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1. Acute Myeloid Leukaemia following Direct Acting Antiviral drugs in HCV-infected patients: a 10 years' retrospective single-center study

Author: Carole Scheifer, Elena Luckina, Bénédicte Lebrun-Vignes, Abdoul-Aziz Diop, Dominique Damais-Thabut, Damien Roos-Weil, Agnès Dechartres, Pascal Lebray, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), Epidemiology in Dermatology and Evaluation in Therapeutics (EpiDermE), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and Dechartres, Agnès
Subjects: Non-Hodgkin Lymphoma (NHL), Lymphoma, Hepatology, [SDV]Life Sciences [q-bio], Gastroenterology, Hepacivirus, Hepatitis C, Chronic, Antiviral Agents, Hepatitis C, [SDV] Life Sciences [q-bio], Acute Myeloid Leukaemia (AML), Leukemia, Myeloid, Acute, anti-HCV Direct Acting Antivirals (DAA), Hematologic Neoplasms, hematological malignancies (HM), Humans, Female, Multiple Myeloma, hepatitis C virus (HCV), Mixed Phenotype Acute Leukaemia (MPAL), Retrospective Studies
Abstract: International audience; Background: After several cases of peculiar hematological malignancies following introduction of new oral anti-hepatitis C virus (HCV) treatments in our recent practice, we aimed to systematically identify all cases of hematological malignancies (HM) in patients with chronic HCV infection and to compare them according to the prescription of oral anti-HCV Direct Acting Antivirals (DAA) treatment or not.Material/methods: In this single-center retrospective observational study, we included all patients with confirmed HM and chronic HCV infection managed between 2010 and 2019 in the Pitié-Salpêtrière hospital, Paris. Non-inclusion criteria were a benign hematological disorder, an HM preceding chronic HCV infection and HCV acute infection. We compared characteristics of patients who received DAA before HM diagnosis to those with no DAA before HM.Results: Over the 10 years, 61 cases of HM among HCV infected patients were identified (female 29%, median age of 58.0 years [IQR 17]). Twenty-one received DAA before the onset of HM (Group DAA+) and 40 did not (Group DAA-) including 22 having received DAA after HM. In the DAA+ group, oral NS5B, NS5A and NS3A inhibitors were used in 90, 76 and 29% respectively. HM developed in the two years following DAA initiation in 76%. Eight (38%) had Non-Hodgkin Lymphoma, 5 (24%) had an Acute Myeloid Leukaemia (AML) including two with a mixed phenotype, 2 each had Hodgkin Lymphoma, Multiple Myeloma or a myeloproliferative disorder and one each had a chronic Lymphocytic Leukaemia or AL Amyloidosis. In the Group DAA-, HM were NHL in 20(50%) patients, Myeloproliferative neoplasms in 7 (17%), Multiple Myeloma in 5, Hodgkin Lymphoma in 3, Myelodysplastic syndrome and AML in 2 (5%) each and Acute Lymphoblastic Leukaemia in one. No significant difference between the groups DAA + and - was found according to age, sex, HCV genotype, viral load, co-infection or type and exposition of previous HCV treatments. AML, liver transplantation and cirrhosis were significantly more frequent in the DAA+ group (p = 0.020, 0.045 and 0.032, respectively).Conclusion: AML seemed more frequent after using DAA treatments, notably in severe HCV patients including cirrhotic and/or liver transplanted patients. A multicentric observational study is ongoing to confirm and explore the results.
Published: 2022
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2. Comparison of two delayed strategies for renal replacement therapy initiation for severe acute kidney injury (AKIKI 2): a multicentre, open-label, randomised, controlled trial

Author: Nicolas de Prost, Saber Barbar, Stéphane Gaudry, Jean-Pierre Quenot, Christophe Vinsonneau, Laurent Argaud, Eric Boulet, Didier Thevenin, Didier Dreyfuss, Marion Beuzelin, Adrien Robine, Cyril Cadoz, Steven Grangé, Béatrice La Combe, Dimitri Titeca-Beauport, Julien Mayaux, Julio Badie, Saad Nseir, Guillaume Chevrel, Karim Asehnoune, Florent Poirson, Kada Klouche, Sébastien Moschietto, Guillaume Louis, Guillaume Thiery, Marc Leone, David Hajage, Pascal Andreu, Elisabeth Coupez, Bertrand Pons, Said Lebbah, Jean-Damien Ricard, Jean-Marie Forel, Laurent Martin-Lefevre, Julien Bohé, Guillaume Geri, Sébastien Besset, Karim Lakhal, Nicolas Chudeau, Alain Combes, Bertrand Rozec, Nadia Aissaoui, Guillaume Lacave, Jean Reignier, CarMeN, laboratoire, Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), UFR Santé, Médecine et Biologie Humaine (UFR SMBH), Université Sorbonne Paris Nord, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), Laboratoire Informatique, Image et Interaction - EA 2118 (L3I), La Rochelle Université (ULR), Centre Hospitalier Henri Duffaut (Avignon), CHU Amiens-Picardie, Université de Bretagne Sud - Lorient (UBS Lorient), Université de Bretagne Sud (UBS), Centre d'Etudes Lasers Intenses et Applications (CELIA), Université de Bordeaux (UB)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Centre National de la Recherche Scientifique (CNRS), Hôpital Henri Mondor, Laboratoire Sciences Analytiques, Bioanalytiques, et Miniaturisation (LSABM), Chimie-Biologie-Innovation (UMR 8231) (CBI), Ecole Superieure de Physique et de Chimie Industrielles de la Ville de Paris (ESPCI Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Ecole Superieure de Physique et de Chimie Industrielles de la Ville de Paris (ESPCI Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Centre hospitalier de Dieppe, CH Belfort-Montbéliard, Centre Hospitalier Sud Francilien, Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand, Centre