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1. NAITRE study on the impact of conditional cash transfer on poor pregnancy outcomes in underprivileged women: protocol for a nationwide pragmatic cluster-randomised superiority clinical trial in France

Author: Elise Thellier, Frédérique Falchier, Philippe Deruelle, Mathieu Morin, Catherine Deneux-Tharaux, Isabelle Fournel, Muriel Doret, Ghada Hatem, Isabelle Le Ray, Franck Perrotin, Laurent Laforet, Nicolas Meunier-Beillard, Thiphaine Barjat, Bruno Crépon, Esther Duflo, Thomas Schmitz, Anne-Claire Bertaux, Xavier Carcopino-Tusoli, Marc Bardou, Astrid Eckman-Lacroix, Aurélie Godard-Marceaux, Centre d'Investigation Clinique 1432 (Dijon) - Module Plurithématique : Périnatalité Cancérologie Handicap et Ophtalmologie (CIC-P803), Université de Bourgogne (UB)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Centre de Recherche en Économie et Statistique (CREST), Ecole Nationale de la Statistique et de l'Analyse de l'Information [Bruz] (ENSAI)-École polytechnique (X)-École Nationale de la Statistique et de l'Administration Économique (ENSAE Paris)-Centre National de la Recherche Scientifique (CNRS), Laboratoire de Neurosciences Intégratives et Cliniques - UFC (EA 481) (NEURO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Centre d'Investigation Clinique de Besançon (Inserm CIC 1431), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté]), Service de Gynécologie Obstétrique [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Service de Gynécologie Obstétrique [AP-HP Hôpital Bicêtre], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Service de Gynécologie-Obstétrique (BREST - Gynéco-Obs), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Service de Gynécologie - Obstétrique [Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Femme Mère Enfant [CHU - HCL] (HFME), Hospices Civils de Lyon (HCL), Service de Gynécologie et Obstétrique [Hôpital de la Croix-Rousse - HCL], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Service d'Obstétrique-Gynécologie [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], Département d'obstétrique et de gynécologie [AP-HP Hôpital Robert Debré], AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Service de Gynécologie Obstétrique (Gynéco-Obs - SAINT ETIENNE), Hôpital Nord (Saint Etienne), Service de gynécologie-obstétrique [CHU Toulouse], CHU Toulouse [Toulouse], Service de gynécologie-obstétrique [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Service de gynécologie obstétrique [CH Saint Denis], Centre Hospitalier de Saint-Denis [Ile-de-France], Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique (CRESS - U1153), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), DHU Risques Et Grossesse, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre d'Investigation Clinique 1432 (Dijon) - Epidemiologie Clinique/Essais Cliniques (CIC-EC), Université de Bourgogne (UB)-Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Economics (Massachusetts Institute of Technology, Cambridge, Massachusetts), Massachusetts Institute of Technology (MIT), Service de gynécologie–obstétrique, CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Université de Bourgogne (UB)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale (INSERM), Ecole Nationale de la Statistique et de l'Analyse de l'Information [Bruz] (ENSAI)-École polytechnique (X)-École Nationale de la Statistique et de l'Administration Économique (ENSAE ParisTech )-Centre National de la Recherche Scientifique (CNRS), Université de Franche-Comté (UFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Centre d'Investigation Clinique de Besançon (CICB), Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement Français du Sang Bourgogne Franche-Comté-Université de Franche-Comté (UFC), Service de gynécologie-obstétrique [CHRU Besançon], Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Bicêtre, Université Paris Diderot - Paris 7 (UPD7)-AP-HP Hôpital universitaire Robert-Debré [Paris], Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Descartes - Paris 5 (UPD5)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Laboratoire de Neurosciences Intégratives et Cliniques - UFC (UR 481) (NEURO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Département d'obstétrique et de gynécologie [Hôpital Robert Debré], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Gynécologie-Obstétrique [CHRU Tours], Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Massachusetts Institute of Technology. Department of Economics, Duflo, Esther, Institut National de la Santé et de la Recherche Médicale (INSERM)-Direction Générale de l'Organisation des Soins (DGOS)-Université de Bourgogne (UB), Centre National de la Recherche Scientifique (CNRS)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique 1432 (Dijon) - Module Plurithématique : Périnatalité Cancérologie Handicap et Ophtalmologie ( CIC-P803 ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Direction Générale de l'Organisation des Soins (DGOS)-Université de Bourgogne ( UB ), Lipides - Nutrition - Cancer [Dijon - U1231] ( LNC ), Université de Bourgogne ( UB ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Centre de Recherche en Économie et Statistique ( CREST ), Ecole Nationale de la Statistique et de l'Analyse de l'Information [Bruz] ( ENSAI ) -École polytechnique ( X ) -École Nationale de la Statistique et de l'Administration Économique ( ENSAE ParisTech ), Laboratoire de Neurosciences Intégratives et Cliniques - UFC ( NEURO ), Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Centre d'Investigation Clinique de Besançon ( CICB ), Etablissement Français du Sang Bourgogne Franche-Comté-Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Franche-Comté ( UFC ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Bicêtre, Service de Gynécologie-Obstétrique ( BREST - Gynéco-Obs ), Centre Hospitalier Régional Universitaire de Brest ( CHRU Brest ), Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), Hôpital Femme Mère Enfant [CHU - HCL] ( HFME ), Hospices Civils de Lyon ( HCL ), Hospices Civils de Lyon ( HCL ) -Hospices Civils de Lyon ( HCL ), Assistance Publique - Hôpitaux de Marseille ( APHM ) -CHU Marseille- Hôpital Nord [CHU - APHM], Université Paris Diderot - Paris 7 ( UPD7 ) -AP-HP Hôpital universitaire Robert-Debré [Paris], Service de Gynécologie Obstétrique ( Gynéco-Obs - SAINT ETIENNE ), Centre Hospitalier Universitaire de Toulouse - CHU Toulouse (FRANCE), CHRU Tours, CH Saint-Denis, Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique ( CRESS - U1153 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité ( CRESS (U1153 / UMR_A 1125) ), Université Sorbonne Paris Cité ( USPC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Institut National de la Recherche Agronomique ( INRA ) -Université Sorbonne Paris Cité ( USPC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Institut National de la Recherche Agronomique ( INRA ), Centre National de la Recherche Scientifique ( CNRS ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Assistance publique - Hôpitaux de Paris (AP-HP), Centre d'Investigation Clinique 1432 (Dijon) - Epidemiologie Clinique/Essais Cliniques ( CIC-EC ), Université de Bourgogne ( UB ) -Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), and Massachusetts Institute of Technology
Subjects: Research design, Adult, Pediatrics, medicine.medical_specialty, Maternal Health, Gestational Age, Prenatal care, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Vulnerable Populations, organisation of health services, clinical governance, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Fetus, Pregnancy, Obstetrics and Gynaecology, Clinical endpoint, Protocol, Medicine, Humans, Infant Health, 030212 general & internal medicine, Socioeconomic status, [ SDV.MHEP.GEO ] Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Referral and Consultation, Motivation, maternal medicine, 030219 obstetrics & reproductive medicine, business.industry, Conditional cash transfer, Infant, Newborn, Pregnancy Outcome, Gestational age, Prenatal Care, General Medicine, Patient Acceptance of Health Care, medicine.disease, 3. Good health, Clinical trial, Pregnancy Complications, Social Class, Research Design, Family medicine, Female, France, business
Abstract: IntroductionPrenatal care is recommended during pregnancy to improve neonatal and maternal outcomes. Women of lower socioeconomic status (SES) are less compliant to recommended prenatal care and suffer a higher risk of adverse perinatal outcomes. Several attempts to encourage optimal pregnancy follow-up have shown controversial results, particularly in high-income countries. Few studies have assessed financial incentives to encourage prenatal care, and none reported materno-fetal events as the primary outcome. Our study aims to determine whether financial incentives could improve pregnancy outcomes in women with low SES in a high-income country.Methods and analysisThis pragmatic cluster-randomised clinical trial includes pregnant women with the following criteria: (1) age above 18 years, (2) first pregnancy visit before 26 weeks of gestation and (3) belonging to a socioeconomically disadvantaged group. The intervention consists in offering financial incentives conditional on attending scheduled pregnancy follow-up consultations. Clusters are 2-month periods with random turnover across centres. A composite outcome of maternal and neonatal morbidity and mortality is the primary endpoint. Secondary endpoints include maternal or neonatal outcomes assessed separately, qualitative assessment of the perception of the intervention and cost-effectiveness analysis for which children will be followed to the end of their first year through the French health insurance database. The study started in June 2016, and based on an expected decrease in the primary endpoint from 18% to 14% in the intervention group, we plan to include 2000 women in each group.Ethics and disseminationEthics approval was first gained on 28 September 2014. An independent data security and monitoring committee has been established. Results of the main trial and each of the secondary analyses will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT02402855; pre-results.
Published: 2017

2. Antenatal prognostic factor of fetal echogenic bowel

Author: Fabien Stenard, Pascal de Lagausie, Florence Bretelle, Nicole Philip, Pascale Hoffmann, Anderson Loundou, Pierre Mace, Isabelle Mortier, Jonathan Lopater, Marie Christine Pellissier, Sabine Sigaudy, Claude D'Ercole, M. Capelle, Thierry Merrot, Candice Ronin, Annie Levy, Service de Génétique, Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Génétique Médicale et Génomique Fonctionnelle (GMGF), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, INSB-INSB-Centre National de la Recherche Scientifique (CNRS), Gynépole, Aix Marseille Université (AMU)- Hôpital Nord [CHU - APHM], Babolat VS, Centre de Recherche Saint-Antoine (UMRS893), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Département de génétique médicale [Hôpital de la Timone - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Obstétrique-Gynécologie [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], Biologie du Cancer et de l'Infection (BCI ), Institut de Recherche Interdisciplinaire de Grenoble (IRIG), Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire d’Aide à la Procréation, Département de Génétique et Procréation (CECOS), Hôpital Couple Enfant de Grenoble-CHU de Grenoble, Department of Obstetrics and Gynaecology, University Hospital of Grenoble, La Tronche, France, UMR 6578 : Anthropologie Bio-Culturelle (UAABC), Université de la Méditerranée - Aix-Marseille 2-Centre National de la Recherche Scientifique (CNRS), Service de Chirurgie et Radiologie Pédiatrique, Université de la Méditerranée - Aix-Marseille 2, Pédiatrie et oncologie pédiatrique [Hôpital de la Timone - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Institut de Recherche Interdisciplinaire de Grenoble (IRIG), and Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)
Subjects: Adult, Pediatrics, medicine.medical_specialty, Intrauterine growth restriction, Gestational Age, Ultrasonography, Prenatal, 03 medical and health sciences, 0302 clinical medicine, Meconium, Pregnancy, Risk Factors, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, medicine, Echogenic Bowel, Humans, 030212 general & internal medicine, Retrospective Studies, 030219 obstetrics & reproductive medicine, medicine.diagnostic_test, business.industry, Infant, Newborn, Pregnancy Outcome, Obstetrics and Gynecology, Gestational age, Retrospective cohort study, medicine.disease, 3. Good health, Reproductive Medicine, Amniocentesis, Female, Trisomy, business
Abstract: International audience; Objective: The aim of this study was to identify antenatal prognostic factors of neonatal outcomes in cases of fetal echogenic bowel (FEB). Study design: A retrospective study in three tertiary referral centers including fetal echogenic bowel over a 10-year period (from January 2003 to December 2013). The echogenicity of the fetal bowel was graded from 1 to 3, according to Slotnick's definition. Associated echographic findings such as bowel dilations, gallbladder abnormalities, calcifications, extra-abdominal abnormalities, intrauterine growth restriction (IUGR) and a decrease in amniotic fluid volume, if present were also recorded. This was followed by the FEB's sonographic evolution. The sonographic evolution was considered favorable if it was stable or decreasing and unfavorable if the echogenicity of the bowel increased or if additional sonographic findings appeared. Neonates had a pediatric examination in the delivery room and upon discharge from the maternity hospital. An outcome was considered good in the case of on-term delivery of a newborn with normal clinical examination and meconium elimination. Results: Complete pregnancy outcome data were available for 409 pregnancies. 338 newborns had uneventful outcomes (82.6%). Antenatal exploration diagnosed 4 cases of aneuploidy (1 case of trisomy 13, 1 case of trisomy 18 and 2 cases of triploidies), 16 cases of congenital infections, 9 cases of cystic fibrosis and 11 cases of bowel abnormalities. After a multivariate analysis, we discovered the sonographic grade of the echogenic bowel was not a prognostic factor of neonatal outcome. The isolated fetal echogenic bowel had a 6.6-fold increase chance of uneventful outcomes (adjusted odd ratio (aOR) 6.6, 95% CI 3-14.4). Notably, favorable sonographic evolution (aOR 8.1, 95% CI 4.1-16) and late gestational age at the time of the diagnosis (aOR 1.17, 95% CI 1.07-1.27) are independent, good prognostic factors of good neonatal outcomes. None of the 180 fetuses with isolated fetal echogenic bowel and favorable sonographic evolution had adverse outcomes. Among these, 4 cases (0.98%) of aneuploidy, 17 cases (4.2%) of congenital infections and 9 cases (2.2%) of cystic fibroses were also diagnosed. No cases of Down syndrome (DS) were reported. Conclusion: Our study shows that the grade should not be considered a prognostic factor of neonatal outcomes. Our data suggests the need to reevaluate the concept of systematic amniocentesis. Sonographic evolution of fetal bowel is an independent, strong prognostic factor for good neonatal outcomes. It also better defines the FEB prognostic. (C) 2017 Elsevier B.V. All rights reserved.
Published: 2017

3. Guideline choice for CTG analysis influences first caesarean decision

Author: Nadège Vejux, Florence Bretelle, Claude D'Ercole, L. Piechon, Anderson Loundou, Renaud Ledu, Service d'Obstétrique-Gynécologie [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, INSB-INSB-Centre National de la Recherche Scientifique (CNRS), Gynépole, Aix Marseille Université (AMU)- Hôpital Nord [CHU - APHM], and Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Adult, medicine.medical_specialty, Cardiotocography, medicine.medical_treatment, Clinical Decision-Making, Decision Making, Gestational Age, 03 medical and health sciences, 0302 clinical medicine, Pregnancy, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Humans, Medicine, Caesarean section, Oximetry, 030212 general & internal medicine, Fetal Monitoring, 10. No inequality, Retrospective Studies, Gynecology, 030219 obstetrics & reproductive medicine, medicine.diagnostic_test, Cesarean Section, business.industry, Obstetrics, Reproducibility of Results, Obstetrics and Gynecology, Guideline, Heart Rate, Fetal, Hydrogen-Ion Concentration, Practice Guidelines as Topic, Pediatrics, Perinatology and Child Health, Female, France, business, Intrapartum Cardiotocography
Abstract: International audience; Objective: To compare intrapartum cardiotocography (CTG) analysis in case of first caesarean section (CS) for non-reassuring CTG according to international guidelines.Methods: Four ObGyns retrospectively analysed first CS for non-reassuring CTG during labour blind to neonatal outcome. CTG were analysed according to French National College of Obstetricians and Gynaecologists (CNGOF) and to the FIGO guidelines. First, CTG analysis was done without obstetrical context, then secondly, it was given. ObGyns stated if CS was justified or not. Inter-operator ObGyn agreement was analysed.Results: Among 587 CS, 100 women met the inclusion criteria with a first CS for non-reassuring CTG. The overall inter observer agreement was low but fair. ObGyns were significantly more concordant using the FIGO than the CNGOF guidelines (kappa coefficient=0.331 [0.27-0.39] versus 0.209 [0.16-0.26] p
Published: 2017

4. Adverse drug reaction related to drug shortage: A retrospective study on the French National Pharmacovigilance Database

Author: Bourneau-Martin, Delphine, Babin, Marina, Grandvuillemin, Aurelie, Mullet, Charlotte, Salvo, Francesco, Singier, Allison, Cellier, Morgane, Fresse, Audrey, de Canecaude, Claire, Pietri, Tessa, Drablier, Guillaume, Geniaux, Helene, Lagarce, Laurence, Laroche, Marie-Laure, Briet, Marie, Admin, Oskar, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre Régional de Pharmacovigilance, de Renseignement sur le Médicament et de Pharmaco épidémiologie de Bourgogne [Dijon], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHU Dijon, Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], Centre Régional de PharmacoVigilance de Lorraine (CRPV Lorraine), CRHU Nancy, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Service Pharmacologie Clinique [CHU Toulouse], Pôle Santé publique et médecine publique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Institut de Neurosciences des Systèmes (INS), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Centre régional de pharmacovigilance, de pharmaco-épidémiologie et d'information sur les médicaments [Limoges], CHU Limoges, Vieillissement Fragilité Prévention e-Santé (VieSanté), OmégaHealth (ΩHealth), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Laboratoire de Biologie Neurovasculaire Intégrée [Angers] (CNRS UMR6214 - INSERM U771), and Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Faculté de Médecine d'Angers
Subjects: Pharmacology, Pharmacovigilance, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Adverse drug reaction, Drug shortage, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Pharmacology (medical), Medication error
Abstract: International audience; AIM: Drug shortage is a growing global health issue. The aim of the study was to evaluate the consequences of drug shortages on patient safety based on data recorded in the French Pharmacovigilance Database. METHODS: All cases involving drug shortages reported from 1985 to the end of 2019 were extracted from the database. RESULTS: Following the selection process, 462 cases were included. The number of cases increased significantly from 2004 to 2019. Cases mainly involved drugs from the nervous system (22.1%, CI95[17.5;27.0]), the cardiovascular system (16.4%, CI95[11.9;21.4]), and anti-infectives for systemic use (14.3%, CI95[9.7;19.2]) ATC classes. Most of the cases reported an adverse drug reaction (ADR) belonging to the SOC nervous system (21%, CI95[18;24]), skin and subcutaneous (14%, CI95[11;17]), general (13%, CI95[10;17]), and gastrointestinal (8%, CI95[5;11]) disorders. Disease worsening was observed in 15.9% of the cases, mostly related to a lack of efficacy of the replacement drug. Half of the cases were considered as serious. Evolution was favourable in 79.4% of the cases. Death and/or life-threatening situations were reported in 5.8% of the cases. Medication errors (ME) were identified in 51 cases (11%), mostly occurring at the administration step and involving a human factor. CONCLUSION: This study emphasises the clinical impact of drug shortage in terms of ADRs, ME and inefficiency. These observations underline the importance of a global health policy programme to limit the occurrence of drug shortages and to reinforce the information provided to patients and health care professionals in this context to limit risk.
Published: 2022

5. Postpartum hemorrhage: guidelines for clinical practice from the French ă College of Gynaecologists and Obstetricians (CNGOF) in collaboration ă with the French Society of Anesthesiology and Intensive Care (SFAR)

Author: Sentilhes , Loïc, Vayssière , Christophe, Deneux-Tharaux , Catherine, Aya , Antoine Guy, Bayoumeu , Francoise, Bonnet , Marie-Pierre, Djoudi , Rachid, Dolley , Patricia, Dreyfus , Michel, Ducroux-Schouwey , Chantal, Dupont , Corinne, François , Anne, Gallot , Denis, Haumonté , Jean-Baptiste, Huissoud , Cyril, Kayem , Gilles, Keïta , Hawa, Langer , Bruno, Mignon , Alexandre, Morel , Olivier, Parant , Olivier, Pelage , Jean-Pierre, Phan , Emmanuelle, Rossignol , Mathias, Tessier , Véronique, Mercier , Frederic J., Goffinet , François, Service d'Obstétrique et Gynécologique [Angers], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Recherche Epidémiologique en Santé Périnatale et Santé des Femmes et des Enfants (UMR_S 953), Université Paris-Sud - Paris 11 (UP11)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Gynécologie-Obstétrique et Médecine de la Reproduction [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Clinatec - Centre de recherche biomédicale Edmond J.Safra (SCLIN), Commissariat à l'énergie atomique et aux énergies alternatives - Laboratoire d'Electronique et de Technologie de l'Information (CEA-LETI), Direction de Recherche Technologique (CEA) (DRT (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Direction de Recherche Technologique (CEA) (DRT (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Centre Hospitalier Universitaire [Grenoble] (CHU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Santé Individu Société (SIS), Université Lumière - Lyon 2 (UL2)-Université Jean Moulin - Lyon 3 (UJML), Université de Lyon-Université de Lyon-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Hospices Civils de Lyon (HCL)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Réseau périnatal Aurore, Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Service de Gynécologie [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Retinoids, Development and Developmental Diseases (R2D2), Université d'Auvergne - Clermont-Ferrand I (UdA), Service d'Obstétrique-Gynécologie [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], Institut cellule souche et cerveau (SBRI), Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique (CRESS - U1153), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service d'Anesthésie-Réanimation, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de gynécologie–obstétrique, CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Service Gynécologie [CHU Toulouse], Pôle Femme-Mère-Couple [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Hôpital Ambroise Paré, Department of Interventional Radiology, Assistance Publique - Hôpitaux de Paris, Sciences et Technologies de la Musique et du Son (STMS), Institut de Recherche et Coordination Acoustique/Musique (IRCAM)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS), Réseau périnatal port-royal, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Saint-Vincent de Paul, Service de Gynécologie et Obstétrique [Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Descartes - Paris 5 (UPD5)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris-Sud - Paris 11 (UP11), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Centre Hospitalier Universitaire [Grenoble] (CHU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Santé Individu Société - SIS (SIS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Jean Monnet [Saint-Étienne] (UJM)-Hospices Civils de Lyon (HCL)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Moulin - Lyon 3 (UJML), Université de Lyon-Université Lumière - Lyon 2 (UL2), Institut cellule souche et cerveau (U846 Inserm - UCBL1), Service de Gynécologie-Obstétrique [CHU Trousseau], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Service de gynécologie obstétrique, CHU Toulouse [Toulouse]-Hôpital Paule de Viguier, CHU Toulouse [Toulouse], Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Lyon-Hospices Civils de Lyon (HCL)-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Université de Caen Normandie (UNICAEN), Normandie Université (NU), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Recherche Agronomique (INRA), Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC), Centre Hospitalier Régional Universitaire de Nîmes (CHRU Nîmes), Clinatec - Centre de recherche biomédicale Edmond J.Safra, Université Joseph Fourier - Grenoble 1 (UJF)-Centre Hospitalier Universitaire [Grenoble] (CHU)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Pôle de Gynécologie-Obstétrique et Reproduction Humaine, CHU Clermont-Ferrand-Université de Clermont-Ferrand, Institut cellule souche et cerveau / Stem Cell and Brain Research Institute (SBRI), Université Claude Bernard Lyon 1 (UCBL), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon, Université Pierre et Marie Curie - Paris 6 (UPMC)-IRCAM-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Saint-Vincent de Paul, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], Université de Montpellier (UM)-Université Montpellier 1 (UM1), Centre Hospitalier Universitaire [Grenoble] (CHU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Joseph Fourier - Grenoble 1 (UJF)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Centre hospitalier universitaire d'Angers, Épidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps, Université Toulouse III - Paul Sabatier ( UPS ), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité ( CRESS (U1153 / UMR_A 1125) ), Institut National de la Recherche Agronomique ( INRA ) -Université Sorbonne Paris Cité ( USPC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Recherche Epidémiologique en Santé Périnatale et Santé des Femmes et des Enfants ( UMR_S 953 ), Université Paris-Sud - Paris 11 ( UP11 ) -Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Service de Gynécologie - Obstétrique et médecine de la reproduction [Caen], Université Joseph Fourier - Grenoble 1 ( UJF ) -Centre Hospitalier Universitaire [Grenoble] ( CHU ) -Commissariat à l'énergie atomique et aux énergies alternatives ( CEA ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Santé Individu Société - SIS ( SIS ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Jean Monnet [Saint-Étienne] ( UJM ) -Hospices Civils de Lyon ( HCL ) -Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Université Jean Moulin - Lyon III ( UJML ) -Université Lumière - Lyon 2 ( UL2 ), Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon ( HCL ) -Hospices Civils de Lyon ( HCL ), Retinoids, Development and Developmental Diseases ( R2D2 ), Université d'Auvergne - Clermont-Ferrand I ( UdA ), Assistance Publique - Hôpitaux de Marseille ( APHM ) -CHU Marseille- Hôpital Nord [CHU - APHM], Institut cellule souche et cerveau / Stem Cell and Brain Research Institute ( SBRI ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique ( CRESS - U1153 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité ( CRESS (U1153 / UMR_A 1125) ), Institut National de la Recherche Agronomique ( INRA ) -Université Sorbonne Paris Cité ( USPC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Institut National de la Recherche Agronomique ( INRA ) -Université Sorbonne Paris Cité ( USPC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP)-Université Paris Diderot - Paris 7 ( UPD7 ) -Hôpital Beaujon, Sciences et Technologies de la Musique et du Son ( STMS ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -IRCAM-Centre National de la Recherche Scientifique ( CNRS ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Saint-Vincent de Paul, and Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Cochin [AP-HP]
Subjects: [ SHS.PSY ] Humanities and Social Sciences/Psychology, [ SDV.MHEP.PSM ] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Quality of Life, [ SHS.ECO ] Humanities and Social Sciences/Economies and finances, [SHS.PSY]Humanities and Social Sciences/Psychology, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, [SHS.ECO]Humanities and Social Sciences/Economics and Finance
Abstract: International audience; Postpartum haemorrhage (PPH) is defined as blood loss >= 500 mL after ă delivery and severe PPH as blood loss >= 1000 mL, regardless of the ă route of delivery (professional consensus). The preventive ă administration of uterotonic agents just after delivery is effective in ă reducing the incidence of PPH and its systematic use is recommended, ă regardless of the route of delivery (Grade A). Oxytocin is the first ă line prophylactic drug, regardless of the route of delivery (Grade A); a ă slowly dose of 5 or 10 IU can be administered (Grade A) either IV or IM ă (professional consensus).After vaginal delivery, routine cord drainage ă (Grade B), controlled cord traction (Grade A), uterine massage (Grade ă A), and routine bladder voiding (professional consensus) are not ă systematically recommended for PPH prevention. After caesarean delivery, ă placental delivery by controlled cord traction is recommended (grade B). ă The routine use of a collector bag to assess postpartum blood loss at ă vaginal delivery is not systematically recommended (Grade B), since the ă incidence of severe PPH is not affected by this intervention. In cases ă of overt PPH after vaginal delivery, placement of a blood collection bag ă is recommended (professional consensus). The initial treatment of PPH ă consists in a manual uterine examination, together with antibiotic ă prophylaxis, careful visual assessment of the lower genital tract, a ă uterine massage, and the administration of 5-10 IU oxytocin injected ă slowly IV or IM, followed by a maintenance infusion not to exceed a ă cumulative dose of 40 IU (professional consensus). If oxytocin fails to ă control the bleeding, the administration of sulprostone is recommended ă within 30 minutes of the PPH diagnosis (Grade C). Intrauterine balloon ă tamponade can be performed if sulprostone fails and before recourse to ă either surgery or interventional radiology (professional consensus). ă Fluid resuscitation is recommended for PPH persistent after first line ă uterotonics, or if clinical signs of severity (Grade B). The objective ă of RBC transfusion is to maintain a haemoglobin concentration (Hb) >8 ă g/dL. During active haemorrhaging, it is desirable to maintain a ă fibrinogen level >= 2 g/L (professional consensus). RBC, fibrinogen and ă fresh frozen plasma (FFP) may be administered without awaiting ă laboratory results (professional consensus). Tranexamic acid may be used ă at a dose of 1 g, renewable once if ineffective the first time in the ă treatment of PPH when bleeding persists after sulprostone administration ă (professional consensus), even though its clinical value has not yet ă been demonstrated in obstetric settings. It is recommended to prevent ă and treat hypothermia in women with PPH by warming infusion solutions ă and blood products and by active skin warming (Grade C). Oxygen ă administration is recommended in women with severe PPH (professional ă consensus). If PPH is not controlled by pharmacological treatments and ă possibly intra-uterine balloon, invasive treatments by arterial ă embolization or surgery are recommended (Grade C). No technique for ă conservative surgery is favoured over any other (professional ă consensus). Hospital-to-hospital transfer of a woman with a PPH for ă embolization is possible once hemoperitoneum is ruled out and if the ă patient's hemodynamic condition so allows (professional consensus). (C) ă 2015 Elsevier Ireland Ltd. All rights reserved.
Published: 2016

