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1. Awareness among French healthcare workers of the transmission of multidrug resistant organisms: a large cross-sectional survey

Author

L. Vaillant, G. Birgand, M. Esposito-Farese, P. Astagneau, C. Pulcini, J. Robert, J. R. Zahar, E. Sales-Wuillemin, F. Tubach, J. C. Lucet, and the PerceptR Study group

Subjects
Healthcare workers, Health personnel/classification/education, Drug resistance, bacterial, Cross-infection/*prevention & control, Cross-sectional studies, Hand disinfection, Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background Much effort has been made over the last two decades to educate and train healthcare professionals working on antimicrobial resistance in French hospitals. However, little has been done in France to assess perceptions, attitudes and knowledge regarding multidrug resistant organisms (MDROs) and, more globally, these have never been evaluated in a large-scale population of medical and non-medical healthcare workers (HCWs). Our aim was to explore awareness among HCWs by evaluating their knowledge of MDROs and the associated control measures, by comparing perceptions between professional categories and by studying the impact of training and health beliefs. Methods A multicentre cross-sectional study was conducted in 58 randomly selected French healthcare facilities with questionnaires including professional and demographic characteristics, and knowledge and perception of MDRO transmission and control. A knowledge score was calculated and used in a logistic regression analysis to identify factors associated with higher knowledge of MDROs, and the association between knowledge and perception. Results Between June 2014 and March 2016, 8716/11,753 (participation rate, 74%) questionnaires were completed. The mean knowledge score was 4.7/8 (SD: 1.3) and 3.6/8 (SD: 1.4) in medical and non-medical HCWs, respectively. Five variables were positively associated with higher knowledge: working in a university hospital (adjusted odds ratio, 1.41, 95% CI 1.16–1.70); age classes 26–35 years (1.43, 1.23–1.6) and 36–45 years (1.19, 1.01–1.40); medical professional status (3.7, 3.09–4.44), working in an intensive care unit (1.28, 1.06–1.55), and having been trained on control of antimicrobial resistance (1.31, 1.16–1.48). After adjustment for these variables, greater knowledge was significantly associated with four cognitive factors: perceived susceptibility, attitude toward hand hygiene, self-efficacy, and motivation. Conclusions We found a low level of MDRO awareness and knowledge of associated control measures among French HCWs. Training on hand hygiene and measures to control MDRO spread may be helpful in shaping beliefs and perceptions on MDRO control among other possible associated factors. Messages should be tailored to professional status and their perception. Other approaches should be designed, with more effective methods of training and cognitive interventions. Trial registration Clinical Trials.gov NCT02265471. Registered 16 October 2014 - Retrospectively registered.

Published
2019
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8. Tanorexie et psoriasis sévère

Author

E. Mahé, R. Curmin, C. Paul, H. Bachelez, E. Sbidian, M. Beylot-Barry, N. Beneton, A. Dupuy, P. Joly, D. Jullien, M.A. Richard, M. Viguier, O. Chosidow, and F. Tubach

Subjects
Ocean Engineering, Safety, Risk, Reliability and Quality
Published
2022
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9. Switchs de biothérapies chez les patients atteints de psoriasis modéré à sévère dans la cohorte française PSOBIOTEQ

Author

R. Curmin, S. Guillo, Y. de Rycke, M. Beylot-Barry, N. Beneton, O. Chosidow, A. Dupuy, P. Joly, D. Jullien, M.A. Richard, M. Viguier, E. Sbidian, C. Paul, H. Bachelez, E. Mahé, and F. Tubach

Subjects
Epidemiology, Public Health, Environmental and Occupational Health, Ocean Engineering, Safety, Risk, Reliability and Quality
Published
2022
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12. Littérature médicale et COVID-19 : comment trois articles ont influencé les médias et la décision publique en France

Author

Z, Amoura, M, Miyara, F, Tubach, V, Pourcher, C, Morélot-Panzini, J, Haroche, G, Gorochov, E, Caumes, P, Hausfater, A, Combes, and T, Similowski

Subjects
Journal, Évaluation par les pairs, SARS-CoV-2, COVID-19, Prépublication, Revue, Authorship, Peer-review, Carrefour Des Spécialités, Humans, Paternité, France, Lettres À La Rédaction, Preprint
Abstract

Cet article détaille le processus et les aléas de publication de trois articles se rapportant au SARS-CoV-2 et à la maladie qu’il provoque (COVID-19). Ces trois articles ont été publiés à un mois d’intervalle, entre mars et mai 2020. Leur médiatisation a conduit les autorités de santé françaises à intervenir. Notre article ne s’intéresse pas et n’évalue pas la qualité scientifique des articles présentés, mais a pour unique objectif d’ouvrir la réflexion sur la publication médicale. En décrivant ces trois cas particuliers, il soulève des questions sur la rétractation des articles, l’évaluation par les pairs, la prépublication, la paternité des articles, et la diffusion des informations scientifiques médicales y compris via les médias de masse. Il discute des nouveaux modes d’édition qui se profilent et de la diffusion des informations publiées en recherche clinique.

Published
2021

13. AB1391 19% PATIENTS WITH CHRONIC RHEUMATIC INFLAMMATORY DISEASES PRESENT AN UNFAVORABLE PREGNANCY OUTCOME: A DESCRIPTIVE ANALYSIS OF THE NATIONAL FRENCH SOCIAL SECURITY DATABASE

Author

A. Moltó, A. Ajrouche, D. Tran, B. Roux, N. Costedoat-Chalumeau, E. Elefant, V. Tsatsaris, J. Fresson, B. Bader-Meunier, B. Fautrel, and F. Tubach

Subjects
Rheumatology, Immunology, Immunology and Allergy, General Biochemistry, Genetics and Molecular Biology
Abstract

Backgroundpatients with chronic rheumatic inflammatory diseases (CRID, i.e. rheumatoid arthritis (RA) or spondyloarthritis (SpA)) have been reported to have poorer pregnancy outcomes than the general population.Objectivesto describe the pregnancy outcomes of singleton in patients with CRID in France in the past decade.Methodsthis is an analysis of the French Health Insurance claims database (SNDS), which represents 87% of the French population) from 2008 to 2016. To be included in the analysis patients had to be identified as RA or SpA according to existing diagnostic algorithms, to have at least one pregnancy declaration in the database, and to have continuous health insurance from 1-year before pregnancy onset to 1-year after end of the pregnancy or until death (if death occured before the 1-year-period after the end of pregnancy) to be included. Only the first singleton pregnancy occurring during the study period was included in this analysis. Both maternal and pregnancy outcomes were considered. Outcomes were identified either by ICM-10 codes or hospital discharge summaries discharge between 2008-2016.ResultsAmong the 35 737 identified adult females with a CRID diagnosis (40.7% with RA and 59.3% with SpA), 27 722 (78%) had a pregnancy during the study period. 11 274 (42%) had received at least one DMARD prior to the pregnancy and were included in the analysis. Among them, only 4025 (36%) were exposed to DMARDs during pregnancy.Mean (SD) age of females at the start of the pregnancy was 32 (5) years, and mean (SD) disease duration was 4 (4) years. Pregnancy ended before 13 WG in 21% and after 37 WG in 70% cases. Live-birth represented the most frequent pregnancy outcome (76.9%), and overall 34.7% patients presented at least one unfavorable outcome (see Table 1).Table 1.Unfavourable outcomeN(%)Pregnancy outcomesMiscarriage ()579 (5.3%)Abortion91 (0.8%)Stillbirth48 (0.4%)Preterm delivery (>= 22WG and )779 (7.1%)Low weight at birth ()287 (2.6%)Perinatal mortality (22WG to 6 days of life)2 (0%)Maternal outcomesSevere maternal infection*211 (1.9%)Newborn outcomesHospitalisation in neonatal intensive care > 48h in full-term newborns (after 37 WG)95 (0.8%)Neonatal mortality (27 first days of life)2 (0%)Severe infection * during first year603 (5.3%)ConclusionMore than 75% pregnancies in patients with CRID resulted in a live-birth. Prevalence of miscarriage was surprisingly low, probably related to under-coding. Maternal and infant outcomes seemed comparable to general population. Whether medications had an impact on such outcomes is currently under evaluation.Disclosure of InterestsNone declared

Published
2022
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14. POS1405 LESS THAN 50% FEMALES WITH CHRONIC RHEUMATIC INFLAMMATORY DISEASES CONTINUE A DMARD DURING PREGNANCY: A DESCRIPTIVE ANALYSIS OF THE NATIONAL FRENCH SOCIAL SECURITY DATABASE

Author

A. Moltó, A. Ajrouche, D. Tran, B. Roux, N. Costedoat-Chalumeau, E. Elefant, V. Tsatsaris, J. Fresson, B. Bader-Meunier, B. Fautrel, and F. Tubach

Subjects
Rheumatology, Immunology, Immunology and Allergy, General Biochemistry, Genetics and Molecular Biology
Abstract

BackgroundTreatment of patients with chronic rheumatic inflammatory diseases (CRID) during pregnancy has changed in the last decade, namely due to the availability of new DMARDs labelled to be used during pregnancy.ObjectivesTo describe the anti-rheumatic drug use during pregnancy in women with CRID (i.e. rheumatoid arthritis (RA) or spondyloarthritis (SpA)) in France over the past decade.MethodsThis is a retrospective cohort study within the French Healthcare database (SNDS), which covers 98% of the French population. Adult women were included if they had RA or SpA according to CIM-10 codes, had started a singleton pregnancy between 2008 and 2017 (index date), and were continuously covered by this health insurance from 1-year before pregnancy onset to 1-year after end of the pregnancy or death (whichever comes first). The treatment exposures of interest were: NSAIDs, oral corticosteroids, csDMARD (methotrexate, leflunomide, sulfasalazine, azathioprine, hydroxychloroquine), biologics (anti-TNF, rituximab, abatacept, tocilizumab, ustekinumab, anakinra). Exposure during pregnancy was defined as at least one drug reimbursement from the 6 months before the last menstrual period (LMP) to the end of pregnancy period.ResultsAmong the 35,737 adult women with a CIRD (40.7% with RA and 59.3% with SpA) who had a past history of DMARD reimbursement, 11,274 (41.7%) started a singleton pregnancy during the study period. In total, during preconception and pregnancy, 4,773 (42.3%) women were not delivered any DMARD nor corticosteroids, 769 (6.8%) were delivered corticosteroids alone, 3,639 (32.2%) a csDMARD alone and 2,862 (25.4%) a biologic (among whom 33.1% associated a csDMARD). Biologics delivered during pregnancy were mainly anti-TNFs (92.1%).Exposure to NSAIDs was more frequent during the first trimester (30% patients) of pregnancy but occurred all along the pregnancy (6% and 2% in the second and third trimesters, respectively). Conversely, exposure to oral corticosteroids was stable during the pregnancy (33% to 27%); however, more than half of the prescriptions corresponded to doses higher than 10mg. Exposure to DMARDs including bDMARDs during pregnancy was more frequent during the first trimester, compared to the rest of the pregnancy (see graph).ConclusionOverall, less than 50% of women with a CRID who received a DMARD prior to the pregnancy continued to retrieve such treatment during pregnancy, and overall less than 20% were delivered biologics during pregnancy. Whether the withdrawal of DMARDs led to unfavorable maternal and pregnancy outcomes needs to be evaluated.AcknowledgementsThis study was conducted thanks to a grant from the French Ministry of Health - Programme Hospitalier de Recherche CliniqueDisclosure of InterestsAnna Moltó Consultant of: UCB, Abbvie, Lilly, Pfizer, BMS, MSD, Novartis, Biogen, Janssen, Grant/research support from: UCB, Aya Ajrouche: None declared, Diep Tran: None declared, Barbara Roux: None declared, Nathalie Costedoat-Chalumeau Grant/research support from: UCB, Elisabeth Elefant: None declared, Vassilis Tsatsaris: None declared, Jeanne Fresson: None declared, Brigitte Bader-Meunier: None declared, Bruno Fautrel: None declared, Florence Tubach: None declared

