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Assess the changes in post-traumatic stress disorder (PTSD), burnout, anxiety, depression, jobstrain, and isostrain levels over time among healthcare workers in emergency departments (EDs) after successive outbreaks of COVID-19. A prospective, multicenter study was conducted in 3 EDs and an emergency medical service. Healthcare workers who participated in our previous study were invited to participate in a follow-up 16 and 18 months and completed the questionnaires to assess symptoms of PTSD, burnout, anxiety, depression, jobstrain, and isostrain. Among the 485 healthcare workers asked to participate, 211 (43.5%) completed the survey at inclusion (122 were followed up at 3 months) and 59 participate to the follow-up study. At 16 months, 10.9% of healthcare workers had symptoms of PTSD and 17.4% at 18 months. At inclusion, 33.5% and 11.7% of healthcare workers had symptoms of anxiety and depression, respectively. A decrease in anxiety between inclusion and 16 months (p = 0.02) and an increase between 16 and 18 months (p = 0.009) was observed. At inclusion, 40.8% of all healthcare workers had symptoms of burnout. There was an increase in symptoms of burnout between inclusion and 18 months (p = 0.006). At inclusion, 43.2% and 29.5% of healthcare workers were exposed to jobstrain and isostrain, respectively. Jobstrain were higher among paramedics and administrative staff compared to physicians (p = 0.001 and p = 0.026, respectively). Successive outbreaks of COVID-19 led to long-term mental health consequences among ED healthcare workers that differed according to occupation. This must be taken into account to rethink the management of teams.

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RATIONALE: Central neuropathic pain resulting from spinal cord injury is notoriously debilitating and difficult to treat with few currently available treatments. A novel molecule with intrathecal administration: Ziconotide has been approved for treatment of refractory neuropathic pain in general. It acts as a presynaptic calcium channel blocker. A pilot study has shown its potential in SCI neuropathic pain patients. OBJECTIVE: The aim of this study is to determine the long-term (6 months) efficacy of chronic intrathecal ziconotide for the treatment of neuropathic SCI pain. STUDY DESIGN: Multicenter, Randomized, Comparative, Placebo controlled, Double blind clinical trial, with a crossover of random alternated periods of 6 months (placebo or ITZ) for a total of 15 months including a total of 44 patients. STUDY POPULATION: • Patients with SCI of various etiologies exhibiting neuropathic pain refractory to non-invasive treatments. • > 18 years. INTERVENTION: Intrathecal administration of ziconotide via an implanted pump. STUDY OUTCOMES: Primary study outcome Difference in pain intensity for all patients between effective treatment and placebo periods. Secondary study outcomes 1. Continuous evaluation of pain intensity. 2. Percentage of patients with at least 30% of pain reduction. 3. Satisfaction level of the patient pain relief. 4. Declarations of serious adverse events. 5. Duration and intensity of spontaneous and provoked pain. 6. Quality of life. 7. Patient global impression of change. 8. Quantification of daily dosages of analgesic drug intake. 9. Long term memory and neurocognitive effects. 10. Assessment of the patient's physical and emotional distress. NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT, AND GROUP RELATEDNESS: Participation in this study is in accordance with current treatment protocols for SCI neuropathic pain in France therefore it proposes a treatment that would currently be considered regular practice even though no RCT evidence is yet available. The study gives patients the advantage of directly testing versus placebo a treatment that otherwise entails significant constraints. A Data Safety Monitoring board (DSMB) will be created for continuous safety analysis. Furthermore, patients will be followed in specialized pain centers offering the possibility of continuing their treatment after the study period.

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Estudios Cruzados , Inyecciones Espinales , Neuralgia , Dimensión del Dolor , Traumatismos de la Médula Espinal , omega-Conotoxinas , Humanos , Analgésicos no Narcóticos/administración & dosificación , Analgésicos no Narcóticos/uso terapéutico , Método Doble Ciego , Neuralgia/tratamiento farmacológico , Neuralgia/etiología , Neuralgia/diagnóstico , omega-Conotoxinas/administración & dosificación , omega-Conotoxinas/efectos adversos , Satisfacción del Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto , Índice de Severidad de la Enfermedad , Traumatismos de la Médula Espinal/complicaciones , Factores de Tiempo , Resultado del Tratamiento , Estudios Multicéntricos como Asunto