6. The Prevalence of Mental Disorders Among Children and Adolescents in the Child Welfare System: A Systematic Review and Meta-Analysis

Author: Guillaume Fond, Laurent Boyer, Anderson Loundou, Marine Alessandrini, Sylvie Tordjman, Pascal Auquier, Guillaume Bronsard, Santé Publique et maladies Chroniques : Qualité de vie Concepts, Usages et Limites, Déterminants (SPMC), Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), INSERM U955, équipe 15, Service de psychiatrie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Hôpital Albert Chenevier-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Hôpital Albert Chenevier-Réseau de coopération scientifique en santé mentale, Fondation FondaMental [Créteil]-Fondation FondaMental [Créteil]-Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Service Psychiatrie de l'Enfant et de l'Adolescent, CHU Pontchaillou [Rennes]-Centre Hospitalier Guillaume Régnier [Rennes]-CHS (Centre Hospitalier Spécialisé lutte Maladies Mentales), Audition (Psychophysique, Modélisation, Neurosciences) (APMN), Laboratoire des systèmes perceptifs (LSP), Département d'Etudes Cognitives - ENS Paris (DEC), École normale supérieure - Paris (ENS Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-École normale supérieure - Paris (ENS Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Centre National de la Recherche Scientifique (CNRS)-Département d'Etudes Cognitives - ENS Paris (DEC), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Centre National de la Recherche Scientifique (CNRS), Centre méditerranéen de médecine moléculaire (C3M), Université Nice Sophia Antipolis (... - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Université Côte d'Azur (UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Hôpital Albert Chenevier-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Hôpital Albert Chenevier-Réseau de coopération scientifique en santé mentale, Centre National de la Recherche Scientifique (CNRS)-Département d'Etudes Cognitives - ENS Paris (DEC), École normale supérieure - Paris (ENS Paris)-École normale supérieure - Paris (ENS Paris)-Centre National de la Recherche Scientifique (CNRS)-Département d'Etudes Cognitives - ENS Paris (DEC), École normale supérieure - Paris (ENS Paris)-École normale supérieure - Paris (ENS Paris), Université Côte d'Azur (UCA)-Université Côte d'Azur (UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM), École normale supérieure - Paris (ENS-PSL), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-École normale supérieure - Paris (ENS-PSL), Université Nice Sophia Antipolis (1965 - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Côte d'Azur (UCA), Santé Publique et maladies Chroniques : Qualité de vie Concepts, Usages et Limites, Déterminants ( SPMC ), Aix Marseille Université ( AMU ) -Assistance Publique - Hôpitaux de Marseille ( APHM ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor-Hôpital Albert Chenevier-Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor-Hôpital Albert Chenevier-Réseau de coopération scientifique en santé mentale, Fondation FondaMental [Créteil]-Fondation FondaMental [Créteil]-Institut Mondor de Recherche Biomédicale ( IMRB ), Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -IFR10, Assistance Publique - Hôpitaux de Marseille ( APHM ) -CHU Marseille, Audition (Psychophysique, Modélisation, Neurosciences) ( APMN ), Laboratoire des systèmes perceptifs, Département d'Etudes Cognitives - ENS Paris ( DEC ), École normale supérieure - Paris ( ENS Paris ) -École normale supérieure - Paris ( ENS Paris ) -Centre National de la Recherche Scientifique ( CNRS ) -Département d'Etudes Cognitives - ENS Paris ( DEC ), École normale supérieure - Paris ( ENS Paris ) -École normale supérieure - Paris ( ENS Paris ) -Centre National de la Recherche Scientifique ( CNRS ), Centre méditérannéen de médecine moléculaire ( C3M ), Université Nice Sophia Antipolis ( UNS ), and Université Côte d'Azur ( UCA ) -Université Côte d'Azur ( UCA ) -Institut National de la Santé et de la Recherche Médicale ( INSERM )
Subjects: [ SDV.MHEP.PSM ] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, [SHS.PSY]Humanities and Social Sciences/Psychology, 0302 clinical medicine, Epidemiology, Prevalence, [ SHS.ECO ] Humanities and Social Sciences/Economies and finances, 030212 general & internal medicine, Child, education.field_of_study, Mental Disorders, 05 social sciences, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, General Medicine, 16. Peace & justice, [SHS.ECO]Humanities and Social Sciences/Economics and Finance, Quality, Anxiety Disorders, 3. Good health, Observational Studies as Topic, Conduct disorder, Meta-analysis, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Anxiety, medicine.symptom, 050104 developmental & child psychology, Research Article, Conduct Disorder, medicine.medical_specialty, Adolescent, Population, MEDLINE, Child Welfare, [ SHS.PSY ] Humanities and Social Sciences/Psychology, 03 medical and health sciences, Prevalence of mental disorders, medicine, Humans, 0501 psychology and cognitive sciences, Psychiatry, education, Depressive Disorder, business.industry, medicine.disease, Confidence interval, Attention Deficit Disorder with Hyperactivity, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Meta-Analysis of Observe Studies In Epidemiology
Abstract: Supplemental Digital Content is available in the text, It remains unclear whether children and adolescents in the child welfare system (CWS) exhibit a higher prevalence of mental disorders compared with the general population. The objective of this study was to perform a systematic review and meta-analysis to assess the prevalence of mental disorders in the CWS. All of the epidemiological surveys assessing the prevalence of mental disorders in children and adolescents in the CWS were included. The pooled prevalence was estimated with random effect models. Potential sources of heterogeneity were explored using meta-regression analyses. Eight studies provided prevalence estimates that were obtained from 3104 children and adolescents. Nearly 1 child or adolescent of every 2 (49%; 95% confidence interval (CI) 43–54) was identified as meeting criteria for a current mental disorder. The most common mental disorder was disruptive disorder (27%; 95% CI 20–34), including conduct disorder (20%; 95% CI 13–27) and oppositional defiant disorder (12%; 95% CI 10–14). The prevalence of attention-deficit/hyperactivity disorder was estimated to be 11% (95% CI 6–15). The prevalence estimates of anxiety and depressive disorders were 18% (95% CI 12–24) and 11% (95% CI 7–15). Posttraumatic stress disorder had the lowest prevalence (4%; 95% CI 2–6). High prevalences of mental disorders in the CWS were reported, which highlights the need for the provision of qualified service. The substantial heterogeneity of our findings is indicative of the need for accurate epidemiological data to effectively guide public policy.
Published: 2016

7. Bilobectomy for lung cancer: contemporary national early morbidity and mortality outcomes

Author: Anderson Loundou, Françoise Le Pimpec-Barthes, Pascal Thomas, Jacques Jougon, Pierre-Emmanuel Falcoz, Gilbert Massard, Laurent Brouchet, Alain Bernard, Marcel Dahan, Epithor Grp, Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS), CHU Strasbourg, Service de chirurgie cardio-vasculaire et thoracique (CHU Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Service de chirurgie thoracique [AP-HP HEGP, Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Université Paris Descartes - Paris 5 (UPD5), Institut des Maladies Métaboliques et Cardiovasculaires (I2MC), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, INSB-INSB-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Toulouse [Toulouse], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Université Paris Descartes - Paris 5 (UPD5), Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes ( URMITE ), Institut de Recherche pour le Développement ( IRD ) -Aix Marseille Université ( AMU ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -IFR48, INSB-INSB-Centre National de la Recherche Scientifique ( CNRS ), Institut de Recherche en Communications et en Cybernétique de Nantes ( IRCCyN ), Mines Nantes ( Mines Nantes ) -École Centrale de Nantes ( ECN ) -Ecole Polytechnique de l'Université de Nantes ( Polytech Nantes ), Université de Nantes ( UN ) -Université de Nantes ( UN ) -PRES Université Nantes Angers Le Mans ( UNAM ) -Centre National de la Recherche Scientifique ( CNRS ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Européen Georges Pompidou [APHP] ( HEGP ) -Université Paris Descartes - Paris 5 ( UPD5 ), Institut des Maladies Métaboliques et Cardiovasculaires ( I2MC ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Hôpital de Rangueil, CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse]-Université Toulouse III - Paul Sabatier ( UPS ), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, and Assistance Publique - Hôpitaux de Marseille ( APHM ) -CHU Marseille
Subjects: Pulmonary and Respiratory Medicine, Adult, Male, medicine.medical_specialty, Lung Neoplasms, medicine.medical_treatment, Operative Time, 030204 cardiovascular system & hematology, 03 medical and health sciences, Bilobectomy, Pneumonectomy, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Carcinoma, Non-Small-Cell Lung, Medicine, Humans, Prospective Studies, Lung cancer, Aged, 2. Zero hunger, Performance status, business.industry, Thoracic Surgery, Video-Assisted, General Medicine, Odds ratio, Middle Aged, Pleural Diseases, medicine.disease, Confidence interval, 3. Good health, Surgery, [ SDV.MHEP.MI ] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Treatment Outcome, Cardiothoracic surgery, Cardiovascular Diseases, 030220 oncology & carcinogenesis, Female, Bronchial Fistula, France, Cardiology and Cardiovascular Medicine, business, Body mass index
Abstract: 23rd European Conference on General Thoracic Surgery, Lisbon, PORTUGAL, MAY 31-JUN 03, 2015; International audience; To determine contemporary early outcomes associated with bilobectomy for lung cancer and to identify their predictors using a nationally representative general thoracic surgery database. A total of 1831 patients, who underwent elective bilobectomy for primary lung cancer between 1 January 2004 and 31 December 2013, were selected. Logistic regression analysis was performed on variables for major adverse events. There were 670 upper and 1161 lower bilobectomies. Video-assisted thoracic surgery was seldom performed (2%). Induction therapy and extended resection were performed in 293 (16%) and 279 patients (15.2%), respectively. Operative mortality was 4.8% (upper: 4.5%/lower: 5%; P = 0.62), and significantly higher following extended procedures when compared with standard bilobectomy (4.3 vs 7.5%; P = 0.013). Pulmonary complication rate was 21.1%. Bronchial fistula occurred in 46 patients (2.5%) and pleural space complications in 296 (16.2%). Their respective incidence rates were significantly higher following lower than upper bilobectomy (3.5 vs 0.7%; P < 0.001 and 17.8 vs 13.3%; P = 0.007). At multivariate analysis, extended procedures [odds ratio (OR), 2.3; 95% confidence interval (CI), 1.03-5.31; P = 0.04], ASA scores of 3 or greater (OR, 2.02; 95% CI, 1.33-3.07; P < 0.001) and World Health Organization performance status 2 or greater (OR, 1.47; 95% CI, 1.01-2.13; P = 0.04) were risk predictors of mortality. Female gender (OR, 0.39; 95% CI, 0.19-0.80; P = 0.01), highest body mass index (BMI) values (OR, 0.91; 95% CI, 0.86-0.96; P = 0.001) and recent years of surgery (OR, 0.91; 95% CI, 0.84-0.99; P = 0.02) were protective. Predictors of bronchial fistula were male gender, lowest BMI values, lower bilobectomy and longest operative times. Male gender, lowest BMI values and longest operative times were also predictors of pulmonary complications, together with highest ASA scores and lowest forced expiratory volume in 1 s values. Risks related to lower bilobectomy lie halfway between those reported for lobectomy and pneumonectomy. Additional surgical measures to prevent pleural space complications and bronchial fistula should be encouraged with this operation. In contrast, upper bilobectomy shares more or less the same hazards as lobectomy.
Published: 2016

8. Bilobectomy for lung cancer: contemporary national early morbidity and ă mortality outcomes

Author: Thomas , Pascal A., Falcoz , Pierre-Emmanuel, Bernard , Alain, Le Pimpec-Barthes , Françoise, Jougon , Jacques, Brouchet , Laurent, Massard , Gilbert, Dahan , Marcel, Loundou , Anderson, Grp , EPITHOR, Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, INSB-INSB-Centre National de la Recherche Scientifique (CNRS), CHU Strasbourg, Service de chirurgie thoracique [AP-HP HEGP, Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Institut des Maladies Métaboliques et Cardiovasculaires (I2MC), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Toulouse [Toulouse], Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Université Paris Descartes - Paris 5 (UPD5), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Université Paris Descartes - Paris 5 (UPD5), Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes ( URMITE ), Institut de Recherche pour le Développement ( IRD ) -Aix Marseille Université ( AMU ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -IFR48, INSB-INSB-Centre National de la Recherche Scientifique ( CNRS ), Institut de Recherche en Communications et en Cybernétique de Nantes ( IRCCyN ), Mines Nantes ( Mines Nantes ) -École Centrale de Nantes ( ECN ) -Ecole Polytechnique de l'Université de Nantes ( Polytech Nantes ), Université de Nantes ( UN ) -Université de Nantes ( UN ) -PRES Université Nantes Angers Le Mans ( UNAM ) -Centre National de la Recherche Scientifique ( CNRS ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Européen Georges Pompidou [APHP] ( HEGP ) -Université Paris Descartes - Paris 5 ( UPD5 ), Institut des Maladies Métaboliques et Cardiovasculaires ( I2MC ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Hôpital de Rangueil, CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse]-Université Toulouse III - Paul Sabatier ( UPS ), and Assistance Publique - Hôpitaux de Marseille ( APHM ) -CHU Marseille
Subjects: [ SHS.PSY ] Humanities and Social Sciences/Psychology, [ SDV.MHEP.PSM ] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, [ SHS.ECO ] Humanities and Social Sciences/Economies and finances, [SHS.PSY]Humanities and Social Sciences/Psychology, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, [SHS.ECO]Humanities and Social Sciences/Economics and Finance, Quality
Abstract: 23rd European Conference on General Thoracic Surgery, Lisbon, PORTUGAL, ă MAY 31-JUN 03, 2015; International audience; To determine contemporary early outcomes associated with bilobectomy for ă lung cancer and to identify their predictors using a nationally ă representative general thoracic surgery database. ă A total of 1831 patients, who underwent elective bilobectomy for primary ă lung cancer between 1 January 2004 and 31 December 2013, were selected. ă Logistic regression analysis was performed on variables for major ă adverse events. ă There were 670 upper and 1161 lower bilobectomies. Video-assisted ă thoracic surgery was seldom performed (2%). Induction therapy and ă extended resection were performed in 293 (16%) and 279 patients ă (15.2%), respectively. Operative mortality was 4.8% (upper: ă 4.5%/lower: 5%; P = 0.62), and significantly higher following extended ă procedures when compared with standard bilobectomy (4.3 vs 7.5%; P = ă 0.013). Pulmonary complication rate was 21.1%. Bronchial fistula ă occurred in 46 patients (2.5%) and pleural space complications in 296 ă (16.2%). Their respective incidence rates were significantly higher ă following lower than upper bilobectomy (3.5 vs 0.7%; P < 0.001 and 17.8 ă vs 13.3%; P = 0.007). At multivariate analysis, extended procedures ă [odds ratio (OR), 2.3; 95% confidence interval (CI), 1.03-5.31; P = ă 0.04], ASA scores of 3 or greater (OR, 2.02; 95% CI, 1.33-3.07; P < ă 0.001) and World Health Organization performance status 2 or greater ă (OR, 1.47; 95% CI, 1.01-2.13; P = 0.04) were risk predictors of ă mortality. Female gender (OR, 0.39; 95% CI, 0.19-0.80; P = 0.01), ă highest body mass index (BMI) values (OR, 0.91; 95% CI, 0.86-0.96; P = ă 0.001) and recent years of surgery (OR, 0.91; 95% CI, 0.84-0.99; P = ă 0.02) were protective. Predictors of bronchial fistula were male gender, ă lowest BMI values, lower bilobectomy and longest operative times. Male ă gender, lowest BMI values and longest operative times were also ă predictors of pulmonary complications, together with highest ASA scores ă and lowest forced expiratory volume in 1 s values. ă Risks related to lower bilobectomy lie halfway between those reported ă for lobectomy and pneumonectomy. Additional surgical measures to prevent ă pleural space complications and bronchial fistula should be encouraged ă with this operation. In contrast, upper bilobectomy shares more or less ă the same hazards as lobectomy.
Published: 2016

9. A Bayesian framework systematic review and meta-analysis of anesthetic ă agents effectiveness/tolerability profile in electroconvulsive therapy ă for major depression

Author: Laurent Boyer, Jean-Arthur Micoulaud-Franchi, Pascal Auquier, Pierre-Michel Llorca, Djamila Bennabi, Guillaume Fond, Emmanuel Haffen, Anderson Loundou, Christophe Lançon, Lore Brunel, Cognition, Action, et Plasticité Sensorimotrice [Dijon - U1093] ( CAPS ), Université de Bourgogne ( UB ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Sommeil, Attention et Neuropsychiatrie [Bordeaux] ( SANPSY ), Université de Bordeaux ( UB ) -CHU de Bordeaux Pellegrin [Bordeaux]-Centre National de la Recherche Scientifique ( CNRS ), Services d’explorations fonctionnelles du système nerveux, clinique du sommeil, CHU Bordeaux [Bordeaux], Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille ( APHM ) -CHU Marseille, Pôle de Psychiatrie 'Solaris', Service Pr. Naudin, Centre Hospitalier Universitaire de Sainte-Marguerite, Service de psychiatrie adulte - B, CHU Clermont-Ferrand, Santé Publique et maladies Chroniques : Qualité de vie Concepts, Usages et Limites, Déterminants ( SPMC ), Aix Marseille Université ( AMU ) -Assistance Publique - Hôpitaux de Marseille ( APHM ), Centre méditérannéen de médecine moléculaire ( C3M ), Université Nice Sophia Antipolis ( UNS ), Université Côte d'Azur ( UCA ) -Université Côte d'Azur ( UCA ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), INSERM U955, équipe 15, Service de psychiatrie, Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor-Hôpital Albert Chenevier-Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor-Hôpital Albert Chenevier-Réseau de coopération scientifique en santé mentale, Fondation FondaMental [Créteil]-Fondation FondaMental [Créteil]-Institut Mondor de Recherche Biomédicale ( IMRB ), Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -IFR10, Sommeil, Attention et Neuropsychiatrie [Bordeaux] (SANPSY), Université de Bordeaux (UB)-CHU de Bordeaux Pellegrin [Bordeaux]-Centre National de la Recherche Scientifique (CNRS), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Département Universitaire de Psychiatrie - [Hôpital Sainte Marguerite - APHM] (Hôpitaux Sud), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud ), Santé Publique et maladies Chroniques : Qualité de vie Concepts, Usages et Limites, Déterminants (SPMC), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM), Centre méditerranéen de médecine moléculaire (C3M), Université Nice Sophia Antipolis (1965 - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Côte d'Azur (UCA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Hôpital Albert Chenevier-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Hôpital Albert Chenevier-Réseau de coopération scientifique en santé mentale, Fondation FondaMental [Créteil]-Fondation FondaMental [Créteil]-Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Sommeil, Addiction et Neuropsychiatrie [Bordeaux] (SANPSY), Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud )-Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), Université Nice Sophia Antipolis (... - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Université Côte d'Azur (UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Centre National de la Recherche Scientifique (CNRS)-CHU de Bordeaux Pellegrin [Bordeaux]-Université de Bordeaux (UB)
Subjects: medicine.medical_treatment, [ SDV.MHEP.PSM ] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, [SHS.PSY]Humanities and Social Sciences/Psychology, Article, 03 medical and health sciences, [ SHS.PSY ] Humanities and Social Sciences/Psychology, 0302 clinical medicine, Electroconvulsive therapy, Seizures, medicine, Humans, [ SHS.ECO ] Humanities and Social Sciences/Economies and finances, Ketamine, Electroconvulsive Therapy, Adverse effect, Depression (differential diagnoses), Anesthetics, Randomized Controlled Trials as Topic, Depressive Disorder, Major, Multidisciplinary, business.industry, Bayes Theorem, Electroencephalography, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, [SHS.ECO]Humanities and Social Sciences/Economics and Finance, Quality, 030227 psychiatry, 3. Good health, Tolerability, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Methohexital, Anesthesia, Meta-analysis, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Propofol, business, 030217 neurology & neurosurgery, medicine.drug
Abstract: International audience; The aim of this study was to assess the efficacy and ă tolerability/acceptability of 6 anesthetic agents in ECT for depressive ă disorders. We systematically reviewed 14 double-blind randomized ă controlled trials (610 participants). Efficacy was measured by the mean ă scores on validated depression scales at 6 ECT (or the nearest score if ă not available), number of responders at the end of treatment and seizure ă duration. The acceptability was measured by the proportion of patients ă who dropped out of the allocated treatment, and the tolerability by the ă number of serious adverse events and post-treatment cognition ă assessment. After excluding the trials responsible for heterogeneity, ă depression scores of patients who were administered methohexital were ă found to be significantly more improved than those who received propofol ă (p = 0.001). On the contrary, those who were administered propofol had ă lower depression scores than those with thiopental at the end of ă treatment (p = 0.002). Compared to propofol, methohexital was found to ă be significantly associated with higher seizure duration (p = 0.018). No ă difference was found for the acceptability profile (all p > 0.05). In ă summary, ketamine and methohexital may be preferred to propofol or ă thiopental in regard of effectiveness in depression scores and increased ă seizure duration. Further studies are warranted to compare ketamine and ă methohexital.
Published: 2016

10. Age-related hearing loss in individuals and their caregivers: Effects of coping on the quality of life among the dyads