Published
2022
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15. AB0366 A PROSPECTIVE OBSERVATIONAL STUDY TO ASSESS THE REAL-WORLD EFFECTIVENESS OF GOLIMUMAB IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS AND PREVIOUSLY TREATED WITH INITIAL TNFα INHIBITORY THERAPY

Author

C. Gaujoux-Viala, J. Sellam, F. Tubach, N. Harid, B. Combe, and R. M. Flipo

Subjects
Rheumatology, Immunology, Immunology and Allergy, General Biochemistry, Genetics and Molecular Biology
Abstract

BackgroundTNF inhibitor (TNFi) treatment is standard for RA patients even though many reasons may lead to TNFi therapy failures such as lack of effectiveness, patient dissatisfaction or limited therapy adherence, or even safety. As a consequence, patients may switch to a different TNFi. The efficacy of golimumab (GLM) in RA patients with inadequate response to TNFi was demonstrated in the Go-AFTER phase III clinical trial.ObjectivesThe objectives of the present Go-BEYOND study were to provide real-world data to evaluate disease activity and treatment persistence with GLM as a second line TNFi therapy in RA patients over a one-year follow-up.MethodsGo-BEYOND is an observational French multicenter prospective cohort study. All consecutive patients over 18 years of age with a diagnosis of active RA were eligible at the time of initial GLM prescription. To be included, patients had to be previously treated with only 1 TNFi (discontinued for any reason) other than GLM. Patients were ineligible if they had been previously treated with other “non-TNFi” biologics or more than one TNFi.The study’s primary outcome was the percentage of RA patients with a Disease Activity Score (DAS28-CRP score) ≤ 3.2 at the 6-month visit (M6 visit). Patients who permanently discontinued their treatment over the 1-year follow-up were considered as non-responders. The secondary outcomes were analyzed descriptively and included (but not limited to) DAS28-CRP score at 12-month visit (M12 visit), EULAR criteria assessment, treatment persistence analysis, HAQ score, RAPID3 score, and patient acceptable symptom state and satisfaction with the injection. The study was approved by a French Ethics Committee in July 2017.ResultsA total of 128 patients (72.7% female, median age 58.2 years, and duration of RA 13.2 ± 11.4 years) met the inclusion criteria. Anti-CPP antibodies and rheumatoid factors were present in 80 (62.5%) and 81 (63.3%) patients, respectively. In the majority, the initial TNFi was etanercept (n=88, 68.8%), then adalimumab (n=25, 19.5%). The reasons for switching to GLM were secondary non-response (i.e., lack of effectiveness after an initial response to the treatment) for 75 (58.6%) patients, then safety (n=22, 17.2%), primary non-response (n=21, 16.4%), and other personal or medical reasons (n=10, 7.8%).At the M6 and M12 visits, a small number of patients, 27 (21.1%) and 48 (37.5%) had respectively permanently discontinued their GLM treatment and were considered as non-responders. At the M6 visit, 48 patients over the 128 included (37.5%) had a DAS28-CRP ≤ 3.2 and 32 (25%) < 2.6. At M12 visit, 41 (32%) patients had a DAS28-CRP ≤ 3.2 and 31 (24.2%) < 2.6. According to EULAR response criteria thresholds, 49 (38.3%) and 45 (35.2%) patients had a good or moderate response to GLM at the M6 and M12 visits.ConclusionThe Go-BEYOND study confirms that in RA, a non-response to a first TNFi does not exclude a response to GLM as a second-line biologic in a substantial proportion of patients in real-life settings.ReferencesNoneAcknowledgementsWe would like to thank the investigators and the entire Go-BEYOND team for their involvement in the study.Disclosure of InterestsCécile Gaujoux-Viala Consultant of: AbbVie; Amgen; Boehringer Ingelheim; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; UCB, Jérémie SELLAM Consultant of: Abbvie; Biogen; BMS; Fresenius Kabi; Janssen; MSD; Novartis; Pfizer; Roche, Florence Tubach: None declared, Naoual HARID Employee of: MSD France - Medical advisor, Bernard Combe Consultant of: AbbVie; Bristol-Myers Squibb; Celltrion; Eli Lilly; Gilead/Galapagos; Janssen; Merck; Novartis; Pfizer; Roche/Chugai; Sanofi; UCB, René-Marc Flipo Consultant of: Abbvie; BMS; Janssen; MSD; Pfizer; Roche-Chugai

Published
2022
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20. Les soins primaires : une définition du champ pour développer la recherche

Author

A. Verga-Gérard, M. Afonso, A. Bénard, A. Chapron, K. Chau, E. Doussiet, F. Guillemin, S. Guillo, D. Gonthier, S. Lafarge, M. Lapeyre-Mestre, M. Oriol, F. Tubach, CIC-EC - Bordeaux, Université Bordeaux Segalen - Bordeaux 2-CHU Bordeaux [Bordeaux]-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'investigation clinique [Nancy] (CIC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Centre d'Investigation Clinique de La Réunion - INSERM (CIC 1410), Université de La Réunion (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de La Réunion (CHU La Réunion), CIC AP-HP [CHU Pitié-Salpêtrière], 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), Centre d'investigation clinique de Toulouse (CIC 1436), 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)-Pôle Santé publique et médecine publique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CIC Saint Etienne, Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Nord (Saint Etienne), VERGA-GERARD, Amandine, Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Pôle Santé publique et médecine publique [CHU Toulouse], Centre d'Investigation Clinique - Epidémiologie Clinique Saint-Etienne (CIC-EC), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), 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), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), and Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne)-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Nord (Saint Etienne)

Subjects
medicine.medical_specialty, Epidemiology, media_common.quotation_subject, Context (language use), Primary care, 0603 philosophy, ethics and religion, Santé publique, 03 medical and health sciences, 0302 clinical medicine, Soins primaires, Nursing, Multidisciplinary approach, Médecine générale, Global health, medicine, 030212 general & internal medicine, Sociology, media_common, Public health, Public Health, Environmental and Occupational Health, 06 humanities and the arts, 16. Peace & justice, 3. Good health, Work (electrical), [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Public Health, 060301 applied ethics, General practice, Inclusion (education), Diversity (politics)
Abstract

International audience; Background - Research in the field of primary care has dramatically increased in France in recent years, especially since 2013 with the introduction of primary care as a thematic priority for research proposals launched by the Ministry of Health (Direction générale de l'offre de soins). Material and methods - The RECaP (Research in Clinical Epidemiology and Public Health) network is a French research network supported by Inserm, which recently implemented a specific working group focusing on research in primary care, based on a multidisciplinary approach. Researchers from different specialties participate in this group. The first aim of the group was to reach a common definition of the perimeter and of the panel of healthcare professionals and structures potentially involved in the field of primary care. For this purpose, a selection of different data sets of sources defining primary care was analyzed by the group, each participant collecting a set of sources, from which a synthesis was made and discussed. Results - A definition of primary care at different levels (international, European and French) was summarized. A special attention was given to the French context in order to adapt the perimeter to the characteristics of the French healthcare system, notably by illustrating the different key elements of the definition with the inclusion of primary care actors and the type of practice premises. Conclusion - In conclusion, this work illustrates the diversity of primary care in France and the potential offered for research purposes.

Published
2018
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21. MOESM1 of Awareness among French healthcare workers of the transmission of multidrug resistant organisms: a large cross-sectional survey

Author

L. Vaillant, G. Birgand, M. Esposito-Farese, P. Astagneau, C. Pulcini, J. Robert, J. Zahar, E. Sales-Wuillemin, F. Tubach, and J. Lucet

Subjects
genetic structures, psychological phenomena and processes
Abstract

Additional file 1: Table S1. Knowledge of antimicrobial resistance and infection control measures. Table S2. Perceptions regarding antimicrobial resistance and control measures. Table S3. Questions on perception of antimicrobial resistance and control measures.

Published
2019
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22. Community-acquired pneumonia in the emergency department: an algorithm to facilitate diagnosis and guide chest CT scan indication

Author

P. Loubet, S. Tubiana, Y.E. Claessens, L. Epelboin, C. Ficko, J. Le Bel, B. Rammaert, N. Garin, V. Prendki, J. Stirnemann, C. Leport, Y. Yazdanpanah, E. Varon, X. Duval, E. Bouvard, M.F. Carette, M.P. Debray, C. Mayaud, N. Houhou, M. Benjoar, F.X. Blanc, A.L. Brun, A. Khalil, H. Lefloch, J.M. Naccache, A. Abry, J.C. Allo, S. Andre, C. Andreotti, N. Baarir, M. Bendahou, L. Benlafia, J. Bernard, A. Berthoumieu, M.E. Billemont, J. Bokobza, E. Burggraff, P. Canavaggio, E. Casalino, S. Castro, C. Choquet, H. Clément, L. Colosi, A. Dabreteau, S. Damelincourt, S. Dautheville, M. Delay, S. Delerme, L. Depierre, F. Djamouri, F. Dumas, M.R.S. Fadel, A. Feydey, Y. Freund, L. Garcia, H. Goulet, P. Hausfater, E. Ilic-Habensus, M.O. Josse, J. Kansao, Y. Kieffer, F. Lecomte, K. Lemkarane, P. Madonna, O. Meyniard, L. Mzabi, D. Pariente, J. Pernet, F. Perruche, J.M. Piquet, R. Ranerison, P. Ray, F. Renai, E. Rouff, D. Saget, K. Saïdi, G. Sauvin, E. Trabattoni, N. Trimech, C. Auger, B. Pasquet, S. Tamazirt, J.M. Treluyer, F. Tubach, J. Wang, O. Chassany, C. Misse, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, Hôpital Princesse Grace [Monaco], Centre Hospitalier Andrée Rosemon [Cayenne, Guyane Française], Ecosystemes Amazoniens et Pathologie Tropicale (EPat), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Guyane (UG), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital d'Instruction des Armées Begin, Service de Santé des Armées, Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Faculté de Médecine et Médecine Dentaire [UCLouvain], Université Catholique de Louvain = Catholic University of Louvain (UCL), Hôpitaux Universitaires de Genève (HUG), Centre National de Référence des Pneumocoques (CNRP), Assistance Publique - Hôpitaux de Paris, Centre Hospitalier Intercommunal de Créteil (CHIC), Université Paris Diderot, Sorbonne Paris Cité, Paris, France, Université Paris Diderot - Paris 7 (UPD7), CIC1425 Bichat [AP-HP Hôpital Bichat - Claude Bernard] (INSERM), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, 0301 basic medicine, Emergency Medical Services, Chest CT scan, [SDV]Life Sciences [q-bio], Tomography, X-Ray Computed/methods, Chest ct, Diagnostic methods, Chest pain, 0302 clinical medicine, Community-acquired pneumonia, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Diagnosis, Public Health Surveillance, 030212 general & internal medicine, ddc:616, Aged, 80 and over, Emergency Medical Services/statistics & numerical data, Area under the curve, Disease Management, General Medicine, Middle Aged, Polymerase chain reaction, 3. Good health, Respiratory pathogens, Community-Acquired Infections, Infectious Diseases, Cohort, Female, Radiography, Thoracic, medicine.symptom, Emergency Service, Hospital, Algorithm, Algorithms, Microbiology (medical), Clinical Decision-Making, 030106 microbiology, Sensitivity and Specificity, 03 medical and health sciences, Community-Acquired Infections/diagnosis/epidemiology/microbiology, medicine, Humans, Aged, Respiratory viruses, Emergency department, business.industry, Pneumonia, medicine.disease, ddc:618.97, Tomography, X-Ray Computed, business, Biomarkers, Pneumonia/diagnosis/epidemiology/microbiology
Abstract