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Study Objective: The present study is aimed at providing an assessment of the changes in burnout, job strain, isostrain, sleepiness, and fatigue levels over time and identifying factors associated with these symptoms among healthcare workers in French emergency departments (EDs). Method: We conducted a prospective, multicenter study in four EDs and an emergency medical service. Participants completed questionnaires at inclusion and at 90 days to assess burnout, job strain, isostrain, sleepiness, and fatigue. Results: A total of 211 respondents (43.5%) completed the questionnaires at inclusion. At the beginning of the study, 84 (40.8%) participants presented symptoms of burnout, 86 (43.2%) had symptoms of job strain, and 58 (29.4%) of isostrain. Forty-two (20.1%) healthcare workers presented symptoms of sleepiness, and 8 (3.8%) had symptoms of fatigue. We found that symptoms of burnout were more frequent for healthcare workers with a previous psychiatric history (55.3% vs. 39.1%, p = 0.02) and were lower among participants who had at least one dependent child (33.1% vs. 48.3%, p = 0.013). Symptoms of job strain were higher among administrative staff compared to physicians (55.6% vs. 28.7%, p = 0.01) and among healthcare workers with managerial responsibilities compared to those without (45.6% vs. 28.8%, p = 0.015). Symptoms of isostrain were higher among administrative staff (42.3%) compared to paramedics (34.1%) and physicians (19.8%, p = 0.026). Conclusion: We identified that potential factors associated with the emergence of symptoms of burnout and job strain are suggested, underlining several areas of improvement for the prevention against mental health disorders in the specific population of ED healthcare workers. Trial Registration: ClinicalTrials.gov identifier: NCT04383886.

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Agotamiento Profesional , COVID-19 , Servicio de Urgencia en Hospital , Personal de Salud , Salud Mental , Humanos , COVID-19/epidemiología , COVID-19/psicología , Masculino , Femenino , Adulto , Personal de Salud/psicología , Servicio de Urgencia en Hospital/estadística & datos numéricos , Persona de Mediana Edad , Agotamiento Profesional/epidemiología , Estudios Prospectivos , Encuestas y Cuestionarios , SARS-CoV-2 , Fatiga/epidemiología , Francia/epidemiología , Brotes de Enfermedades , Estrés Laboral/epidemiología

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INTRODUCTION: The decisions of withholding or withdrawing life-sustaining treatments are difficult to make in the context of emergency departments (EDs) because most patients are unable to communicate. Relatives are thus asked to participate in the decision-making process, although they are unprepared to face such situations. We therefore aimed to develop a standardised intervention for announcing decisions of withholding or withdrawing life-sustaining treatments in EDs and assess the efficacy of the intervention on the stress of relatives. METHODS AND ANALYSIS: The DISCUSS trial is a multicentre stepped-wedge cluster randomised study and will be conducted at nine EDs in France. A standardised intervention based on human simulation will be codesigned with partner families and implemented at three levels: the relatives, the healthcare professionals (HCP) and the EDs. The intervention will be compared with a control based on treatment as usual. A total of 538 families are planned to be included: 269 in the intervention group and 269 in the control group. The primary endpoint will be the symptoms of post-traumatic stress disorder (PTSD) at 90 days. The secondary endpoints will be symptoms of PTSD at 7 and 30 days, diagnosis of PTSD at 90 days and anxiety and depression scores at 7, 30 and 90 days. Satisfaction regarding the training, the assertiveness in communication and real-life stress of HCPs will be measured at 90 days. ETHICS AND DISSEMINATION: This study was approved by the ethics committee Est III from Nancy and the French national data protection authority. All relatives and HCPs will be informed regarding the study objectives and data confidentiality. Written informed consent will be obtained from participants, as required by French law for this study type. The results from this study will be disseminated at conferences and in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT06071078.

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Servicio de Urgencia en Hospital , Familia , Privación de Tratamiento , Humanos , Toma de Decisiones , Familia/psicología , Francia , Estudios Multicéntricos como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Trastornos por Estrés Postraumático/terapia , Estrés Psicológico , Privación de Tratamiento/ética

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Introduction: The arrival date young patient's first orthodontic consultation is unrestricted but may influence the choice of treatment plan as well as its modalities. The objective of this study was to determine the factors that influence the date of the first consultation at the orthodontic office: advice from a third party or a health professional, the patient's gender, the socioeconomic level, the actual need for orthodontic treatment, and the vertical and anteroposterior skeletal dysmorphia. Materials and Methods: Young patient's file younger than 16 years were systematically included. A Wilcoxon and Kruskal-Wallis test was performed in univariate and multivariate analysis. The threshold was 5%. Results: 456 young patients were included. Anteroposterior skeletal discrepancy, referral by an acquaintance, and socioeconomic level appeared to be factors influencing patient arrival date. Gender, actual need for orthodontic treatment, referral from a health professional, and vertical skeletal discrepancy did not influence the arrival date at the office. Discussion: The date of consultation is not related to the actual orthodontic treatment need. Word-of-mouth seems to play an important role. Patients seem to relate an anteroposterior discrepancy to the need to consult an orthodontist, but do not relate it to vertical discrepancy, although ventilation may be related to severe dysmorphia. Conclusion: This study encourages more communication about orthodontic treatment indications with patients and caregivers.