Author: Valérie Aghababian, Sébastien Lazzarotto, Anderson Loundou, Zeinab Hamidou, Tanguy Leroy, Pascal Auquier, Karine Baumstarck, Greps, Laboratoire, Aix Marseille Université (AMU), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Santé Publique et maladies Chroniques : Qualité de vie Concepts, Usages et Limites, Déterminants (SPMC), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM), Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), Groupe de Recherche en Psychologie Sociale (GRePS), Université Lumière - Lyon 2 (UL2), Aix Marseille Université ( AMU ), Assistance Publique - Hôpitaux de Marseille ( APHM ) -CHU Marseille, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Santé Publique et maladies Chroniques : Qualité de vie Concepts, Usages et Limites, Déterminants ( SPMC ), Aix Marseille Université ( AMU ) -Assistance Publique - Hôpitaux de Marseille ( APHM ), Centre de résonance magnétique biologique et médicale ( CRMBM ), and Aix Marseille Université ( AMU ) -Assistance Publique - Hôpitaux de Marseille ( APHM ) -Centre National de la Recherche Scientifique ( CNRS )
Subjects: Gerontology, Coping (psychology), caregivers, Hearing loss, [ SDV.MHEP.PSM ] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, media_common.quotation_subject, Medicine (miscellaneous), [SHS.PSY]Humanities and Social Sciences/Psychology, Social psychology, [SHS.PSY] Humanities and Social Sciences/Psychology, [ SHS.PSY ] Humanities and Social Sciences/Psychology, 03 medical and health sciences, 0302 clinical medicine, Optimism, Quality of life, [ SHS.ECO ] Humanities and Social Sciences/Economies and finances, Medicine, 030223 otorhinolaryngology, Pharmacology, Toxicology and Pharmaceutics (miscellaneous), age-related hearing impairment, ComputingMilieux_MISCELLANEOUS, media_common, Original Research, lcsh:R5-920, business.industry, Family caregivers, Health Policy, Avoidance coping, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, [SHS.ECO]Humanities and Social Sciences/Economics and Finance, 3. Good health, coping, Mood, Patient Preference and Adherence, Health, 030220 oncology & carcinogenesis, dyads, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Quality of Life, Anxiety, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, emotional status, medicine.symptom, lcsh:Medicine (General), business, Social Sciences (miscellaneous)
Abstract: Sébastien Lazzarotto,1,2 Karine Baumstarck,1 Anderson Loundou,1 Zeinab Hamidou,1,3 Valérie Aghababian,1 Tanguy Leroy,1,4 Pascal Auquier1 1EA 3279, Self-Perceived Health Assessment Research Unit, School of Medicine, Aix Marseille Université, 2French Regional Institute for Prevention of Aging, Marseille, 3National Clinical Research Quality of Life in Oncology Platform, Marseille, 4Social Psychology Research Group (GRePS EA 4163), Université Lumière Lyon 2, Bron, France Objectives: Age-related hearing loss (ARHL) impacts the daily living and quality of life (QoL) of affected individuals and the functioning of family caregivers. In the specific context of voluntary medical checkups, we examined sample dyads (ARHL individual and the caregiver) to determine whether QoL of patients and caregivers is influenced by coping strategies implemented either by themselves or their relatives.Methods: This was a cross-sectional study with a descriptive/correlative design performed in a French preventive health center (Regional Institute for Prevention of Aging, Marseille, France) for the beneficiaries of pension funds of private sector employees. The samples included beneficiary–caregiver dyads. The beneficiaries had bilateral (mild to moderately severe) ARHL. Self-reported data were collected as follows: QoL using the World Health Organization Quality of Life questionnaire, coping strategies using the Brief Coping Orientation to Problems Experienced Scale, and anxiety and mood using visual analog scales.Results: The final sample comprised 44 beneficiaries and 44 caregivers. The caregiver was the partner of the beneficiary in 73% of cases. The QoL scores of the social dimension were significantly lower for beneficiaries and caregivers compared with French age- and sex-matched controls. Among beneficiaries and caregivers, coping strategies based on problem solving were the most commonly used strategies. The use of positive thinking strategies was associated with higher QoL scores. The more one member of the dyad used an avoidance coping strategy, the more the other member used a positive thinking strategy.Conclusion: This study emphasizes that QoL of individuals with age-related hearing impairment and their natural caregivers is related to the coping strategies that they use. This finding suggests that targeted interventions should be offered to help individuals who experience emotional difficulties to implement more efficient coping strategies. Keywords: age-related hearing impairment, caregivers, dyads, quality of life, coping, emotional status&nbsp
Published: 2016

11. Intra- and interobserver agreement among obstetric experts in court regarding the review of abnormal fetal heart rate tracings and obstetrical management

Author: Anderson Loundou, Xavier Carcopino, Florence Bretelle, Renaud Le Dû, Laura Sabiani, Claude D'Ercole, Léon Boubli, Santé Publique et maladies Chroniques : Qualité de vie Concepts, Usages et Limites, Déterminants (SPMC), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Service d'Obstétrique-Gynécologie [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS), Gynépole, Aix Marseille Université (AMU)- Hôpital Nord [CHU - APHM], Aix-Marseille Université - Faculté de médecine (AMU MED), Aix Marseille Université (AMU), Service de gynécologie-obstétrique [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Institut méditerranéen de biodiversité et d'écologie marine et continentale (IMBE), Avignon Université (AU)-Aix Marseille Université (AMU)-Institut de recherche pour le développement [IRD] : UMR237-Centre National de la Recherche Scientifique (CNRS), and INSB-INSB-Centre National de la Recherche Scientifique (CNRS)
Subjects: Adult, Clinical audit, Pediatrics, medicine.medical_specialty, Abnormal fetal heart rate, Cerebral palsy, Patient Admission, Pregnancy, Intensive Care Units, Neonatal, medicine, Humans, Partogram, Fetal Monitoring, Retrospective Studies, Observer Variation, Clinical Audit, business.industry, Obstetrics, Malpractice, Infant, Newborn, Obstetrics and Gynecology, Retrospective cohort study, Heart Rate, Fetal, Hydrogen-Ion Concentration, Middle Aged, Delivery, Obstetric, Fetal Blood, medicine.disease, Respiration, Artificial, Fetal heart rate, Apgar Score, Female, Apgar score, France, [SDE.BE]Environmental Sciences/Biodiversity and Ecology, business
Abstract: International audience; OBJECTIVE: The objective of the study was to evaluate the intra-and interobserver agreement among obstetric experts in court regarding the retrospective review of abnormal fetal heart rate tracings and obstetrical management of patients with abnormal fetal heart rate during labor. STUDY DESIGN: A total of 22 French obstetric experts in court reviewed 30 cases of term deliveries of singleton pregnancies diagnosed with at least 1 hour of abnormal fetal heart rate, including 10 cases with adverse neonatal outcome. The experts reviewed all cases twice within a 3-month interval, with the first review being blinded to neonatal outcome. For each case reviewed, the experts were provided with the obstetric data and copies of the complete fetal heart rate recording and the partogram. The experts were asked to classify the abnormal fetal heart rate tracing and to express whether they agreed with the obstetrical management performed. When they disagreed, the experts were asked whether they concluded that an error had been made and whether they considered the obstetrical management as the cause of cerebral palsy in children if any. RESULTS: Compared with blinded review, the experts were significantly more likely to agree with the obstetric management performed (P \textless .001) and with the mode of delivery (P \textless .001) when informed about the neonatal outcome and were less likely to conclude that an error had been made (P \textless .001) or to establish a link with potential cerebral palsy (P = .003). The experts' intraobserver agreement for the review of abnormal fetal heart rate tracing and obstetrical management were both mediocre (kappa = 0.46-0.51 and kappa = 0.48-0.53, respectively). The interobserver agreement for the review of abnormal fetal heart rate tracing was low and was not improved by knowledge of the neonatal outcome (kappa = 0.11-0.18). The interobserver agreement for the interpretation of obstetrical management was also low (kappa = 0.08-0.19) but appeared to be improved by knowledge of the neonatal outcome (kappa = 0.15-0.32). CONCLUSION: The intra-and interobserver agreement among obstetric experts in court for the review of abnormal fetal heart rate tracing and the appropriateness of obstetrical care is poor, suggesting a lack of objectivity of obstetrical expertise as currently performed in court.
Published: 2015

12. Online training on skin cancer diagnosis in rheumatologists: results from a nationwide randomized web-based survey

Author: Viguier, Manuelle, Rist, Stéphanie, Aubin, François, Leccia, Marie-Thérèse, Richard, Marie-Aleth, Esposito-Farèse, Marina, Gaudin, Philippe, Pham, Thao, Richette, Pascal, Wendling, Daniel, Sibilia, Jean, Tubach, Florence, Dufrene, Charles, Darras, Yannick, Sauvage, Eric, Carret, Sophie, Amoura, Zahir, Benveniste, Olivier, Boyer, Olivier, Durez, Patrick, Fautrel, Bruno, Guerne, Pierre-André, Hachulla, Eric, Jullien, Denis, Mouthon, Luc, Puechal, Xavier, Sellam, Jérémie, Hôpital Saint-Louis, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Service de Rhumatologie, Centre Hospitalier Régional d'Orléans (CHRO), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Clinique de Dermatologie Allergologie et Photobiologie, Centre Hospitalier Universitaire [Grenoble] (CHU), Centre de Recherches en Oncologie biologique et Oncopharmacologie (CRO2), Aix Marseille Université (AMU)- Hôpital de la Timone [CHU - APHM] (TIMONE)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Dermatologie, Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Clinique Universitaire de Rhumatologie, hôpital Sud, CHU de Grenoble, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Université Paris Diderot - Paris 7 (UPD7)-Hôpital Lariboisière-APHP, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Immuno-Rhumatologie Moléculaire, Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Club Rhumatismes et Inflammation, HAL AMU, Administrateur, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181) (CEF2P / CARCINO), Assistance publique - Hôpitaux de Paris (AP-HP)-Université Paris Diderot - Paris 7 ( UPD7 ), Centre Hospitalier Régional d'Orléans ( CHR ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Centre Hospitalier Universitaire [Grenoble] ( CHU ), Centre de Recherches en Oncologie biologique et Oncopharmacologie ( CRO2 ), Aix Marseille Université ( AMU ) - Hôpital de la Timone [CHU - APHM] ( TIMONE ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Assistance Publique - Hôpitaux de Marseille ( APHM ) - Hôpital de la Timone [CHU - APHM] ( TIMONE ), Centre de Pharmaco-épidémiologie (Céphépi), Université Paris Diderot - Paris 7 ( UPD7 ) -AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance Publique - Hôpitaux de Marseille ( APHM ) -CHU Marseille, Université Paris Diderot - Paris 7 ( UPD7 ) -Hôpital Lariboisière-APHP, Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ), Immunorhumathologie moléculaire, Institut National de la Santé et de la Recherche Médicale ( INSERM ), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Subjects: Adult, Male, medicine.medical_specialty, Randomization, Skin Neoplasms, Population, lcsh:Medicine, [SDV.CAN]Life Sciences [q-bio]/Cancer, THERAPY, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, [SDV.CAN] Life Sciences [q-bio]/Cancer, Rheumatology, Internal medicine, Physicians, Surveys and Questionnaires, medicine, NECROSIS-FACTOR INHIBITORS, Humans, Medical diagnosis, education, lcsh:Science, METAANALYSIS, RISK, education.field_of_study, Internet, Multidisciplinary, integumentary system, business.industry, Incidence (epidemiology), lcsh:R, Middle Aged, medicine.disease, Confidence interval, 3. Good health, Surgery, RHEUMATOID-ARTHRITIS, Rheumatoid arthritis, lcsh:Q, Education, Medical, Continuing, Female, Skin cancer, business, Research Article
Abstract: International audience; Patients with inflammatory rheumatisms, such as rheumatoid arthritis, are more prone to develop skin cancers than the general population, with an additional increased incidence when receiving TNF blockers. There is therefore a need that physicians treating patients affected with inflammatory rheumatisms with TNF blockers recognize malignant skin lesions, requiring an urgent referral to the dermatologist and a potential withdrawal or modification of the immunomodulatory treatment. We aimed to demonstrate that an online training dedicated to skin tumors increase the abilities of rheumatologists to discriminate skin cancers from benign skin tumors. A nationwide randomized web-based survey involving 141 French rheumatologists was conducted. The baseline evaluation included short cases with skin lesion pictures and multiple choice questions assessing basic knowledge on skin cancers. For each case, rheumatologists had to indicate the nature of skin lesion (benign; premalignant/ malignant), their level of confidence in this diagnosis (10-points Likert scale), and the precise dermatological diagnosis among 5 propositions. Different scores were established. After randomization, only one group had access to the online formation consisting in 4 elearning modules on skin tumors, of 15 minutes each (online training group). After reevaluation, the trained and the non-trained group (control group) were compared. The primary end-point was the number of adequate diagnoses of the nature of the skin lesions. The mean number of adequate diagnosis for the benign versus premalignant/malignant nature of the lesions was higher in the online training group (13.4 vs. 11.2 points; p value
Published: 2015

13. Cyclophosphamide added to glucocorticoids in acute exacerbation of idiopathic pulmonary fibrosis (EXAFIP): a randomised, double-blind, placebo-controlled, phase 3 trial

Author: Abdellatif Tazi, Aurélie Le Borgne-Krams, Marine Cachanado, Tabassome Simon, Sylvain Marchand-Adam, Morgane Didier, Lidwine Wemeau-Stervinou, Sandrine Hirschi, Frédéric Rivière, Arnaud Bourdin, François Lebargy, Stéphane Dominique, Aude Gibelin, Alexandre Chabrol, Tristan Dégot, Jacques Cadranel, Martine Reynaud-Gaubert, Marie-Pierre Debray, Sylvie Leroy, Frédéric Gagnadoux, Emmanuel Bergot, François-Xavier Blanc, Alexandra Rousseau, Raphael Borie, Pierre Yves Brillet, Guillaume Beltramo, Mallorie Kerjouan, Hilario Nunes, Olivia Freynet, Julie Traclet, Bruno Crestani, Anne-Sophie Gamez, Grégoire Prévot, Jean Pastré, Dominique Israel-Biet, Marie-Christine Dombret, Laurent Plantier, Cécile Chenivesse, Laurence Berard, Ana Nieves, Emmanuel Gomez, Dominique Valeyre, Stéphane Jouneau, Anne Gondouin, Elodie Blanchard, C. Launois, Nathalie Bautin, Jean-Marc Naccache, Vincent Cottin, Antoine Parrot, Philippe Bonniaud, Centre de référence maladies rares des maladies pulmonaires rares de l’adulte (CHU Dijon) (CRMR des maladies pulmonaires rares de l’adulte), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Sorbonne Université (SU), Centre hospitalier Saint-Joseph [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Foch [Suresnes], CHU Pontchaillou [Rennes], École des Hautes Études en Santé Publique [EHESP] (EHESP), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Hôpital Avicenne [AP-HP], Laboratoire d'Excellence INFLAMEX [Paris], Université Sorbonne Paris Cité (USPC), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), AP-HP - Hôpital Bichat - Claude Bernard [Paris], CHU Saint-Antoine [AP-HP], Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, CHU Dijon, Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Les Hôpitaux Universitaires de Strasbourg (HUS), Nouvel Hôpital Civil de Strasbourg, Centre Hospitalier Universitaire de Reims (CHU Reims), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Lille, Hôpital Albert Calmette, Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre de Référence des Maladies Pulmonaires Rares [Hôpital Louis Pradel - HCL], Hôpital Louis Pradel [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Hospices Civils de Lyon (HCL), Université de Lyon, CIC CHU Lyon (inserm), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Université Côte d'Azur (UCA), Centre Hospitalier Universitaire de Nice (CHU Nice), Université d'Angers (UA), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Hôpital d'instruction des Armées Percy, Service de Santé des Armées, Hôpital Côte de Nacre [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Hôpital JeanMinjoz, CHU Bordeaux [Bordeaux], Hôpital Haut-Lévêque [CHU Bordeaux], unité de recherche de l'institut du thorax UMR1087 UMR6291 (ITX), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ), Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Rouen, Normandie Université (NU), CHU Tenon [AP-HP], Immunologie humaine, physiopathologie & immunothérapie (HIPI (UMR_S_976 / U976)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Institut de Recherche Saint-Louis - Hématologie Immunologie Oncologie (Département de recherche de l’UFR de médecine, ex- Institut Universitaire Hématologie-IUH) (IRSL), Université Paris Cité (UPCité), Physiopathologie et Epidémiologie des Maladies Respiratoires (PHERE (UMR_S_1152 / U1152)), CHU Montpellier, Université de Lille, Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP), Centre d’Infection et d’Immunité de Lille - INSERM U 1019 - UMR 9017 - UMR 8204 (CIIL), Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre National de la Recherche Scientifique (CNRS), Roche, Ministere de la Sante et des Solidarites, Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )-Institut National de la Santé et de la Recherche Médicale (INSERM)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université d'Angers (UA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), CHU Marseille-Assistance Publique-Hôpitaux de Marseille (AP-HM), Hôpital Larrey [Toulouse], CHU Toulouse [Toulouse], Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), Université de Paris (UP), Centre National de la Recherche Scientifique (CNRS)-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Université de Lille-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), and Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Pulmonary and Respiratory Medicine, medicine.medical_specialty, education.field_of_study, Exacerbation, Cyclophosphamide, business.industry, [SDV]Life Sciences [q-bio], Population, medicine.disease, Placebo, 3. Good health, 03 medical and health sciences, Idiopathic pulmonary fibrosis, 0302 clinical medicine, 030228 respiratory system, Methylprednisolone, Internal medicine, Clinical endpoint, Medicine, 030212 general & internal medicine, business, education, Adverse effect, ComputingMilieux_MISCELLANEOUS, medicine.drug
Abstract: Summary Background The use of cyclophosphamide in patients with acute exacerbation of idiopathic pulmonary fibrosis (IPF) is unknown. Our study was designed to evaluate the efficacy and safety of four cyclophosphamide pulses in addition to high-dose methylprednisolone in this population. Methods In this double-blind, placebo-controlled trial done in 35 departments across 31 hospitals in France, adult patients (≥18 years) with acute exacerbation of IPF and those with suspected acute exacerbation of IPF were randomly assigned in a 1:1 ratio using a web-based system to receive either intravenous pulses of cyclophosphamide (600 mg/m2) plus uromitexan as haemorrhagic cystitis prophylaxis (200 mg/m2) at the time of cyclophosphamide administration and then again, 4 h later, or placebo at days 0, 15, 30, and 60. Random assignment was stratified according to the severity of IPF and was block-balanced with variable block sizes of four or six patients. Patients receiving mechanical ventilation, with active infection, with active cancer, or who were registered on the lung transplant waiting list were excluded. All patients received standardised high-dose glucocorticoids. The investigators, patients, and the sponsor were masked to the treatment assignments. The primary endpoint was 3-month all-cause mortality, analysed by a χ2 test adhering to an intention-to-treat principle. The trial is now complete and registered with ClinicalTrials.gov , NCT02460588 . Findings Between Jan 22, 2016, and July 19, 2018, 183 patients were assessed for eligibility, of whom 120 patients were randomly assigned and 119 patients (62 [52%] with severe IPF) received at least one dose of cyclophosphamide (n=60) or placebo (n=59), all of whom were included in the intention-to-treat analysis. The 3-month all-cause mortality was 45% (27/60) in patients given cyclophosphamide compared with 31% (18/59) in the placebo group (difference 14·5% [95% CI −3·1 to 31·6]; p=0·10). Similar results were found after adjustment by IPF severity (odds ratio [OR] 1·89 [95% CI 0·89–4·04]). The risk of death at 3 months, independent of the treatment received, was higher with severe than non-severe IPF (OR 2·62 [1·12–6·12]) and was lower with the use of antifibrotic therapy (OR 0·33 [0·13–0·82]). Adverse events were similar between groups by 6 months (25 [42%] in the cyclophosphamide group vs 30 [51%] in the placebo group) and their proportion, including infections, did not differ. Overall infection was the main adverse event and occurred in 20 (33%) of 60 patients in the cyclophosphamide group versus 21 (36%) of 59 patients in the placebo group. Interpretation In patients with acute exacerbation of IPF, adding intravenous cyclophosphamide pulses to glucocorticoids increased 3-month mortality. These findings provide evidence against the use of intravenous cyclophosphamide in such patients. Funding Programme Hospitalier de Recherche Clinique of the French Ministry of Health (PHRC 2014–502), Roche Pharmaceuticals.
Published: 2022

14. [The French mesothelioma network from 1998 to 2013]

Author: Galateau-Sallé, Françoise, Gilg Soit Ilg, Anabelle, Le Stang, Nolwenn, Brochard, Patrick, Pairon, Jean-Claude, Astoul, Philippe, Frenay, Catherine, Blaizot, Gaëtane, Chamming'S, Soizick, Ducamp, Stéphane, Rousvoal, Thomas, De Quillacq, Anne, Abonnet, Véronique, Abdalsamad, Issam, Begueret, Hugues, Brambilla, Elisabeth, Capron, Frédérique, Copin, Marie-Christine, Danel, C., De Lajartre, Anne-Yvonne, Foulet-Rogé, Armelle, Garbe, Louise, Groussard, Odile, Giusiano, S., Hofman, Véronique, Lantuejoul, Sylvie, Piquenot, Jean-Michel, Rouquette, Isabelle, Sagan, Christine, Thivolet-Bejui, Françoise, Vignaud, Jean-Michel, Scherpereel, A., Jaurand, Marie-Claude, Jean, D., Hainaut, Pierre, Chérié-Challine, Laurence, Goldberg, Marcel, Luce, Danièle, Imbernon, Ellen, Centre national référent cancers rares - mésothéliomes malins pleuraux et tumeurs péritonéales rares ( MESOPATH ), CHU Caen-Hôpital côte de nacre, Registre MESONATCHU, Département santé travail ( DST-InVS ), Institut de Veille Sanitaire, Institut de Santé Publique, d'Epidémiologie et de Développement ( ISPED ), Université Bordeaux Segalen - Bordeaux 2, Institut Mondor de Recherche Biomédicale ( IMRB ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ), Institut Interuniversitaire de Médecine du Travail de Paris Ile de France ( IIMTPIF ), CHI Créteil-Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ), Oncologie thoracique, maladies de la plèvre et pneumologie interventionnelle, Assistance Publique - Hôpitaux de Marseille ( APHM ) -CHU Marseille- Hôpital Nord [CHU - APHM], Biomolécules et inflammation pulmonaire, Institut Pasteur de Lille, Réseau International des Instituts Pasteur ( RIIP ) -Réseau International des Instituts Pasteur ( RIIP ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Lille, Droit et Santé, Service de pneumologie et oncologie thoracique, Hôpital Calmette-Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), Genomique Fonctionnelle des Tumeurs Solides, Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris Descartes - Paris 5 ( UPD5 ) -IFR105-Université Paris Diderot - Paris 7 ( UPD7 ), International Prevention Research Institute ( IPRI ), Registre Multicentrique à Vocation Nationale des Mésothéliomes Pleuraux (MESONAT), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Département santé travail (DST-InVS), Institut de Veille Sanitaire (INVS), Institut de Santé Publique, d'Epidémiologie et de Développement (ISPED), Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Institut Interuniversitaire de Médecine du Travail de Paris Ile-de-France (IIMTPIF), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé, Hôpital Calmette-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Génomique Fonctionnelle des Tumeurs Solides (U1162), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), International Prevention Research Institute (IPRI), and Guellaen, Georges
Subjects: Pathology, Clinical, Time Factors, clinicobiological database, Pleural Neoplasms, register of cancers, medicolegal impact, therapeutic impact, expert pathological second opinion, mesothelioma, diagnostic impact, [SDV.BBM] Life Sciences [q-bio]/Biochemistry, Molecular Biology, Humans, [SDV.BBM]Life Sciences [q-bio]/Biochemistry, Molecular Biology, France, Referral and Consultation, [ SDV.BBM ] Life Sciences [q-bio]/Biochemistry, Molecular Biology, Societies, Medical
Abstract: International audience; Mesothelioma is a rare disease less than 0.3% of cancers in France, very aggressive and resistant to the majority of conventional therapies. Asbestos exposure is nearly the only recognized cause of mesothelioma in men observed in 80% of case. In 1990, the projections based on mortality predicted a raise of incidence in mesothelioma for the next three decades. Nowadays, the diagnosis of this cancer is based on pathology, but the histological presentation frequently heterogeneous, is responsible for numerous pitfalls and major problems of early detection toward effective therapy. Facing such a diagnostic, epidemiological and medico-legal context, a national and international multidisciplinary network has been progressively set up in order to answer to epidemiological survey, translational or academic research questions. Moreover, in response to the action of the French Cancer Program (action 23.1) a network of pathologists was organized for expert pathological second opinion using a standardized procedure of certification for mesothelioma diagnosis. We describe the network organization and show the results during this last 15years period of time from 1998-2013. These results show the major impact on patient's management, and confirm the interest of this second opinion to provide accuracy of epidemiological data, quality of medico-legal acknowledgement and accuracy of clinical diagnostic for the benefit of patients. We also show the impact of these collaborative efforts for creating a high quality clinicobiological, epidemiological and therapeutic data collection for improvement of the knowledge of this dramatic disease.
Published: 2014