Hospitalier Le Mans (CH Le Mans), Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Assistance Publique - Hôpitaux de Marseille (APHM), Centre Hospitalier de Lens, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Géomécanique, Matériaux et Structures (GEOMAS), Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA), Microbes évolution phylogénie et infections (MEPHI), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Service Anesthésie et Réanimation [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Centre Hospitalier de Versailles André Mignot (CHV), Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 (CIC Lille), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Ambroise Paré [AP-HP], Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre hospitalier régional Metz-Thionville (CHR Metz-Thionville), Service de Réanimation Médicale (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Hôpital Louis Mourier - AP-HP [Colombes], Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Programme Hospitalier de Recherche Clinique., Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Université de La Rochelle (ULR), Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, Centre National de la Recherche Scientifique (CNRS)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université de Bordeaux (UB), Laboratoire de Tribologie et Dynamique des Systèmes (LTDS), École Centrale de Lyon (ECL), Université de Lyon-Université de Lyon-École Nationale des Travaux Publics de l'État (ENTPE)-Ecole Nationale d'Ingénieurs de Saint Etienne-Centre National de la Recherche Scientifique (CNRS), Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Ecole Superieure de Physique et de Chimie Industrielles de la Ville de Paris (ESPCI Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL), Centre Hospitalier Fleyriat [Bourg en Bresse], Centre Hospitalier Sud Francilien [Corbeil-Essonnes] (CH Sud Francilien), Centre Hospitalier de Béthune Beuvry (CH Béthune Beuvry), Hôpital Nord [CHU - APHM], GH Carnelle Portes de l'Oise, Hôpital Lapeyronie [Montpellier] (CHU), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord
Subjects: medicine.medical_specialty, MESH: Acute Kidney Injury, [SDV]Life Sciences [q-bio], medicine.medical_treatment, Population, 030204 cardiovascular system & hematology, urologic and male genital diseases, MESH: Severity of Illnes Index, 03 medical and health sciences, MESH: Aged, 80 and over, 0302 clinical medicine, Oliguria, Intensive care, Internal medicine, Medicine, MESH: Time-to-Treatment, 030212 general & internal medicine, Renal replacement therapy, education, Blood urea nitrogen, MESH: Aged, education.field_of_study, MESH: Humans, MESH: Middle Aged, business.industry, Hazard ratio, Acute kidney injury, General Medicine, medicine.disease, MESH: Male, MESH: Prospective Studies, 3. Good health, [SDV] Life Sciences [q-bio], MESH: France, MESH: Intensive Care Units, medicine.symptom, MESH: Renal Remplacement Therapy, business, MESH: Female, Kidney disease
Abstract: International audience; BACKGROUND: Delaying renal replacement therapy (RRT) for some time in critically ill patients with severe acute kidney injury and no severe complication is safe and allows optimisation of the use of medical devices. Major uncertainty remains concerning the duration for which RRT can be postponed without risk. Our aim was to test the hypothesis that a more-delayed initiation strategy would result in more RRT-free days, compared with a delayed strategy. METHODS: This was an unmasked, multicentre, prospective, open-label, randomised, controlled trial done in 39 intensive care units in France. We monitored critically ill patients with severe acute kidney injury (defined as Kidney Disease: Improving Global Outcomes stage 3) until they had oliguria for more than 72 h or a blood urea nitrogen concentration higher than 112 mg/dL. Patients were then randomly assigned (1:1) to either a strategy (delayed strategy) in which RRT was started just after randomisation or to a more-delayed strategy. With the more-delayed strategy, RRT initiation was postponed until mandatory indication (noticeable hyperkalaemia or metabolic acidosis or pulmonary oedema) or until blood urea nitrogen concentration reached 140 mg/dL. The primary outcome was the number of days alive and free of RRT between randomisation and day 28 and was done in the intention-to-treat population. The study is registered with ClinicalTrial.gov, NCT03396757 and is completed. FINDINGS: Between May 7, 2018, and Oct 11, 2019, of 5336 patients assessed, 278 patients underwent randomisation; 137 were assigned to the delayed strategy and 141 to the more-delayed strategy. The number of complications potentially related to acute kidney injury or to RRT were similar between groups. The median number of RRT-free days was 12 days (IQR 0-25) in the delayed strategy and 10 days (IQR 0-24) in the more-delayed strategy (p=0·93). In a multivariable analysis, the hazard ratio for death at 60 days was 1·65 (95% CI 1·09-2·50, p=0·018) with the more-delayed versus the delayed strategy. The number of complications potentially related to acute kidney injury or renal replacement therapy did not differ between groups. INTERPRETATION: In severe acute kidney injury patients with oliguria for more than 72 h or blood urea nitrogen concentration higher than 112 mg/dL and no severe complication that would mandate immediate RRT, longer postponing of RRT initiation did not confer additional benefit and was associated with potential harm. FUNDING: Programme Hospitalier de Recherche Clinique.