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Introduction: La date d'arrivée du jeune patient en première consultation orthodontique est libre mais peut influencer le choix du plan de traitement, ainsi que ses modalités. L'objectif de cette étude était de déterminer les facteurs qui influencent la date de première consultation au cabinet d'orthodontie : le conseil d'un tiers ou d'un professionnel de santé, le genre du patient, le niveau socio-économique, le besoin réel de traitement orthodontique, la dysmorphie squelettique verticale et antéro-postérieure. Matériels et méthodes: Les dossiers de jeunes patients de moins de 16 ans ont été systématiquement inclus. Un test de Wilcoxon et Kruskal-Wallis a été effectué en analyse univariée et multivariée. Le seuil retenu était de 5 %. Résultats: Au total, 456 patients ont été inclus. Le décalage squelettique antéro-postérieur, le fait d'être adressé par une connaissance et le niveau socio-économique semblent être des facteurs influençant la date d'arrivée du jeune patient. Le genre, le besoin réel de traitement orthodontique, le fait d'être adressé par un professionnel de santé, le décalage squelettique vertical n'ont pas d'influence sur la date d'arrivée au cabinet. Discussion: La date de consultation n'est pas liée au besoin réel de traitement. Le bouche à oreille semble jouer un rôle important. Les patients semblent faire le lien entre un décalage antéro-postérieur et la nécessité de consulter un orthodontiste, mais ne le font pas pour le décalage vertical alors que la ventilation peut être liée à des dysmorphies sévères. Conclusion: Cette étude encourage à communiquer davantage sur les indications de traitement orthodontique avec les patients et les soignants.

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Ortodoncia Correctiva , Humanos , Masculino , Femenino , Adolescente , Niño , Ortodoncia Correctiva/métodos , Ortodoncia Correctiva/estadística & datos numéricos , Derivación y Consulta/estadística & datos numéricos , Factores de Tiempo , Maloclusión/terapia , Factores Socioeconómicos , Consultorios Odontológicos/estadística & datos numéricos , Ortodoncia/métodos , Ortodoncia/estadística & datos numéricos , Factores Sexuales

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BACKGROUND: First-line standard-of-care for unresectable, pleural mesothelioma (PM) changed with the phase 3 CheckMate 743 study results, showing that nivolumab plus ipilimumab (Nivo + Ipi) significantly extended overall survival (OS) versus platinum + pemetrexed chemotherapy for PM (median OS 18.1 versus 14.1 months; hazard ratio: 0.74; p = 0.002). Efficacy and safety data in real-world (rw) settings are needed to confirm these results. METHODS: This French multicenter, retrospective cohort study was undertaken to assess the outcomes of treatment-naïve PM patients given Nivo + Ipi via an early-access program (EAP). The primary objective was investigator-assessed real world -progression-free survival (PFS). The secondary objectives were the combination's -overall survival (OS) and safety. RESULTS: From 1 April 2021 to 15 Feb 2022, the analysis included 201 of the 305 EAP-enrolled patients treated in 63 centers (79.6 % men; median age: 75 years; 91.8 % Eastern Cooperative Oncology Group performance status (ECOG-PS) 0/1; 74.5 % epithelioid histology). With median (95 % CI) follow-up for all patients of 18.4 (17.7-19.2) months, -PFS and OS were 6.3 (5.3-7.5) and 18.9 (17.6-not reached (NR)) months, with 1-year OS at 66.4 % (60.1-73.3 %). Median OS and 1-year survival rates were 21.0 (18.7-NR) and 70.8 % (63.9 %-780.6 %), and 14.1 (10.9-21.0) months and 54.9 % (42.8 %-70.4 %) for epithelioid and non-epithelioid PM subgroups, respectively. PFS was equal between the two subgroups. Grade 3-4 adverse events occurred in 23.3 % of patients and three deaths were treatment-related. CONCLUSIONS: For this unselected PM population, efficacy and safety outcomes compared favorably with CheckMate 743 trial results.

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Protocolos de Quimioterapia Combinada Antineoplásica , Ipilimumab , Nivolumab , Neoplasias Pleurales , Humanos , Nivolumab/administración & dosificación , Nivolumab/uso terapéutico , Nivolumab/efectos adversos , Ipilimumab/administración & dosificación , Ipilimumab/uso terapéutico , Ipilimumab/efectos adversos , Masculino , Femenino , Anciano , Estudios Retrospectivos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias Pleurales/tratamiento farmacológico , Neoplasias Pleurales/mortalidad , Neoplasias Pleurales/patología , Persona de Mediana Edad , Anciano de 80 o más Años , Mesotelioma/tratamiento farmacológico , Mesotelioma/mortalidad , Mesotelioma/patología , Mesotelioma Maligno/tratamiento farmacológico , Mesotelioma Maligno/patología , Adulto , Tasa de Supervivencia , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/mortalidad , Neoplasias Pulmonares/patología