15. Fetal skeletal computed tomography: When? How? Why?

Author: Nicole Philip, K. Chaumoitre, B. Bourlière-Najean, Sabine Sigaudy, P. Petit, Guillaume Gorincour, A. Potier, Florence Bretelle, Michel Panuel, Claude D'Ercole, Service d'imagerie médicale, CHU Marseille, Anthropologie bio-culturelle, Droit, Ethique et Santé (ADES), Aix Marseille Université (AMU)-EFS ALPES MEDITERRANEE-Centre National de la Recherche Scientifique (CNRS), Service de Radiologie Pédiatrique, Université de la Méditerranée - Aix-Marseille 2, Service de gynécologie-obstétrique [Conception], Université de la Méditerranée - Aix-Marseille 2-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Service de gynécologie-obstétrique [Nord], Université de la Méditerranée - Aix-Marseille 2-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital nord, Département de génétique médicale [Hôpital de la Timone - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Obstétrique-Gynécologie [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], Université de la Méditerranée - Aix-Marseille 2-Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Assistance Publique - Hôpitaux de Marseille (APHM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Timone [CHU - APHM] (TIMONE)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille-Hôpital Nord [CHU - APHM]
Subjects: medicine.medical_specialty, Bone disease, Cephalometry, [SDV]Life Sciences [q-bio], [SHS.ANTHRO-BIO]Humanities and Social Sciences/Biological anthropology, Prenatal diagnosis, Constitutional bone diseases, Ultrasonography, Prenatal, Group B, Congenital Abnormalities, Diagnosis, Differential, Fetus, Imaging, Three-Dimensional, Pregnancy, Image Interpretation, Computer-Assisted, Humans, Medicine, Abnormalities, Multiple, Radiology, Nuclear Medicine and imaging, Femur, Bone Diseases, Developmental, 2D ultrasound, Radiological and Ultrasound Technology, business.industry, Ultrasound, Infant, Newborn, Dysostoses, Dysostosis, Retrospective cohort study, General Medicine, medicine.disease, 3. Good health, Female, Radiology, Tomography, X-Ray Computed, business, Short femur, Femoral Fractures, CT
Abstract: Purpose To study the additional role of fetal skeletal computed tomography in suspected prenatal bone abnormalities. Materials and methods Two centers included in a retrospective study all fetuses who benefited from skeletal computed tomography for a suspected constitutional bone disease or focal dysostosis. Results A total of 198 patients were included. CT was performed in 112 patients (56%) for an isolated short femur below the third percentile (group A), in 15 patients (8%) for bowed or fractured femur (group B), in 23 patients (12%) for biometric discrepancy between a short femur and increased head circumference (group C) and in 48 patients (24%) for suspected focal dysostosis (group D). CT was interpreted as normal in 126 cases (64%), i.e. 87% in group A, 0% in group B, 65% in group C and 25% in group D. When including only cases with postnatal or postmortem clinical and/or radiological confirmation was available, CT provided additional and/or more accurate information than ultrasound in 20% of cases in group A, 66% in group B, 30% in group C and 72% in group D. Sixty-seven percent of patients in whom CT was interpreted as normal were lost to follow-up. Conclusion In isolated short femur, fetal skeletal CT is normal in the great majority of cases although protocolized follow-up of these babies is absolutely compulsory, as a large proportion is lost to follow-up. Fetal skeletal CT can confirm or improve imaging for the suspected diagnosis in suspected focal dysostosis or constitutional bone disease.
Published: 2014

16. Evaluation of the Housing First program in patients with severe mental disorders in France: study protocol for a randomized controlled trial

Author: V. Girard, Thémis Apostolidis, Cécile Fortanier, Bruno Falissard, Aurélie Tinland, Christian Laval, Christophe Lançon, Tim Greacen, Pascal Auquier, Laurent Boyer, Benjamin Videau, Pauline Rhenter, Service de Psychiatrie, Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud )-CHU Marseille, Santé Publique et maladies Chroniques : Qualité de vie Concepts, Usages et Limites, Déterminants (SPMC), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM), Recherche Clinique et Innovation, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], Laboratoire de Recherche, Hôpital Maison Blanche-Etablissement Public de Santé Maison Blanche, Troubles du comportement alimentaire de l'adolescent (UMR_S 669), Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de Psychologie Sociale (LPS), Aix Marseille Université (AMU), This work is supported by institutional grants from the 2011 Programme Hospitalier de Recherche Clinique National, the French Ministry of Health (Direction Générale de la Santé), as well as grants from Janssen Pharmaceutical Companies and the Fondation de France., BMC, Ed., Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11), Hôpital Sainte-Marguerite [CHU - APHM] ( Hôpitaux Sud ) -CHU Marseille, Santé Publique et maladies Chroniques : Qualité de vie Concepts, Usages et Limites, Déterminants ( SPMC ), Aix Marseille Université ( AMU ) -Assistance Publique - Hôpitaux de Marseille ( APHM ), Assistance Publique - Hôpitaux de Marseille ( APHM ) -CHU Marseille- Hôpital Nord [CHU - APHM], Troubles du comportement alimentaire de l'adolescent ( UMR_S 669 ), Université Paris-Sud - Paris 11 ( UP11 ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Laboratoire de Psychologie Sociale ( LPS ), and Aix Marseille Université ( AMU )
Subjects: Research design, Program evaluation, Housing First, Time Factors, Cost-Benefit Analysis, Medicine (miscellaneous), Severity of Illness Index, law.invention, Study Protocol, Disability Evaluation, 0302 clinical medicine, Patient Admission, Randomized controlled trial, law, Pharmacology (medical), 030212 general & internal medicine, Prospective Studies, Evaluation, Mental Disorders, 1. No poverty, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, Homelessness, Health Care Costs, Community Mental Health Services, 3. Good health, Treatment Outcome, Research Design, Mental illness, Ill-Housed Persons, France, Independent Living, Housing first program, medicine.medical_specialty, Bipolar disorder, Context (language use), 03 medical and health sciences, Intervention (counseling), medicine, Humans, Disabled Persons, Psychiatry, Psychiatric Status Rating Scales, Emergency Services, Psychiatric, business.industry, medicine.disease, 030227 psychiatry, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Sample Size, Housing, Schizophrenia, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Independent living, Program Evaluation
Abstract: Background Recent studies in North American contexts have suggested that the Housing First model is a promising strategy for providing effective services to homeless people with mental illness. In the context of the highly generous French national health and social care system, which is easily accessible and does not require out-of-pocket payment, the French Health Ministry insists on rigorous techniques, including randomized protocols, to evaluate the impact of Housing First approaches in France. Method and design A prospective randomized trial was designed to assess the impact of a Housing First intervention on health outcomes and costs over a period of 24 months on homeless people with severe mental illness, compared to Treatment-As-Usual. The study is being conducted in four cities in France: Lille, Marseille, Paris and Toulouse. The inclusion criteria are as follows: over 18 years of age, absolutely homeless or in precarious housing, and possessing a ‘high’ level of need: diagnosis of schizophrenia or bipolar disorder and moderate to severe disability according to the Multnomah Community Ability Scale (score ≤ 62) and at least one of the following three criteria: 1) having been hospitalized for mental illness two or more times in any one year during the preceding five years; 2) co-morbid alcohol or substance use; and 3) having been recently arrested or incarcerated. Participants will be randomized to receiving the Housing First intervention or Treatment-As-Usual. The Housing First intervention provides immediate access to independent housing and community care. The primary outcome criterion is the use of high-cost health services (that is,, number of hospital admissions and number of emergency department visits) during the 24-month follow-up period. Secondary outcome measures include health outcomes, social functioning, housing stability and contact with police services. An evaluation of the cost-effectiveness and cost-utility of Housing First will also be conducted. A total of 300 individuals per group will be included. Discussion This is the first study to examine the impact of a Housing First intervention compared to Treatment-As-Usual in France. It should provide key information to policymakers concerning the cost-effectiveness and health outcomes of the Housing First model in the French context. Trial registration The current clinical trial number is NCT01570712
Published: 2013

17. Delivery for women with a previous cesarean: guidelines for clinical practice from the French College of Gynecologists and Obstetricians (CNGOF)

Author: Jean-Baptiste Haumonte, Loïc Sentilhes, Gael Beucher, Denis Gallot, Pierre Diemunsch, Claude D'Ercole, Philippe Deruelle, Olivier Parant, Gilles Kayem, Yann Sellier, Patrick Rozenberg, Thomas Schmitz, Sonia Heimann, Christophe Vayssière, Emmanuel Lopez, Catherine Deneux-Tharaux, Service de gynécologie-obstétrique [Angers], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Service Gynécologie [CHU Toulouse], Pôle Femme-Mère-Couple [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Gynécologie-Obstétrique et Médecine de la Reproduction [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Recherche Epidémiologique en Santé Périnatale et Santé des Femmes et des Enfants (UMR_S 953), Université Paris-Sud - Paris 11 (UP11)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Environnement périnatal et croissance - EA 4489 (EPS), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service de Gynécologie - Obstétrique [Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service d'Anesthesie - Réanimation, Les Hôpitaux Universitaires de Strasbourg (HUS)-Hôpital de Hautepierre [Strasbourg], Service de Gynécologie [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Retinoids, Development and Developmental Diseases (R2D2), Université d'Auvergne - Clermont-Ferrand I (UdA), Service d'Obstétrique-Gynécologie [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], Césarine, Association d'Usagers 'Césarine', Service de Gynécologie-Obstétrique [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Médecine Néonatale [Port-Royal], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu, Service de gynécologie-obstétrique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Robert Debré-Université Paris Diderot - Paris 7 (UPD7), Service d'endocrinologie, gynécologie et diabétologie pédiatriques [CHU Necker], CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de gynécologie et obstétrique [CHI Poissy-Saint Germain], CHI Poissy-Saint-Germain, Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Debs, Nayla, Service de gynécologie obstétrique, CHU Toulouse [Toulouse]-Hôpital Paule de Viguier, CHU Toulouse [Toulouse], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Descartes - Paris 5 (UPD5)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris-Sud - Paris 11 (UP11), Université Paris Diderot - Paris 7 (UPD7)-Hôpital Robert Debré-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Angers, Épidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps, Université Toulouse III - Paul Sabatier ( UPS ), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Service de Gynécologie - Obstétrique [Caen], CHU Caen, Recherche Epidémiologique en Santé Périnatale et Santé des Femmes et des Enfants ( UMR_S 953 ), Université Paris-Sud - Paris 11 ( UP11 ) -Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Environnement périnatal et croissance, Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ) -Université de Lille, Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), Service de Gynécologie-Obstétrique [Estaing], CHU Estaing, Retinoids, Development and Developmental Diseases ( R2D2 ), Université d'Auvergne - Clermont-Ferrand I ( UdA ), Assistance Publique - Hôpitaux de Marseille ( APHM ) -CHU Marseille- Hôpital Nord [CHU - APHM], Assistance publique - Hôpitaux de Paris (AP-HP)-Hopital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Cochin [AP-HP]-Hôtel-Dieu, Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Robert Debré-Université Paris Diderot - Paris 7 ( UPD7 ), and Service de Gynécologie-Obstétrique [Poissy]
Subjects: medicine.medical_specialty, Bishop score, 03 medical and health sciences, Cicatrix, 0302 clinical medicine, Obstetrics and gynaecology, Pregnancy, Uterine malformation, medicine, Humans, 030212 general & internal medicine, Cesarean Section, Repeat, Labor, Induced, maternal and neonatal m orbidity, Misoprostol, trial of labor after cesarean, maternal and neonatal mortality, uterine rupture, Gynecology, 030219 obstetrics & reproductive medicine, cesarean section, business.industry, Vaginal delivery, Obstetrics, Contraindications, Obstetrics and Gynecology, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, medicine.disease, Trial of Labor, 3. Good health, Uterine rupture, Reproductive Medicine, Pelvimetry, vaginal birth after cesarean, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, medicine.drug
Abstract: International audience; The primary cause of uterine scars is a previous cesarean. In women with a previous cesarean, the risks of maternal complications are rare and similar after a trial of labor after cesarean (TOLAC) and after an elective repeat cesarean delivery (ERCD), but the risk of uterine rupture is higher with TOLAC (level of evidence [LE]2). Maternal morbidity in women with previous cesareans is higher when TOLAC fails than when it leads to successful vaginal delivery (LE2). Although maternal morbidity increases progressively with the number of ERCD, maternal morbidity of TOLAC decreases with the number of successful previous TOLAC (LE2). The risk-benefit ratio considering the risks of short- and long-term maternal complications is favorable to TOLAC in most cases (LE3). Globally, neonatal complications are rare regardless of the mode of delivery for women with previous cesareans. The risks of fetal, perinatal, and neonatal mortality during TOLAC are low. Nonetheless, these risks are significantly higher than those associated with ERCD (LE2). The risks of mask ventilation, intubation for meconium-stained amniotic fluid, and neonatal sepsis all increase in TOLAC (LE2). The risk of transient respiratory distress increases in ERCD (LE2). To reduce this risk, and except in particular situations, ERCD must not be performed before 39 weeks (grade B). TOLAC is possible for women with a previous cesarean before 37 weeks, with 2 previous cesareans, with a uterine malformation, a low vertical incision or an unknown incision, with a myomectomy, postpartum fever, an interval of less than 6 months between the last cesarean delivery and the conception of the following pregnancy, if the obstetric conditions are favorable (professional consensus). ERCD is recommended in women with a scar in the uterine body (grade B) and a history of 3 or more cesareans (professional consensus). Ultrasound assessment of the risk of uterine rupture in women with uterine scars has not been shown to have any clinical utility and is therefore not recommended during pregnancy to help decide the mode of delivery (professional consensus). Use of X-ray pelvimetry to decide about TOLAC is associated with an increase in the repeat cesarean rate without any reduction in the rate of uterine rupture (LE2). It is unnecessary for deciding mode of delivery and for managing labor during TOLAC (grade C). TOLAC should be encouraged for women with a previous vaginal delivery either before or after the cesarean, a favorable Bishop score or spontaneous labor, and for preterm births (grade C). For women with a fetus with an estimated weight of more than 4500 g, especially in the absence of a previous vaginal delivery and those with supermorbid obesity (BMI>50), ERCD must be planned from the outset (grade C). For all of the other clinical situations envisioned (maternal age>35 years, diabetes, morbid obesity, prolonged pregnancy, breech presentation and twin pregnancy), TOLAC is possible but the available data do not allow specific guidelines about the choice of mode of delivery, in view of the low levels of proof (grade C). The decision about planned mode of delivery must be shared by the patient and her physician and made by the 8th month, taking into account the individual risk factors for TOLAC failure and uterine rupture (professional consensus). TOLAC is the preferred choice for women who do not have several risk factors (professional consensus). The availability onsite of an obstetrician and anesthetist must be pointed out to the patient. If the woman continues to prefer a repeat cesarean after adequate information and time to think about it, her preference should be honored (professional consensus). Labor should be induced in woman with a previous cesarean only for medical indications (professional consensus). Induction of labor increases the risk of uterine rupture, which can be estimated at 1% if oxytocin is used and 2% with vaginal prostaglandins (LE2). Mechanical methods of induction have not been studied sufficiently. Misoprostol appears to increase the risk of uterine rupture strongly (LE4). Based on the information now available, its use is not recommended (professional consensus). Routine use of internal tocodynamometry does not prevent uterine rupture (professional consensus). The increased risk of uterine rupture associated with oxytocin use is dose-dependent (LE3). In the active phase, it is recommended that the total duration of failure to progress should not exceed 3h; at that point, a cesarean should be performed (professional consensus). Epidural analgesia must be encouraged. The simple existence of a uterine scar is not an indication for a routine manual uterine examination after VBAC (grade C).
Published: 2013

18. Validation of Artificial Intelligence to Support the Automatic Coding of Patient Adverse Drug Reaction Reports, Using Nationwide Pharmacovigilance Data

Author: Guillaume L, Martin, Julien, Jouganous, Romain, Savidan, Axel, Bellec, Clément, Goehrs, Mehdi, Benkebil, Ghada, Miremont, Joëlle, Micallef, Francesco, Salvo, Antoine, Pariente, Louis, Létinier, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Agence nationale de sécurité du médicament et des produits de santé [Saint-Denis] (ANSM), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Assistance Publique - Hôpitaux de Marseille (APHM), Agence Nationale de Sécurité du Médicament et des Produits de Santé, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut de Neurosciences des Systèmes (INS), and Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Pharmacology, Pharmacovigilance, COVID-19 Vaccines, Drug-Related Side Effects and Adverse Reactions, Artificial Intelligence, Adverse Drug Reaction Reporting Systems, COVID-19, Humans, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Pharmacology (medical), Toxicology
Abstract: International audience; INTRODUCTION: Adverse drug reaction reports are usually manually assessed by pharmacovigilance experts to detect safety signals associated with drugs. With the recent extension of reporting to patients and the emergence of mass media-related sanitary crises, adverse drug reaction reports currently frequently overwhelm pharmacovigilance networks. Artificial intelligence could help support the work of pharmacovigilance experts during such crises, by automatically coding reports, allowing them to prioritise or accelerate their manual assessment. After a previous study showing first results, we developed and compared state-of-the-art machine learning models using a larger nationwide dataset, aiming to automatically pre-code patients' adverse drug reaction reports. OBJECTIVES: We aimed to determine the best artificial intelligence model identifying adverse drug reactions and assessing seriousness in patients reports from the French national pharmacovigilance web portal. METHODS: Reports coded by 27 Pharmacovigilance Centres between March 2017 and December 2020 were selected (n = 11,633). For each report, the Portable Document Format form containing free-text information filled by the patient, and the corresponding encodings of adverse event symptoms (in Medical Dictionary for Regulatory Activities Preferred Terms) and seriousness were obtained. This encoding by experts was used as the reference to train and evaluate models, which contained input data processing and machine-learning natural language processing to learn and predict encodings. We developed and compared different approaches for data processing and classifiers. Performance was evaluated using receiver operating characteristic area under the curve (AUC), F-measure, sensitivity, specificity and positive predictive value. We used data from 26 Pharmacovigilance Centres for training and internal validation. External validation was performed using data from the remaining Pharmacovigilance Centres during the same period. RESULTS: Internal validation: for adverse drug reaction identification, Term Frequency-Inverse Document Frequency (TF-IDF) + Light Gradient Boosted Machine (LGBM) achieved an AUC of 0.97 and an F-measure of 0.80. The Cross-lingual Language Model (XLM) [transformer] obtained an AUC of 0.97 and an F-measure of 0.78. For seriousness assessment, FastText + LGBM achieved an AUC of 0.85 and an F-measure of 0.63. CamemBERT (transformer) + Light Gradient Boosted Machine obtained an AUC of 0.84 and an F-measure of 0.63. External validation for both adverse drug reaction identification and seriousness assessment tasks yielded consistent and robust results. CONCLUSIONS: Our artificial intelligence models showed promising performance to automatically code patient adverse drug reaction reports, with very similar results across approaches. Our system has been deployed by national health authorities in France since January 2021 to facilitate pharmacovigilance of COVID-19 vaccines. Further studies will be needed to validate the performance of the tool in real-life settings.
Published: 2022

19. Quantitative Brain Sodium MRI Depicts Corticospinal Impairment in Amyotrophic Lateral Sclerosis

Author: Lothar R. Schad, Shahram Attarian, Wafaa Zaaraoui, Aude-Marie Grapperon, Maxime Guye, Jean-Philippe Ranjeva, Ben Ridley, Sylviane Confort-Gouny, Etienne Fortanier, Annie Verschueren, Adil Maarouf, Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), Aix Marseille Université (AMU), Centre National de la Recherche Scientifique (CNRS), Centre de référence des maladies rares neuromusculaires, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, AP-HM, Pôle d'imagerie médicale, Hôpital de la Timone, CEMEREM, Marseille, France, University of Heidelberg, Medical Faculty, Centre de référence des maladies neuromusculaires et de la SLA, Hôpital de la Timone [CHU - APHM] (TIMONE), Centre d'Exploration Métabolique par Résonance Magnétique [Hôpital de la Timone - APHM] (CEMEREM), Hôpital de la Timone [CHU - APHM] (TIMONE)-Centre de résonance magnétique biologique et médicale (CRMBM), and Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Adult, Male, medicine.medical_specialty, [SDV.IB.IMA]Life Sciences [q-bio]/Bioengineering/Imaging, medicine.medical_treatment, Sodium, Pyramidal Tracts, chemistry.chemical_element, Corpus callosum, computer.software_genre, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, 0302 clinical medicine, Atrophy, Voxel, Internal medicine, medicine, Humans, Radiology, Nuclear Medicine and imaging, Prospective Studies, Amyotrophic lateral sclerosis, Prospective cohort study, ComputingMilieux_MISCELLANEOUS, Aged, business.industry, Amyotrophic Lateral Sclerosis, Brain, Middle Aged, medicine.disease, Magnetic Resonance Imaging, Transcranial magnetic stimulation, chemistry, Evaluation Studies as Topic, 030220 oncology & carcinogenesis, Sodium MRI, Cardiology, Female, Sodium Isotopes, business, computer
Abstract: Background Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that mainly affects the upper and lower motor neurons. Recent sodium (23Na) MRI studies have shown that abnormal sodium concentration is related to neuronal suffering in neurodegenerative conditions. Purpose To use 23Na MRI to investigate abnormal sodium concentrations and map their distribution in the brains of study participants with ALS as compared with healthy control subjects. Materials and Methods Twenty-seven participants with ALS (mean age, 54 years ± 10 [standard deviation], eight women) and 30 healthy control subjects (mean age, 50 years ± 10; 16 women) were prospectively recruited between September 2015 and October 2017 and were examined by using conventional proton MRI and sodium MRI at 3 T. Voxel-based statistical mapping was used to compare quantitative whole-brain total sodium concentration (TSC) maps in participants with ALS with those in control subjects and to localize regions of abnormal elevated TSC. Potential overlap of abnormal elevated TSC with regions of atrophy as detected with 1H MRI also was investigated. Results Voxel-based statistical mapping analyses revealed higher sodium concentration in motor regions (bilateral precentral gyri, corticospinal tracts, and the corpus callosum) of participants with ALS (two-sample t test, P < .005; age and sex as covariates). In these regions, mean TSC was higher in participants with ALS (mean, 45.6 mmol/L wet tissue ± 3.2) than in control subjects (mean, 41.8 mmol/L wet tissue ± 2.7; P < .001; Cohen d = 1.28). Brain regions showing higher TSC represented a volume of 15.4 cm3 that did not overlap with gray matter atrophy occupying a volume of 16.9 cm3. Elevated TSC correlated moderately with corticospinal conduction failure assessed with transcranial magnetic stimulation in the right upper limb (Spearman ρ = -0.57; 95% confidence interval: -0.78, -0.16; P = .005; n = 23). Conclusion Quantitative 23Na MRI is sensitive to alterations of brain sodium homeostasis within disease-relevant regions in patients with amyotrophic lateral sclerosis (ALS). This supports further investigation of abnormal sodium concentration as a potential marker of neurodegenerative processes in patients with ALS that could be used as a secondary endpoint in clinical trials. © RSNA, 2019 Online supplemental material is available for this article.
Published: 2019

20. Spontaneous Reports of Serious Adverse Drug Reactions Resulting From Drug–Drug Interactions: An Analysis From the French Pharmacovigilance Database