Published: 2021
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3. Impact of persistence with tumour necrosis factor inhibitors on healthcare resource utilization and costs in chronic inflammatory joint diseases

Author: Eric Van Ganse, Laurie Levy-Bachelot, Christophe Hudry, Florence Tubach, Macha Woronoff-Lemsi, Manon Belhassen, Bruno Fautrel, PELyon Pharmaco Epidémiologie [Lyon] (Santé Publique et Epidémiologie), Health Service and Performance Research (HESPER), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, Département de Biostatistique, Santé Publique et Information Médicale [CHU Pitié-Salpêtrière] (BIOSPIM ), 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 de Pharmacoépidémiologie de l'AP-HP (Cephepi), Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables (ECEVE (U1123 / UMR_S_1123)), Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité), Centre d'investigation clinique pluridisciplinaire [CHU Pitié Salpêtrière] (CIC-P 1421), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), MSD France, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Service de Rhumatologie [CHU Pitié Salpêtrière], 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)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), and Gestionnaire, Hal Sorbonne Université
Subjects: rheumatoid arthritis, medicine.medical_specialty, [SDV]Life Sciences [q-bio], Population, tumour necrosis factor inhibitors, 030226 pharmacology & pharmacy, healthcare costs, Persistence (computer science), Arthritis, Rheumatoid, Cohort Studies, 03 medical and health sciences, Psoriatic arthritis, 0302 clinical medicine, Internal medicine, ankylosing spondylitis, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, education, Retrospective Studies, psoriatic arthritis, Pharmacology, Ankylosing spondylitis, education.field_of_study, medicine.diagnostic_test, business.industry, Magnetic resonance imaging, persistence, Health Care Costs, medicine.disease, [SDV] Life Sciences [q-bio], Antirheumatic Agents, Rheumatoid arthritis, Propensity score matching, reimbursement claims data, Tumor Necrosis Factor Inhibitors, business, Cohort study
Abstract: International audience; Aim: To assess persistence with subcutaneous (SC) tumour necrosis factor (TNF) inhibitors as well as the impact of persistence on healthcare resource utilization (HCRU) and costs in patients with chronic inflammatory joint diseases.Methods: In this cohort study using population-based French claims data (from 2011 to 2014), we measured persistence with SC TNF inhibitors within 12 months (M0-12) following treatment initiation in treatment-naïve and treatment-experienced users (divided into three cohorts: rheumatoid arthritis [RA], ankylosing spondylitis [AS] and psoriatic arthritis [PsA]). Persistent patients were propensity score matched to nonpersistent patients at M12. The impact of persistence status on HCRU and costs was assessed during M12-24.Results: Of treatment-naïve (n = 3,804) and treatment-experienced (n = 2,279) users, only 56.1% and 46.8% were persistent at M12, respectively. Nonpersistent patients had more outpatient visits, computerized tomography scans, spine or joint magnetic resonance imaging procedures and disease-related hospitalizations, while persistent patients had more rheumatologist visits. Nonpersistent patients had lower drug costs but higher nondrug-related healthcare and hospitalization costs than persistent patients. In AS and PsA, overall healthcare costs were similar in persistent and nonpersistent patients. In RA, overall healthcare costs were lower in persistent patients (15,753€ vs 17,590€ in treatment-naïve and 17,622€ vs 21,177€ in treatment-experienced).Conclusion: Persistence with SC TNF inhibitors within first 12 months following treatment initiation was low in both treatment-naïve and treatment-experienced patients. Differences were observed in distribution of costs between persistent and nonpersistent patients, showing that nonpersistence with SC TNF inhibitors can lead to increased HCRU and higher costs.
Published: 2020
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4. Surgery for glioblastomas in the elderly: an Association des Neuro-oncologues d'Expression Française (ANOCEF) trial

Author: Florence Laigle-Donadey, Philippe Metellus, Jacques Guyotat, Philippe Menei, François Proust, Henry Dufour, Olivier Chinot, Jérôme Honnorat, Thierry Faillot, Philippe Paquis, Philippe Peruzzi, Evelyne Emery, Jean-Sébastien Guillamo, Alexandre Carpentier, Michel Wager, Said Lebbah, David Hajage, Jean-Yves Delattre, Philippe Cornu, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Privé Clairval [Marseille], Hospices Civils de Lyon (HCL), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Institut Marseille Maladies Rares (MarMaRa), Aix Marseille Université (AMU), Hôpital de la Timone [CHU - APHM] (TIMONE), Institut NeuroMyoGène (INMG), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Département de Neurochirurgie [Hôpital Pasteur de Nice], Hôpital Pasteur [Nice] (CHU), Service de neurologie [Reims], Centre Hospitalier Universitaire de Reims (CHU Reims), Service de Neurochirurgie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Sorbonne Université (SU), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Hajage, David, Service d'Onco-neurologie = Département de neurologie 2 [CHU Pitié Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de Neurochirurgie [CHU Pitié-Salpêtrière], and Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi)
Subjects: surgery, tumor, [STAT.ME] Statistics [stat]/Methodology [stat.ME], oncology, glioblastoma, biopsy, General Medicine, elderly, [STAT.ME]Statistics [stat]/Methodology [stat.ME]