International audience; Objective: The aim was to create and validate a community-acquired pneumonia (CAP) diagnostic algorithm to facilitate diagnosis and guide chest computed tomography (CT) scan indication in patients with CAP suspicion in Emergency Departments (ED).Methods: We performed an analysis of CAP suspected patients enrolled in the ESCAPED study who had undergone chest CT scan and detection of respiratory pathogens through nasopharyngeal PCRs. An adjudication committee assigned the final CAP probability (reference standard). Variables associated with confirmed CAP were used to create weighted CAP diagnostic scores. We estimated the score values for which CT scans helped correctly identify CAP, therefore creating a CAP diagnosis algorithm. Algorithms were externally validated in an independent cohort of 200 patients consecutively admitted in a Swiss hospital for CAP suspicion.Results: Among the 319 patients included, 51% (163/319) were classified as confirmed CAP and 49% (156/319) as excluded CAP. Cough (weight = 1), chest pain (1), fever (1), positive PCR (except for rhinovirus) (1), C-reactive protein ≥50 mg/L (2) and chest X-ray parenchymal infiltrate (2) were associated with CAP. Patients with a score below 3 had a low probability of CAP (17%, 14/84), whereas those above 5 had a high probability (88%, 51/58). The algorithm (score calculation + CT scan in patients with score between 3 and 5) showed sensitivity 73% (95% CI 66-80), specificity 89% (95% CI 83-94), positive predictive value (PPV) 88% (95% CI 81-93), negative predictive value (NPV) 76% (95% CI 69-82) and area under the curve (AUC) 0.81 (95% CI 0.77-0.85). The algorithm displayed similar performance in the validation cohort (sensitivity 88% (95% CI 81-92), specificity 72% (95% CI 60-81), PPV 86% (95% CI 79-91), NPV 75% (95% CI 63-84) and AUC 0.80 (95% CI 0.73-0.87).Conclusion: Our CAP diagnostic algorithm may help reduce CAP misdiagnosis and optimize the use of chest CT scan.

Published
2020
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24. Analyse du réseau de prise en charge de la transplantation rénale au sein du groupe hospitalier AP-HP.6

Author

S. Tezenas du Montcel, F. Tubach, M. Fages, P. Rufat, S. Drouin, and Benjamin Granger

Subjects
Epidemiology, Public Health, Environmental and Occupational Health
Abstract

Introduction La transformation des organisations est contrainte par une logique d’efficience, sous-tendue par l’amelioration de la qualite et la gestion des risques, et l’emergence du financement au parcours. L’objectif est d’analyser le reseau de prise en charge des transplantations renales au sein du GH AP–HP.6. Methodes Une etude observationnelle appliquant les methodes issues des analyses de reseaux sociaux a l’organisation des soins, a ete mise en place. Les donnees issues du PMSI pour 2017 des six hopitaux composant le groupe hospitalier AP–HP.6 ont ete analysees. Les sejours selectionnes sont ceux des patients qui ont eu une transplantation renale (GHM 27C02) a l’exclusion des seances (GHM 28Z). Les mesures de centralite developpees par Linton Freeman ont ete utilisees pour decrire le reseau et le positionnement des unites medicales et identifier les sous-structures homogenes. Resultats En 2017, 189 patients ont eu une transplantation renale cumulant 677 sejours repartis principalement sur deux hopitaux. Le reseau est compose de 36 URM et de 122 relations (faible densite = 0,09). Une reciprocite (0,93) et une transitivite eleve (0,36) laisse entendre que l’on a des services localement tres lies entre eux. On distingue deux sous-ensembles sur deux hopitaux : un premier compose de 21 noeuds avec une tres forte centralite du service d’urologie et de nombreux services peripheriques, laissant sous-entendre un pilotage chirurgical ; un second compose de 15 noeuds centre autour des services d’urgence nephrologique et de transplantation et de nephrologie, temoin d’un pilotage plus medicalise. Discussion/Conclusion Le schema d’organisation de la prise en charge repond a une clusterisation autant geographique que disciplinaire. Les differences inter-hopitaux s’expliquent par des modalites organisationnelles propres a chaque equipe de greffe ; aussi les differentes strategies de « bed management » des institutions peuvent expliquer le recours a des services plus peripheriques. Les analyses de reseaux fournissent un outil puissant pour decrire les organisations et accompagner leurs mutations en integrant des indicateurs de resultat et de satisfaction afin que les transformations se fassent pour le bien de tous.

Published
2019
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25. Erratum to: 36th International Symposium on Intensive Care and Emergency Medicine