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In hospitalized children, height should be measured. When world health organization (WHO) height measurement gold standards is impossible, the ideal height estimation technique is still unclear. We conducted an international prospective study in eight different pediatric intensive care units to assess the accuracy, precision, practicability, safety, and inter-rater reliability of 12 different height estimation techniques, based on body segment measurement extrapolation, or other calculations using previous or projected heights. All extrapolation techniques were performed on each child, and later compared to their WHO gold standard heights. A total of 476 patients were enrolled. In the < 2-year subgroup, board length use and growth chart extrapolation performed best. In the ≥ 2-year subgroup, growth chart extrapolation and parents' report were the most accurate, followed by height measurement alongside the body with a tape measure. In both groups, body segment extrapolations were poorly predictive and showed mean bias and limits of agreement that varied a lot with age. Most body segment-based techniques presented with frequent measurement difficulties, but children's safety was rarely compromised. The inter-rater reliability of body segment measurement was low in the < 2-year subgroup.Conclusions: To accurately estimate height in hospitalized children, health care professionals should integrate the accuracy, precision, practicability, and reliability of each measurement technique to select the most appropriate one. Body segment-based techniques were the least accurate and should probably not be used. Simple techniques like growth chart extrapolation, or measurement alongside the body (and length board measurement in the youngest) should be implemented in daily practice.Trial Registration: The study protocol was registered (12th April 2019) on the clinical-trial.gov website (NCT03913247).

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Background and study aims Accurate endoscopic characterization of colorectal lesions is essential for predicting histology but is difficult even for experts. Simple criteria could help endoscopists to detect and predict malignancy. The aim of this study was to evaluate the value of the green sign and chicken skin aspects in detection of malignant colorectal neoplasia. Patients and methods We prospectively characterized and evaluated the histology of all consecutive colorectal lesions detected during screening or referred for endoscopic resection (Pro-CONECCT study). We evaluated the diagnostic accuracy of the green sign and chicken skin aspects for detection of superficial and deep invasive lesions. Results 461 patients with 803 colorectal lesions were included. The green sign had a negative predictive value of 89.6% (95% confidence interval [CI] 87.1%-91.8%) and 98.1% (95% CI 96.7%-99.0%) for superficial and deep invasive lesions, respectively. In contrast to chicken skin, the green sign showed additional value for detection of both lesion types compared with the CONECCT classification and chicken skin (adjusted odds ratio [OR] for superficial lesions 5.9; 95% CI 3.4-10.2; P <0.001), adjusted OR for deep lesions 9.0; 95% CI 3.9-21.1; P <0.001). Conclusions The green sign may be associated with malignant colorectal neoplasia. Targeting these areas before precise analysis of the lesion could be a way of improving detection of focal malignancies and prediction of the most severe histology.

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BACKGROUND: Long-term data showing the benefits of endovascular thrombectomy for stroke with large infarct are scarce. The TENSION trial showed the safety and efficacy of endovascular thrombectomy in patients with ischaemic stroke and large infarct at 90 days. We aimed to investigate the safety and efficacy at 12 months of endovascular thrombectomy in patients who were enrolled in the TENSION trial. METHODS: TENSION was an open-label, blinded endpoint, randomised trial done at 40 hospitals across Europe and one hospital in Canada. We included patients (aged ≥18 years) with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and who had a large infarct, as indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 on standard-of-care stroke imaging. We randomly assigned patients (1:1) to receive either endovascular thrombectomy with medical treatment or medical treatment only up to 12 h from stroke onset. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days. Here, we report the prespecified 12-month follow-up analyses for functional outcome (using the simplified modified Rankin Scale questionnaire), quality of life (using the Patient-Reported Outcomes Measurement Information System 10-item [PROMIS-10] and EQ-5D questionnaires), post-stroke anxiety and depression (using the Patient Health Questionnaire-4 [PHQ-4]), and overall survival. Outcomes (except survival) were assessed in the intention-to-treat population; the survival analysis was based on treatment received. This trial is registered with ClinicalTrials.gov, NCT03094715, and is completed. FINDINGS: We enrolled patients between July 17, 2018, and Feb 21, 2023, when the trial was stopped early for efficacy. 253 patients were randomly assigned, 125 (49%) to endovascular thrombectomy and 128 (51%) to medical treatment only. Median follow-up was 8·36 months (IQR 0·02-12·00). Endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better functional outcome at 12 months (adjusted common odds ratio 2·39 [95% CI 1·47-3·90]). Endovascular thrombectomy was also associated with a better quality of life compared with medical treatment only, as reflected by median scores on the EQ-5D questionnaire index (0·7 [IQR 0·4-0·9] vs 0·4 [0·2-0·7]), median scores for health status on the EQ-5D questionnaire visual analogue scale (50 [IQR 35-70] vs 30 [5-60]), and median global physical health scores on the PROMIS-10 questionnaire (T-score 39·8 [IQR 37·4-50·8] vs 37·4 [32·4-44·9]); although there was not enough evidence to suggest a difference between groups in global mental health scores on PROMIS-10 (41·1 [IQR 36·3-48·3] vs 38·8 [31·3-44·7]) or the numbers of patients reporting anxiety (13 [22%] of 58 vs 15 [42%] of 36) and depression (18 [31%] vs 18 [50%]) on PHQ-4. Overall survival was slightly better in the endovascular thrombectomy group compared with medical treatment only (adjusted hazard ratio 0·70 [95% CI 0·50-0·99]). INTERPRETATION: In patients with acute ischaemic stroke from large vessel occlusion with established large infarct, compared with medical treatment only, endovascular thrombectomy was associated at 12 months after stroke with better functional outcome, quality of life, and overall survival. These findings suggest that the benefits of endovascular thrombectomy in patients with an ischaemic stroke and a large infarct are sustained in the long term and support the use of endovascular thrombectomy in these patients. FUNDING: European Union Horizon 2020 Research and Innovation Programme.