Abstract: OBJECTIVE The role of surgery in the treatment of malignant gliomas in the elderly is not settled. The authors conducted a randomized trial that compared tumor resection with biopsy only—both followed by standard therapy—in such patients. METHODS Patients ≥ 70 years of age with a Karnofsky Performance Scale (KPS) score ≥ 50 and presenting with a radiological suspicion of operable glioblastoma (GBM) were randomly assigned between tumor resection and biopsy groups. Subsequently, they underwent standard radiotherapy during the first years of the trial (2008–2017), with the addition of adjunct therapy with temozolomide when this regimen became standard (2017–2019). The primary endpoint was survival, and secondary endpoints were progression-free survival (PFS), cognitive status (Mini-Mental State Examination), autonomy (KPS), quality of life (European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 and QLQ-BN20), and perioperative morbidity and mortality. RESULTS Between 2008 and 2019, 107 patients from 9 centers were enrolled in the study; 101 were evaluable for analysis because a GBM was histologically confirmed (50 in the surgery arm and 51 in the biopsy arm). There was no statistically significant difference in median survival between the surgery (9.37 months) and the biopsy (8.96 months, p = 0.36) arms (adjusted HR 0.79, 95% CI 0.52–1.21, p = 0.28). However, the surgery group had an increased PFS (5.06 vs 4.02 months; p = 0.034) (adjusted HR 0.50, 95% CI 0.32–0.78, p = 0.002). Less deterioration of quality of life and KPS score evolution than in the biopsy group was observed. Surgery was not associated with increased mortality or morbidity. CONCLUSIONS This study suggests that debulking surgery is safe, and—compared to biopsy—is associated with a less severe deterioration of quality of life and autonomy, as well as a significant although modest improvement of PFS in elderly patients suffering from newly diagnosed malignant glioma. Although resection does not provide a significant survival benefit in the elderly, the authors believe that the risk/benefit analysis favors an attempt at optimal tumor resection in this population, provided there is careful preoperative geriatric evaluation. Clinical trial registration no.: NCT02892708 (ClinicalTrials.gov)
Published: 2022
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5. Evolution of Drug Survival with Biological Agents and Apremilast Between 2012 and 2018 in Patients with Psoriasis from the PsoBioTeq Cohort

Author: Olivier Chosidow, Hervé Bachelez, Thomas Bettuzzi, Marie Beylot-Barry, Pascal Joly, Alain Dupuy, Florence Tubach, Emmanuel Mahé, Nathalie Beneton, Manuelle Viguier, Marie-Aleth Richard, Denis Jullien, Hugo Arlegui, Emilie Sbidian, Carle Paul, CHU Henri Mondor [Créteil], Epidemiology in Dermatology and Evaluation in Therapeutics (EpiDermE), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Imagine - Institut des maladies génétiques (IHU) (Imagine - U1163), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Bordeaux Research In Translational Oncology [Bordeaux] (BaRITOn), Université de Bordeaux (UB)-CHU Bordeaux [Bordeaux]-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Unité différenciation épidermique et auto-immunité rhumatoïde (UDEAR), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Victor Dupouy, Centre Hospitalier Le Mans (CH Le Mans), Hospices Civils de Lyon (HCL), Hôpital de la Timone [CHU - APHM] (TIMONE), Physiopathologie, Autoimmunité, maladies Neuromusculaires et THErapies Régénératrices (PANTHER), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Pontchaillou, 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 Henri Mondor (CIC Henri Mondor), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Dynamic Microbiology - EA 7380 (DYNAMIC), École nationale vétérinaire - Alfort (ENVA)-Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES)-Université Paris-Est (UPE)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), AOM 09 195, Amgen, Pfizer, Novartis, AbbVie, Meso Scale Diagnostics, MSD, Novartis Pharma, Janssen Pharmaceuticals, MSD France, Ministère des Affaires Sociales et de la Santé, Société Française de Dermatologie et de Pathologie Sexuellement Transmissible, SFD: JMD/MDM/177-11, NCT01617018, Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM, LEO Pharma Research Foundation, Assistance publique-Hôpitaux de Paris, Jonchère, Laurent, CHU Henri Mondor, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: medicine.medical_specialty, [SDV]Life Sciences [q-bio], Dermatology, Biological Factors, Primary outcome, drug survival, Psoriasis, Internal medicine, apre-milast, medicine, Humans, Biological Products, treatment, business.industry, Proportional hazards model, Hazard ratio, General Medicine, psoriasis, Middle Aged, [SDV.MHEP.DERM] Life Sciences [q-bio]/Human health and pathology/Dermatology, medicine.disease, Thalidomide, Drug survival, [SDV] Life Sciences [q-bio], Antirheumatic Agents, Cohort, Observational study, Female, Apremilast, business, biologic, [SDV.MHEP.DERM]Life Sciences [q-bio]/Human health and pathology/Dermatology, medicine.drug
Abstract: International audience; Drug survival reflects treatment effectiveness and safety in real life. There is limited data on the variation of drug survival with the availability of systemic treatments with additional biological disease-modifying antirheumatic drugs (bDMARDs) or synthetic disease-modifying antirheumatic drugs (sDMARDs). The aim of this study was to determine whether the increasing number of available systemic treatments for psoriasis affects drug survival over time. Patients were selected from the PsoBioTeq cohort, a French prospective observational cohort enrolling patients with moderate to severe psoriasis. All patients initiating a first bDMARD or sDMARD were included. The primary outcome was comparison of drug survival over time. A multivariate Cox proportional hazard ratio model was computed. A total of 1,866 patients were included; 739 females (39%), median age 47 years. In the multivariate Cox model, no association was found between the calendar year of initiation and drug survival (hazard ratio) over-lapping from 0.80 (0.42–1.52) to 1.17 (0.64–2.17), p = 0.633). In conclusion, drug survival in psoriasis is not affected by the year of initiation.