Author: Louis, Létinier, Amandine, Ferreira, Alexandre, Marceron, Marina, Babin, Joëlle, Micallef, Ghada, Miremont-Salamé, Antoine, Pariente, Otten, Lisa, Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Institut de Neurosciences des Systèmes (INS), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU)
Subjects: Pharmacology, hemorrhages, immune system diseases, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, pharmacovigilance, adverse drug reaction, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, virus diseases, spontaneous reporting, drug–drug interaction, antithrombotic agents, drug-drug interaction, Original Research
Abstract: International audience; Few data are available on the clinical impact of drug–drug interactions (DDIs). Most of the studies are limited to the analysis of exposure to potential DDI or the targeted impact of the combination of a few drugs or therapeutic classes. The analysis of adverse drug reaction (ADR) reports could be a mean to study generally the adverse effects identified due to a DDI. Our objective was to describe the characteristics of ADRs resulting from DDIs reported to the French Pharmacovigilance system and to identify the drugs most often implicated in these ADRs. Considering all ADR reports from January 01, 2012, to December 31, 2016, we identified all cases of ADR resulting from a DDI (DDI-ADRs). We then described these in terms of patients’ characteristics, ADR seriousness, drugs involved (two or more per case), and ADR type. Of the 4,027 reports relating to DDI-ADRs, 3,303 were related to serious ADRs. Patients with serious DDI-ADRs had a median age of 76 years (interquartile range: 63–84); 53% were male. Of all serious DDI-ADRs, 11% were life-threatening and 8% fatal. In 36% of cases, the DDI causing the ADR involved at least three drugs. Overall, 8,424 different drugs were mentioned in the 3,303 serious DDI-ADRs considered. Altogether, drugs from the “antithrombotic agents” subgroup were incriminated in 34% of serious DDI-ADRs. Antidepressants were the second most represented therapeutic/pharmacological subgroup (5% of serious DDI-ADRs). Among the 3,843 ADR types reported in the 3,303 serious DDI-ADRs considered, the most frequently represented were hemorrhage (40% clinical hemorrhage; 6% biological hemorrhage), renal failure (8%), pharmacokinetic alteration (5%), and cardiac arrhythmias (4%). Hemorrhagic accidents are still an important part of serious ADRs resulting from DDIs reported in France. The other clinical consequences of DDIs seem less well identified by pharmacovigilance. Moreover, more than one-third of serious DDI-ADRs involved at least three drugs.
Published: 2021

21. Pitch perception modification due to antiepileptics: A literature and pharmacovigilance databases review

Author: Marie-Noëlle Osmont, Sylvie Picard, Hoel Charbonnel, Eric Bellissant, Lucie-Marie Scailteux, Elisabeth Polard, Adeline Degremont, Louise Triquet, Anne Default, Guillaume Gentilhomme, Brendan Le Daré, CHU Pontchaillou [Rennes], Hôpital Lapeyronie [Montpellier] (CHU), Chercheur indépendant, Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Marseille-Assistance Publique-Hôpitaux de Marseille (AP-HM), Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Pediatrics, medicine.medical_specialty, Lacosamide, [SDV]Life Sciences [q-bio], Lamotrigine, 030226 pharmacology & pharmacy, Felbamate, 03 medical and health sciences, 0302 clinical medicine, Antiepileptic, Pharmacovigilance, medicine, Pharmacology (medical), Perfect pitch, Oxcarbazepine, business.industry, Carbamazepine, Hearing loss, Pitch perception, 3. Good health, Levetiracetam, business, Primidone, psychological phenomena and processes, medicine.drug
Abstract: National audience; Pitch perception modifications are among the little-known adverse effects observed with antiepileptics, mainly affecting patients treated with carbamazepine (CBZ). Here, we describe an original French case of pitch perception modification due to CBZ resulting in perfect pitch loss. We also reviewed the literature as well as French and world health organisation global pharmacovigilance database. The case report concerns a 22-year-old patient with perfect pitch with untreated left temporal partial epilepsy. Following a generalized seizure, the introduction of CBZ prolonged release (200mg twice a day) is decided. As soon as CBZ is introduced, the patient notices a change in pitch perception, about a semitone lower. This adverse effect persisted despite a gradual decrease in doses. The patient reported a total recovery of his perfect pitch when CBZ stopped completely 11 years later. In the French pharmacovigilance database, only one other case of pitch perception modification under CBZ was recorded (no cases were found with oxcarbazepine, lacosamide, sodium valproate, lamotrigine, levetiracetam, phenobarbital, phenytoin, primidone, ethosuximide, vigabatrine, felbamate, gabapentin, tiagabine and topiramate). In the literature, 27 cases of pitch perception modification have been published with CBZ, 1 case with oxcarbazepine and 1 case with lacosamide. Pitch perception modification is a very rare adverse effect of CBZ, oxcarbazepine and lacosamide, identified in the literature mainly in the Japanese population, in experienced musicians. A rapid onset after the introduction of treatment, a complete resolution of symptoms, in most cases upon discontinuation of treatment, is observed, with no sequelae reported. Due to the impact on quality of life, especially in patients whose profession is related to music, knowledge of this adverse event seems important to evoke this diagnosis.
Published: 2020

22. Inventory of the Recommendations for Patients with Pollen Allergies and Evaluation of Their Scientific Relevance

Author: Daniel Bley, Denis Charpin, Jean-Pierre Besancenot, Solenne Roubelat, Michel Thibaudon, Aix-Marseille Université - École de médecine (AMU SMPM MED), Aix-Marseille Université - Faculté des sciences médicales et paramédicales (AMU SMPM), Aix Marseille Université (AMU)-Aix Marseille Université (AMU), Réseau National de Surveillance Aérobiologique (RNSA), Service de Pneumologie et Allergologie, and Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille
Subjects: medicine.medical_specialty, Allergy, Health Planning Guidelines, Immunology, Public interest, [SHS]Humanities and Social Sciences, 03 medical and health sciences, 0302 clinical medicine, Patient Education as Topic, Health care, medicine, Immunology and Allergy, Mainstream, Relevance (law), Animals, Humans, 030223 otorhinolaryngology, News media, ComputingMilieux_MISCELLANEOUS, business.industry, Rhinitis, Allergic, Seasonal, General Medicine, Allergens, Antigens, Plant, medicine.disease, 3. Good health, 030228 respiratory system, Family medicine, Evidence-Based Practice, Hay fever, Pollen, France, business, Developed country
Abstract: Pollens are responsible for allergic rhinitis, conjunctivitis, and asthma. The incidence of these diseases, which have adversely impacted the social and professional lives of people who are allergic to pollen, has tripled in the past 25 years. Official institutes, health care institutions, public interest groups, and mainstream news media provide people who are allergic to pollen with advice aimed at reducing their symptoms. The aim of this work was to provide an inventory of the prevention guidelines in the world and to evaluate their scientific relevance. A PubMed search was carried out using specific keywords. The scientific relevance of the recommendations was evaluated based on the publications disproving or confirming their merit. The guidelines issued by 12 countries in Europe, North America, and Australia were inventoried. The recommendations for avoidance were most often based on scientific data regarding their impact on pollen exposures, but they have not been clinically validated. Several studies provided additional details, however, that allowed the guidelines to be further substantiated. These guidelines have been adopted in numerous industrialized countries in the world, and they generally appear to be of relevance.
Published: 2020

23. Safety of immune checkpoint inhibitor rechallenge after discontinuation for grade ≥2 immune-related adverse events in patients with cancer

Author: Marion Allouchery, Ghada Miremont-Salamé, Franck Rouby, Mathieu Puyade, Celia Bertin, Thomas Lombard, Marion Sassier, Mickael Martin, Marie-Christine Perault-Pochat, Marina Atzenhoffer, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Ischémie Reperfusion en Transplantation d’Organes Mécanismes et Innovations Thérapeutiques ( IRTOMIT), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Centre régional de pharmacovigilance de Caen Basse-Normandie (CRPV), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Hôpital Henri Mondor, Hospices Civils de Lyon (HCL), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], Laboratoire de neurosciences expérimentales et cliniques (LNEC), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Otten, Lisa
Subjects: Male, Cancer Research, medicine.medical_specialty, Drug-Related Side Effects and Adverse Reactions, medicine.medical_treatment, Immunology, 03 medical and health sciences, 0302 clinical medicine, Immune system, Internal medicine, Neoplasms, Pharmacovigilance, medicine, Immunology and Allergy, Humans, 030212 general & internal medicine, Adverse effect, Prospective cohort study, Immune Checkpoint Inhibitors, RC254-282, Aged, Pharmacology, business.industry, Melanoma, [SCCO.NEUR]Cognitive science/Neuroscience, autoimmunity, [SCCO.NEUR] Cognitive science/Neuroscience, Cancer, Correction, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Immunotherapy, Middle Aged, medicine.disease, Discontinuation, Oncology, 030220 oncology & carcinogenesis, Molecular Medicine, Female, immunotherapy, business, hormones, hormone substitutes, and hormone antagonists
Abstract: BackgroundSafety of rechallenge of immune checkpoint inhibitor (ICI) after grade ≥2 immune-related adverse events (irAEs) leading to ICI discontinuation remains unclear.MethodsAll adverse drug reactions involving at least one ICI reported up to December 31, 2019 were extracted from the French pharmacovigilance database. Patients were included if they experienced at least one grade ≥2 irAE resulting in ICI discontinuation, with subsequent ICI rechallenge. The primary outcome was the recurrence of at least one grade ≥2 irAE in these patients after ICI rechallenge.ResultsWe included 180 patients: 61.1% were men (median age of 66 years), 43.9% had melanoma and 78.9% were receiving anti-programmed cell death 1. First ICI discontinuation was related to 191 irAEs. After ICI rechallenge, 38.9% of the patients experienced at least one grade ≥2 irAE. Among them, 70.0% experienced the same irAE, 25.7% a distinct irAE, and 4.3% both the same and a distinct irAE. Lower recurrence rates of irAEs were associated with rechallenge with the same ICI treatment (p=0.02) or first endocrine irAEs (p=0.003). Gastrointestinal irAEs were more likely to recur (p=0.007). The median duration from ICI discontinuation to rechallenge and the severity of the initial irAE did not predict recurrent irAEs after ICI rechallenge (p=0.53 and p=0.40, respectively).ConclusionsIn this study, 61.1% of the patients who discontinued ICI treatment for grade ≥2 irAEs experienced no recurrent grade ≥2 irAEs after ICI rechallenge. Although ICI rechallenge appears to be safe under close monitoring, it should always be discussed balancing usefulness of rechallenge, patient comorbidities and risk of recurrence of first irAE(s). Due to inherent bias associated with pharmacovigilance studies, further prospective studies are needed to assess risk factors that may influence patient outcomes after ICI rechallenge.
Published: 2020

24. Acute Coronary Syndrome With Immune Checkpoint Inhibitors: A Proof-of-Concept Case and Pharmacovigilance Analysis of a Life-Threatening Adverse Event

Author: Charles Dolladille, Franck Thuny, Franck Paganelli, Ugo Scemama, Ariel Cohen, Franck Rouby, Joachim Alexandre, Stéphane Ederhy, Joe-Elie Salem, Jennifer Cautela, Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Nord [CHU - APHM], Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), CHU Marseille-Assistance Publique-Hôpitaux de Marseille (AP-HM), Service de pharmacologie médicale [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CIC Paris Est, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université - Faculté de Médecine (SU FM), Sorbonne Université (SU), Département de Pharmacologie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Signalisation, électrophysiologie et imagerie des lésions d’ischémie-reperfusion myocardique (SEILIRM), Normandie Université (NU)-Normandie Université (NU), Thrombose, atherothrombose et pharmacologie appliquée, Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Institut de Neurosciences des Systèmes (INS), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre d'investigation clinique Paris Est [CHU Pitié Salpêtrière] (CIC Paris-Est), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Service de Pharmacologie médicale [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre d'investigation clinique pluridisciplinaire [CHU Pitié Salpêtrière] (CIC-P 1421), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], and CCSD, Accord Elsevier
Subjects: Male, medicine.medical_specialty, Acute coronary syndrome, Immune checkpoint inhibitors, [SDV]Life Sciences [q-bio], 030204 cardiovascular system & hematology, Proof of Concept Study, Pharmacovigilance, 03 medical and health sciences, Antineoplastic Agents, Immunological, 0302 clinical medicine, medicine, Humans, Immunologic Factors, 030212 general & internal medicine, Acute Coronary Syndrome, Intensive care medicine, Adverse effect, Aged, Aged, 80 and over, business.industry, Middle Aged, medicine.disease, Causality, Thrombosis, 3. Good health, [SDV] Life Sciences [q-bio], Female, Cardiology and Cardiovascular Medicine, business, Isolated cases
Abstract: International audience; Isolated cases of acute coronary syndrome (ACS) associated with immune checkpoint inhibitors (ICIs) have been described without the establishment of a formal cause-and-effect relationship between treatment and adverse event. We reported a case of ACS after the first administration of an ICI and with a fatal recurrence in another coronary area immediately after readministration. According to guidelines, causality was considered to be certain. Subsequently, we queried the French pharmacovigilance database and found 4 cases of ACS with coronary artery thrombosis. Causality was probable in those patients. These data suggest that ACS may be another life-threatening cardiac adverse event occurring with ICI exposure.
Published: 2020

25. Medication Reconciliation Associated with Comprehensive Geriatric Assessment in Older Patients with Cancer: ChimioAge Study

Author: Couderc, Anne-Laure, Boisseranc, Celia, Rey, Dominique, Nouguerede, Emilie, Greillier, Laurent, Barlesi, Fabrice, Duffaud, Florence, Deville, Laurent, Honoré, Stéphane, Villani, Patrick, Correard, Florian, Assistance Publique - Hôpitaux de Marseille (APHM), Anthropologie bio-culturelle, Droit, Ethique et Santé (ADES), Aix Marseille Université (AMU)-EFS ALPES MEDITERRANEE-Centre National de la Recherche Scientifique (CNRS), Aix Marseille Université (AMU), Service d’Oncologie Médicale [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, and CHU Marseille-Assistance Publique-Hôpitaux de Marseille (AP-HM)
Subjects: Aged, 80 and over, Male, geriatric assessment, [SDV]Life Sciences [q-bio], [SDV.MHEP.GEG]Life Sciences [q-bio]/Human health and pathology/Geriatry and gerontology, Clinical Decision-Making, antineoplastic protocols, [SDV.CAN]Life Sciences [q-bio]/Cancer, Medical Oncology, Patient Care Planning, [SHS]Humanities and Social Sciences, [SDV.ETH]Life Sciences [q-bio]/Ethics, aged, Neoplasms, Clinical Interventions in Aging, Polypharmacy, medication reconciliation, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Humans, Female, Prospective Studies, ComputingMilieux_MISCELLANEOUS, Original Research, treatment failure
Abstract: Anne-Laure Couderc,1,2 Celia Boisseranc,3 Dominique Rey,1 Emilie Nouguerede,1 Laurent Greillier,4,5 Fabrice Barlesi,4,5 Florence Duffaud,4,6 Jean-Laurent Deville,6 Stéphane Honoré,3,4 Patrick Villani,1,2 Florian Correard3,4 1Internal Medicine, Geriatry and Therapeutic Unit, AP-HM, Marseille, France;Coordination Unit for Geriatric Oncology (UCOG), PACA West, Marseille, France; 2Aix-Marseille Université, CNRS, EFS, ADES, Marseille, France; 3Pharmacology Department, AP-HM, Marseille, France; 4Aix-Marseille University, Marseille, France; 5Multidisciplinary Oncology and Therapeutic Innovations Unit, AP-HM, Marseille, France; 6Oncology Unit, AP-HM, Marseille, FranceCorrespondence: Anne-Laure CoudercCoordination Unit for Geriatric Oncology (UCOG), PACA West, University Hospital of Marseille (AP-HM), 270 Boulevard De Sainte Marguerite, Marseille 13009, FranceTel +33 491744530Fax +33 491744833Email anne-laure.couderc@ap-hm.frBackground: Polymorbidity induces polypharmacy in older patients may lead to potential drug–drug interactions (DDI) which can modify the tolerance and safety of oncological treatments and alter the intended therapeutic effect. The objective of our study was to describe the decision-making process for oncological treatment and related outcomes, in a population of older adults undergoing a comprehensive geriatric assessment (CGA) associated to a comprehensive medication reconciliation (CMR) prior to initiating oncological treatment.Methods: ChimioAge is a prospective observational study conducted between 01/2017 and 07/2018 at Marseille University Hospital and approved by the French National Ethics Committee. It comprised all consecutive patients aged 70 years and over who were referred for a CGA as part of CMR, before initiating systemic treatment.Results: One hundred and seventy-one cancer patients were included. Mean age was 79.2 years, over half had metastatic cancers, 75% had an ECOG performance status zero or one, and two-thirds were independent in daily activities. Two-thirds of the patients had polypharmacy and the CMR identified potential DDI with systemic treatment in 43.3% of patients. Following the CGA, the CMR and the hospital oncologists decision, 30% of the patients received adapted systemic treatment with reduced doses at initiation. They presented fewer toxicities – irrespective of grade and type – than patients who received standard treatment (p< 0.001) and had comparable overall survival (Log rank p=0.21).Conclusion: This is one of the first studies to highlight the value in conducting CMR and a CGA simultaneously before initiating systemic treatment in older patients with cancer. These two evaluations could give oncologists decisive information to personalize cancer treatment of older patients and optimize treatment dose to offer the best efficacy and minimize toxicity.Keywords: aged, antineoplastic protocols, geriatric assessment, medication reconciliation, treatment failure
Published: 2020

26. Antibiotic resistance: Tools for effective translational research

Author: Solen Kernéis, C. Dumartin, Romain Guilhaumou, Marie-Clémence Verdier, Didier Concordet, Joanie del Bano, Mohamed Khelifa, Claire Le Jeunne, Bruno Valtier, Evelyne Jouvin-Marche, Antoine Andremont, William Couet, Marie-Cécile Ploy, Mourez Michaël, Cyril Guyard, Bruno Coignard, Didier Guillemot, Alain Bousquet-Mélou, Christian Brun-Buisson, Anti-infectieux : supports moléculaires des résistances et innovations thérapeutiques (RESINFIT), CHU Limoges-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Sorbonne Paris Nord, Pfizer, CHU Cochin [AP-HP], Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], Epidémiologie et modélisation de la résistance aux antimicrobiens - Epidemiology and modelling of bacterial escape to antimicrobials, Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Pasteur [Paris], Innovations Thérapeutiques et Résistances (InTheRes), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Ecole Nationale Vétérinaire de Toulouse (ENVT), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, Santé publique France, Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Aix-Marseille Université - Faculté de pharmacie (AMU PHARM), Aix Marseille Université (AMU), BIOASTER, Institute for Advanced Biosciences / Institut pour l'Avancée des Biosciences (Grenoble) (IAB), Centre Hospitalier Universitaire [Grenoble] (CHU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang - Auvergne-Rhône-Alpes (EFS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), Sanofi-Aventis R&D, SANOFI Recherche, Evotec, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Biostatistique, Biomathématique, Pharmacoépidémiologie et Maladies Infectieuses (B2PHI), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Raymond Poincaré [AP-HP], Ecole Nationale Vétérinaire de Toulouse (ENVT), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National Polytechnique (Toulouse) (Toulouse INP), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Direction des maladies infectieuses - Infectious Diseases Division [Saint-Maurice], Santé publique France - French National Public Health Agency [Saint-Maurice, France], Service de Pharmacologie Clinique [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Institut de Neurosciences des Systèmes (INS), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), BIOASTER Microbiology Technology Institute [Lyon], Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut Pasteur [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CHU Marseille-Assistance Publique-Hôpitaux de Marseille (AP-HM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), and Université de Limoges (UNILIM)-Université de Limoges (UNILIM)-CHU Limoges
Subjects: medicine.medical_specialty, media_common.quotation_subject, Public health, Microbiota, [SDV]Life Sciences [q-bio], Translational research, 030226 pharmacology & pharmacy, 3. Good health, 03 medical and health sciences, 0302 clinical medicine, Effective interventions, Antibiotic resistance, Impact, Risk analysis (engineering), Work (electrical), medicine, Stewardship, Pharmacology (medical), Quality (business), Profitability index, Antibio-resistance, Business, Innovation, media_common
Abstract: Refers to : Marie-Cécile Ploy, Antoine Andremont, Bruno Valtier, Claire Le Jeunne - Antibiorésistance : outils pour une recherche translationnelle efficace - Therapies, Volume 75, Issue 1, January–February 2020, Pages 1-6; National audience; The rising emergence of bacterial resistances has led to a crisis which threatens human, animal and environmental health. The impact of the emergency is enormous in terms of public health and economics. Although there is a global awareness of the warnings and programmes supporting innovative actions to combat fight against antibiotic resistance, it must be admitted that proposed new antibiotics fail to find the economic profitability necessary for them to reach the market and become available for patients and the community. Moreover, it is necessary to develop tools/indicators to define effective interventions against antibiotic resistance. The work of the think-tank reported in this article concentrated on two aspects of translational research: - prevention and the impact on health of the antibiotic resistance issue, and - the specific requirements of clinical research leading to innovation in the fight against antibiotic resistance. This article, which reflects the thoughts of a group of French experts, proposes directly operational solutions which could be rapidly implemented and radically transform the quality and quantity of our resources available for the combat.
Published: 2020

27. Dimension reduction and analysis of a 10-year physicochemical and biological water database applied to water resources intended for human consumption in the Provence-Alpes-Cote d'Azur region, France

Author: Vincent Valles, Tarik Bahaj, Ilias Kacimi, Moad Morarech, Laurent Barbiero, Abdessamad Tiouiouine, Tarik Bouramtane, Marc Moulin, Fabrice Dassonville, Suzanne Yameogo, Université Mohammed V de Rabat [Agdal], Institut de l'Environnement et Recherches Agricoles [Ouagadougou] (INERA), Institut de Recherche pour le Développement (IRD), Environnement Méditerranéen et Modélisation des Agro-Hydrosystèmes (EMMAH), Avignon Université (AU)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Géosciences Environnement Toulouse (GET), Institut national des sciences de l'Univers (INSU - CNRS)-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Observatoire Midi-Pyrénées (OMP), Météo France-Centre National d'Études Spatiales [Toulouse] (CNES)-Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Météo France-Centre National d'Études Spatiales [Toulouse] (CNES)-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD), Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), CHU Marseille-Assistance Publique-Hôpitaux de Marseille (AP-HM), Bureau de Recherches Géologiques et Minières (BRGM) (BRGM), Université Abdelmalek Essaâdi (UAE), Université Mohammed V de Rabat [Agdal] (UM5), Centre national de la recherche scientifique et technologique [Ouagadougou] (CNRST), Institut de Recherche pour le Développement (IRD)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut national des sciences de l'Univers (INSU - CNRS)-Observatoire Midi-Pyrénées (OMP), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut national des sciences de l'Univers (INSU - CNRS)-Centre National d'Études Spatiales [Toulouse] (CNES)-Centre National de la Recherche Scientifique (CNRS)-Météo-France -Institut de Recherche pour le Développement (IRD)-Institut national des sciences de l'Univers (INSU - CNRS)-Centre National d'Études Spatiales [Toulouse] (CNES)-Centre National de la Recherche Scientifique (CNRS)-Météo-France -Centre National de la Recherche Scientifique (CNRS), and Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille
Subjects: Multivariate statistics, lcsh:Hydraulic engineering, multivariate statistics, 0208 environmental biotechnology, Geography, Planning and Development, Context (language use), 02 engineering and technology, 010501 environmental sciences, Aquatic Science, computer.software_genre, 01 natural sciences, Biochemistry, hydrochemistry, hydrochemistry, water resource, hydrogeology, multivariate statistics, France, lcsh:Water supply for domestic and industrial purposes, lcsh:TC1-978, Dimension (data warehouse), 0105 earth and related environmental sciences, Water Science and Technology, lcsh:TD201-500, Database, Dimensionality reduction, 15. Life on land, [SDE.ES]Environmental Sciences/Environmental and Society, 6. Clean water, 020801 environmental engineering, Water resources, Ranking, hydrogeology, 13. Climate action, Principal component analysis, [SDE]Environmental Sciences, water resource, Environmental science, Water quality, France, computer
Abstract: The SISE-Eaux database of water intended for human consumption, archived by the French Regional Health Agency (ARS) since 1990, is a rich source of information. However, more or less regular monitoring over almost 30 years and the multiplication of parameters lead to a sparse matrix (observations &times, parameters) and a large dimension of the hyperspace of data. These characteristics make it difficult to exploit this database for a synthetic mapping of water quality, and to identify of the processes responsible for its diversity in a complex geological context and anthropized environment. A 10-year period (2006&ndash, 2016) was selected from the Provence-Alpes- C&ocirc, te d&rsquo, Azur region database (PACA, southeastern France). We extracted 5,295 water samples, each with 15 parameters. A treatment by principal component analysis (PCA) followed with orthomax rotation allows for identifying and ranking six principal components (PCs) totaling 75% of the initial information. The association of the parameters with the principal components, and the regional distribution of the PCs make it possible to identify water-rock interactions, bacteriological contamination, redox processes and arsenic occurrence as the main sources of variability. However, the results also highlight a decrease of useful information, a constraint linked to the vast size and diversity of the study area. The development of a relevant tool for the protecting and managing of water resources will require identifying of subsets based on functional landscape units or the grouping of groundwater bodies.
Published: 2020

28. Thyroiditis and immune check point inhibitors: the post-marketing experience using the French National Pharmacovigilance database