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Procedimientos Endovasculares , Accidente Cerebrovascular Isquémico , Trombectomía , Humanos , Trombectomía/métodos , Masculino , Femenino , Procedimientos Endovasculares/métodos , Anciano , Accidente Cerebrovascular Isquémico/cirugía , Accidente Cerebrovascular Isquémico/terapia , Persona de Mediana Edad , Resultado del Tratamiento , Calidad de Vida , Anciano de 80 o más Años

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BACKGROUND: In an open-label multicenter non-randomized non-comparative phase II study in patients with stage IIIB/IV non-squamous non-small cell lung cancer (NSCLC), oncogenic addiction (EGFR mutation or ALK/ROS1 fusion), with disease progression after tyrosine-kinase inhibitor and no prior chemotherapy (NCT04042558), atezolizumab, carboplatin, pemetrexed with or without bevacizumab showed some promising result. Beyond the clinical evaluation, we assessed safety and patient-reported outcomes (PROs) to provide additional information on the relative impact of adding atezolizumab to chemotherapy with and without bevacizumab in this population. MATERIALS: Patients received platinum-pemetrexed-atezolizumab-bevacizumab (PPAB cohort) or, if not eligible, platinum-pemetrexed-atezolizumab (PPA cohort). The incidence, nature, and severity of adverse events (AEs) were assessed. PROs were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-Core 30 and EORTC QLQ-Lung Cancer 13). RESULT: Overall, 68 (PPAB) and 72 (PPA) patients were evaluable for safety. Grade 3-4 AEs occurred in 83.8% (PPAB) and 63.9% (PPA). Grade 3-4 atezolizumab-related AEs occurred in 29.4% and 19.4%, respectively. Grade 3-4 bevacizumab-related AEs occurred in 36.8% (PPAB). Most frequent grade 3-4 AEs were neutropenia (19.1% in PPAB; 23.6% in PPA) and asthenia (16.2% in PPAB; 9.7% in PPA). In PPAB, we observed a global stability in global health security (GHS) score, fatigue and dyspnea with a constant tendency of improvement, and a significant improvement in cough. In PPA, we observed a significant improvement in GHS score with a significant improvement in fatigue, dyspnea and cough. At week 54, we observed an improvement from baseline in GHS score for 49.2% of patients. In both cohorts, patients reported on average no clinically significant worsening in their overall health or physical functioning scores. CONCLUSION: PPAB and PPA combinations seem tolerable and manageable in patients with stage IIIB/IV non-squamous NSCLC with oncogenic addiction (EGFR mutation or ALK/ROS1 fusion) after targeted therapies.

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Quinasa de Linfoma Anaplásico , Anticuerpos Monoclonales Humanizados , Protocolos de Quimioterapia Combinada Antineoplásica , Bevacizumab , Carcinoma de Pulmón de Células no Pequeñas , Receptores ErbB , Neoplasias Pulmonares , Mutación , Estadificación de Neoplasias , Medición de Resultados Informados por el Paciente , Proteínas Tirosina Quinasas , Proteínas Proto-Oncogénicas , Humanos , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Carcinoma de Pulmón de Células no Pequeñas/genética , Carcinoma de Pulmón de Células no Pequeñas/patología , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/patología , Masculino , Bevacizumab/uso terapéutico , Bevacizumab/administración & dosificación , Femenino , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Receptores ErbB/genética , Quinasa de Linfoma Anaplásico/genética , Persona de Mediana Edad , Anciano , Proteínas Proto-Oncogénicas/genética , Adulto , Anciano de 80 o más Años , Terapia Molecular Dirigida , Proteínas de Fusión Oncogénica/genética , Progresión de la Enfermedad , Calidad de Vida

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BACKGROUND: Recent studies, including the TENSION trial, support the use of endovascular thrombectomy (EVT) in acute ischemic stroke with large infarct (Alberta Stroke Program Early Computed Tomography Score (ASPECTS) 3-5). OBJECTIVE: To evaluate the cost-effectiveness of EVT compared with best medical care (BMC) alone in this population from a German healthcare payer perspective. METHODS: A short-term decision tree and a long-term Markov model (lifetime horizon) were used to compare healthcare costs and quality-adjusted life years (QALYs) between EVT and BMC. The effectiveness of EVT was reflected by the 90-day modified Rankin Scale (mRS) outcome from the TENSION trial. QALYs were based on published mRS-specific health utilities (EQ-5D-3L indices). Long-term healthcare costs were calculated based on insurance data. Costs (reported in 2022 euros) and QALYs were discounted by 3% annually. Cost-effectiveness was assessed using incremental cost-effectiveness ratios (ICERs). Deterministic and probabilistic sensitivity analyses were performed to account for parameter uncertainties. RESULTS: Compared with BMC, EVT yielded higher lifetime incremental costs (€24 257) and effects (1.41 QALYs), resulting in an ICER of €17 158/QALY. The results were robust to parameter variation in sensitivity analyses (eg, 95% probability of cost-effectiveness was achieved at a willingness to pay of >€22 000/QALY). Subgroup analyses indicated that EVT was cost-effective for all ASPECTS subgroups. CONCLUSIONS: EVT for acute ischemic stroke with established large infarct is likely to be cost-effective compared with BMC, assuming that an additional investment of €17 158/QALY is deemed acceptable by the healthcare payer.