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null Author et al, R. M. Bateman, M. D. Sharpe, J. E. Jagger, C. G. Ellis, J. Solé-Violán, M. López-Rodríguez, E. Herrera-Ramos, J. Ruíz-Hernández, L. Borderías, J. Horcajada, N. González-Quevedo, O. Rajas, M. Briones, F. Rodríguez de Castro, C. Rodríguez Gallego, F. Esen, G. Orhun, P. Ergin Ozcan, E. Senturk, C. Ugur Yilmaz, N. Orhan, N. Arican, M. Kaya, M. Kucukerden, M. Giris, U. Akcan, S. Bilgic Gazioglu, E. Tuzun, R. Riff, O. Naamani, A. Douvdevani, R. Takegawa, H. Yoshida, T. Hirose, N. Yamamoto, H. Hagiya, M. Ojima, Y. Akeda, O. Tasaki, K. Tomono, T. Shimazu, S. Ono, T. Kubo, S. Suda, T. Ueno, T. Ikeda, H. Ogura, H. Takahashi, J. Kang, Y. Nakamura, T. Kojima, Y. Izutani, T. Taniguchi, M. O, C. Dinter, J. Lotz, B. Eilers, C. Wissmann, R. Lott, M. M. Meili, P. S. Schuetz, H. Hawa, M. Sharshir, M. Aburageila, N. Salahuddin, V. Chantziara, S. Georgiou, A. Tsimogianni, P. Alexandropoulos, A. Vassi, F. Lagiou, M. Valta, G. Micha, E. Chinou, G. Michaloudis, A. Kodaira, H. Imaizumi, M. 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Best, A. Vercueil, G. Auzinger, A. Borgman, A. G. Proudfoot, E. Grins, K. E. Emiley, J. Schuitema, S. J. Fitch, G. Marco, J. Sturgill, M. G. Dickinson, M. Strueber, A. Khaghani, P. Wilton, S. M. Jovinge, C. Sampson, S. Harris-Fox, M. E. Cove, L. H. Vu, A. Sen, W. J. Federspiel, J. A. Kellum, C. Mazo Torre, J. Riera, S. Ramirez, B. Borgatta, L. Lagunes, J. Rello, A. K. Kuzovlev, A. Goloubev, S. Nenchuk, V. Karavana, C. Glynos, A. Asimakos, K. Pappas, C. Vrettou, M. Magkou, E. Ischaki, G. Stathopoulos, S. Zakynthinos, I. Kozhevnikova, F. Dalla Corte, S. Grasso, P. Casolari, G. Caramori, T. Andrianjafiarinoa, T. Randriamandrato, T. Rajaonera, S. El-Dash, E. L. V. Costa, M. R. Tucci, F Leleu, L Kontar, G. Bacari-Risal, M. Amato, S. El Dash, null Remmington, A. Fischer, S. Squire, M. Boichat, H. Honzawa, H. Yasuda, T. Adati, S. Suzaki, M. Horibe, M. Sasaki, M. Sanui, J. Daniel, H. Miranda, K. Milinis, M. Cooper, G. R. Williams, E. McCarron, S. Simants, I. Patanwala, I. Welters, Y. Su, J. Fernández Villanueva, R. Fernández Garda, A. López Lago, E. Rodríguez Ruíz, R. Hernández Vaquero, S. Tomé Martínez de Rituerto, E. Varo Pérez, N. Lefel, F. Schaap, D. Bergmans, S. Olde Damink, M. Van de Poll, K. Tizard, C. Lister, L. Poole, D. Ringaitiene, D. Gineityte, V. Vicka, I. Norkiene, J. Sipylaite, A. O’Loughlin, V. Maraj, J. Dowling, M. B. Velasco, D. M. Dalcomune, E. B. Dias, S. L. Fernandes, T. Oshima, S. Graf, C. Heidegger, L. Genton, V. Karsegard, Y. Dupertuis, C. Pichard, N. Friedli, Z. Stanga, L. Vandersteen, B. Stessel, S. Evers, A. Van Assche, L. Jamaer, J. Dubois, H. Castro, J. Valente, P. Martins, P. Casteloes, C. Magalhaes, S. Cabral, M. Santos, B. Oliveira, A. Salgueiro, S. Duarte, S. Castro, M. Melo, S. Gray, K. Maipang, R. Bhurayanontachai, L. G. Grädel, P. Schütz, P. Langlois, W. Manzanares, M. Lemieux, G. Elke, F. Bloos, D. Heyland, I. Aramendi, N. Babo, M. Hoshino, Y. Haraguchi, S. Kajiwara, T. Mitsuhashi, T. Tsubata, M. Aida, T. Rattanapraphat, C. Kongkamol, B. Xavier, C. Koutsogiannidis, M. Moschopoulou, G. Taskin, M. Çakir, AK Güler, A. Taskin, N. Öcal, S. Özer, L. Yamanel, J. M. Wong, C. Fitton, S. Anwar, S. Stacey, M. Aggou, B. Fyntanidou, S. Patsatzakis, E. Oloktsidou, K. Lolakos, E. Papapostolou, V. Grosomanidis, S. Gaudry, V. Desailly, P. Pasquier, PB Brun, AT Tesnieres, JD Ricard, D. Dreyfuss, A. Mignon, J. C White, A. Stilwell, G. Friedlaender, M. Peters, S. Stipulante, A. Delfosse, AF Donneau, A. Ghuysen, C. Feldmann, D. Freitag, W. Dersch, M. Irqsusi, D. Eschbach, T. Steinfeldt, H. Wulf, T. Wiesmann, J. Cholkraisuwat, S. Beitland, E. Nakstad, H. Stær-Jensen, T. Drægni, G. Andersen, D. Jacobsen, C. Brunborg, B. Waldum-Grevbo, K. Sunde, K. Hoyland, D. Pandit, K. Hayakawa, K. Kotzampassi, L. Loukipoudi, E. Doumaki, M. M. Admiraal, M. Van Assen, M. J. Van Putten, M. Tjepkema-Cloostermans, A. F. Van Rootselaar, F. Ragusa, A. Marudi, S. Baroni, A. Gaspari, E. Bertellini, T. Abdullah, S. Abdel Monem, S. Alcorn, S. McNeill, S. Russell, W. Eertmans, C. Genbrugge, I. Meex, J. Dens, F. Jans, C. De Deyne, B Avard, R Burns, A. Patarchi, T. Spina, H. Tanaka, N. Otani, S. Ode, S. Ishimatsu, J. Cho, J. B. Moon, C. W. Park, T. G. Ohk, M. C. Shin, M. H. Won, S. Dakova, Z. Ramsheva, K. Ramshev, A Marudi, S Baroni, A Gaspari, E Bertellini, P. E. Ozcan, S. Sencer, C. Ulusoy, M. Fallenius, M. B. Skrifvars, M. Reinikainen, S. Bendel, R. Raj, M. Abu-Habsa, C. Hymers, A. Borowska, H. Sivadhas, S. Sahiba, S. Perkins, J. Rubio, J. A. Rubio, R. Sierra, S. English, M. Chasse, A. Turgeon, F. Lauzier, D. Griesdale, A. Garland, D. Fergusson, R. Zarychanski, A. Tinmouth, C. Van Walraven, K. Montroy, J. Ziegler, R. Dupont Chouinard, R. Carignan, A. Dhaliwal, C. Lum, J. Sinclair, G. Pagliarello, L. McIntyre, T. Groza, N. Moreau, D. Castanares-Zapatero, P. Hantson, M. Carbonara, F. Ortolano, T. Zoerle, S. Magnoni, S. Pifferi, V. Conte, N. Stocchetti, L. Carteron, T. Suys, C. Patet, H. Quintard, M. Oddo, V. Spatenkova, E. Pokorna, P. Suchomel, N. Ebert, T. Bylinski, C. Hawthorne, M. Shaw, I. Piper, J. Kinsella, A. K. Kink, I. R. Rätsep, A. Boutin, L. Moore, J. Lacroix, P. Lessard-Bonaventure, A. F. Turgeon, R. Green, M. Erdogan, M. Butler, P. Desjardins, D. A. Fergusson, B. Goncalves, B. Vidal, C. Valdez, A. C. Rodrigues, L. Miguez, G. Moralez, T. Hong, A. Kutz, P. Hausfater, D. Amin, T. Struja, S. Haubitz, A. Huber, T. Brown, J. Collinson, C. Pritchett, T. Slade, M. Le Guen, S. Hellings, R. Ramsaran, A. Alsheikhly, T. Abe, L. Kanapeckaite, R. Bahl, M. Q. Russell, K. J. Real, R. M. Lyon, N. P. Oveland, J. Penketh, M. Mcdonald, F. Kelly, M. Alfafi, W. Almutairi, B. Alotaibi, A. E Van den Berg, Y. Schriel, L. Dawson, I. A. Meynaar, D. Silva, S. Fernandes, J. Gouveia, J. Santos Silva, J. Foley, A. Kaskovagheorgescu, D. Evoy, J. Cronin, J. Ryan, M. Huck, C. Hoffmann, J. Renner, P. Laitselart, N. Donat, A. Cirodde, J. V. Schaal, Y. Masson, A. Nau, O. Howarth, K. Davenport, P. Jeanrenaud, S. Raftery, P. MacTavish, H. Devine, J. McPeake, M. Daniel, T. Quasim, S. Alrabiee, A. Alrashid, O. Gundogan, C. Bor, E. Akýn Korhan, K. Demirag, M. Uyar, F. Frame, C. Ashton, L. Bergstrom Niska, P. Dilokpattanamongkol, T. Suansanae, C. Suthisisang, S. Morakul, C. Karnjanarachata, V. Tangsujaritvijit, S. Mahmood, H. Al Thani, A. Almenyar, S. E. Morton, Y. S. Chiew, C. Pretty, J. G. Chase, G. M. Shaw, P. Kordis, V. Grover, I. Kuchyn, K. Bielka, Z. Aidoni, G. Stavrou, C. Skourtis, S. D. Lee, K. Williams, I. D. Weltes, S. Berhane, C. Arrowsmith, C. Peters, S. Robert, R. B. Panerai, T. G. Robinson, E. Borg-Seng-Shu, M. De Lima Oliveira, N. C. Mian, R. Nogueira, S. P. Zeferino, M. Jacobsen Teixeira, P. Killeen, M. McPhail, W. Bernal, J. Maggs, J. Wendon, T. Hughes, L. U. Taniguchi, E. M. Siqueira, J. M. Vieira Jr, L. C. Azevedo, A. N. Ahmad, E. Helme, S. Hadfield, J. Shak, C. Senver, R. Howard-Griffin, P. Wacharasint, P. Fuengfoo, N. Sukcharoen, R. Rangsin, D. Sbiti-Rohr, H. Na, S. Song, S. Lee, E. Jeong, K. Lee, E. Zoumpelouli, E. A Volakli, V. Chrysohoidou, K. Charisopoulou, E. Kotzapanagiotou, K. Manavidou, Z. Stathi, B. AlGhamdi, Q. Marashly, K. Zaza, M. Khurshid, Z. Ali, M. Malgapo, M. Jamil, A. Shafquat, M. Shoukri, M. Hijazi, F. A. Rocha, K. Ebecken, L. S. Rabello, M. F. Lima, R. Hatum, F. V. De Marco, A. Alves, J. E. Pinto, M. Godoy, P. E. Brasil, F. A. Bozza, J. I. Salluh, M. Soares, J. Krinsley, G. Kang, J. Perry, H. Hines, K. M. Wilkinson, C. Tordoff, B. Sloan, M. C. Bellamy, E. Moreira, F. Verga, M. Barbato, G. Burghi, M Soares, U. V. Silva, A. P. Torelly, J. M. Kahn, D. C. Angus, M. F. Knibel, R. Marshall, T. Gilpin, D. Mota, B. Loureiro, J. Dias, O. Afonso, F. Coelho, A. Martins, F. Faria, H. Al Orainni, F. AlEid, H. Tlaygeh, A. Itani, A. Hejazi, J. Messika, J. D. Ricard, S. Guillo, B. Pasquet, E. Dubief, F. Tubach, K. James, P. Temblett, L. Davies, C. Lynch, S. Pereira, S. Cavaco, J. Fernandes, I. Moreira, E. Almeida, F. Seabra Pereira, M. Malheiro, F. Cardoso, I. Aragão, T. Cardoso, M. Fister, P. Muraray Govind, N. Brahmananda Reddy, R. Pratheema, E. D. Arul, J. Devachandran, N. Chin-Yee, G. D’Egidio, K. Thavorn, K. Kyeremanteng, A. G. Murchison, K. Swalwell, J. Mandeville, D. Stott, I. Guerreiro, C. Goossens, M. B. Marques, S. Derde, S. Vander Perre, T. Dufour, S. E. Thiessen, F. Güiza, T. Janssens, G. Hermans, I. Vanhorebeek, K. De Bock, G. Van den Berghe, L. Langouche, B. Miles, S. Madden, M. Weiler, P. Marques, C. Rodrigues, M. Boeira, K. Brenner, C. Leães, A. Machado, R. Townsend, J. Andrade, R. Kishore, C. Fenlon, T. Fiks, A. Ruijter, M. Te Raa, P. Spronk, P. Docherty, J. Dickson, E. Moltchanova, C. Scarrot, T. Hall, W. C. Ngu, J. M. Jack, A. Pavli, X. Gee, E. Akin Korhan, M. Shirazy, A. Fayed, S. Gupta, A. Kaushal, S. Dewan, A. Varma, E. Ghosh, L. Yang, L. Eshelman, B. Lord, E. Carlson, R. Broderick, J. Ramos, D. Forte, F. Yang, J. Feeney, K. Wilkinson, K. Shuker, M. Faulds, D. Bryden, L. England, K Shuker, A Tridente, M Faulds, A Matheson, J. Gaynor, D Bryden, S South Yorkshire Hospitals Researc ᅟ, B. Peroni, R. Daglius-Dias, L. Miranda, C. Cohen, C. Carvalho, I. Velasco, J. M. Kelly, A. Neill, G. Rubenfeld, N. Masson, A. Min, E. Boezeman, J. Hofhuis, A. Hovingh, R. De Vries, G. Cabral-Campello, M. Van Mol, M. Nijkamp, E. Kompanje, P. Ostrowski, K. Kiss, B. Köves, V. Csernus, Z. Molnár, Y. Hoydonckx, S. Vanwing, V. Medo, R. Galvez, J. P. Miranda, C. Stone, T. Wigmore, Y. Arunan, A. Wheeler, Y. Wong, C. Poi, C. Gu, P. Molmy, N. Van Grunderbeeck, O. Nigeon, M. Lemyze, D. Thevenin, J. Mallat, M. Correa, R. T. Carvalho, A. Fernandez, C. McBride, E. Koonthalloor, C. Walsh, A. Webber, M. Ashe, K. Smith, E. A. Volakli, M. Dimitriadou, P. Mantzafleri, O. Vrani, A. Arbouti, T. Varsami, J. A. Bollen, T. C. Van Smaalen, W. C. De Jongh, M. M. Ten Hoopen, D. Ysebaert, L. W. Van Heurn, W. N. Van Mook, A. Roze des Ordons, P. Couillard, C. Doig, R. V. Van Keer, R. D. Deschepper, A. F. Francke, L. H. Huyghens, J. B. Bilsen, B. Nyamaizi, C. Dalrymple, A. Dobru, E. Marrinan, A. Ankuli, R. Struthers, R. Crawford, P. Mactavish, P. Morelli, M. Degiovanangelo, F. Lemos, V. MArtinez, J. Cabrera, A. Rutten, S. Van Ieperen, S. De Geer, M. Van Vugt, E. Der Kinderen, A. Giannini, G Miccinesi, T Marchesi, and E Prandi

Subjects
0301 basic medicine, 03 medical and health sciences, medicine.medical_specialty, 030219 obstetrics & reproductive medicine, 030104 developmental biology, 0302 clinical medicine, business.industry, Intensive care, Emergency medicine, Medicine, Critical Care and Intensive Care Medicine, business
Published
2016
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27. Utilisation de la ceinture thoracique Autopulse™, dispositif automatisé de massage cardiaque externe, dans la réanimation de l’arrêt cardiaque extrahospitalier: quel impact sur l’hémodynamique ?

Author

Jean Mantz, François-Xavier Duchateau, C. Broche, A. Ricard-Hibon, F. Tubach, P. Gueye, P. Plaisance, S. Curac, and D. Payen

Subjects
Gynecology, medicine.medical_specialty, business.industry, Emergency Medicine, Medicine, External cardiac massage, business
Abstract

Objectifs L’objectif de l’etude a ete d’evaluer l’impact de l’utilisation d’un dispositif de massage cardiaque externe (MCE) automatique (ceinture thoracique [CT] Autopulse ™) sur la pression arterielle (PA) au cours de la reanimation specialisee de l’arret cardiaque (AC) extrahospitalier, en particulier sur la PA diastolique, determinant de la perfusion coronaire.

Published
2011
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28. Quantification des lymphocytes T mémoires spécifiques des curares dans le diagnostic de l’anaphylaxie peropératoire

Author

S. Petit, Bernard Noël, Sylvie Chollet-Martin, S. Peltier, Aurélie Gouel-Chéron, Delphine Joseph, Dan Longrois, S. Baillard, F. Tubach, Marc Pallardy, C. Neukirch, Friederike Jönsson, N. Gigant, Pierre Bruhns, F. Sahli, L. de Chaisemartin, and Rami Bechara

Subjects
Immunology and Allergy
Abstract

Introduction L’anaphylaxie peroperatoire est une reaction d’hypersensibilite aigue dont les principaux responsables sont les curares. Le mecanisme classique implique des IgE specifiques et la liberation d’histamine par les mastocytes et les basophiles. Cependant, des resultats de modeles animaux et d’etudes cliniques (etude NASA) suggerent un mecanisme alternatif dependant d’IgG specifiques. Les deux mecanismes IgE et IgG ont en commun l’existence de lymphocytes T (LT) memoires specifiques qui sont necessaires pour la commutation isotypique. Leur existence est bien documentee dans l’allergie aux betalactamines, mais beaucoup moins dans le cas des curares et il n’existe pas de donnees sur leur eventuel interet diagnostique. Methodes Les PBMC de 26 patients avec une suspicion d’anaphylaxie aux curares inclus prospectivement a partir de 10 departements d’anesthesie franciliens (etude NASA) ont ete utilises. Vingt donneurs sains ont ete utilises comme controles. L’antigene a l’origine de la sensibilisation aux curares n’etant pas connu, nous avons construit et caracterise par MALDI-TOF des bioconjugues albumine-suxamethonium. Les PBMC ont ete cultives pendant 48 h avec ces bioconjugues et un cocktail de stimulants permettant d’activer les cellules presentatrices d’antigene. Apres 48 h, l’activation des LT a ete quantifiee par mesure de l’expression du CD154 (cytometrie en flux) et la production cytokinique (INF-g, IL-5, IL-13) a ete mesuree par Fluorospot. Resultats Les LT CD154+ etaient significativement plus nombreux chez les patients par rapport aux temoins (p Conclusion Notre etude met en evidence l’existence de LT memoires specifiques des curares et produisant de l’INF-g et montre qu’ils pourraient constituer un outil interessant dans le diagnostic de l’anaphylaxie peroperatoire.