Author: Nadine Petitpain, Julie Garon-Czmil, Franck Rouby, Marion Sassier, Georges Weryha, Marc Klein, Pierre Gillet, Samy Babai, Melissa Yelehe-Okouma, Centre Régional de PharmacoVigilance de Lorraine (CRPV Lorraine), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Service d'Endocrinologie et Gynécologie Médicale [CHRU Nancy], Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Institut de Neurosciences des Systèmes (INS), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de Pharmacologie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre régional de pharmacovigilance [CHU Henri-Mondor], CHU Henri Mondor [Créteil], Ingénierie Moléculaire et Physiopathologie Articulaire (IMoPA), Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), CHU Marseille-Assistance Publique-Hôpitaux de Marseille (AP-HM), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Université de Caen Normandie (UNICAEN), Normandie Université (NU), and CHU Henri Mondor
Subjects: Adult, Male, Thyroiditis, Time Factors, Databases, Factual, Levothyroxine, Ipilimumab, Pembrolizumab, Antibodies, Monoclonal, Humanized, computer.software_genre, Risk Assessment, 030226 pharmacology & pharmacy, Pharmacovigilance, Young Adult, 03 medical and health sciences, Antineoplastic Agents, Immunological, 0302 clinical medicine, Risk Factors, Product Surveillance, Postmarketing, Adverse Drug Reaction Reporting Systems, Humans, Medicine, Pharmacology (medical), ComputingMilieux_MISCELLANEOUS, Aged, Retrospective Studies, Aged, 80 and over, Pharmacology, Database, business.industry, Thyroid, Middle Aged, medicine.disease, 3. Good health, Discontinuation, Nivolumab, medicine.anatomical_structure, Female, France, business, computer, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, 030217 neurology & neurosurgery, medicine.drug
Abstract: Immunotherapy with immune checkpoint inhibitors (ICIs) for cancer has become increasingly prescribed in recent years. Indeed, it is used to treat both solid and hematological malignancies due to their considerable potential in treating melanoma, non-small cell lung and other cancers. Immune-mediated related adverse endocrine toxicity, and especially thyroiditis, is seen as a growing problem needing specific screening and management. This study aims at describing thyroid dysfunctions induced by the ICIs marketed in France, which are registered in the French Pharmacovigilance database. This database was queried for nivolumab, pembrolizumab, and ipilimumab-induced adverse drug reactions reported before April 30, 2017. Both a pharmacologist and an endocrinologist have reviewed each case to select only those of peripheral thyroiditis (thyrotoxicosis and hypothyroidism). During this period, 110 thyroiditis following ICI therapy were reported. Sex/ratio was around one. Most of the cases (47.2%) were asymptomatic. Although some thyrotoxicosis cases were severe, no orbitopathy was reported. Hypothyroidism and thyrotoxicosis were equally described. Antithyroid antibodies were positive in only 16% patients. The ultrasonography was informative in 19% patients. Levothyroxine supplementation was necessary in 57% patients, leading to 19% recovery. With a dedicated optimized management, most of the cases did not require immunotherapy discontinuation. Finally, immune-mediated related thyroiditis is increasing due to a wider prescription of ICI therapy in various cancer conditions and systematic screening. Often asymptomatic, they lead to a local activation accompanied by hormonal deficiency in the long run. It is necessary to carry out an early and sustained multidisciplinary screening to allow immunotherapy continuation.
Published: 2018

29. Is failure of fetal head engagement during previous delivery a contraindication for trial of labor: A French retrospective study

Author: Armelle Bertrand, Maria Katsogiannou, Claude D'Ercole, Jean-Baptiste Haumonte, Franck Mauviel, Julie Blanc, Microbes évolution phylogénie et infections (MEPHI), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Service d'Obstétrique-Gynécologie [Marseille], and Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM]
Subjects: Adult, medicine.medical_specialty, Multivariate analysis, Contraindications, Procedure, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Pregnancy, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, medicine, Humans, Fetal head, [SDV.MP.PAR]Life Sciences [q-bio]/Microbiology and Parasitology/Parasitology, Prospective Studies, Stage (cooking), Prospective cohort study, Contraindication, ComputingMilieux_MISCELLANEOUS, Retrospective Studies, Univariate analysis, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, 030219 obstetrics & reproductive medicine, Obstetrics, Vaginal delivery, business.industry, Obstetrics and Gynecology, Retrospective cohort study, Vaginal Birth after Cesarean, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, Trial of Labor, 3. Good health, Reproductive Medicine, 030220 oncology & carcinogenesis, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, Female, France, business
Abstract: Objective To study whether history of cesarean delivery for arrest of descent (failure of fetal head engagement or unsuccessful instrumental delivery), is a factor of unsuccessful vaginal birth after cesarean delivery. Methods Multicenter prospective study of patients undergoing TOL after previous caesarean delivery between May 2012 and May 2013 in 6 maternities. Univariate statistical analysis was performed depending of previous cesarean delivery indication. Multivariate analysis was used to determine independent association between these factors and TOLAC success. Results Four hundred and eighty women with previous cesarean delivery were included and separated into two groups: the study group was composed of patients with history of CD for arrest of descent (failure of fetal head engagement or unsuccessful instrumental delivery) (n = 31); control group included all other indications for CD (n = 449). Overall, of the 480 women included in the study, 71.2 % underwent a TOL for a subsequent delivery (n = 342): 68 % in the study group (n = 21) vs 71.5 % in the control group (n = 321). Vaginal birth after cesarean (VBAC) was obtained in 66.6 % vs 61% in the study and control group respectively (p = 0.656). Univariate analysis of factors that may influence the success rate of (VBAC) did not show any difference between the two groups. Multivariate analysis showed that VBAC was only significantly associated with history of vaginal delivery subsequent to prior CD for arrest of descent. Conclusion This study reassures us in our clinical practice allowing TOL in cases of history of CD for fetal head engagement failure or instrumental delivery failure in the second stage of labor.
Published: 2019

30. La simulation médicale comme outil dans la formation des professionnels de la périnatalité

Author: Tosello, B., Blanc, J., Kelway, C., Pellegrin, V., Quarello, E., Comte, F., Zakarian, C., D'Ercole, C., D’ercole, C., Anthropologie bio-culturelle, Droit, Ethique et Santé (ADES), Aix Marseille Université (AMU)-EFS ALPES MEDITERRANEE-Centre National de la Recherche Scientifique (CNRS), Laboratoire de mécanique des solides (LMS), École polytechnique (X)-MINES ParisTech - École nationale supérieure des mines de Paris, Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Centre National de la Recherche Scientifique (CNRS), Service d'Obstétrique-Gynécologie [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], Gynépole, Aix Marseille Université (AMU)- Hôpital Nord [CHU - APHM], and École polytechnique (X)-Mines Paris - PSL (École nationale supérieure des mines de Paris)
Subjects: 030219 obstetrics & reproductive medicine, Skills, [SDV]Life Sciences [q-bio], education, Obstetrics and Gynecology, Perinatal, Newborn, Nouveau-né, Education, 03 medical and health sciences, 0302 clinical medicine, Reproductive Medicine, Compétences, 030225 pediatrics, Périnatalité, Enseignement, Simulation
Abstract: Resume Bien que la technologie joue un role de plus en plus important dans les systemes de sante moderne, la performance humaine demeure un determinant majeur de la surete, de l’efficacite et de l’efficience des soins delivres aux patients. Ce constat est particulierement operant en salle d’accouchement. Ainsi, la formation des professionnels doit avoir pour objectifs non seulement l’acquisition de la theorie et de la pratique a titre individuelle mais egalement l’apprentissage d’un travail d’equipe s’articulant de maniere coordonnee. L’enseignement par simulation constitue un complement solide de l’enseignement theorique et repond aux exigences de connaissances, des savoir-faire et etre. Ainsi, nous proposons d’explorer comment l’enseignement par simulation dans les situations d’urgence du peripartum est-il actuellement un outil pedagogique incontournable en formation initiale et dans le maintien des connaissances. Nous l’aborderons suivant trois volets : individuelle, collective (equipe) et l’impact de la simulation sur la pratique. Le choix de cette strategie educative permet d’ameliorer les competences cliniques necessaires a une performance optimale dans des environnements complexes, imprevisibles, a fort enjeu, comme la naissance. Neanmoins, l’impact clinique a long terme de l’entrainement sur simulateur reste a explorer, et les modalites de simulation, techniques ou non techniques, conduisant a un benefice direct pour la mere et le devenir neonatal restent a identifier.
Published: 2018

31. Severe perineal morbidity of instrumental deliveries using Thierry's spatulas and vacuum extraction: A prospective observational cohort study

Author: F. Marchand, Florence Bretelle, S. Hamouda, Léon Boubli, Claude D'Ercole, Xavier Carcopino, Julien Mancini, Laboratoire de microbiologie, Hôpital d'enfants de Tunis, Laboratoire d'Enseignement et de Recherche sur le Traitement de l'Information Médicale (LERTIM), Université de la Méditerranée - Aix-Marseille 2, ORL et Chirurgie cervico-faciale pédiatrique - [Hôpitaux Timone et Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE)- Hôpital Nord [CHU - APHM], Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, INSB-INSB-Centre National de la Recherche Scientifique (CNRS), Service de Gynécologie Obstétrique, Hôpital Nord [CHU - APHM], Service d'Obstétrique-Gynécologie [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], UMR 6578 : Anthropologie Bio-Culturelle (UAABC), Université de la Méditerranée - Aix-Marseille 2-Centre National de la Recherche Scientifique (CNRS), Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS), Hôpital de la Timone [CHU - APHM] (TIMONE)-Aix Marseille Université (AMU)- Hôpital Nord [CHU - APHM]-Assistance Publique - Hôpitaux de Marseille (APHM), and COMBE, Isabelle
Subjects: Adult, Episiotomy, medicine.medical_specialty, Vacuum Extraction, Obstetrical, medicine.medical_treatment, Anal Canal, Perineum, Obstetrical Forceps, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Pregnancy, Perineal tear, medicine, Humans, 030212 general & internal medicine, Intestinal Mucosa, Risk factor, Pelvis, Rupture, 030219 obstetrics & reproductive medicine, Vaginal delivery, business.industry, Vacuum extraction, Significant difference, Obstetrics and Gynecology, 3. Good health, Surgery, body regions, medicine.anatomical_structure, Reproductive Medicine, Case-Control Studies, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Female, business, Cohort study
Abstract: International audience; Objectives. - To evaluate the risk of severe perineal tear following instrumental vaginal delivery (IVD) performed with spatulas and vacuum extraction. Secondary objectives were to estimate the impact of episiotomy on this risk. Methods. - From December 2008 to October 2012, women who underwent spatulas or vacuum were prospectively included. Each spontaneous vaginal delivery (SVD) following each included IVD were included as control cases (1-1 ratio). Careful perineal examination was systematically performed. Severe perineal tear was defined by the occurrence of anal sphincter rupture with or without anal mucosa tear. Results. - A total of 761 patients were included in the current study: 248 (64%) spatulas, 137 (36%) vacuums and 381 (49%) SVDs. Severe perineal tear was diagnosed in 19 (2.5%) cases. Episiotomy had been performed in 276 (36.9%) patients. Only spatulas extraction was found to significantly increase the risk of severe perineal tear (AOR = 7.66; 95% CI: 2.06-28; P=0.02). Although vacuum extraction seemed to increase this risk, it was not found to be significant (AOR = 3.25; 95% CI: 0.65-16.24; P=0.15). No significant difference was observed between the risk of severe perineal tear following spatulas and vacuum (AOR = 2.36; 95% CI: 0.63-8.82; P=0.202). Finally, neither foetal macrosomia, nor episiotomy, nor foetal extraction with the head in the deep pelvis, nor delivery at night had a significant impact on the probability of severe perineal tear. Conclusions. - Spatulas extraction is an independent risk factor for severe perineal tear. The practice of episiotomy was not shown to have any significant impact on this risk. (C) 2015 Elsevier Masson SAS. All rights reserved.
Published: 2017

32. How to improve vaccine acceptability (evaluation, pharmacovigilance, communication, public health, mandatory vaccination, fears and beliefs)

Author: Geneviève Chêne, Franck Gérald, Thomas Borel, Géraldine Ménin, Farid Kheloufi, Jacques Morel, Marie-Christine Truchet, Claire Roger, Franck Rouby, Véronique Lamarque-Garnier, Jehan-Michel Behier, Odile Launay, Clémentine Schilte, Mathieu Molimard, Alain Dutilleul, Véronique Dufour, Laurent Simon, Arnaud Gagneur, Stéphane Schück, Annick Opinel, Jean-Louis Koeck, François Faurisson, Benoît Soubeyrand, Brigitte Autran, Soizic Courcier, Telma Lery, Odile Gelpi, Xavier Bresse, Sanofi Pasteur [Lyon, France], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut Pasteur [Paris] (IP), CIC Cochin Pasteur (CIC 1417), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu-Groupe hospitalier Broca-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Takeda France, Les entreprises du Médicament (LEEM), Sanofi Pasteur MSD, Epidémiologie, santé publique et développement, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR99-ISPED, Laboratoire GlaxoSmithKline [ Marly-le-Roi], Infovac-France, Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Sherbrooke (UdeS), ACS-France - Action Contre les Spondylarthropathies (Action Contre les Spondylarthropathies ), Assistance Publique - Hôpitaux de Marseille (APHM), Direction centrale du service de santé des armées (DCSSA), EVAL Santé, Janssen Cilag, CHU Bordeaux [Bordeaux], Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Kappa, Blossom Vaccinology, Pfizer, Institut Pasteur [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université de Paris (UP)-Groupe hospitalier Broca-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu-Institut National de la Santé et de la Recherche Médicale (INSERM), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Marseille-Assistance Publique-Hôpitaux de Marseille (AP-HM), Le pharmacien de France, and CCSD, Accord Elsevier
Subjects: Vaccination Coverage, 030309 nutrition & dietetics, MESH: Pharmacovigilance, Motivational interviewing, Mandatory Programs, Pharmacovigilance, 0302 clinical medicine, Information system, Information systems, MESH: Health Education / trends, Pharmacology (medical), Health Education, Vaccines, 0303 health sciences, Schools, Communication, Vaccination, Hesitancy, MESH: Vaccination Coverage, MESH: Patient Acceptance of Health Care, Mandatory vaccination, 030205 complementary & alternative medicine, 3. Good health, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, MESH: Communication, France, Public Health, MESH: Public Health, MESH: Mandatory Programs, medicine.medical_specialty, MESH: Schools, MESH: Vaccination / trends, MESH: Motivation, Education, 03 medical and health sciences, medicine, Humans, Motivation, Medical education, Immunization Programs, Public health, Patient Acceptance of Health Care, MESH: Immunization Programs / trends, MESH: France, MESH: Vaccines, Intervention (law), Immunization, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Business, Vaccine
Abstract: International audience; A flagship recommendation of the citizen's steering committee on immunization, the mandatory immunization for infants extended to 11 vaccines, introduced in January 2018, is part of a set of recommendations that must be considered as a whole, each component being indispensable to the achievement of objectives: restore confidence in vaccination and increase immunization coverage. Roundtable # 6 participants identified a decade of concrete initiatives that could address, at least in part, the committee's recommendations, including: developing information systems and data generation; simplify the vaccination journey and increase vaccination opportunities; developing training of health professionals; learning vaccines at school; using motivational interviewing in educational intervention; undertaking local initiatives; improving supply and communicate on the value of vaccines. To carry out these actions, it has been proposed that a joint ministerial task-force bringing together the different stakeholders at the national level should be set up to promote their implementation and follow-up, and at regional level, the establishment of an Agences régionales de santé awareness plan making vaccination a priority.
Published: 2019

33. Tumor multifocality with vagus nerve involvement as a phenotypic marker of SDHD mutation in patients with head and neck paragangliomas: A 18 F‐FDOPA PET/CT study

Author: Pauline Romanet, Ugo Scemama, David Taïeb, Frederic Sebag, Karel Pacak, Arthur Varoquaux, Frederic Castinetti, Anderson Loundou, Nicolas Fakhry, Anne Barlier, Marion Montava, Jean‐Pierre Lavieille, Vincent Amodru, Marseille medical genetics - Centre de génétique médicale de Marseille (MMG), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d’imagerie médicale [Hôpital Nord - APHM], Hôpital Nord [CHU - APHM], Laboratoire de Biomécanique Appliquée (LBA UMR T24), Aix Marseille Université (AMU)-Université Gustave Eiffel, ORL et Chirurgie cervico-faciale pédiatrique - [Hôpitaux Timone et Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE)- Hôpital Nord [CHU - APHM], Laboratoire Parole et Langage (LPL), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Centre de recherche en neurobiologie - neurophysiologie de Marseille (CRN2M), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), Assistance Publique - Hôpitaux de Marseille (APHM), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Centre de Recherche en Cancérologie de Marseille (CRCM), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Aix Marseille Université (AMU), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, and Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Male, Vagus Nerve Diseases, Fluorine Radioisotopes, Heterozygote, medicine.medical_specialty, SDHB, 030209 endocrinology & metabolism, [SDV.CAN]Life Sciences [q-bio]/Cancer, [SDV.BC.BC]Life Sciences [q-bio]/Cellular Biology/Subcellular Processes [q-bio.SC], medicine.disease_cause, Carotid paraganglioma, Article, Neoplasms, Multiple Primary, 03 medical and health sciences, 0302 clinical medicine, Paraganglioma, Positron Emission Tomography Computed Tomography, medicine, [SDV.MHEP.AHA]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, Cranial Nerve Neoplasms, ComputingMilieux_MISCELLANEOUS, Retrospective Studies, Paraganglioma, Extra-Adrenal, Mutation, PET-CT, business.industry, Age Factors, Vagus Nerve, Middle Aged, medicine.disease, Phenotype, Dihydroxyphenylalanine, 3. Good health, Vagus nerve, Succinate Dehydrogenase, Otorhinolaryngology, Head and Neck Neoplasms, 030220 oncology & carcinogenesis, Female, SDHD, Radiology, business
Abstract: BACKGROUND: (18)F-FDOPA PET/CT was proved to be a highly sensitive imaging method for detecting head and neck paraganglioma (HNPGL). The primary aim of the study was to evaluate the relationship between tumor characteristics and the SDHx-mutational status in a large series of patients with HNPGL evaluated by (18)F-FDOPA PET/CT. METHODS: A total of 104 patients with HNPGL (65 sporadic/39 SDHx-mutated) were included. RESULTS: In comparison to SDHB/SDC/SDHx-negative cases, patients with SDHD were younger at diagnosis and had a higher rate of multifocal, vagal, and carotid paraganglioma. In patients with SDHD, vagal paraganglia represented the primary site of tumor origin. Multicentric involvement of the vagus nerve alone or in association with other locations was found to be a typical feature of SDHD cases compared to other cases (odds ratio = 59.4). CONCLUSION: The present study shows that tumor multifocality within the vagus nerve is a phenotypic marker of SDHD mutation. This information is essential in the choice of the therapeutic strategy.
Published: 2018

34. Thrombotic microangiopathy associated with gemcitabine use: Presentation and outcome in a national French retrospective cohort

Author: Julien Mancini, Pascale Poullin, Joëlle Micallef, Florence Daviet, Marion Sallée, Paul Coppo, Aurélie Grandvuillemin, Franck Rouby, Noémie Jourde-Chiche, Renaud Sabatier, Steven Grangé, Véronique Frémeaux-Bacchi, Bertrand Pourroy, Stéphane Burtey, Florence Duffaud, Julie Moussi-Frances, Centre de néphrologie et transplantation rénale [Hôpital de la Conception - APHM], Hôpital de la Conception [CHU - APHM] (LA CONCEPTION )-Assistance Publique - Hôpitaux de Marseille (APHM), Centre régional de pharmacovigilance de Marseille [CHU de Marseille], CHU Marseille, Institut de Neurosciences des Systèmes (INS), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d\'hémaphérèse, Hôpital de la Conception, APHM, Marseille, France, Service d'hémaphérèse, Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION )-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION ), Hôpital de la Conception [CHU - APHM] (LA CONCEPTION ), Centre recherche en CardioVasculaire et Nutrition (C2VN), Institut National de la Recherche Agronomique (INRA)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Chirurgie urologique et transplantation rénale [Hôpital de la Conception - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION ), Hôpital de la Timone [CHU - APHM] (TIMONE), Centre de Recherche en Cancérologie de Marseille (CRCM), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Aix Marseille Université (AMU), Service Pharmacie [Hôpital de la Timone - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Centre Régional de Pharmacovigilance, de Renseignement sur le Médicament et de Pharmaco épidémiologie de Bourgogne [Dijon], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Service de réanimation médicale [Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), CHU Saint-Antoine [APHP], Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service de réanimation médicale [CHU Rouen], Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital de la Conception [CHU - APHM] (LA CONCEPTION)-Assistance Publique - Hôpitaux de Marseille (APHM), CHU Marseille-Assistance Publique-Hôpitaux de Marseille (AP-HM), and Prémilleux, Annick
Subjects: Male, medicine.medical_specialty, Antimetabolites, Antineoplastic, Thrombotic microangiopathy, medicine.medical_treatment, [SDV]Life Sciences [q-bio], chemotherapy, 030226 pharmacology & pharmacy, Gastroenterology, Deoxycytidine, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Neoplasms, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Adverse effect, Dialysis, ComputingMilieux_MISCELLANEOUS, Aged, Retrospective Studies, Pharmacology, adverse drug reactions, business.industry, Thrombotic Microangiopathies, Acute kidney injury, Retrospective cohort study, Original Articles, Eculizumab, Middle Aged, medication safety, medicine.disease, Gemcitabine, 3. Good health, [SDV] Life Sciences [q-bio], acute kidney injury, pharmacovigilance, Female, Fresh frozen plasma, France, business, medicine.drug
Abstract: International audience; Aims Gemcitabine has been associated with thrombotic microangiopathy (TMA). We conducted a national retrospective study of gemcitabine-associated TMA (G-TMA). Methods From 1998 to 2015, all cases of G-TMA reported to the French Pharmacovigilance Network and the French TMA Reference Center, and cases explored for complement alternative pathway abnormalities, were analysed. Results G-TMA was diagnosed in 120 patients (median age 61.5 years), after a median of 210 days of treatment, and a cumulative dose of 12 941 mg m(-2). Gemcitabine indications were: pancreatic (52.9%), pulmonary (12.6%) and breast (7.6%) cancers, metastatic in 34.2% of cases. Main symptoms were oedema (56.7%) and new-onset or exacerbated hypertension (62.2%). Most patients presented with haemolytic anaemia (95.6%) and thrombocytopenia (74.6%). Acute kidney injury was reported in 97.4% and dialysis was required in 27.8% of patients. Treatment consisted of: plasma exchange (PE; 39.8%), fresh frozen plasma (21.4%), corticosteroids (15.3%) and eculizumab (5.1%). A complete remission of TMA was obtained in 42.1% of patients and haematological remission in 23.1%, while 34.7% did not improve. The survival status was known for 52 patients, with 29 deaths (54.7%). Patients treated with PE, despite a more severe acute kidney injury, requiring dialysis more frequently, displayed comparable rates of remission, but with more adverse events. No abnormality in complement alternative pathway was documented in patients explored. Conclusion This large cohort confirms the severity of G-TMA, associated with severe renal failure and death. Oedema and hypertension could be monitored in patients treated with gemcitabine to detect early TMA. The benefit of PE or eculizumab deserves further investigation.
Published: 2018

35. Development of a nomogram for individual preterm birth risk evaluation

Author: Jean-Pierre Menard, Anderson Loundou, Julie Blanc, Claude D'Ercole, Florence Bretelle, Florence Fenollar, Marion Gioan, Sainte Musse Hospital, Toulon, Vecteurs - Infections tropicales et méditerranéennes (VITROME), Institut de Recherche Biomédicale des Armées (IRBA)-Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU), Cellule d'Evaluation Médicale, Assistance Publique - Hôpitaux de Marseille (APHM), Gynépole, Aix Marseille Université (AMU)- Hôpital Nord [CHU - APHM], Service d'Obstétrique-Gynécologie [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], Microbes évolution phylogénie et infections (MEPHI), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), and Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut de Recherche Biomédicale des Armées [Brétigny-sur-Orge] (IRBA)
Subjects: Adult, Fetal Membranes, Premature Rupture, medicine.medical_specialty, Population, Cervix Uteri, Short cervix, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Logistic regression, Risk Assessment, Nomogram, Miscarriage, 03 medical and health sciences, Obstetric Labor, Premature, 0302 clinical medicine, Pregnancy, Risk Factors, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Humans, Medicine, Prospective Studies, 030212 general & internal medicine, Prospective cohort study, education, Premature birth, education.field_of_study, Late miscarriage, 030219 obstetrics & reproductive medicine, Receiver operating characteristic, business.industry, Obstetrics, High risk, Obstetrics and Gynecology, Vaginosis, Bacterial, Bacterial vaginosis, medicine.disease, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, 3. Good health, Asymptomatic, Abortion, Spontaneous, Nomograms, Reproductive Medicine, Female, business
Abstract: Objective This study aimed to develop a new tool for personalised preterm birth risk evaluation in high-risk population. Study design 813 high-risk asymptomatic pregnant women included in a French multicentric prospective study were analysed. Clinical and paraclinical variables, including screening for bacterial vaginosis with molecular biology, cervical length, have been used to create the nomogram, based on the logistic regression model. The validity was checked by bootstrap. A downloadable calculator was build. Results Nine risk factors were included in this model: history of late miscarriage and/or preterm delivery, active smoking, ultrasound cervical length, term of pregnancy at screening, bacterial vaginosis, premature rupture of membranes, daily travel more than 30 min. Discrimination and calibration of the nomogram revealed good predictive abilities. The area under the receiver operating characteristic curve was 0.77 (95% CI; 0.72–0.81). The mean absolute error was 0.018, which showed proper calibration. The optimal risk threshold was 23.2% with a sensitivity of 74%, a specificity of 72.7% and a predictive negative value of 90.6%. Conclusion The nomogram can help to better define individual preterm birth risk in high-risk pregnancies.
Published: 2018