Published: 2022
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6. Health-related quality of life of COVID-19 two and 12 months after intensive care unit admission

Author: Alexandre Demoule, Elise Morawiec, Maxens Decavele, Raphaelle Ohayon, Roxane Malrin, Maria Alejandra Galarza-Jimenez, Pierantonio Laveneziana, Capucine Morelot-Panzini, Thomas Similowski, Yann De Rycke, Jesus Gonzalez-Bermejo, Laveneziana, Pierantonio, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Neurophysiologie Respiratoire Expérimentale et Clinique (UMRS 1158), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Sorbonne Université (SU), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Centre d'investigation clinique pluridisciplinaire [CHU Pitié Salpêtrière] (CIC-P 1421), and Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP]
Subjects: [SDV] Life Sciences [q-bio], Dyspnea, Mechanical ventilation, Sixminute walk test, Acute respiratory distress syndrome, Pulmonary function tests Dyspnea Health-related quality of life Mechanical ventilation Mortality Sixminute walk test Exercise capacity Acute respiratory distress syndrome COVID-19, Health-related quality of life, [SDV]Life Sciences [q-bio], Exercise capacity, COVID-19, Mortality, Critical Care and Intensive Care Medicine, Pulmonary function tests
Abstract: Purpose To describe health-related quality of life (HRQoL) and dyspnea of COVID-19, 2 and 12 months after an intensive care unit (ICU) stay. Methods Patients discharged from the ICU between April and June 2020 and subsequently transferred to an inpatient rehabilitation facility were assessed 2 months and 12 months after ICU admission. HRQoL was assessed by the EuroQoL EQ-5D-3L (visual analog scale and time trade-off normalized to the French population algorithm) and dyspnea was assessed by the modified Medical Research Council (mMRC) dyspnea scale. Results We enrolled 94 patients. Median EQ-5D-3L time trade-off was 0.80 (interquartile range, 0.36–0.91) at 2 months and 0.91 (0.52–1.00) at 12 months (P = 0.12). EQ-5D-3L visual analog scale was 70 (60–85) at 2 months and 70 (60–85) at 12 months (P = 0.07). The mMRC dyspnea scale was 3 (2–4) at ICU discharge, 1 (0–2), P Conclusions Twelve months after ICU admission for COVID-19 and subsequent rehabilitation, a substantial proportion of patients reported alterations of HRQoL, dyspnea and symptoms that were not present prior to admission and a substantial proportion of these patients had not returned to work. Factors associated with a risk of poorer 12-month quality of life, may help to identify at-risk patients.
Published: 2022
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7. Residual Microscopic Peritoneal Metastases after Macroscopic Complete Cytoreductive Surgery for Advanced High-Grade Serous Ovarian Carcinoma: A Target for Folate Receptor Targeted Photodynamic Therapy?

Author: Morgane Moinard, Jeremy Augustin, Marine Carrier, Elisabeth Da Maïa, Alix Penel, Jérémie Belghiti, Maryam Nikpayam, Clémentine Gonthier, Geoffroy Canlorbe, Samir Acherar, Nadira Delhem, Céline Frochot, Catherine Uzan, Henri Azaïs, Arnoux, Philippe, Laboratoire Réactions et Génie des Procédés (LRGP), Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), 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 de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Institut Universitaire de Cancérologie [Paris] (IUC), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Laboratoire de Chimie Physique Macromoléculaire (LCPM), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Thérapies Laser Assistées par l'Image pour l'Oncologie - U 1189 (ONCO-THAI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Lille, and Institut Universitaire de Cancérologie [Sorbonne Université] (IUC)
Subjects: epithelial ovarian cancer, folate receptor, photodynamic therapy, [SDV.CAN] Life Sciences [q-bio]/Cancer, Drug Discovery, Pharmaceutical Science, Molecular Medicine, cytoreductive surgery, peritoneal carcinomatosis, [SDV.CAN]Life Sciences [q-bio]/Cancer, gynecologic oncology
Abstract: Despite conventional treatment combining complete macroscopic cytoreductive surgery (CRS) and systemic chemotherapy, residual microscopic peritoneal metastases (mPM) may persist as the cause of peritoneal recurrence in 60% of patients. Therefore, there is a real need to specifically target these mPM to definitively eradicate any traces of the disease and improve patient survival. Therapeutic targeting method, such as photodynamic therapy, would be a promising method for such a purpose. Folate receptor alpha (FRα), as it is specifically overexpressed by cancer cells from various origins, including ovarian cancer cells, is a good target to address photosensitizing molecules. The aim of this study was to determine FRα expression by residual mPM after complete macroscopic CRS in patients with advanced high-grade serous ovarian cancer (HGSOC). A prospective study conducted between 1 June 2018 and 10 July 2019 in a single referent center accredited by the European Society of Gynecological Oncology for advanced EOC surgical management. Consecutive patients presenting with advanced HGSOC and eligible for complete macroscopic CRS were included. Up to 13 peritoneal biopsies were taken from macroscopically healthy peritoneum at the end of CRS and examined for the presence of mPM. In case of detection of mPM, a systematic search for RFα expression by immunohistochemistry was performed. Twenty-six patients were included and 26.9% presented mPM. In the subgroup of patients with mPM, FRα expression was positive on diagnostic biopsy before neoadjuvant chemotherapy for 67% of patients, on macroscopic peritoneal metastases for 86% of patients, and on mPM for 75% of patients. In the subgroup of patients with no mPM, FRα expression was found on diagnostic biopsy before neoadjuvant chemotherapy in 29% of patients and on macroscopic peritoneal metastases in 78% of patients. FRα is well expressed by patients with or without mPM after complete macroscopic CRS in patients with advanced HGSOC. In addition to conventional cytoreductive surgery, the use of a therapeutic targeting method, such as photodynamic therapy, by addressing photosensitizing molecules that specifically target FRα may be studied.