Published
2018
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29. [Infants' attachment security in a vulnerable French sample]

Author

S, Tereno, N, Guedeney, R, Dugravier, T, Greacen, T, Saïas, F, Tubach, S, Ulgen, I, Matos, and A, Guédeney

Subjects
Adult, Male, Parenting, Infant, Mothers, Object Attachment, Vulnerable Populations, Mother-Child Relations, Young Adult, Patient Education as Topic, Case-Control Studies, Infant Behavior, Infant Care, Humans, Female, Maternal Behavior, Reinforcement, Psychology
Abstract

Attachment is a long lasting emotional link established between infants and their caregivers. The quality of early relationships allows infants to safely explore their environment and contribute to the establishment of a broad range of social skills. Several intervention programs targeting infant attachment have been implemented in different contexts, showing diverse degrees of efficacy.The present paper describes, for the first time, children's attachment quality distributions in a French multi-risk population, with a preventive intervention, usual or reinforced.In the CAPEDP study (Parenting and Attachment in Early Childhood: reducing mental health disorder risks and promoting resilience), a sub-sample of 117 women was recruited to assess the effects of this home-visiting program on children's attachment security. With that intent, the Strange Situation Paradigm was used when infants were between 12 and 16 months of age.In the intervention group, 63% (n=41) of the infants were coded as secure, while 15% (n=10) of them were coded as insecure-avoidant and 22% (n=14) as insecure-ambivalent/resistant. 56% (n=29) of control group infants (usual care) were coded as secure, while 27% (n=14) were coded as insecure-avoidant and 17% (n=9) as insecure-ambivalent/resistant. Even if the percentage of children with a secure attachment in the reinforced intervention group was higher than that of the control group, this difference did not reach the threshold of significance [ChiIntervention group distributions were closer to normative samples, and these distributions show the clinical impact of our program. In general, preventive interventions focused on attachment quality have moderate effects but, in our case, several factors might have contributed to lower the statistical impact of the program. Firstly, the control group cannot be considered has having received zero intervention for two reasons: (a) the French usual perinatal health system (Maternal and Infant Protection System) is particularly generous and (b) the effect of this usual system might have been increased by the project intensive assessment protocol (6 visits during 28 months). Secondly, it is possible that the full effect of the intervention had not yet been detected because, when a child's attachment was assessed, only two thirds of the intervention visits had been performed (29 of 44 visits). A "sleeper effect" is still possible: we hope that a more clear result will be seen when children are assessed again, at 48 months, in our follow-up study (CAPEDP-A II). By clarifying the mechanisms involved in the development of a secure attachment, our study aims to contribute and refine the development of early preventive intervention strategies in high perinatal and psychosocial vulnerability contexts.

Published
2015

30. Spontaneous adverse drug reaction reporting in France: A retrospective analysis of reports made to the French medicines agency from 2002 to 2014

Author

P. Maison, D. Beziz, F. Tubach, A. Lillo-Le-Louët, M. Benkebil, and D. Bonnet-zamponi

Subjects
Drug, Pediatrics, medicine.medical_specialty, Epidemiology, business.industry, media_common.quotation_subject, MedDRA, Public Health, Environmental and Occupational Health, Pharmacist, medicine.disease, Interquartile range, Internal medicine, Pharmacovigilance, medicine, Retrospective analysis, business, Specialist Physician, Adverse drug reaction, media_common
Abstract

Introduction The French pharmacovigilance system is coordinated by the French Medicines Agency (‘Agence nationale de securite du medicament et des produits de sante’ [ANSM]). The availability of a database containing all adverse drug reactions (ADRs) spontaneously reported by healthcare professionals and since 2011 by consumers, represents a major tool to ensure the drug safety. The aim of this study is to describe the characteristics of the reports and the reporting trends in the French pharmacovigilance spontaneous reporting database over the past 13 years. Methods We analyzed all ADR reports submitted to the ANSM via the network of 31 regional centres of pharmacovigilance (CRPV) from January 2002 to December 2014. Drugs and ADRs were respectively translated to anatomical therapeutic chemical (ATC) codes and Medical Dictionary for Regulatory Activities (MedDRA) classifications. Results In total 329,105 reports were received from ANSM for the 13-year study period, with linearly increase over time. Overall, 56.4% of reports were considered as serious. The median (interquartile range [IQR]) age of the patients was 57 (35–73) and the male/female ratio was 0.80. The median (IQR) time between the date of occurrence of the ADR and the date of report was 38 days (13–116). The reporter was a specialist physician in 72.0% of the reports, a pharmacist in 15.3%, and a general practitioner (GP) in 7.5%. The ADRs were most frequently related to nervous system drugs (21.6%), followed by systemic anti-infectives (16.7%) and cardiovascular drugs (16.3%). According to the Medical Dictionary for Regulatory Activities (MedDRA) coding, the system organ most often reported was skin and subcutaneous tissue disorders (17.7%), followed by general disorders and administration site conditions (11.4%), nervous system disorders (10.0%), gastrointestinal disorders (9.4%) and blood and lymphatic system disorders (6.8%). Conclusion This description of the data of the French pharmacovigilance database involving all drugs and ADRs follows a previous analysis describing ADR reports collected between 1986 and 2001 and shows an increasing tendency to reporting over time. In this study, seriousness of reports and age of patients has increased. The contribution of GPs remained very low and stable and the time lag between the suspected ADR and reporting shortened. There has been no significant change according to other characteristics.

Published
2016
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31. Personal and occupational predictors of sciatica in the GAZEL cohort

Author

A. Ozguler, M.‐F. Landre, Annette Leclerc, and F. Tubach

Subjects
Adult, Male, musculoskeletal diseases, Automobile Driving, medicine.medical_specialty, Sciatica, Risk Factors, Epidemiology, Humans, Medicine, Prospective Studies, Risk factor, Prospective cohort study, Models, Statistical, business.industry, Public Health, Environmental and Occupational Health, Odds ratio, Middle Aged, Low back pain, Body Height, Confidence interval, nervous system diseases, Occupational Diseases, Cohort, Physical therapy, Female, medicine.symptom, business, Low Back Pain, Follow-Up Studies
Abstract

Background The objectives of this prospective study were to investigate personal and occupational predictors of sciatica and to compare the risk factors for sciatica and those for low back pain without sciatica. Methods The study analysed data from 841 men, initially free from low back pain, who were followed for 2 years. Subjects were participants in the French GAZEL cohort of employees of the national electricity and gas company. The predictive factors for sciatica and low back pain without sciatica were compared with a polytomous model. Results Height and driving were predictors only for sciatica, and bending forward and backward at work was a predictor only for low back pain without sciatica. The odds ratio (OR) for sciatica associated with 'height >180 cm' was 3, with a 95% confidence interval (CI) of 1.4-6.5; for driving >2 h daily it was 2 (CI = 0.94-4.10) and for driving >2 h several days a week 2.7 (CI = 1.20-6.10). Conclusion This study confirmed that height and driving are risk factors for sciatica and that sciatica has specific predictors different from those for other types of low back pain. Future studies should consider sciatica separately from these.

Published
2003
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32. Connaissance et pratiques de l'antibioprophylaxie de l’endocardite infectieuse : synthèse des études cas témoins

Author

P Ravaud and F Tubach

Subjects
Gynecology, medicine.medical_specialty, Infectious Diseases, business.industry, Endocardial disease, medicine, Consensus conference, business, Antibacterial agent
Abstract

Resume L’antibioprophylaxie de l’endocardite infectieuse chez les patients a risque est consideree comme une pratique raisonnable depuis plus de 40 ans. Ses indications et ses modalites ne reposent pas sur des bases scientifiques bien etablies et son efficacite n’a pas ete demontree dans des essais randomises. Chez l’homme, seules trois etudes cas temoins fournissent des renseignements quantitatifs sur le risque d’endocardite infectieuse lie a differents gestes invasifs et sur l’efficacite clinique de l’antibioprophylaxie de l’endocardite infectieuse. Cet article fait la synthese de ces etudes cas temoins et met en evidence leurs differences methodologiques et leurs limites d’interpretation.

Published
2002
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34. Aortic Event Rate in the Marfan Population: A Cohort Study

Author

Guillaume Jondeau, F. Tubach, and D. Detaint

Subjects
medicine.medical_specialty, education.field_of_study, business.industry, Event (relativity), Emergency medicine, Population, Medicine, Surgery, business, education, Cardiology and Cardiovascular Medicine, Cohort study
Published
2012
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35. Drug-specific risk of non-tuberculosis opportunistic infections in patients receiving anti-TNF therapy reported to the 3-year prospective French RATIO registry

Author

D, Salmon-Ceron, F, Tubach, O, Lortholary, O, Chosidow, S, Bretagne, N, Nicolas, E, Cuillerier, B, Fautrel, C, Michelet, J, Morel, X, Puéchal, D, Wendling, M, Lemann, P, Ravaud, X, Mariette, Stéphane, Bretagne, Service de médecine interne et centre de référence des maladies rares [CHU Cochin], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Centre d'infectiologie Necker-Pasteur [CHU Necker], Institut Pasteur [Paris]-CHU Necker - Enfants Malades [AP-HP], Service de Dermatologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service des maladies infectieuses et réanimation médicale [Rennes] = Infectious Disease and Intensive Care [Rennes], CHU Pontchaillou [Rennes], Service de Rhumatologie [CH Le Mans], Centre Hospitalier Le Mans (CH Le Mans), Service de Rhumatologie, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Service de gastro-entérologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Régulation de la réponse immune, infection VIH-1 et autoimmunité, Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM), RATIO group, Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Cochin [AP-HP], Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques, Université Paris Diderot - Paris 7 ( UPD7 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri-Mondor, Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ), Service de rhumatologie [CHU Pitié Salpêtrière] ( GRC-08 EEMOIS ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Assistance publique - Hôpitaux de Paris (AP-HP), Service des maladies infectieuses et réanimation médicale, Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Pontchaillou, Centre Hospitalier du Mans, Hôpital Jean Minjoz, Assistance publique - Hôpitaux de Paris (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Université Paris-Sud - Paris 11 ( UP11 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Institut Pasteur [Paris] (IP)-CHU Necker - Enfants Malades [AP-HP], Épidémiologie et Évaluation des Maladies Ostéoarticulaires Inflammatoires et Systémiques (GRC-08 EEMOIS), Service des maladies infectieuses et réanimation médicale [Rennes], Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou

