospitalizaciónRESUMEN
OBJECTIVES: To investigate lung perfusion in systemic sclerosis (SSc). METHODS: The study population included 101 patients who underwent dual-energy CT (DECT) in the follow-up of SSc with pulmonary function tests obtained within 2 months. Fifteen patients had right heart catheterization-proven PH. RESULTS: Thirty-seven patients had no SSc-related lung involvement (Group A), 56 patients had SSc-related interstitial lung disease (Group B) of variable extent (Group B mild: ≤ 10% of lung parenchyma involved: n = 17; Group B moderate: between 11 and 50%: n = 31; Group B severe: > 50%: n = 8), and 8 patients had PVOD/PCH (Group C). Lung perfusion was abnormal in 8 patients in Group A (21.6%), 14 patients in Group B (25%), and 7 patients in Group C (87.5%). In Group A and Group B mild (n = 54), (a) patients with abnormal lung perfusion (n = 14; 26%) had a higher proportion of NYHA III/IV scores of dyspnea (7 [50%] vs 7 [17.5%]; p = 0.031) and a shorter mean walking distance at the 6MWT (397.0 [291.0; 466.0] vs 495.0 [381.0; 549.0]; p = 0.042) but no evidence of difference in the DLCO% predicted (61.0 [53.0; 67.0] vs 68.0 [61.0; 78.0]; p = 0.055) when compared to patients with normal lung perfusion (n = 40; 74%); (b) a negative correlation was found between the iodine concentration in both lungs and the DLCO% predicted but it did not reach statistical significance (r = -0.27; p = 0.059) and no correlation was found with the PAPs (r = 0.16; p = 0.29) and walking distance during the 6MWT (r = -0.029; p = 0.84). CONCLUSIONS: DECT lung perfusion provides complementary information to standard HRCT scans, depicting perfusion changes in SSc patients with normal or minimally infiltrated lung parenchyma. KEY POINTS: ⢠In a retrospective observational study of 101 consecutive patients with SSc, dual-energy CT pulmonary angiography was obtained to evaluate lung perfusion. ⢠Lung perfusion was abnormal in 14 out of 54 patients (26%) with no or mild SSc-related lung infiltration. ⢠Patients with abnormal perfusion and no or mild SSc-related lung infiltration had more severe scores of dyspnea and shorter walking distance than patients with similar lung findings and normal perfusion, suggesting the presence of small vessel vasculopathy.