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Cardiac output (CO) is one of the primary prognostic factors evaluated during the follow-up of patients treated for pulmonary hypertension (PH). It is recommended that it be measured using the thermodilution technique during right heart catheterization. The difficulty to perform iterative invasive measurements on the same individual led us to consider a non-invasive option. The aims of the present study were to assess the agreement between CO values obtained using bioreactance (Starling™ SV) and thermodilution, and to evaluate the ability of the bioreactance monitor to detect patients whose CO decreased by more than 15% during follow-up and, accordingly, its usefulness for patient monitoring. A prospective cohort study evaluating the performance of the Starling™ SV monitor was conducted in patients with clinically stable PH. Sixty patients referred for hemodynamic assessment were included. CO was measured using both the thermodilution technique and bioreactance during two follow-up visits. A total of 60 PH patients were included. All datasets were available at the baseline visit (V0) and 50 of them were usable during the follow-up visit (V1). Median [IQR] CO was 4.20 l/min [3.60-4.70] when assessed by bioreactance, and 5.30 l/min [4.57-6.20] by thermodilution (p<0.001). The Spearman correlation coefficient was 0.51 [0.36-0.64], and the average deviation on Bland-Altman plot was -1.25 l/min (95% CI [-1.48-1.01], p<0.001). The ability of the monitor to detect a variation in CO of more than 15% between two follow-up measurements, when such variation existed using thermodilution, was insufficient for clinical practice (AUC = 0.54, 95% CI [0.33-0.75]).

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Gasto Cardíaco , Hipertensión Pulmonar , Termodilución , Humanos , Gasto Cardíaco/fisiología , Femenino , Masculino , Hipertensión Pulmonar/fisiopatología , Hipertensión Pulmonar/diagnóstico , Persona de Mediana Edad , Termodilución/métodos , Estudios de Seguimiento , Estudios Prospectivos , Anciano , Reproducibilidad de los Resultados , Monitoreo Fisiológico/métodos , Cateterismo Cardíaco , Adulto

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BACKGROUND: Dysphagia, particularly sarcopenic dysphagia, is frequent in frail older patients. Sarcopenic dysphagia is a swallowing disorder caused by sarcopenia, corresponding to a loss of muscle mass and strength. It frequently leads to inhalation and to the decrease of food intake, leading the patient to enter a vicious circle of chronic malnutrition and frailty. The awareness of the major health impacts of sarcopenic dysphagia is recent, explaining a low rate of screening in the population at risk. In this context, methods of prevention, evaluation and intervention of sarcopenic dysphagia adapted to the most at-risk population are necessary. METHODS: The DYSPHAGING (dysphagia & aging) pilot study is a prospective, multicentre, non-comparative study aiming to estimate the feasibility of an intervention on allied health professionals using the DYSPHAGING educational sheet designed to implement a two-step procedure 'screen-prevent' to mitigate swallowing disorders related to sarcopenic dysphagia. After obtaining oral consent, patients are screened using Eating Assessment Tool-10 Score. In case of a score≥2, procedures including positional manoeuvres during mealtimes, food and texture adaptation should be implemented. The primary endpoint of the study is the feasibility of this two-step procedure (screening-prevention measures) in the first 3 days after patient's consent.The study will include 102 patients, with an expected 10% rate of non-analysable patients. Participants will be recruited from acute geriatric wards, rehabilitation centres and long-term care units, with the hypothesis to reach a feasibility rate of 50% and reject a rate lower than 35%. ETHICS AND DISSEMINATION: The study protocol was approved according to French legislation (CPP Ile-de-France VII) on 15 February 2023. The results of the primary and secondary objectives will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05734586.