Subjects
Male, MESH: Antirheumatic Agents, Opportunistic infection, Anti-Inflammatory Agents, MESH : Aged, MESH: Epidemiologic Methods, Receptors, Tumor Necrosis Factor, Etanercept, MESH: Antibodies, Monoclonal, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Pneumocystosis, Immunology and Allergy, MESH : Female, 030212 general & internal medicine, MESH : Tumor Necrosis Factor-alpha, MESH: Aged, MESH: Immunoglobulin G, MESH: Middle Aged, MESH: Immunologic Factors, Antibodies, Monoclonal, Middle Aged, MESH : Adult, MESH : Antirheumatic Agents, 3. Good health, [ SDV.MHEP.MI ] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Antirheumatic Agents, Rheumatoid arthritis, MESH : Antibodies, Monoclonal, Female, France, medicine.drug, Adult, medicine.medical_specialty, MESH : Immunoglobulin G, MESH : Male, Immunology, Opportunistic Infections, MESH : Anti-Inflammatory Agents, Antibodies, Monoclonal, Humanized, MESH : Immunologic Factors, General Biochemistry, Genetics and Molecular Biology, MESH : Antibodies, Monoclonal, Humanized, MESH : Epidemiologic Methods, 03 medical and health sciences, Rheumatology, Psoriasis, Internal medicine, medicine, Adalimumab, Humans, Immunologic Factors, MESH : Middle Aged, Risk factor, MESH : France, Aged, 030203 arthritis & rheumatology, MESH: Humans, Tumor Necrosis Factor-alpha, business.industry, MESH : Humans, MESH : Opportunistic Infections, MESH: Adult, MESH: Opportunistic Infections, medicine.disease, MESH: Receptors, Tumor Necrosis Factor, Infliximab, MESH : Receptors, Tumor Necrosis Factor, MESH: Male, MESH: France, MESH: Antibodies, Monoclonal, Humanized, Immunoglobulin G, MESH: Tumor Necrosis Factor-alpha, MESH: Anti-Inflammatory Agents, Epidemiologic Methods, business, MESH: Female
Abstract

BackgroundAnti-tumour necrosis factor (TNF) therapy may be associated with opportunistic infections (OIs).ObjectiveTo describe the spectrum of non-tuberculosis OIs associated with anti-TNF therapy and identify their risk factors.MethodsA 3-year national French registry (RATIO) collected all cases of OI in patients receiving anti-TNF treatment for any indication in France. A case–control study was performed with three controls treated with anti-TNF agents per case, matched for gender and underlying inflammatory disease.Results45 cases were collected of non-TB OIs in 43 patients receiving infliximab (n=29), adalimumab (n=10) or etanercept (n=4) for rheumatoid arthritis (n=26), spondyloarthritides (n=3), inflammatory colitis (n=8), psoriasis (n=1) or other conditions (n=5). One-third (33%) of OIs were bacterial (4 listeriosis, 4 nocardiosis, 4 atypical mycobacteriosis, 3 non-typhoid salmonellosis), 40% were viral (8 severe herpes zoster, 3 varicella, 3 extensive herpes simplex, 4 disseminated cytomegalovirus infections), 22% were fungal (5 pneumocystosis, 3 invasive aspergillosis, 2 cryptococcosis) and 4% were parasitic (2 leishmaniasis). Ten patients (23%) required admission to the intensive care unit, and four patients (9%) died. Risk factors for OIs were treatment with infliximab (OR=17.6 (95% CI 4.3 - 72.9); p10 mg/day or intravenous boluses during the previous year (OR=6.3 (2.0 to 20.0); p=0.002).ConclusionVarious and severe OIs, especially those with intracellular micro-organisms, may develop in patients receiving anti-TNF treatment. Monoclonal anti-TNF antibody rather than soluble TNF receptor therapy and steroid use >10 mg/day are independently associated with OI.

Published
2011
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36. Neurological complications of HIV infection in critically ill patients: clinical features and outcomes

Author

Lila Bouadma, F. Tubach, Bruno Mourvillier, Romain Sonneville, Isabelle F. Klein, Michel Wolff, Carine Roy, A. Foucrier, H. Ferrand, and Bernard Regnier

Subjects
Microbiology (medical), Adult, Male, Systemic disease, medicine.medical_specialty, Pediatrics, AIDS Dementia Complex, Critical Illness, HIV Infections, Acquired immunodeficiency syndrome (AIDS), Interquartile range, Central Nervous System Diseases, Seizures, Antiretroviral Therapy, Highly Active, medicine, Humans, Hospital Mortality, Coma, AIDS-Related Opportunistic Infections, business.industry, Delirium, Retrospective cohort study, Middle Aged, medicine.disease, Prognosis, Surgery, Intensive Care Units, Infectious Diseases, Female, medicine.symptom, Intracranial Hypertension, business, Complication, Viral load
Abstract

We aimed to investigate the prognosis of HIV-infected patients with acute neurological complications at the highly active antiretroviral therapy (HAART) era.We performed a retrospective study in HIV-infected patients admitted to a medical ICU with neurological complications between 2001 and 2008.Among the 210 studied patients (median [interquartile range] CD4-cell count: 80 [18-254]/μL; HIV viral load: 4.8 [2-5.3] log₁₀/mL), 40 (19%) had unknown HIV status at admission. Neurological complications consisted in delirium (45%), coma (39%), seizures (32%) and/or intracranial hypertension (21%). Admission diagnoses were AIDS-defining CNS disease for 88 (42%) patients, non-AIDS-defining CNS disease for 45 (21%), and systemic disease with neurological signs for 77 (37%). Seizures (p=0.003), focal deficit (p0.001) and intracranial hypertension (p0.001) were more frequently observed in patients with AIDS-defining CNS disease. Factors independently associated with ICU mortality (29.5%) were intracranial hypertension [odds ratio (OR), 5.09; 95% confidence interval (95% CI), 2.17-11.91], vasopressor use [OR, 3.92; 95% CI, 1.78-8.60] and SAPS II score [per 10-point increment, OR, 1.59; 95% CI, 1.31-1.93].Prognosis of HIV-infected patients with neurological complications depends rather on clinical presentation than on HIV-related parameters. Intracranial hypertension symptoms at admission have a major impact on outcome.

Published
2010

37. Risk of Tuberculosis Is Higher With Anti-Tumor Necrosis Factor Monoclonal Antibody Therapy Than With Soluble Tumor Necrosis Factor Receptor Therapy The Three-Year Prospective French Research Axed on Tolerance of Biotherapies Registry

Author

F, Tubach, D, Salmon, P, Ravaud, Y, Allanore, P, Goupille, M, Bréban, B, Pallot-Prades, S, Pouplin, A, Sacchi, R M, Chichemanian, S, Bretagne, D, Emilie, M, Lemann, O, Lortholary, O, Lorthololary, X, Mariette, Zeller, Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Génétique, immunothérapie, chimie et cancer (GICC), UMR 6239 CNRS [2008-2011] (GICC UMR 6239 CNRS), Université de Tours-Centre National de la Recherche Scientifique (CNRS), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Hôpital Saint-Louis, Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Cytokines, chimiokines et immunopathologie, Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Necker - Enfants Malades [AP-HP], Immunologie antivirale systémique et cérébrale, Université Paris-Sud - Paris 11 (UP11)-IFR93-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département d'épidémiologie, biostatistique et recherche clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], 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], Service de rhumatologie [CHU Cochin], Service de rhumatologie, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Service de Rhumatologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Ambroise Paré [AP-HP], Hôpital Bellevue, Service de rhumatologie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Service de médecine interne (CH F. Quesnay), Centre hospitalier F. Quesnay, Centre régional de pharmacovigilance, Centre Régional de Pharmacovigilance, Service de parasitologie [Mondor], Service d'hépato-gastro-entérologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Université Paris-Sud - Paris 11 (UP11)-IFR13-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'infectiologie Necker-Pasteur [CHU Necker], Institut Pasteur [Paris]-CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques, Université Paris Diderot - Paris 7 (UP7) - Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Cochin [APHP], Génétique, Immunothérapie, Chimie et Cancer (GICC), Université François Rabelais - Tours - Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Henri Mondor - Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Assistance publique - Hôpitaux de Paris (AP-HP) - Université Paris Diderot - Paris 7 (UP7), Université Paris-Sud - Paris 11 (UP11) - Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Necker - Enfants malades, Assistance publique - Hôpitaux de Paris (AP-HP) - Université Paris Descartes - Paris 5 (UPD5), Université Paris-Sud - Paris 11 (UP11) - IFR93 - Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Tours (UT)-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Cambefort, Jeanne, Université Paris Diderot - Paris 7 ( UPD7 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Assistance publique - Hôpitaux de Paris (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Cochin [AP-HP], CHRU Tours, Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Ambroise Paré, Service de rhumatologie [Rouen], Université de Rouen Normandie ( UNIROUEN ), Normandie Université ( NU ) -Normandie Université ( NU ) -CHU Rouen, Service de médecine interne ( CH F. Quesnay ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ), Assistance publique - Hôpitaux de Paris (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris]-Université Paris Diderot - Paris 7 ( UPD7 ), Université Paris-Sud - Paris 11 ( UP11 ) -IFR13-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Necker - Enfants Malades [AP-HP], Université Paris-Sud - Paris 11 ( UP11 ) -IFR93-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Gillet, Catherine, Institut Pasteur [Paris] (IP)-CHU Necker - Enfants Malades [AP-HP], CHU Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), and Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)

Subjects
Male, rheumatoid arthritis, Oncology, [SDV]Life Sciences [q-bio], Receptors, Tumor Necrosis Factor, anti-TNF-alpha, Etanercept, Arthritis, Rheumatoid, 0302 clinical medicine, Risk Factors, Immunology and Allergy, Pharmacology (medical), Prospective Studies, Registries, 030212 general & internal medicine, Monoclonal antibody therapy, Behcet Syndrome, Antibodies, Monoclonal, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, Middle Aged, Colitis, 3. Good health, [SDV] Life Sciences [q-bio], Treatment Outcome, tuberculosis, Rheumatoid arthritis, Female, Tumor necrosis factor alpha, France, medicine.drug, Adult, safety, medicine.medical_specialty, Tuberculosis, Immunology, Antibodies, Monoclonal, Humanized, inflammatory chronic diseases, 03 medical and health sciences, Rheumatology, Internal medicine, Spondylarthritis, medicine, Adalimumab, Humans, Risk factor, Aged, 030203 arthritis & rheumatology, Tumor Necrosis Factor-alpha, business.industry, medicine.disease, Infliximab, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Case-Control Studies, Immunoglobulin G, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business
Abstract

International audience; Objective. Tuberculosis (TB) is associated with anti-tumor necrosis factor (anti-TNF) monoclonal anti-body (mAb) therapy, but whether this association is drug-specific remains a concern. Our objective was to describe cases of TB associated with anti-TNF mAb therapy, identify risk factors, and estimate the incidence. Methods. We conducted an incidence study and a case-control analysis to investigate the risk of newly diagnosed TB associated with the use of anti-TNF agents. As part of the French Research Axed on Tolerance of Biotherapies (RATIO) registry, for 3 years we collected cases of TB among French patients receiving anti-TNF mAb therapy for any indication; for each case, 2 patients treated with anti-TNF agents served as control subjects. Results. We collected 69 cases of TB in patients treated for rheumatoid arthritis (n = 40), spondylarthritides (n = 18), inflammatory colitis (n = 9), psoriasis (n = 1) and Behcet's disease (n = 1) with infliximab (n = 36), adalimumab (n = 28), and etanercept (n = 5). None of the patients had received correct chemoprophylactic treatment. The sex- and age-adjusted incidence rate of TB was 116.7 per 100,000 patient-years. The standardized incidence ratio (SIR) was 12.2 (95% confidence interval [95% CI] 9.7-15.5) and was higher for therapy with infliximab and adalimumab than for therapy with etanercept (SIR 18.6 [95% CI 13.4-25.8] and SIR 29.3 [95% CI 20.3-42.4] versus SIR 1.8 [95% CI 0.7-4.3], respectively). In the case-control analysis, exposure to infliximab or adalimumab versus etanercept was an independent risk factor for TB (odds ratio [OR] 13.3 [95% CI 2.6-69.0] and OR 17.1 [95% CI 3.6-80.6], respectively). Other risk factors were age, the first year of anti-TNF mAb treatment, and being born in an endemic area. Conclusion. The risk of TB is higher for patients receiving anti-TNF mAb therapy than for those receiving soluble TNF receptor therapy. The increased risk with early anti-TNF treatment and the absence of correct chemoprophylactic treatment favor the reactivation of latent TB.