36. Prospective comparison of 68Ga-DOTATATE and 18F-FDOPA PET/CT in patients with various pheochromocytomas and paragangliomas with emphasis on sporadic cases

Author: Eva Beschmout, Aurélien Archier, Isabelle Morange, Arthur Varoquaux, Anderson Loundou, Anne Barlier, Carole Guerin, Karel Pacak, David Taïeb, Philippe Garrigue, Frederic Sebag, Benjamin Guillet, Marion Montava, Frederic Castinetti, Nicolas Fakhry, Sophie Gabriel, Centre de résonance magnétique biologique et médicale (CRMBM), Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Vascular research center of Marseille (VRCM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU), Centre Européen de Recherche en Imagerie médicale (CERIMED), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-École Centrale de Marseille (ECM)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Centre National de la Recherche Scientifique (CNRS), HOPITAL NORD MARSEILLE - APHM - SERV RADIOPHARM, Service d'ORL, CHU Nord, Laboratoire de Biomécanique Appliquée (LBA UMR T24), Aix Marseille Université (AMU)-Université Gustave Eiffel-Aix Marseille Université (AMU)-Université Gustave Eiffel, Centre Hospitalier Universitaire Conception (CHU Conception), Institute für arbeitsschutz deutschen gesetzlichen unfallversicherung (IFA), Aix Marseille Université (AMU), Centre de recherche en neurobiologie - neurophysiologie de Marseille (CRN2M), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service de chirurgie générale et endocrinienne, Hôpital de la Timone [CHU - APHM] (TIMONE), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Aix Marseille Université (AMU)-Institut Français des Sciences et Technologies des Transports, de l'Aménagement et des Réseaux (IFSTTAR)-Aix Marseille Université (AMU)-Institut Français des Sciences et Technologies des Transports, de l'Aménagement et des Réseaux (IFSTTAR), Physiologie, Environnement et Génétique pour l'Animal et les Systèmes d'Elevage [Rennes] (PEGASE), AGROCAMPUS OUEST-Institut National de la Recherche Agronomique (INRA), Centre National de la Recherche Scientifique (CNRS)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-École Centrale de Marseille (ECM)-Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), Service de Radiopharmacie [Hôpital de la Timone- Hôpital Nord - APHM], and Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE)- Hôpital Nord [CHU - APHM]
Subjects: Adult, Male, SDHB, Adrenal Gland Neoplasms, [SHS.PSY]Humanities and Social Sciences/Psychology, 030209 endocrinology & metabolism, Pheochromocytoma, 030218 nuclear medicine & medical imaging, Paraganglioma, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Positron Emission Tomography Computed Tomography, Image Processing, Computer-Assisted, Organometallic Compounds, Humans, Medicine, False Positive Reactions, Radiology, Nuclear Medicine and imaging, Prospective Studies, Aged, Aged, 80 and over, PET-CT, medicine.diagnostic_test, biology, business.industry, Fibrous dysplasia, General Medicine, Middle Aged, [SHS.ECO]Humanities and Social Sciences/Economics and Finance, medicine.disease, biology.organism_classification, Quality, Dihydroxyphenylalanine, 3. Good health, Pheos, Positron emission tomography, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, SDHD, business, Nuclear medicine
Abstract: International audience; Purpose Pheochromocytomas/paragangliomas (PHEOs/PGLs) overexpress ă somatostatin receptors and recent studies have already shown excellent ă results in the localization of these tumors using Ga-68-labeled ă somatostatin analogs (Ga-68-DOTA-SSA), especially in patients with ă germline succinate dehydrogenase subunit B gene (SDHB) mutations and ă head and neck PGLs (HNPGLs). The value of Ga-68-DOTA-SSA has to be ă established in sporadic cases, including PHEOs. Thus, the aim of this ă study was to compare Ga-68-DOTATATE PET/CT, F-18-FDOPA PET/CT, and ă conventional imaging in patients with various PHEOs/PGLs with a special ă emphasis on sporadic cases, including those located in the adrenal ă gland. ă Design Ga-68-DOTATATE, F-18-FDOPA PET/CT, and conventional imaging ă (contrast-enhanced CT and MRI with MR angiography sequences) were ă prospectively performed in 30 patients (8 with SDHD mutations, 1 with a ă MAX mutation and 21 sporadic cases) with PHEO/PGL at initial diagnosis ă or relapse. ă Results The patient-based sensitivities were 93 % (28/30), 97 % ă (29/30), and 93 % (28/30) for Ga-68-DOTATATE PET/CT, F-18-FDOPA PET/CT, ă and conventional imaging, respectively. The lesion-based sensitivities ă were 93 % (43/46), 89 % (41/46), and 76 % (35/46) for Ga-68-DOTATATE ă PET/CT, F-18-FDOPA PET/CT, and conventional imaging respectively (p = ă 0.042). Ga-68-DOTATATE PET/CT detected a higher number of HNPGLs (30/30) ă than F-18-FDOPA PET/CT (26/30; p = 0.112) and conventional imaging ă (24/30; p = 0.024). Ga-68-DOTATATE PET/CT missed two PHEOs of a few ă millimeters in size and a large recurrent PHEO. One lesion was ă considered false-positive on Ga-68-DOTATATE PET/CT and corresponded to a ă typical focal lesion of fibrous dysplasia on MRI. Among the 11 lesions ă missed by conventional imaging, 7 were detected by conventional imaging ă with knowledge of the PET results (4 HNPGLs, 2 LNs, and 1 recurrent ă PHEO). ă Conclusion Ga-68-DOTATATE PET/CT is the most sensitive tool in the ă detection of HNPGLs, especially SDHD-related tumors, which may be very ă small and fail to concentrate sufficient F-18-FDOPA. The present study ă further expands the use of Ga-68-DOTATATE for all patients with HNPGLs, ă regardless of their genotype. Ga-68-DOTATATE PET/CT may be inferior to ă F-18-FDOPA PET/CT in the detection PHEOs.
Published: 2015

37. Managing pain and anxiety during transabdominal chorionic villus sampling. A noninferiority randomized trial of nitrous oxide vs local anesthesia

Author: Xavier-Côme Donato, Edwin Quarello, Maria Katsogiannou, Marie Raffray, Brigitte Planchet-Barraud, Anderson Loundou, Eric Glowaczower, Marie-Pierre Brechard, Raoul Desbriere, Microbes évolution phylogénie et infections (MEPHI), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Hôpital Saint-Joseph [Marseille], Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, and Service de Gynécologie-Obstétrique, Pôle Parents Enfants,Hôpital Saint-Joseph
Subjects: Adult, Lidocaine, Visual analogue scale, Nitrous Oxide, Chorionic villus sampling, Pain, Context (language use), law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, law, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Pregnancy, medicine, Humans, Pain Management, Local anesthesia, [SDV.MP.PAR]Life Sciences [q-bio]/Microbiology and Parasitology/Parasitology, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, Pain Measurement, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, 030219 obstetrics & reproductive medicine, medicine.diagnostic_test, business.industry, Obstetrics and Gynecology, General Medicine, equipment and supplies, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, Confidence interval, 3. Good health, Chorionic Villi Sampling, Anesthesia, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, Anxiety, Female, medicine.symptom, business, medicine.drug, Anesthesia, Local
Abstract: Introduction Transabdominal chorionic villus sampling (CVS) is an invasive procedure for prenatal diagnosis reported to be associated with anxiety and pain. In this context, the need for analgesia during CVS has been considered useful. Even though several authors have been interested in pain management during amniocentesis, no study has been published on pain reduction during CVS. Our objective was to evaluate pain and anxiety management during transabdominal CVS using nitrous oxide (N2 O) and local anesthesia. Material and methods In a randomized controlled noninferiority trial, self-administered nitrous oxide (N2 O) inhalation (equimolar premix of oxygen and nitrous oxide) was compared with local anesthesia (1% lidocaine) before CVS. Primary outcome was pain and secondary outcome was anxiety, both measured on a visual analog scale 30-60 minutes before, immediately after (5-10 minutes) and 30-60 minutes after CVS. With a statistical power of 90%, type I error of 5% and two-sided test and potential exclusions, a sample size of 96 patients per group was enrolled and randomized. No patient was enrolled before the trial registration date. Results From 13 March 2013 through 10 February 2015, 192 patients (96 per group) were screened and randomized. Most characteristics were similar across groups. Pain in the N2 O group was 2.65 ± 0.22 vs 3.32 ± 0.26 in local anesthesia group [mean ± standard error of mean (SEM)]. Mean anxiety in the N2 O group was 3.17 ± 0.27 vs 5.19 ± 0.30 in the local anesthesia group. Conclusion N2 O was as efficient and even superior to local anesthesia for both pain and anxiety reduction during CVS, as the 95% confidence intervals were both below the prespecified noninferiority margin of 0.8 and below zero.
Published: 2018

38. Adverse consequences of low-dose methotrexate medication errors: data from French poison control and pharmacovigilance centers

Author: Romain Torrents, David Boels, Anne Marie Patat, Antoine Villa, Thierry Vial, Delphine Castellan, Hélène Theophile, Behrouz Kassai, Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Hospices Civils de Lyon (HCL), Centres antipoison et de toxicovigilance (CAPTV Angers), Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), CHU Marseille-Assistance Publique-Hôpitaux de Marseille (AP-HM), Centre antipoison et de toxicovigilance (Paris) (CAPTV Paris), Université Paris Diderot - Paris 7 (UPD7)-Hôpitaux Universitaires Saint-Louis, Lariboisière, Fernand-Widal, CHU Bordeaux [Bordeaux], Centre antipoison et de toxicovigilance (Marseille) (CAPTV Marseille), Assistance Publique - Hôpitaux de Marseille (APHM), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Evaluation et modélisation des effets thérapeutiques, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Centre Antipoison et Toxicovigilance du Grand Ouest (Angers) (CAPTV Angers), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, and CCSD, Accord Elsevier
Subjects: Male, Pediatrics, Databases, Factual, Poison control, Administration, Oral, Arthritis, Rheumatoid, Pharmacovigilance, 0302 clinical medicine, Medicine, Medication Errors, 030212 general & internal medicine, Aged, 80 and over, Cumulative dose, Age Factors, Medication error, Middle Aged, 3. Good health, Survival Rate, Female, France, medicine.symptom, medicine.drug, Adult, medicine.medical_specialty, Poison Control Centers, Drug-Related Side Effects and Adverse Reactions, Context (language use), Asymptomatic, Risk Assessment, Drug Administration Schedule, Drug toxicity, 03 medical and health sciences, Sex Factors, Rheumatology, Humans, Dosing, Mortality, Adverse effect, Aged, 030203 arthritis & rheumatology, Dose-Response Relationship, Drug, business.industry, Logistic Models, Methotrexate, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Multivariate Analysis, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Follow-Up Studies
Abstract: Objective The objectives of this study are to carefully describe the context of methotrexate medication errors, to details medical consequences and management approaches, and to determine the rate of fatal outcome. Methods Data on methotrexate medication errors were obtained from the French network of poison control and pharmacovigilance centres, which collected and documented reported drug-induced adverse effects. Cases were included if the intake was more than 2-fold the intended weekly dose or a weekly cumulative dose ≥ 30 mg and a follow-up of at least 4 days after the last dose. Data were analysed for demographics, treatment indication, prescribed dose, drug interactions, clinical complications and medical outcomes. Results Seventy four patients were included. The causes of methotrexate errors resulted from an erroneous prescription renewal (23.3%), incomprehensiveness of the weekly schedule by patients or at-home caregivers (56.2%) and administration of a wrong dose by a health care professional (20.5%). Of the 70 patients who took methotrexate daily, the mean daily dose received over the whole duration of the error was 9.6 ± 4.1 mg (range 2.5–22.5) with a mean duration of the error of 11.7 ± 12.2 days (range 2 to 90). Thirteen (18%) patients remained asymptomatic and 61 (82%) developed complications of which 46 (62.2%) were severe. Nine (14.8%) patients died within 11 to 45 days after the first dosing error. Compared to patients with no or mild symptoms, those with severe symptoms were more likely to be older (75.6 ± 10.8 vs. 69.5 ± 12.9 years) and to be exposed to a higher cumulative dose (94.8 ± 46.2 vs. 68.0 ± 45.7 mg). Conclusions This study confirms that dosing errors with methotrexate can be lethal and persisted despite several warnings from drug agencies. Further measures are awaited from the European Medicine Agency.
Published: 2018

39. Use of a personalized iterative score to evaluate risk of venous thromboembolism during pregnancy and puerperium

Author: Florence Bretelle, Caroline Rambeaud, Cécile Chau, Marine Vial, Jennifer Campagna, Anderson Loundou, Université Pierre et Marie Curie - Paris 6 - UFR de Médecine Pierre et Marie Curie (UPMC), Université Pierre et Marie Curie - Paris 6 (UPMC), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Microbes évolution phylogénie et infections (MEPHI), and Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS)
Subjects: medicine.medical_specialty, Pregnancy Complications, Cardiovascular, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Pregnancy, Risk Factors, Prenatal Diagnosis, medicine, Odds Ratio, Humans, [SDV.MP.PAR]Life Sciences [q-bio]/Microbiology and Parasitology/Parasitology, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, Retrospective Studies, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, 030219 obstetrics & reproductive medicine, Framingham Risk Score, Obstetrics, business.industry, Heparin, Age Factors, Obstetrics and Gynecology, Anticoagulants, General Medicine, Odds ratio, Puerperal Disorders, Venous Thromboembolism, medicine.disease, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, Confidence interval, 3. Good health, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, Observational study, Female, business, Risk assessment, Venous thromboembolism, Stockings, Compression
Abstract: OBJECTIVE To determine whether a personalized iterative venous thromboembolism (VTE) risk score improved preventive prophylaxis during pregnancy and puerperium. METHODS An observational retrospective comparative study was conducted at single French hospital. Women who gave birth from February 1 to April 30, 2012 (n=557) or from February 1 to April 30, 2015 (n=512) underwent VTE risk assessment. The VTE risk score comprised known risk factors for this condition. RESULTS Use of the VTE risk score at the first consultation increased the likelihood of appropriate treatment (odds ratio [OR] 1.5, 95% confidence interval [CI] 1.2-1.9; P=0.002) and reduced the risk of undertreatment (OR 0.5, 95% CI 0.4-0.7; P
Published: 2018

40. Meta-Analysis Reveals the Association Between Male Occupational Exposure to Solvents and Impairment of Semen Parameters

Author: Virginie Villes, I. Sari-Minodier, Anderson Loundou, Oana Ianos, Marie-Pascale Lehucher-Michel, Jeanne Perrin, Aix-Marseille Université - Faculté de médecine (AMU MED), Aix Marseille Université (AMU), Centre Clinico-Biologique d’Assistance Médicale à la Procréation - CECOS [Hôpital de la Conception - APHM], Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Institut méditerranéen de biodiversité et d'écologie marine et continentale (IMBE), Avignon Université (AU)-Aix Marseille Université (AMU)-Institut de recherche pour le développement [IRD] : UMR237-Centre National de la Recherche Scientifique (CNRS), Service de Médecine et Santé au Travail - AP-HM - La Timone, Epidémiologie et Sciences Sociales Appliquées à l'Innovation Médicale, Université de la Méditerranée - Aix-Marseille 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'études et de recherche sur les services de santé et la qualité de vie (CEReSS), Unité d'Aide Méthodologique, and Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille
Subjects: Male, Carbon disulfide, Physiology, Ejaculate volume, Semen, Aromatic hydrocarbons, [SDV.CAN]Life Sciences [q-bio]/Cancer, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, [SDV.BDLR.RS]Life Sciences [q-bio]/Reproductive Biology/Sexual reproduction, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Occupational Exposure, Nerchlorethylene, Humans, Medicine, 030212 general & internal medicine, Glycol ethers, [SDV.BDD.GAM]Life Sciences [q-bio]/Development Biology/Gametogenesis, [SDV.EE.SANT]Life Sciences [q-bio]/Ecology, environment/Health, 030219 obstetrics & reproductive medicine, Sperm Count, business.industry, Public Health, Environmental and Occupational Health, Sperm, [SDE.ES]Environmental Sciences/Environmental and Society, 3. Good health, Semen Analysis, N-dimethylformamide, chemistry, Male fertility, Strictly standardized mean difference, Meta-analysis, Solvents, Occupational exposure, [SDV.TOX.ECO]Life Sciences [q-bio]/Toxicology/Ecotoxicology, Solvent exposure, business
Abstract: International audience; Objectives: Solvent exposure is among the most common occupational exposures to chemical toxicants; data about the impact of such exposure on semen parameters are contradictory. We conducted the first meta-analysis to evaluate the risk of alteration in semen parameters related to occupational exposure to solvents. Methods: From the PubMed database, we selected studies analyzing the semen of subjects occupationally exposed to solvents, compared with unexposed controls. The meta-analysis was performed on the various semen parameters analyzed in both populations. Results: Seven studies were included in the study. The meta-analysis revealed a significant decrease in ejaculate volume [standardized mean difference (SMD) ¼ À0.35 (À0.63 to À0.07)] and sperm concentration [SMD ¼ À0.36 (À0.64 to À0.08)] in workers exposed to solvents compared with unexposed controls. Conclusion: Our results highlight the importance of preventing reprotoxic risks to male fertility in the workplace.
Published: 2018

41. Risk factors for death in septic shock A retrospective cohort study comparing trauma and non-trauma patients

Author: Coralie Vigne, Karine Baumstarck, Anderson Loundou, Emmanuelle Hammad, Marc Leone, Julie Alingrin, Laurent Zieleskiewicz, François Antonini, Gary Duclos, Sophie Medam, Service Anesthésie et Réanimation [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Aix Marseille Université (AMU), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, INSB-INSB-Centre National de la Recherche Scientifique (CNRS), Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS), Hôpital Nord [CHU - APHM]-Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), and COMBE, Isabelle
Subjects: Adult, Male, medicine.medical_specialty, mouse model, efficacy, Observational Study, 030204 cardiovascular system & hematology, comorbidities, law.invention, mosquito-borne diseases, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, law, death, Internal medicine, Humans, Medicine, severe trauma, Retrospective Studies, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, business.industry, Septic shock, Mortality rate, Area under the curve, 030208 emergency & critical care medicine, Retrospective cohort study, General Medicine, Odds ratio, Middle Aged, medicine.disease, Shock, Septic, Intensive care unit, 3. Good health, age, Shock (circulatory), Cohort, Wounds and Injuries, septic shock, ectoparasiticide, Female, France, medicine.symptom, Stegomyia albopicta (= Aedes albopictus), business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Research Article
Abstract: International audience; The aim of this study was to compare septic shock directly associated-mortality between severe trauma patients and nontrauma patients to assess the role of comorbidities and age. We conducted a retrospective study in an intensive care unit (ICU) (15 beds) of a university hospital (928 beds). From January 2009 to May 2015, we reviewed 2 anonymized databases including severe trauma patients and nontrauma patients. We selected the patients with a septic shock episode. Among 385 patients (318 nontrauma patients and 67 severe trauma patients), the ICU death rate was 43%. Septic shock was directly responsible for death among 35% of our cohort, representing 123 (39%) nontrauma patients and 10 (15%) trauma patients (P
Published: 2017

42. Risk Factor Analysis of Bird Beak Occurrence after Thoracic Endovascular Aortic Repair

Author: Carine Guivier-Curien, Valérie Deplano, Y.S. Alimi, Olivier Hartung, B. Dona, Anderson Loundou, Mourad Boufi, Olivier Boiron, Institut de Recherche sur les Phénomènes Hors Equilibre (IRPHE), Aix Marseille Université (AMU)-École Centrale de Marseille (ECM)-Centre National de la Recherche Scientifique (CNRS), Assistance Publique - Hôpitaux de Marseille (APHM), Laboratoire de Biomécanique Appliquée (LBA UMR T24), Aix Marseille Université (AMU)-Université Gustave Eiffel, Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, and Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-École Centrale de Marseille (ECM)
Subjects: Adult, Male, Traumatic aortic rupture, Aortic arch, medicine.medical_specialty, Adolescent, Fistula, medicine.medical_treatment, Aorta, Thoracic, 030204 cardiovascular system & hematology, Risk Assessment, Thoracic aortic aneurysm, Young Adult, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, medicine.artery, Stent graft, medicine, Humans, Thoracic aorta, 030212 general & internal medicine, Risk factor, [PHYS.MECA.BIOM]Physics [physics]/Mechanics [physics]/Biomechanics [physics.med-ph], Aged, Retrospective Studies, Aged, 80 and over, MESH: Stent graft, Malapposition, Anatomy, Proximal landing zone, Medicine(all), business.industry, Endovascular Procedures, Stent, Middle Aged, medicine.disease, Surgery, Apposition, Multivariate Analysis, cardiovascular system, Female, Stents, Tomography, X-Ray Computed, business, Cardiology and Cardiovascular Medicine
Abstract: International audience; Objectives: The aim was to analyze the role played by anatomy and stent graft in the incidence of incomplete apposition to aortic arch.Methods: Between 2007 and 2014 data including available and suitable computed tomographic angiography (CIA) imaging of patients who had undergone thoracic endovascular aortic repair were reviewed. The study included 80 patients (65 men, 54 +/- 21 years) treated for traumatic aortic rupture (n = 27), thoracic aortic aneurysm (n = 15), type B aortic dissection (n = 24), penetrating aortic ulcer (n = 5), intramural hematoma (n = 2), aorto-oesophageal fistula (n = 2), and aortic mural thrombus (n = 5). Pre- and post-operative CIA images were analyzed to characterize bird beak in terms of length and angle, and to calculate aortic angulation within a 30 mm range at the proximal deployment zone.Results: Bird beak configuration was detected in 46 patients (57%): mean stent protrusion length was 16 mm (range: 8-29 mm) and mean bird beak angle was 20 degrees (range: 7-40 degrees). The bird beak effect was significantly more frequent after traumatic aortic rupture treatment (p = .05) and in landing zone 2 (p = .01). No influence of either stent graft type or generation, or degree of oversizing was observed (p = .29, p = .28, p = .81 respectively). However, the mean aortic angle of patients with bird beak was higher in the Pro-form group than that in the Zenith TX2 group (62 degrees vs. 48 degrees, p = .13). Multivariate analysis identified the aortic angle of the deployment zone as the unique independent risk factor of malapposition (HR = 1.05, 95% Cl 1-1.10, p = .005). The cutoff value of 51 degrees was found to be predictive of bird beak occurrence with a sensitivity of 58% and a specificity of 85%.Conclusions: Assessment of proximal landing zone morphology to avoid deployment zones generating an aortic angle of over 50 degrees can be recommended to improve aortic curvature apposition with the current available device
Published: 2015
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43. Examination of factors in type I endoleak development after thoracic endovascular repair