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Trastornos de Deglución , Sarcopenia , Anciano , Humanos , Trastornos de Deglución/complicaciones , Trastornos de Deglución/diagnóstico , Estudios de Factibilidad , Proyectos Piloto , Estudios Prospectivos , Sarcopenia/complicaciones

RESUMEN

BACKGROUND: The ileocecal valve (ICV) is considered to be one of the most difficult locations for endoscopic submucosal dissection (ESD). The objective of this study was to evaluate the efficacy and safety of traction-assisted ESD in this situation. METHODS: All patients who underwent traction-assisted ESD for an ICV lesion at three centers were identified from a prospective ESD database. En bloc and R0 rates were evaluated. Factors associated with non-R0 resection were explored. RESULTS: 106 patients with an ICV lesion were included. The median lesion size was 50 mm (interquartile range 38-60) and 58.5% (62/106) invaded the terminal ileum. The en bloc and R0 resection rates were 94.3% and 76.4%, respectively. Factors associated with non-R0 resection were lesions covering ≥75% of the ICV (odds ratio [OR] 0.21. 95%CI 0.06-0.76; P=0.02), and involving the anal lip (OR 0.36, 95%CI 0.13-0.99; P=0.04) or more than two sites on the ICV (OR 0.27, 95%CI 0.07-0.99; P=0.03). CONCLUSION: Traction-assisted ESD for treatment of ICV lesions was a safe and feasible option. Large lesions and anal lip involvement appeared to be factors predictive of difficulty.

RESUMEN

BACKGROUND: Invasive candidiasis is still recognized as a major cause of morbidity and mortality. To support clinicians in the optimal use of antifungals for the treatment of invasive candidiasis, a computerized decision support system (CDSS) was developed based on institutional guidelines. OBJECTIVES: To evaluate the correlation of this newly developed CDSS with clinical practices, we set-up a retrospective multicentre cohort study with the aim of providing the concordance rate between the CDSS recommendation and the medical prescription (NCT05656157). PATIENTS AND METHODS: Adult patients who received caspofungin or fluconazole for the treatment of an invasive candidiasis were included. The analysis of factors associated with concordance was performed using mixed logistic regression models with department as a random effect. RESULTS: From March to November 2022, 190 patients were included from three centres and eight departments: 70 patients from centre A, 84 from centre B and 36 from centre C. Overall, 100 patients received caspofungin and 90 received fluconazole, mostly (59%; 112/190) for empirical/pre-emptive treatment. The overall percentage of concordance between the CDSS and medical prescriptions was 91% (173/190) (confidence interval 95%: 82%-96%). No significant difference in concordance was observed considering the centres (P > 0.99), the department of inclusion (P = 0.968), the antifungal treatment (P = 0.656) or the indication of treatment (P = 0.997). In most cases of discordance (n = 13/17, 76%), the CDSS recommended fluconazole whereas caspofungin was prescribed. The clinical usability evaluated by five clinicians was satisfactory. CONCLUSIONS: Our results demonstrated the high correlation between current antifungal clinical practice and this user-friendly and institutional guidelines-based CDSS.

Asunto(s)

Antifúngicos , Candidiasis Invasiva , Caspofungina , Sistemas de Apoyo a Decisiones Clínicas , Fluconazol , Humanos , Estudios Retrospectivos , Antifúngicos/uso terapéutico , Antifúngicos/administración & dosificación , Masculino , Femenino , Persona de Mediana Edad , Fluconazol/uso terapéutico , Fluconazol/administración & dosificación , Anciano , Candidiasis Invasiva/tratamiento farmacológico , Caspofungina/uso terapéutico , Caspofungina/administración & dosificación , Adulto , Anciano de 80 o más Años , Pautas de la Práctica en Medicina/estadística & datos numéricos

RESUMEN

INTRODUCTION: Atopic dermatitis (AD), a chronic type 2 inflammatory skin disease, is frequently associated with ocular surface diseases (OSD) which may appear or worsen under anti-type 2-targeted treatments. However, the exact prevalence of OSD and the ophthalmology referral criteria remain ill-defined in AD patients before initiating such biotherapies. We aimed to characterize the prevalence, the nature and the factors related to OSD development in AD that may justify an ophthalmological management. METHODS: A total of 98 consecutive AD inpatients without biological treatment were retrospectively included. These were systematically evaluated by an ophthalmologist during their dermatological care. Clinical and laboratory data were analysed to characterize OSD and their risk factors. RESULTS: OSD were found in 83/98 AD patients (85%); mainly dry eye syndrome (64%, 63/98), allergic conjunctivitis (42%, 41/98), posterior (33%, 32/98), and anterior blepharitis (27%, 26/98). In AD patients without ocular symptoms, OSDs were also frequently found (63%, 12/19) and were mostly mild. Risk factors for OSD were history of allergic rhinitis, allergic sensitization, head and neck AD, ocular symptoms (foreign body sensation in the eye, burning, itching, photophobia), and total IgE level >3,000 kU/L. CONCLUSION: The prevalence of OSD was high, even in asymptomatic patients. The risk factors identified may indicate the need for ophthalmological examination for therapeutic management, especially when biological agents targeting type 2 inflammation are considered.