Published
2009
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38. SAT0531 Updated Eular Evidence-Based Recommendations for the Management of Gout

Author

P. Richette, M. Doherty, E. Pascual, V. Barskova, F. Becce, M. Coyfish, H. Janssens, T. Jansen, F. Lioté, C. Mallen, G. Nuki, F. Perez-Ruiz, J. Pimentão, T. Piwell, L. Punzi, A. So, A.-K. Tausche, T. Uhlig, J. Zavada, W. Zhang, F. Tubach, and T. Bardin

Subjects
Rheumatology, Immunology, Immunology and Allergy, General Biochemistry, Genetics and Molecular Biology
Published
2014
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40. IgG anti-beta2-glycoprotein I antibodies in adult patients with systemic lupus erythematosus: prevalence and diagnostic value for the antiphospholipid syndrome

Author

F, Tubach, G, Hayem, J L, Marchand, M, Weber, E, Palazzo, M, de Bandt, S, Roux, M F, Kahn, and O, Meyer

Subjects
Adult, Male, Adolescent, Thrombosis, Middle Aged, Predictive Value of Tests, Risk Factors, Seroepidemiologic Studies, beta 2-Glycoprotein I, Antibodies, Anticardiolipin, Immunoglobulin G, Lupus Coagulation Inhibitor, Humans, Lupus Erythematosus, Systemic, Female, Child, Biomarkers, Aged, Glycoproteins
Abstract

To investigate the prevalence of serum anti-beta2-glycoprotein I (anti-beta2-GPI) antibodies and other antiphospholipid antibodies (aPL) in patients with systemic lupus erythematosus (SLE). To study their diagnostic value for the antiphospholipid syndrome (APS).Anti-beta2-GPI and IgG anticardiolipin (aCL) were determined in sera from 102 consecutive patients with SLE using ELISA. Serum and plasma tests were also done for lupus anticoagulant (LAC), syphilis, and antibodies to dsDNA. Clinical and laboratory features of APS were observed.Prevalences were 23.5% for aCL and 18.6% for anti-beta2-GPI. Correlations between the presence of aCL and anti-beta2-GPI and between their titers were statistically significant (p0.0001). No associations were found between anti-beta2-GPI and disease activity criteria (SLEDAI, ECLAM, dsDNA). Anti-beta2-GPI were significantly associated with LAC (p = 0.005), APS (p = 0.005), and a high aCL titer (aCL5 SD; por =0.001). LAC was the best diagnostic criterion for APS.These data suggest that determination of anti-beta2-GPI in addition to aCL and LAC is unlikely to improve the diagnosis of APS in patients with SLE.

Published
2000

41. Anticentromere antibodies in rheumatologic practice are not consistently associated with scleroderma

Author

F, Tubach, G, Hayem, A, Elias, P, Nicaise, T, Haim, M F, Kahn, and O, Meyer

Subjects
Adult, Centrosome, Male, Scleroderma, Systemic, Sjogren's Syndrome, Antibodies, Antinuclear, Humans, Enzyme-Linked Immunosorbent Assay, Female, Raynaud Disease, Middle Aged, Fluorescent Antibody Technique, Indirect, Biomarkers
Abstract

Anticentromere antibodies identified by indirect immunofluorescence are a valuable aid to the diagnosis and prognosis of patients with systemic sclerosis since they are associated in 50% to 80% of cases with limited cutaneous systemic sclerosis, a pattern usually associated with a good prognosis. We studied clinical presentations in rheumatology patients with anticentromere antibodies by indirect immunofluoresence and by ELISA and/or Western blot, but without scleroderma or Raynaud's phenomenon. Eight of 34 (23.5%) rheumatology clinic patients with centromere antibodies met these criteria, seven women and one man, with a median symptom duration of six years (range 1-20 years). Four had Sjögren's syndrome, one had isolated xerostomia, one systemic lupus erythematosus, one seronegative symmetric polyarthritis and one primary biliary cirrhosis with arthralgia. The mean anticentromere antibody titer in these eight patients was similar to that in the patients who had at least Raynaud's phenomenon. Given the low incidence of scleroderma, these data illustrate the poor predictive value of anticentromere antibodies for the diagnosis of scleroderma in rheumatology clinic patients.

Published
1997

42. Liver steatosis is not associated with fibrosis in patients with chronic HCV infection

Author

Patrick Marcellin, Nathalie Boyer, Dominique Valla, Dominique Vidaud, Michel Vidaud, F. Tubach, Dominique Cazals, M. Martinot, Claude Degott, M.-C. Guimont, Tarik Asselah, and K. Nahon

Subjects
medicine.medical_specialty, Hepatology, Liver steatosis, Fibrosis, business.industry, Internal medicine, medicine, In patient, medicine.disease, business, Gastroenterology
Published
2003
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43. Late onset spondyloarthropathy: comparison with early onset patients

Author

L J KAY, D J WALKER, J M LE PARC, F TUBACH, and D CAPLANNE

Subjects
medicine.medical_specialty, business.industry, Spondyloarthropathy, Inflammatory arthritis, Immunology, Arthritis, Late onset, medicine.disease, General Biochemistry, Genetics and Molecular Biology, Surgery, Rheumatology, Internal medicine, Psoriasis, Immunology and Allergy, Medicine, Age of onset, business, Spondylitis, Early onset
Abstract

We read with interest the article by Caplanne and colleagues1 and note the association between psoriasis and spondyloarthropathy in three of their eight cases. We have reviewed our series of 228 cases of psoriasis and inflammatory arthritis. Forty five patients (20 female) had spondyloarthropathy according to the Amor criteria.2 Five of 45 (three female) had their first symptoms at the age of 55 or older according to patient recall and case note review. The older onset spondyloarthropathy group had a higher rate of cervical spine involvement than those with younger onset (χ2=4.73, p=0.0296) in agreement with Caplanne et al, but we were unable to demonstrate higher rates of thoracic spine involvement (p=0.852), shoulder involvement3(p=1.000) or chest wall arthritis (p=0.847). All five …

Published
1997
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44. Risk of congenital malformations and miscarriages following maternal use of oral fluconazole during the first trimester of pregnancy: a systematic review and meta-analysis.

Author

Latour M, Vauzelle C, Elefant E, Tubach F, Padberg S, Martin B, Joseph-Delaffon K, Dechartres A, and Marin B

Abstract

The risks related to fluconazole use during the first trimester of pregnancy (T1) remain controversial. The aims of this systematic review and meta-analysis were to assess the association between oral fluconazole during T1 and major congenital malformations (MCM) overall and by subtype, minor malformations and miscarriages.We searched MEDLINE, EMBASE, Cochrane, ICTRP and ClinicalTrials.gov from inception to 02/12/24. Randomized controlled trials and observational studies were included. ROBINS-I was used for risk of bias assessment. Both fixed- and random-effects models meta-analyses were performed. GRADE was used to assess the certainty of the evidence.Among 1403 references, nine observational studies were included (3,764,897 pregnancies, including 116,425 exposed to fluconazole). The association between any fluconazole use during T1 and overall MCM was significant when combining crude estimates (ORc 1.18, 95%CI (1.08-1.29), I 2 23%, seven studies), but not when combining adjusted estimates (ORa 1.02, 95%CI (0.98-1.07), I 2 0%, six studies). Results were consistent for cumulative dose of fluconazole. In sensitivity analyses considering only studies with a valid definition of MCM, the association between fluconazole > 150 mg and overall MCM remained significant when combining adjusted estimates. For the subtypes of MCM (cardiac, genito-urinary, musculoskeletal) we found no significant association. A significant association was found between fluconazole use and miscarriages (ORa 1.60, 95% CI (1.06-2.42).Fluconazole use during T1 does not significantly increase the risk of MCM overall or by subtype when considering adjusted estimates. However, potential risks, particularly at cumulative doses greater than 150 mg which show a potential association with MCM, deserve much attention.PROSPERO Registration The protocol was registered on the 23rd September 2021 (registration number: CRD42021274003)., Competing Interests: Declarations. Conflict of interest: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024. Springer Nature B.V.)

Published
2024
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45. Biomarkers of COVID-19 short-term worsening: a multiparameter analysis within the prospective multicenter COVIDeF cohort.

Author

Cancella de Abreu M, Ropers J, Oueidat N, Pieroni L, Frère C, Fontenay M, Torelino K, Chauvin A, Hekimian G, Marcelin AG, Parfait B, Tubach F, and Hausfater P

Subjects
Humans, Male, Female, Prospective Studies, Middle Aged, Aged, France epidemiology, Severity of Illness Index, C-Reactive Protein analysis, C-Reactive Protein metabolism, Procalcitonin blood, Troponin T blood, Pandemics, Natriuretic Peptide, Brain blood, Cohort Studies, SARS-CoV-2, Peptide Fragments blood, COVID-19 blood, COVID-19 diagnosis, Biomarkers blood
Abstract

Background: During a pandemic like COVID-19, hospital resources are constrained and accurate severity triage of the patients is required., Objective: The objective of this study is to estimate the predictive performances of candidate biomarkers for short-term worsening (STW) of COVID-19., Design: Prospective, multicenter (20 hospitals in Paris) cohort study of consecutive COVID-19 patients with systematic biobanking at admission, during the first waves of COVID-19 in France in 2020 (COVIDeF cohort)., Setting and Participants: Consecutive COVID-19 patients were screened for inclusion. They were excluded in presence of severity criteria defined by either an ICU admission, mechanical ventilation (including noninvasive ventilation), acute respiratory distress, or in-hospital death before sampling. Routine blood tests measured during usual care and centralized systematic measurement of creatine kinase, C-reactive protein (CRP), procalcitonin, soluble urokinase plasminogen activator receptor (suPAR), high-sensitive troponin T (TnT-hs), N terminal pro-B natriuretic peptide (NT-proBNP), calprotectin, platelet factor 4, mid-regional pro-adrenomedullin (MR-proADM), and proendothelin were performed., Outcome Measures and Analyses: The primary outcome was STW, defined by a severity criteria within 7 days. A backward stepwise logistic regression model and a 'best subset' approach were used to identify independent association, and the area under the receiving operator characteristics (AUROC) was computed., Results: Five hundred and eleven patients were analyzed, of whom 60 (11.7%) experienced STW. Median time to occurrence of a severity criteria was 3 days. At admission, lower values of eosinophils, lymphocytes, platelets, alanine aminotransferase, and higher values of neutrophils, creatinine, urea, CRP, TnT-hs, suPAR, NT-proBNP, calprotectin, procalcitonin, MR-proADM, and proendothelin were predictive of worsening. Stepwise logistic regression identified three biomarkers significantly associated with worsening: CRP [adjusted odds ratio (aOR): 1.10, 95% confidence interval (95% CI): 1.06-1.15 for a 10-unit increase, AUROC: 0.73 (0.66-0.79)], procalcitonin [aOR: 0.42, 95% CI: 0.22-0.81, AUROC: 0.69 (0.64-0.88)], and MR-proADM [aOR: 2.85, 95% CI: 1.74-4.69, AUROC: 0.75 (0.69-0.81)]. These biomarkers outperformed clinical variables except diabetes and cancer comorbidities., Conclusion: In this multicenter prospective study that assessed a large panel of biomarkers for COVID-19 patients, CRP, procalcitonin, and MR-proADM were independently associated with the risk of STW., Trial Registration: ClinicalTrials.gov NCT04352348., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Published
2024
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46. Appropriateness of intended antibiotic prescribing using clinical case vignettes in primary care, and related factors.