Author: Yves S. Alimi, Valérie Deplano, Carine Guivier-Curien, Fatma Aouini, Bianca Dona, Mourad Boufi, Anderson Loundou, Aix-Marseille Université - Faculté de médecine (AMU MED), Aix Marseille Université (AMU), Institut de Recherche sur les Phénomènes Hors Equilibre (IRPHE), Aix Marseille Université (AMU)-École Centrale de Marseille (ECM)-Centre National de la Recherche Scientifique (CNRS), Laboratoire de Biomécanique Appliquée (LBA UMR T24), Aix Marseille Université (AMU)-Université Gustave Eiffel, Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Assistance Publique - Hôpitaux de Marseille (APHM), and Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-École Centrale de Marseille (ECM)
Subjects: Male, Time Factors, Endoleak, medicine.medical_treatment, Aorta, Thoracic, Kaplan-Meier Estimate, Risk Factors, Computed tomography angiography, Aged, 80 and over, RISK, OUTCOMES, medicine.diagnostic_test, TEVAR, Endovascular Procedures, Hazard ratio, Middle Aged, 3. Good health, ARCH, Treatment Outcome, Cardiothoracic surgery, DISEASES, Female, Stents, Radiology, Cardiology and Cardiovascular Medicine, STENT-GRAFT REPAIR, Adult, Traumatic aortic rupture, medicine.medical_specialty, Adolescent, Aortic Diseases, Prosthesis Design, Aortography, Thoracic aortic aneurysm, DISSECTIONS, Blood Vessel Prosthesis Implantation, Young Adult, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Blood vessel prosthesis, medicine.artery, medicine, AORTIC-ANEURYSMS, MANAGEMENT, Humans, [PHYS.MECA.BIOM]Physics [physics]/Mechanics [physics]/Biomechanics [physics.med-ph], Aged, Proportional Hazards Models, Retrospective Studies, Aorta, Chi-Square Distribution, business.industry, Stent, medicine.disease, Blood Vessel Prosthesis, Surgery, Emergencies, Tomography, X-Ray Computed, business, PROXIMAL LANDING ZONE
Abstract: International audience; Objective: The objective of this study was to assess the effects of operative indication, anatomy, and stent graft on type I endoleak occurrence after thoracic endovascular aortic repair.Methods: A retrospective review was conducted of patients admitted for thoracic endovascular aortic repair between 2007 and 2013. All computed tomography angiography imaging was analyzed for the presence of endoleak and measurement of diameters and lengths. Variables studied included underlying disease, emergency, achieved aortic neck length, difference between proximal and distal neck diameters, landing zone 2, and stent graft characteristics (diameter, number, type of device, oversizing degree, and covered aorta length).Results: The study population involved 84 patients (mean age, 56 years; range, 17-94 years) who were treated for thoracic aortic aneurysm (TAA) (n = 29; 34.5%), traumatic aortic rupture (n = 27; 32%), type B aortic dissection (n = 19; 22.5%), intramural hematoma (n = 2; 2%), penetrating aortic ulcer (n = 5; 6%), and aortoesophageal fistula (n = 2; 2%). Of these, 60 patients (71.5%) were treated emergently and 24 (28.5%) electively. Primary type I endoleak was noted in eight patients (9.5%), of which two resolved spontaneously. After a mean follow-up of 32 months (range, 3-76 months), secondary type I endoleak was detected in four patients (4.5%). All of them occurred after emergent TAA treatment. Comparison between emergent and elective groups revealed no significant differences in neck length (19.5 mm vs 26.5 mm; P = .197), oversizing degree (11.1% vs 10.9%; P = .811), or endoleak rates (13.3% vs 8.3%; P = .518). Hemorrhagic shock was not predictive of endoleak (P = .483). Cox regression analysis of the different anatomic and stent graft-related factors revealed short proximal landing zone as the unique independent predictor of type I endoleak (hazard ratio, 0.89; 95% confidence interval, 0.81-0.99; P = .032).Conclusions: Endoleak risk seems not to be increased by an emergency setting. However, the relatively high rate of late endoleak observed after emergent TAA repair advocates for close follow-up, contrary to traumatic aortic rupture. Furthermore, regardless of the pathologic process, a longer proximal landing zone is likely to guarantee early and late success.
Published: 2015
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44. Unexplained infertility: live-birth's prognostic factors to determine the ART management

Author: Blandine Courbiere, Anderson Loundou, Jeanne Perrin, Odile Paulmyer-Lacroix, Alexandra Ohannessian, Audrey Gnisci, Centre Clinico-Biologique d’Assistance Médicale à la Procréation - CECOS [Hôpital de la Conception - APHM], Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Laboratoire de Reproduction [Hôpital de la Conception AP-HM] (Centre de Reproduction Assistée), Institut méditerranéen de biodiversité et d'écologie marine et continentale (IMBE), Avignon Université (AU)-Aix Marseille Université (AMU)-Institut de recherche pour le développement [IRD] : UMR237-Centre National de la Recherche Scientifique (CNRS), and Centre National de la Recherche Scientifique (CNRS)-Institut de recherche pour le développement [IRD] : UMR237-Aix Marseille Université (AMU)-Avignon Université (AU)
Subjects: Adult, Male, Infertility, medicine.medical_specialty, Pregnancy Rate, Reproductive Techniques, Assisted, [SDV]Life Sciences [q-bio], medicine.medical_treatment, media_common.quotation_subject, Fertility, Fertilization in Vitro, Male infertility, 03 medical and health sciences, 0302 clinical medicine, Pregnancy, medicine, Humans, Insemination, Artificial, ComputingMilieux_MISCELLANEOUS, Retrospective Studies, Unexplained infertility, media_common, 030219 obstetrics & reproductive medicine, In vitro fertilisation, Obstetrics, business.industry, Pregnancy Outcome, Obstetrics and Gynecology, Prognosis, medicine.disease, Time-to-Pregnancy, Pregnancy rate, Female, Live birth, business, Live Birth, 030215 immunology
Abstract: BACKGROUND: The purpose of this retrospective observational study was to identify prognostic factors that lead to a live birth (LB) in couples with unexplained infertility in order to define the best assisted-reproductive technique (ART) strategy. METHODS: Prognostic factors of couples with unexplained infertility managed initially with gonadotropin intrauterine inseminations (IUI) at a single university fertility center were analyzed. Infertility was not considered “unexplained” in case of mild male infertility and suspicion of diminished ovarian reserve (FSH>10 IU/L). ART management consisted to start with IUI cycles and then, if failure, to propose in vitro fertilization (IVF). Couples were compared according to the results of IUI cycles in terms of LB. RESULTS: Between January 2011 and July 2015, 133 couples with unexplained infertility were included (320 IUI cycles). The average age of women was 31.6±4.6 years and the average number of IUI per couple was 2.4±1.2. The IUI live birth rate (LBR) was 37.6%, with an average of 2 cycles to obtain a pregnancy. For 63 couples, no pregnancy occurred after IUI cycles. The prognostic factors of the two groups “LB after IUI” vs. “no LB after IUI” were not statistically different. The remaining 20 couples had a spontaneous pregnancy with a LB. Cumulative LBR, including spontaneous and ART pregnancies, was 65.7 %. Of the 63 couples with no LB after IUI, 33.3% dropped-out from infertility treatments before starting IVF. CONCLUSIONS: To avoid couple’s drop-out, we advise to start infertility treatment for unexplained infertility with two IUI before undergoing IVF if IUI failure.
Published: 2017

45. Incidence of salivary side effects after radioiodine treatment using a new specifically-designed questionnaire

Author: Cyrille Chossegros, Sophie Gabriel, Frederic Sebag, David Taïeb, Karine Baumstarck-Barrau, Nicolas Fakhry, Eric Moreddu, Olivier Mundler, Service d'ORL et Chirurgie Cervico-Facial, Hôpital de la Timone [CHU - APHM] (TIMONE), Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), CEA-Direction des Energies (ex-Direction de l'Energie Nucléaire) (CEA-DES (ex-DEN)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Anthropologie bio-culturelle, Droit, Ethique et Santé (ADES), Aix Marseille Université (AMU)-EFS ALPES MEDITERRANEE-Centre National de la Recherche Scientifique (CNRS), Service de Chirurgie Générale et Endocrinienne [La Timone - Marseille], Service de médecine nucléaire [Marseille], Université de la Méditerranée - Aix-Marseille 2-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Aix Marseille Université (AMU), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Department of Nuclear Medicine, Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, and Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: medicine.medical_specialty, Visual Analog Scale, [SDV]Life Sciences [q-bio], [SDV.CAN]Life Sciences [q-bio]/Cancer, 030209 endocrinology & metabolism, medicine.disease_cause, Xerostomia, Sialadenitis, Cohort Studies, Iodine Radioisotopes, 03 medical and health sciences, 0302 clinical medicine, Surveys and Questionnaires, Internal medicine, medicine, salivary, Humans, Thyroid Neoplasms, Thyroid cancer, Thyroid neoplasm, ComputingMilieux_MISCELLANEOUS, business.industry, Incidence (epidemiology), medicine.disease, Dry mouth, University hospital, recombinant Human TSH, 3. Good health, Surgery, radioiodine, Otorhinolaryngology, 030220 oncology & carcinogenesis, Thyroid malignancy, Oral Surgery, medicine.symptom, Large group, business, thyroid neoplasm, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience; Sialadenitis is one of the common complications of radioiodine treatment for thyroid malignancy. The aim of this study was to evaluate the prevalence of radioiodine-induced sialadenitis and other side effects by using a self-administered questionnaire. From 1 January 2011 to 31 December 2012 all consecutive patients with a newly-established diagnosis of thyroid cancer who were treated with adjuvant radioiodine at La Timone University Hospital were sent a self-administered questionnaire on salivary complaints that had been specifically designed for this study. A total of 413 patients sent the questionnaire back, of whom 100 (24%) had experienced pain, 116 (28%) discomfort or swelling, and 147 (36%) dry mouth or xerostomia. This survey has highlighted the number of side effects of radioiodine treatment in a large group of patients and corroborates previous observations. Our new self-administered questionnaire may be useful to others for follow-up and research.
Published: 2017

46. IMPACT OF C1Q BINDING TO HLA DONOR-SPECIFIC ANTIBODIES ON THE MORTALITY AND THE DEVELOPMENT OF CHRONIC REJECTION (CLAD) IN LUNG TRANSPLANTATION

Author: Agnès Basire, Martine Reynaud-Gaubert, Anderson Loundou, Julie Di Cristofaro, Pascale Paule, Matthieu Pelardy, Luc Lyonnet, Coralie Frassati, Pascal Thomas, Carine Gomez, Christophe Picard, Anthropologie bio-culturelle, Droit, Ethique et Santé (ADES), Aix Marseille Université (AMU)-EFS ALPES MEDITERRANEE-Centre National de la Recherche Scientifique (CNRS), Etablissement Français du Sang - Alpes-Méditerranée (EFS - Alpes-Méditerranée), Etablissement Français du Sang, Unité de Recherche sur les Maladies Infectieuses Tropicales Emergentes (URMITE), Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Hôpital Nord [CHU - APHM], COMBE, Isabelle, INSB-INSB-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, and INSB-INSB-Centre National de la Recherche Scientifique (CNRS)
Subjects: [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, ComputingMilieux_MISCELLANEOUS
Abstract: International audience; no abstract
Published: 2017

47. The Accuracy of Large Loop Excision of the Transformation Zone Specimen Dimensions in Determining Volume

Author: Carcopino, Xavier, Mancini, Julien, Prendiville, Walter, Gondry, Jean, Chevreau, Julien, Lamblin, Gery, Atallah, Anthony, Lavoué, Vincent, Caradec, Claire, Baldauf, Jean-Jacques, Bryand, Angélique, Henno, Sébastien, Agostini, Aubert, Douvier, Serge, Jarniat, Adelaïde, Riethmuller, Didier, Mendel, Anne, Brun, Jean-Luc, Rakotomahenina, Hajanarina, Preaubert, Lise, Hôpital Nord [CHU - APHM], Service d'Obstétrique-Gynécologie [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], Aix Marseille Université (AMU), Biostatistique et technologies de l'information et de la communication (BioSTIC) - [Hôpital de la Timone - APHM] (BiosTIC ), Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Centre international de Recherche sur le Cancer (CIRC), Membranes et cibles thérapeutiques (MCT), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Recherche Biomédicale des Armées (IRBA), Université de Picardie Jules Verne (UPJV), CHU Amiens-Picardie, Hôpital Femme Mère Enfant [CHU - HCL] (HFME), Hospices Civils de Lyon (HCL), Physiopathologie et Pharmacotoxicologie Placentaire Humaine (U1139), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Gynécologie et Obstétrique [Rennes] = Gynaecology [Rennes], CHU Pontchaillou [Rennes], Service de gynécologie–obstétrique, CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Département de Gynécologie-Obstétrique [CHU Strasbourg], Assistance Publique - Hôpitaux de Marseille (APHM), Service de Gynécologie Obstétrique, Médecine Foetale et Stérilité Conjugale - Chirurgie Gynécologie et Oncologique [CHU de Dijon], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Service de Gynécologie Obstétrique [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), CHU Bordeaux [Bordeaux], Dupuis, Christine, Hôpital de la Timone [CHU - APHM] (TIMONE)-Assistance Publique - Hôpitaux de Marseille (APHM), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Recherche Biomédicale des Armées [Brétigny-sur-Orge] (IRBA), Département Gynécologie et oncologie [CHU Dijon], Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Recherche Biomédicale des Armées (IRBA)-Aix Marseille Université (AMU), Service de Gynécologie et Obstétrique [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-CHU Pontchaillou [Rennes]-hôpital Sud, Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Université de Franche-Comté (UFC), Unité de soins obstétricaux [CHRU Besançon] (Pôle Mère-Femme), and Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)
Subjects: [SDV] Life Sciences [q-bio], [SDV]Life Sciences [q-bio]
Abstract: International audience; Objective: The aim of the study was to determine which mathematical formula of specimen dimensions is the most accurate method of determining volume of the excised specimen at loop excision of the transformation zone.Materials and methods: A multicenter prospective observational study was conducted. A total of 258 patients who had a loop excision of the transformation zone performed as treatment of cervical intraepithelial neoplasia 2-3 were included. The dimensions and the volume of the specimen were measured at the time of the procedure, before formaldehyde fixation. The volume was measured by immersing the specimen in a graduated cylinder using Archimedes fluid displacement technique. The measured volume was compared with the calculated volume using different volume formulas, that is, a cone, a cylinder, a parallelepiped, and a hemiellipsoid. The main outcome measure was the relationship between calculated volume (using the dimensions of thickness, length, and circumference) and the measured volume of the specimen.Results: The mean (SD) thickness, length, and circumference of specimens were 8.8 mm (3.8), 12.7 mm (5.9), and 45.7 mm (16.8), respectively. The mean (SD) measured volume was 2.53 (1.49) mL. Using the formula for the volume of a cone, a cylinder, a parallelepiped and a hemiellipsoid, estimated volumes were 1.03 mL (1.22), 3.10 mL (3.65), 6.20 mL (7.31), and 2.07 mL (2.44), respectively. The highest intraclass correlation coefficient between measured and calculated volume was observed when using the formula for the volume of a hemiellipsoid specimen (0.47, 95% CI = 0.36-0.56).Conclusions: The hemiellipsoid formula is the most accurate determinant of the excised volume. Other formulas do not allow for an accurate estimation of the excised volume.
Published: 2017

48. Neonatal twin outcomes according to the planned mode of delivery: a national prospective population-based cohort study with propensity score analysis

Author: Schmitz, Thomas, Prunet, Caroline, Azria, Elie, Bongain, Andre, Chabanier, Pierre, d'Ercole, Claude, Deruelle, Philippe, Tayrac, Renaud, Dreyfus, Michel, Dupont, Corinne, Gondry, Jean, Kayem, Gilles, Langer, Bruno, Marpeau, Loic, Morel, Olivier, Perrotin, Franck, Pierre, Fabrice, Riethmuller, Didier, Senat, Marie-Victoire, Sentilhes, Loic, Vayssiere, Christophe, Winer, Norbert, Ancel, Pierre-Yves, Goffinet, Francois, Département d'obstétrique et de gynécologie [Hôpital Robert Debré], Université Paris Diderot - Paris 7 (UPD7)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique (CRESS - U1153), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Gynécologie-Obstétrique-Reproduction, Hôpital l'Archet, Centre de compétences des microangiopathies thrombotiques, CHU Bordeaux [Bordeaux], pôle gynécologie-obstétrique et médecine foetale, Service d'Obstétrique-Gynécologie [Marseille], Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille- Hôpital Nord [CHU - APHM], Service de Gynécologie - Obstétrique [Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Department of Obstetrics and Gynecologyl, CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Santé Individu Société - SIS (SIS), Université Lumière - Lyon 2 (UL2)-Université Jean Moulin - Lyon 3 (UJML), Université de Lyon-Université de Lyon-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Hospices Civils de Lyon (HCL)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe de Recherche sur l'Analyse Multimodale de la Fonction Cérébrale - UMR INSERM_S 1105 (GRAMFC), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Strasbourg, Service de Gynécologie-Obstétrique et Médecine de la Reproduction [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Département Homme au Travail (HT), Institut national de recherche et de sécurité (Vandoeuvre lès Nancy) (INRS ( Vandoeuvre lès Nancy)), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Imagerie et cerveau (iBrain - Inserm U1253 - UNIV Tours ), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Commissariat à l'énergie atomique et aux énergies alternatives - Laboratoire d'Electronique et de Technologie de l'Information (CEA-LETI), Direction de Recherche Technologique (CEA) (DRT (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Service de Gynécologie Obstétrique [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Gynécologie Obstétrique [AP-HP Hôpital Bicêtre], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Université Paris-Sud - Paris 11 - Faculté de médecine (UP11 UFR Médecine), Université Paris-Sud - Paris 11 (UP11), Service d'Obstétrique et Gynécologique [Angers], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre d'Epidémiologie et de Recherche en santé des POPulations (CERPOP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'obstétrique-gynécologie [Nantes], Centre hospitalier universitaire de Nantes (CHU Nantes), DHU Risques Et Grossesse, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), DESSAIVRE, Louise, Santé Individu Société (SIS), and Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: [SDV] Life Sciences [q-bio], [SDV]Life Sciences [q-bio]
Abstract: 37th Annual Pregnancy Meeting of the Society-for-Maternal-Fetal-Medicine (SMFM), Las Vegas, NV, JAN 23-28, 2017; International audience
Published: 2017

49. T cell Polarization toward T(H)2/T(FH)2 and T(H)17/T(FH)17 in Patients with IgG4-related Disease

Author: S. Palat, Nathalie Costedoat-Chalumeau, Alexis Régent, François Maurier, Catherine Farnarier, Anderson Loundou, Jean-Robert Harlé, Julie Graveleau, Bernard Bonotte, Aurélie Grados, Maxime Samson, Mikael Ebbo, Benjamin Terrier, Emmanuelle Bernit, Christelle Piperoglou, Mohamed Hamidou, Nathalie Morel, Nicolas Schleinitz, Frédéric Vély, Matthieu Groh, Sylvain Audia, Amandine Forestier, Hôpital de la Timone [CHU - APHM] (TIMONE), Centre d'Immunologie de Marseille - Luminy (CIML), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Laboratoire d'Immunologie [Hôpital de la Conception - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION)-Centre National de la Recherche Scientifique (CNRS), Service des maladies infectieuses et tropicales, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Université Paris Descartes - Paris 5 (UPD5), Institut Cochin (IC UM3 (UMR 8104 / U1016)), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS BFC)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Immunologie - Immunopathologie - Immunothérapeutique (I3), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Service de médecine interne et centre de référence des maladies rares [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de médecine interne et immunologie clinique (SOC 1) [CHU de Dijon], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Laboratory of Translational Immunology [Utrecht, the Netherlands], University Medical Center [Utrecht], Service de médecine interne, Hôpital Sainte-Blandine-Centre hospitalier régional Metz-Thionville (CHR Metz-Thionville), Centre hospitalier de Saint-Nazaire, Service de médecine interne [Nantes], Université de Nantes (UN)-Hôtel-Dieu-Centre hospitalier universitaire de Nantes (CHU Nantes), Service de Médecine interne A et polyclinique médicale [CHU Limoges], CHU Limoges, Aix Marseille Université (AMU), Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Service de Chirurgie, Assistance Publique - Hôpitaux de Marseille (APHM)-Hospices Civiles de Marseille-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Service d'Immunologie [AP-HM], Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Centre National de la Recherche Scientifique (CNRS)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre hospitalier régional Metz-Thionville (CHR Metz-Thionville)-Hôpital Sainte-Blandine, Assistance Publique - Hôpitaux de Marseille (APHM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION )-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Université Paris Diderot - Paris 7 (UPD7), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (HOTE GREFFON), Université de Franche-Comté (UFC)-Etablissement français du sang [Bourgogne-France-Comté] (EFS [Bourgogne-France-Comté])-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], Hôpital de la Conception [CHU - APHM] (LA CONCEPTION ), and Assistance Publique - Hôpitaux de Marseille (APHM)-Hospices Civiles de Marseille-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION )
Subjects: 0301 basic medicine, medicine.medical_treatment, T cell, Immunology, plasmablasts, Biology, CXCR3, Peripheral blood mononuclear cell, Flow cytometry, 03 medical and health sciences, Interleukin 21, T helper cells, medicine, Immunology and Allergy, Cytotoxic T cell, IgG4-related disease, B cell, medicine.diagnostic_test, 3. Good health, 030104 developmental biology, Cytokine, medicine.anatomical_structure, Sjögren’s syndrome, T follicular helper cells, [SDV.IMM]Life Sciences [q-bio]/Immunology
Abstract: International audience; IgG4-related disease (IgG4-RD) is a fibro-inflammatory disorder involving virtually every organ with a risk of organ dysfunction. Despite recent studies regarding B cell and T cell compartments, the disease's pathophysiology remains poorly understood. We examined and characterized subsets of circulating lymphocytes in untreated patients with active IgG4-RD. Twenty-eight consecutive patients with biopsy-proven IgG4-RD were included in a prospective, multicentric study. Lymphocyte's subsets were analyzed by flow cytometry, with analysis of T(H)1/T(H)2/T(H)17, T-FH cells, and cytokine release by peripheral blood mononuclear cells. Results were compared to healthy controls and to patients with primary Sjogren's syndrome. Patients with IgG4-RD showed an increase of circulating T regulatory, T(H)2, T(H)17, and CD4(+)CXCR5(+)PD1(+) TFH cell subsets. Accordingly, increased levels of IL-10 and IL-4 were measured in IgG-RD patients. TFH increase was characterized by the specific expansion of T(FH)2 (CCR6(-)CXCR3(-)), and to a lesser extent of (T(FH)17 (CCR6(+)CXCR3(-))) cells. Interestingly, CD4(+)CXCR5(+)PD1(+) TFH cells normalized under treatment. IgG4-RD is characterized by a shift of circulating T cells toward a T(H)2/T(FH)2 and T(H)17/T(FH)17 polarization. This immunological imbalance might be implicated in the disease's pathophysiology. Treatment regimens targeting such T cells warrant further evaluation.
Published: 2017

50. Unexplained infertility: live-birth’s prognostic factors to determine the ART management

Author: Ohannessian, Alexandra, Loundou, Anderson, Gnisci, Audrey, Paulmyer-Lacroix, Odile, Perrin, Jeanne, Courbiere, Blandine, Centre Clinico-Biologique d’Assistance Médicale à la Procréation - CECOS [Hôpital de la Conception - APHM], Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Unité d'Aide Méthodologique, Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, Institut méditerranéen de biodiversité et d'écologie marine et continentale (IMBE), Avignon Université (AU)-Aix Marseille Université (AMU)-Institut de recherche pour le développement [IRD] : UMR237-Centre National de la Recherche Scientifique (CNRS), Centre National de la Recherche Scientifique (CNRS)-Institut de recherche pour le développement [IRD] : UMR237-Aix Marseille Université (AMU)-Avignon Université (AU), and TASSISTRO, Virginie
Subjects: [SDV.EE.SANT]Life Sciences [q-bio]/Ecology, environment/Health, [SDV.MHEP.GEO] Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Infertility - Fertilization in vitro - Reproductive techniques, [SDV.EE.SANT] Life Sciences [q-bio]/Ecology, environment/Health, [SDV.BDLR]Life Sciences [q-bio]/Reproductive Biology, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, assisted - Pregnancy, [SDV.BDLR] Life Sciences [q-bio]/Reproductive Biology
Abstract: International audience; BACKGROUND: The purpose of this retrospective observational study was to identify prognostic factors that lead to alive birth (LB) in couples with unexplained infertility in order to define the best assisted-reproductive technique (ART)strategy.METHODS: Prognostic factors of couples with unexplained infertility managed initially with gonadotropin intrauterineinseminations (IUI) at a single university fertility center were analyzed. Infertility was not considered “unexplained” incase of mild male infertility and suspicion of diminished ovarian reserve (FSH>10 IU/L). ART management consisted tostart with IUI cycles and then, if failure, to propose in vitro fertilization (IVF). Couples were compared according to theresults of IUI cycles in terms of LB.RESULTS: Between January 2011 and July 2015, 133 couples with unexplained infertility were included (320 IUI cycles).The average age of women was 31.6±4.6 years and the average number of IUI per couple was 2.4±1.2. The IUI livebirth rate (LBR) was 37.6%, with an average of 2 cycles to obtain a pregnancy. For 63 couples, no pregnancy occurredafter IUI cycles. The prognostic factors of the two groups “LB after IUI” vs. “no LB after IUI” were not statistically different.The remaining 20 couples had a spontaneous pregnancy with a LB. Cumulative LBR, including spontaneous andART pregnancies, was 65.7 %. Of the 63 couples with no LB after IUI, 33.3% dropped-out from infertility treatmentsbefore starting IVF.CONCLUSIONS: To avoid couple’s drop-out, we advise to start infertility treatment for unexplained infertility with twoIUI before undergoing IVF if IUI failure.
Published: 2017

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