Published: 2022
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8. Comparison of Clinical Profiles and Mortality Outcomes Between Influenza and COVID-19 Patients Invasively Ventilated in the ICU: A Retrospective Study From All Paris Public Hospitals From 2016 to 2021

Author: Clémence Marois, Thomas Nedelec, Juliette Pelle, Antoine Rozes, Stanley Durrleman, Carole Dufouil, Alexandre Demoule, Admin, Oskar, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), REanimation et Soins intensifs du Patient en Insuffisance Respiratoire aigüE [CHU Pitié-Salpêtrière] (GRC RESPIRE), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut du Cerveau = Paris Brain Institute (ICM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Algorithms, models and methods for images and signals of the human brain (ARAMIS), Sorbonne Université (SU)-Inria de Paris, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Institut du Cerveau = Paris Brain Institute (ICM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Centre d'investigation clinique Paris Est [CHU Pitié Salpêtrière] (CIC Paris-Est), Centre d'investigation clinique pluridisciplinaire [CHU Pitié Salpêtrière] (CIC-P 1421), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], Neurophysiologie Respiratoire Expérimentale et Clinique (UMRS 1158), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Groupe de recherche cinique Réanimation et soins intensifs du patient en Insuffisance respiratoire aigüe (GRC 30 - RESPIRE), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)
Subjects: [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, COVID-19, Intensive care unit, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, General Medicine, Invasive mechanical ventilation, Mortality, Influenza
Abstract: International audience; Studies comparing outcomes of ICU patients admitted for either COVID-19 or seasonal influenza are limited. Our objective was to describe baseline clinical profiles, care procedures, and mortality outcomes by infection status (influenza vs COVID-19) of patients who received invasive mechanical ventilation in the ICU. DESIGN: Retrospective observational study. SETTING: Data were extracted from the Assistance Publique-Hopitaux de Paris database from September 1, 2016, to April 20, 2021. It includes data from the 39 university hospitals. PATIENTS: A total of 752 influenza adult patients and 3,465 COVID-19 adult patients received invasive mechanical ventilation in one of the ICUs of the Paris area university hospitals, France. INTERVENTION: The characteristics and outcome by infection status were compared. Factors associated with mortality were assessed using Cox proportional hazard models after controlling for potential confounders, including infection status. MEASUREMENTS AND MAIN RESULTS: The median age at admission to the ICU was 67 (interquartile range [IQR], 57-77) and 63 yr (IQR, 54-71 yr) for influenza and COVID-19 patients, respectively. At ICU admission, COVID-19 patients were more frequently obese, more frequently had diabetes mellitus or high blood pressure, and were less likely to have chronic heart failure, chronic respiratory disease, chronic kidney failure, or active cancer than influenza patients. The overall survival at 90 days was 57% for COVID-19 patients and 66% for influenza patients (p < 0.001). In a multivariable Cox model, higher age, organ transplant, severe acute respiratory syndrome coronavirus 2 infection, and chronic kidney failure were associated with shorter survival, whereas obesity and high blood pressure were associated with longer survival after invasive ventilation. CONCLUSIONS: COVID-19 and influenza patients requiring mechanical ventilation in the ICU differed by many characteristics. COVID-19 patients showed lower survival independently of potential confounders.
Published: 2022
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9. Efficacy of Acyclovir to Suppress Herpes Simplex Virus Oropharyngeal Reactivation in Patients Who Are Mechanically Ventilated

Author: Luyt, Charles-Edouard, Hajage, David, Burrel, Sonia, Hraiech, Sami, Diallo, Mamadou, Papazian, Laurent, Boutolleau, David, Service de Pneumologie, Médecine Intensive et Réanimation - R3S [CHU Pitié-Salpêtrière] (SPMIR-R3S), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CIC Paris Est, Service de Département de santé publique, Centre National de Référence Herpèsvirus [CHU Pitié Salpêtrière], Service de virologie [CHU Pitié-Salpêtrière], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Aix Marseille Université (AMU), Assistance Publique - Hôpitaux de Marseille (APHM), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre d'investigation clinique Paris Est [CHU Pitié Salpêtrière] (CIC Paris-Est), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Service de Réanimation Médicale [CHU Pitié-Salpétrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre d'investigation clinique pluridisciplinaire [CHU Pitié Salpêtrière] (CIC-P 1421), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Service de Département de santé publique [CHU Pitié-Salpêtrière], Service de Virologie [CHU Pitié-Salpêtrière], Gestionnaire, Hal Sorbonne Université, and Service de Pneumologie - R3S [CHU Pitié-Salpêtrière] (SPMIR-R3S)
Subjects: [SDV.MP.VIR] Life Sciences [q-bio]/Microbiology and Parasitology/Virology, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2021
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10. Progression-free survival as a surrogate for overall survival in oncology trials: a methodological systematic review

Author: Yann De Rycke, Lisa Belin, Agnès Dechartres, Aidan Tan, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Département de Biostatistique, Santé Publique et Information Médicale [CHU Pitié-Salpêtrière] (BIOSPIM ), 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), National University Hospital [Singapore] (NUH), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), and Gestionnaire, Hal Sorbonne Université
Subjects: Oncology, Cancer Research, medicine.medical_specialty, [SDV]Life Sciences [q-bio], MEDLINE, Cochrane Library, Article, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Neoplasms, medicine, Overall survival, Humans, 030212 general & internal medicine, Progression-free survival, Drug Approval, Cancer, Surrogate endpoint, business.industry, Progression-Free Survival, [SDV] Life Sciences [q-bio], Outcomes research, 030220 oncology & carcinogenesis, business, Biomarkers
Abstract: BackgroundProgression-free survival (PFS) is a surrogate endpoint widely used for overall survival (OS) in oncology. Validation of PFS as a surrogate must be done for each indication and each intervention. We aimed to identify all studies evaluating the validity of PFS as a surrogate for OS in oncology, and to describe their methodological characteristics.MethodsWe conducted a systematic review by searching MEDLINE via PubMed and the Cochrane Library with no limitation on time, selected relevant studies and extracted data in duplicate on how surrogacy was evaluated (meta-analytic approach, assessment of correlation and level of evaluation).ResultsWe identified 91 studies evaluating the validity of PFS as a surrogate for OS in 24 cancer localisations. Although a meta-analytic approach was used in 83 (91%) studies, the methods used to validate PFS as a surrogate of OS were heterogeneous across studies. Of the 47 studies concluding that PFS is a good surrogate for OS, for 15 (32%), there was no quantitative argument for surrogacy.ConclusionsAlthough most studies used a meta-analytic approach as recommended, our methodological review highlights heterogeneity in methods and reporting, which stresses the importance of developing and applying clear recommendations in this area.