Author

Delory T, Maillard A, Tubach F, Böelle PY, Bouvet E, Lariven S, Jeanmougin P, and Le Bel J

Subjects
Humans, Female, Male, Middle Aged, France, Adult, Decision Support Systems, Clinical, Logistic Models, Multivariate Analysis, Anti-Bacterial Agents therapeutic use, Practice Patterns, Physicians' statistics & numerical data, Primary Health Care, Inappropriate Prescribing statistics & numerical data
Abstract

Background: Factors associated with the appropriateness of antibiotic prescribing in primary care have been poorly explored. In particular, the impact of computerised decision-support systems (CDSS) remains unknown., Objectives: We aim at investigating the uptake of CDSS and its association with physician characteristics and professional activity., Methods: Since May 2022, users of a CDSS for antibiotic prescribing in primary care in France have been invited, when registering, to complete three case vignettes assessing clinical situations frequently encountered in general practice and identified as at risk of antibiotic misuse. Appropriateness of antibiotic prescribing was defined as the rate of answers in line with the current guidelines, computed by individuals and by specific questions. Physician's characteristics associated with individual appropriate antibiotic prescribing (< 50%, 50-75% and > 75% appropriateness) were identified by multivariate ordinal logistic regression., Results: In June 2023, 60,067 physicians had registered on the CDSS. Among the 13,851 physicians who answered all case vignettes, the median individual appropriateness level of antibiotic prescribing was 77.8% [Interquartile range, 66.7%-88.9%], and was < 50% for 1,353 physicians (10%). In the multivariate analysis, physicians' characteristics associated with appropriateness were prior use of the CDSS (OR = 1.71, 95% CI 1.56-1.87), being a general practitioner vs. other specialist (OR = 1.34, 95% CI 1.20-1.49), working in primary care (OR = 1.14, 95% CI 1.02-1.27), mentoring students (OR = 1.12, 95% CI 1.04-1.21) age (OR = 0.69 per 10 years increase, 95% CI 0.67-0.71)., Conclusion: Individual appropriateness for antibiotic prescribing was high among CDSS users, with a higher rate in young general practitioners, previously using the system. CDSS could improve antibiotic prescribing in primary care.

Published
2024
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47. Prognostic factors for patients with cancer-associated dermatomyositis: a retrospective, multicenter cohort study of 73 patients.

Author

Teboul A, Allenbach Y, Tubach F, Belin L, Cassius C, Demortier J, Dossier A, Faucon C, Kasser C, Mekinian A, Monseau G, Fouchard M, Chambrelan E, Viguier M, Kluger N, Mahévas T, Bergeret B, Bachmeyer C, Lenormand C, Hotz C, Diaz E, Cordel N, Benveniste O, Bessis D, Bouaziz JD, and Chasset F

Abstract

Objectives: To investigate factors associated with dermatomyositis (DM) complete clinical response and overall survival with a focus on the use of immunosuppressive therapies in patients with cancer-associated DM., Methods: We performed a multicentre, retrospective cohort study. Multivariable survival analyses used a Cox model with time-dependent covariates and adjustments with inverse probability censoring weighting., Results: We included 73 patients with cancer-associated DM. Median follow-up was 3.92 years. Overall, 40 (54.8%) patients achieved cancer remission, with DM complete clinical response in 28/40 (70.0%). DM complete clinical response was associated with cancer remission (hazard ratio [HR] 2.46, 95%CI [1.13-5.32]) and younger age (HR 0.68, 95%CI [0.49-0.95]). Risk of mortality was associated with sustained cancer activity (HR 12.93, 95% CI [2.42-69.25]), male sex (HR 2.82, 95% CI [1.19-6.70]), and older age (HR 1.86, 95% CI [1.26-2.79]) but not sustained DM activity (HR 0.40, 95%CI [0.13-1.26]). Oral corticosteroids use was a protective factor only on univariate analysis (HR 0.18, 95% CI [0.08-0.42])., Conclusion: This study provides strong evidence of a significant association between the evolutions of DM and cancer, both in terms of overall survival and DM complete clinical response. Immunosuppressive treatments for DM were not significantly associated with mortality., Trial Registration: ClinicalTrials.gov, NCT04637672., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Published
2024
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48. Conducting observational analyses with the target trial emulation approach: a methodological systematic review.

Author

Simon-Tillaux N, Martin GL, Hajage D, Scheifer C, Beydon M, Dechartres A, and Tubach F

Subjects
Humans, Research Design, Bias, Randomized Controlled Trials as Topic, Observational Studies as Topic
Abstract

Objectives: Target trial emulation is an approach that is increasingly used to improve transparency in observational studies and help mitigate biases. For studies declaring that they emulated a target trial, we aimed to evaluate the specification of the target trial, examine its consistency with the observational emulation and assess the risk of bias in the observational analysis., Design: Methodological systematic review reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement., Data Sources: The database MEDLINE (Medical Literature Analysis and Retrieval System Online) was interrogated for all studies published from 1 January 2021 to 3 July 2022. We performed an additional manual search of 20 general medical and specialised journals that spanned the same period., Eligibility Criteria: All studies that declared emulating a hypothetical or real randomised trial were eligible., Data Extraction and Synthesis: Two independent reviewers performed the whole systematic review process (screening and selection of studies, data extraction and risk of bias assessment). The main outcomes were the definition of the key protocol components of the target trial and its emulation, consistency between the target trial and its emulation and risk of bias according to the ROBINS-I (Risk Of Bias In Non-randomised Studies - of Interventions) tool., Results: Among the selected sample of 100 studies, 24 (24%) did not specify the target trial. Only 40 studies (40%) provided detailed information on all components of the target trial protocol. Eligibility criteria, intervention strategies and outcomes were consistent between the target trial and its emulation in 35 studies (46% of those specifying the target trial). Overall, 28 studies (28%) exhibited serious risk of bias and 41 (41%) had misalignments in the timing of eligibility assessment, treatment assignment and the start of follow-up (time-zero). As compared with studies that did not specify the target trial, those that did specify the trial less frequently seemed to have both time-zero issues (39% vs 52%) and serious risk of bias (26% vs 33%)., Conclusions: One-quarter of studies declaring that they emulated a target trial did not specify the trial. Target trials and their emulations were particularly inconsistent for studies emulating a real randomised trial. Risk of methodological issues seemed lower in observational analyses that specified versus did not specify the target trial., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare that they have no competing interest related to the study. GLM declares consulting fees from Synapse Medicine, unrelated to the study., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2024
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49. Use of the French National Health Data System (SNDS) in pharmacoepidemiology: A systematic review in its maturation phase.

Author

Maillard O, Bun R, Laanani M, Verga-Gérard A, Leroy T, Gault N, Estellat C, Noize P, Kaguelidou F, Sommet A, Lapeyre-Mestre M, Fourrier-Réglat A, Weill A, Quantin C, and Tubach F

Subjects
France epidemiology, Humans, Data Systems, Pharmacoepidemiology methods, Databases, Factual
Abstract

Aim of the Study: The French National Health Data System (SNDS) comprises healthcare data that cover 99% of the population (over 67 million individuals) in France. The aim of this study was to present an overview of published pharmacoepidemiological studies using the SNDS in its maturation phase., Methods: We conducted a systematic literature review of original research articles in the Pubmed and EMBASE databases from January 2012 until August 2018., Results: A total of 316 full-text articles were included, with an annual increase over the study period. Only 16 records were excluded after screening because they did not involve the SNDS but other French healthcare databases. The study design was clearly reported in only 66% of studies of which 57% were retrospective cohorts and 22% cross-sectional studies. The reported study objectives were drug utilization (65%), safety (22%) and effectiveness (9%). Almost all ATC groups were studied but the most frequent ones concerned the nervous system in 149 studies (49%), cardiovascular system drugs in 104 studies (34%) and anti-infectives for systemic use in 50 studies (16%)., Conclusion: The SNDS is of growing interest for studies on drug use and safety, which could be conducted more in specific populations, including children, pregnant women and the elderly, as these populations are often not included in clinical trials., (Copyright © 2024 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)

Published
2024
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50. Sensitivity and specificity of strategies to identify patients with hemostasis abnormalities leading to an increased risk of bleeding before scheduled intervention: the Hemorisk study.

Author

Ajzenberg N, Longrois D, Faille D, de Tymowski C, De Raucourt E, Boudaoud L, Sigaut S, Martin-Toutain I, Raux M, Helley D, Josserand J, Flaujac C, Duchemin J, Samama CM, Gouin-Thibault I, Beloeil H, Peynaud-Debayle E, Keita-Meyer H, Bourrienne MC, Quintin C, Paugam-Burtz C, Rosencher N, Valentin JB, Giboin C, and Tubach F

Subjects
Humans, Female, Male, Middle Aged, Surveys and Questionnaires, Aged, Partial Thromboplastin Time, Platelet Count, Risk Assessment, Risk Factors, Predictive Value of Tests, France, Adult, Reproducibility of Results, Blood Coagulation Disorders diagnosis, Blood Coagulation Disorders blood, Preoperative Care, Blood Coagulation Tests, Blood Coagulation drug effects, Sensitivity and Specificity, Prospective Studies, Hemostasis, Prothrombin Time, Hemorrhage diagnosis, Hemorrhage blood
Abstract

Background: Preoperative identification of patients with hemostasis abnormalities leading to an increased bleeding risk is based on routine hemostasis tests: prothrombin time (PT), activated partial thromboplastin time (APTT), and platelet count. Because of their low predictive performance, guidelines recommend replacing them with structured bleeding risk questionnaires, but none is validated in this population., Objectives: To assess the diagnostic accuracy of 3 strategies, performed at the preanesthesia visit before scheduled interventions, and to identify patients with hemostasis abnormalities leading to an increased bleeding risk METHODS: A multicenter study was performed in 7 French academic hospitals, involving patients scheduled for surgical intervention, without antiplatelet/anticoagulant treatment. The 3 strategies consisted of 1-a structured screening questionnaire; 2-PT, APTT, and platelet count ordered in selected patients; and 3-systematic PT, APTT, and platelet count. The reference standard comprised von Willebrand factor activity/antigen, factor (F)VIII, FIX, FXI, platelet function analyzer, and, when required, FII, FV, FX, and FVII and hemostasis consultation., Results: Eighteen (1.2%) of 1484 patients had a hemostasis abnormality leading to an increased bleeding risk according to reference standard. In the overall cohort, sensitivity of the questionnaire-based strategy was 50% (95% CI, 26%-74%; specificity, 87% [95% CI, 85%-88%]); sensitivity was 0% (95% CI, 0%-41%) in men vs 82% (95% CI, 48%-98%) in women. For selective routine tests, sensitivity was 33% (95% CI, 13%-59%) and specificity 97% (95% CI, 96%-98%). Corresponding values for systematic routine tests were 44% (95% CI, 22%-69%) and 93% (95% CI, 91%-94%)., Conclusion: Sensitivity was low for all 3 strategies investigated. The structured screening questionnaire had clinically acceptable diagnostic accuracy only in women., Competing Interests: Declaration of competing interests There are no competing interests to disclose., (Copyright © 2024 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.)

Published
2024
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