Asunto(s)

Dermatitis Atópica , Humanos , Dermatitis Atópica/complicaciones , Dermatitis Atópica/epidemiología , Masculino , Femenino , Estudios Retrospectivos , Adulto , Persona de Mediana Edad , Prevalencia , Factores de Riesgo , Síndromes de Ojo Seco/epidemiología , Síndromes de Ojo Seco/etiología , Síndromes de Ojo Seco/diagnóstico , Conjuntivitis Alérgica/epidemiología , Conjuntivitis Alérgica/complicaciones , Adulto Joven , Blefaritis/epidemiología , Blefaritis/etiología , Adolescente , Anciano , Oftalmopatías/epidemiología , Oftalmopatías/etiología

RESUMEN

INTRODUCTION: When initial resection of rectal neuroendocrine tumors (r-NETs) is not R0, persistence of local residue could lead to disease recurrence. This study aimed to evaluate the interest of systematic resection of non-R0 r-NET scars. METHODS: Retrospective analysis of all the consecutive endoscopic revisions and resections of the scar after non-R0 resections of r-NETs. RESULTS: A total of 100 patients were included. Salvage endoscopic procedure using endoscopic submucosal dissection or endoscopic full-thickness resection showed an R0 rate of near 100%. Residual r-NET was found in 43% of cases. DISCUSSION: In case of non-R0 resected r-NET, systematic scar resection by endoscopic full-thickness resection or endoscopic submucosal dissection seems necessary.

Asunto(s)

Resección Endoscópica de la Mucosa , Tumores Neuroendocrinos , Neoplasias del Recto , Humanos , Tumores Neuroendocrinos/cirugía , Cicatriz/etiología , Cicatriz/patología , Estudios Retrospectivos , Resultado del Tratamiento , Recurrencia Local de Neoplasia/cirugía , Neoplasias del Recto/cirugía , Neoplasias del Recto/patología , Resección Endoscópica de la Mucosa/métodos

Asunto(s)

Neoplasias Intestinales , Tumores Neuroendocrinos , Humanos , Estudios de Cohortes , Tumores Neuroendocrinos/cirugía , Proteínas de Neoplasias , Neoplasias Intestinales/cirugía

RESUMEN

BACKGROUND: Chronic rhinosinusitis (CRS), encompasses many different clinical patterns with variable response to treatment. Precise criteria specifying disease severity and control are lacking in the current literature. Our aim was to perform a cross-cultural adaptation of the CRS-PRO, creating a French version for use as a routine questionnaire in the assessment of patients with CRS. METHODS: The CRS-PRO questionnaire was translated according to the recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) through a three-step procedure including a backward translation. RESULTS: Seven of 12 items were initially discordant between the three translators before achieving consensus (Step 1). Two of 12 items were discordant between the backward translation and the initial CRS-PRO version regarding the word "mucus"(Step 2). Step 3 allowed the creation of a French proof-read version of the CRS-PRO questionnaire. Thirty patients were included for initial validation, mean age of 49.2 ± 15 years and 63.3% (19/30) male. It took them 67 ± 23 s to complete the questionnaire without any patients requiring more than 2 min. CONCLUSION: This study presents the French version of the CRS-PRO questionnaire-an adapted, validated, and well-accepted instrument to evaluate the CRS symptoms in the French speaking population.

Asunto(s)

Comparación Transcultural , Humanos , Masculino , Adulto , Persona de Mediana Edad , Reproducibilidad de los Resultados , Psicometría , Encuestas y Cuestionarios , Enfermedad Crónica

RESUMEN

BACKGROUND: The concept of surgical centralization is becoming more and more accepted for specific surgical procedures. OBJECTIVE: The aim of this study was to evaluate the relationship between procedure volume and the outcomes of surgical small intestine (SI) neuroendocrine tumor (NET) resections. METHODS: We conducted a retrospective national study that included patients who underwent SI-NET resection between 2019 and 2021. A high-volume center (hvC) was defined as a center that performed more than five SI-NET resections per year. The quality of the surgical resections was evaluated between hvCs and low-volume centers (lvCs) by comparing the number of resected lymph nodes (LNs) as the primary endpoint. RESULTS: A total of 157 patients underwent surgery in 33 centers: 90 patients in four hvCs and 67 patients in 29 lvCs. Laparotomy was more often performed in hvCs (85.6% vs. 59.7%; p < 0.001), as was right hemicolectomy (64.4% vs. 38.8%; p < 0.001), whereas limited ileocolic resection was performed in 18% of patients in lvCs versus none in hvCs. A bi-digital palpation of the entire SI length (95.6% vs. 34.3%, p < 0.001), a cholecystectomy (93.3% vs. 14.9%; p < 0.001), and a mesenteric mass resection (70% vs. 35.8%; p < 0.001) were more often performed in hvCs. The proportion of patients with ≥8 LNs resected was significantly higher (96.3% vs. 65.1%; p < 0.001) in hvCs compared with lvCs, as was the proportion of patients with ≥12 LNs resected (87.8% vs. 52.4%). Furthermore, the number of patients with multiple SI-NETs was higher in the hvC group compared with the lvC group (43.3% vs. 25.4%), as were the number of tumors in those patients (median of 7 vs. 2; p < 0.001). CONCLUSIONS: Optimal SI-NET resection was significantly more often performed in hvCs. Centralization of surgical care of SI-NETs is recommended.

Asunto(s)

Tumores Neuroendocrinos , Humanos , Estudios de Cohortes , Estudios Retrospectivos , Hospitales de Alto Volumen , Hospitales de Bajo Volumen