Published: 2020
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11. Predicting 90-day survival of patients with COVID-19: Survival of Severely Ill COVID (SOSIC) scores

Author: Schmidt, Matthieu, Guidet, Bertrand, Demoule, Alexandre, Ponnaiah, Maharajah, Fartoukh, Muriel, Puybasset, Louis, Combes, Alain, Hajage, David, Mercat, Alain, Asfar, Pierre, Beloncle, François, Demiselle, Julien, Pham, Tài, Pavot, Arthur, Monnet, Xavier, Richard, Christian, Dres, Martin, Mayaux, Julien, Beurton, Alexandra, Daubin, Cédric, Descamps, Richard, Joret, Aurélie, Du Cheyron, Damien, Pene, Frédéric, Chiche, Jean-Daniel, Jozwiak, Mathieu, Jaubert, Paul, Voiriot, Guillaume, Teulier, Marion, Blayau, Clarisse, L’her, Erwen, Aubron, Cécile, Bodenes, Laetitia, Ferriere, Nicolas, Auchabie, Johann, Le Meur, Anthony, Pignal, Sylvain, Mazzoni, Thierry, Quenot, Jean-Pierre, Andreu, Pascal, Roudau, Jean-Baptiste, Labruyère, Marie, Nseir, Saad, Preau, Sébastien, Poissy, Julien, Mathieu, Daniel, Benhamida, Sarah, Paulet, Rémi, Roucaud, Nicolas, Thyrault, Martial, Daviet, Florence, Hraiech, Sami, Parzy, Gabriel, Sylvestre, Aude, Jochmans, Sébastien, Bouilland, Anne-Laure, Monchi, Mehran, Danguy Des Déserts, Marc, Mathais, Quentin, Rager, Gwendoline, Pasquier, Pierre, Jean, Reignier, Amélie, Seguin, Charlotte, Garret, Emmanuel, Canet, Dellamonica, Jean, Saccheri, Clément, Lombardi, Romain, Kouchit, Yanis, Jacquier, Sophie, Mathonnet, Armelle, Nay, Mai-Ahn, Runge, Isabelle, Martino, Frédéric, Flurin, Laure, Rolle, Amélie, Carles, Michel, Coudroy, Rémi, Thille, Arnaud, Frat, Jean-Pierre, Rodriguez, Maeva, Beuret, Pascal, Tientcheu, Audrey, Vincent, Arthur, Michelin, Florian, Tamion, Fabienne, Carpentier, Dorothée, Boyer, Déborah, Girault, Christophe, Gissot, Valérie, Ehrmann, Stéphan, Salmon Gandonniere, Charlotte, Elaroussi, Djlali, Delbove, Agathe, Fedun, Yannick, Huntzinger, Julien, Lebas, Eddy, Kisoka, Grâce, Grégoire, Céline, Marchetta, Stella, Lambermont, Bernard, Argaud, Laurent, Baudry, Thomas, Bertrand, Pierre-Jean, Dargent, Auguste, Guitton, Christophe, Chudeau, Nicolas, Landais, Mickaël, Darreau, Cédric, Ferre, Alexis, Gros, Antoine, Lacave, Guillaume, Bruneel, Fabrice, Neuville, Mathilde, Devaquet, Jérôme, Tachon, Guillaume, Gallot, Richard, Chelha, Riad, Galbois, Arnaud, Jallot, Anne, Chalumeau Lemoine, Ludivine, Kuteifan, Khaldoun, Pointurier, Valentin, Jandeaux, Louise-Marie, Mootien, Joy, Damoisel, Charles, Sztrymf, Benjamin, Chommeloux, Juliette, Luyt, Charles-Edouard, Schortgen, Frédérique, Rusel, Leon, Jung, Camille, Gobert, Florent, Vimpere, Damien, Lamhaut, Lionel, Sauneuf, Bertrand, Charrrier, Liliane, Calus, Julien, Desmeules, Isabelle, Painvin, Benoît, Tadie, Jean-Marc, Castelain, Vincent, Michard, Baptiste, Herbrecht, Jean-Etienne, Baldacini, Mathieu, Weiss, Nicolas, Demeret, Sophie, Marois, Clémence, Rohaut, Benjamin, Moury, Pierre-Henri, Savida, Anne-Charlotte, Couadau, Emmanuel, Série, Mathieu, Alexandru, Nica, Bruel, Cédric, Fontaine, Candice, Garrigou, Sonia, Courtiade Mahler, Juliette, Leclerc, Maxime, Ramakers, Michel, Garçon, Pierre, Massou, Nicole, van Vong, Ly, Sen, Juliane, Lucas, Nolwenn, Chemouni, Franck, Stoclin, Annabelle, Avenel, Alexandre, Faure, Henri, Gentilhomme, Angélie, Ricome, Sylvie, Abraham, Paul, Monard, Céline, Textoris, Julien, Rimmele, Thomas, Montini, Florent, Lejour, Gabriel, Lazard, Thierry, Etienney, Isabelle, Kerroumi, Younes, Dupuis, Claire, Bereiziat, Marine, Coupez, Elisabeth, Thouy, François, Hoffmann, Clément, Donat, Nicolas, Chrisment, Anne, Blot, Rose-Marie, Kimmoun, Antoine, Jacquot, Audrey, Mattei, Matthieu, Levy, Bruno, Ravan, Ramin, Dopeux, Loïc, Liteaudon, Jean-Mathias, Roux, Delphine, Rey, Brice, Anghel, Radu, Schenesse, Deborah, Gevrey, Vincent, Castanera, Jermy, Petua, Philippe, Madeux, Benjamin, Hartman, Otto, Piagnerelli, Michael, Joosten, Anne, Noel, Cinderella, Biston, Patrick, Noel, Thibaut, Bouar, Gurvan, Boukhanza, Messabi, Demarest, Elsa, Bajolet, Marie-France, Charrier, Nathanaël, Quenet, Audrey, Zylberfajn, Cécile, Dufour, Nicolas, Mégarbane, Buno, Voicu, Sqébastian, Deye, Nicolas, Malissin, Isabelle, Legay, François, Debarre, Matthieu, Barbarot, Nicolas, Fillatre, Pierre, Delord, Bertrand, Laterrade, Thomas, Saghi, Tahar, Pujol, Wilfried, Cungi, Pierre-Julien, Esnault, Pierre, Cardinale, Mickael, Hong Tuan Ha, Vivien, Fleury, Grégory, Brou, Marie-Ange, Zafimahazo, Daniel, Tran-Van, David, Avargues, Patrick, Carenco, Lisa, Robin, Nicolas, Ouali, Alexandre, Houdou, Lucie, Le Terrier, Christophe, Suh, Noémie, Primmaz, Steve, Pugin, Jérome, Weiss, Emmanuel, Gauss, Tobias, Moyer, Jean-Denis, Paugam Burtz, Catherine, La Combe, Béatrice, Smonig, Rolland, Violleau, Jade, Cailliez, Pauline, Chelly, Jonathan, Marchalot, Antoine, Saladin, Cécile, Bigot, Christelle, Fayolle, Pierre-Marie, Fatséas, Jules, Ibrahim, Amr, Resiere, Dabor, Hage, Rabih, Cholet, Clémentine, Cantier, Marie, Trouiler, Pierre, Montravers, Philippe, Lortat-Jacob, Brice, Tanaka, Sebastien, Tran Dinh, Alexy, Duranteau, Jacques, Harrois, Anatole, Dubreuil, Guillaume, Werner, Marie, Godier, Anne, Hamada, Sophie, Zlotnik, Diane, Nougue, Hélène, Mekontso-Dessap, Armand, Carteaux, Guillaume, Razazi, Keyvan, de Prost, Nicolas, Mongardon, Nicolas, Langeron, Olivier, Levesque, Eric, Attias, Arié, de Roquetaillade, Charles, Chousterman, Benjamin, Mebazaa, Alexandre, Gayat, Etienne, Garnier, Marc, Pardo, Emmanuel, Satre-Buisson, Lea, Gutton, Christophe, Yvin, Elise, Marcault, Clémence, Azoulay, Elie, Darmon, Michael, Ait Oufella, Hafid, Hariri, Geoffroy, Urbina, Tomas, Mazerand, Sandie, Heming, Nicholas, Santi, Francesca, Moine, Pierre, Annane, Djillali, Bouglé, Adrien, Omar, Edris, Lancelot, Aymeric, Begot, Emmanuelle, Plantefeve, Gaétan, Contou, Damien, Mentec, Hervé, Pajot, Olivier, Faguer, Stanislas, Cointault, Olivier, Lavayssiere, Laurence, Nogier, Marie-Béatrice, Jamme, Matthieu, Pichereau, Claire, Hayon, Jan, Outin, Hervé, Dépret, François, Coutrot, Maxime, Chaussard, Maité, Guillemet, Lucie, Goffin, Pierre, Thouny, Romain, Guntz, Julien, Jadot, Laurent, Persichini, Romain, Jean-Michel, Vanessa, Georges, Hugues, Caulier, Thomas, Pradel, Gaël, Hausermann, Marie-Hélène, Nguyen-Valat, Thi My Hue, Boudinaud, Michel, Vivier, Emmanuel, Rosseli, Sylvène, Bourdin, Gaël, Pommier, Christian, Vinclair, Marc, Poignant, Simon, Mons, Sandrine, Bougouin, Wulfran, Bruna, Franklin, Maestraggi, Quentin, Roth, Christian, Bitker, Laurent, Dhelft, François, Bonnet-Chateau, Justine, Filippelli, Mathilde, Morichau-Beauchant, Tristan, Thierry, Stéphane, Le Roy, Charlotte, Saint Jouan, Mélanie, Goncalves, Bruno, Mazeraud, Aurélien, Daniel, Matthieu, Sharshar, Tarek, Cadoz, Cyril, Gaci, Rostane, Gette, Sébastien, Louis, Guillaune, Sacleux, Sophe-Caroline, Ordan, Marie-Amélie, Cravoisy, Aurélie, Conrad, Marie, Courte, Guilhem, Gibot, Sébastien, Benzidi, Younès, Casella, Claudia, Serpin, Laurent, Setti, Jean-Lou, Besse, Marie-Catherine, Bourreau, Anna, Pillot, Jérôme, Rivera, Caroline, Vinclair, Camille, Robaux, Marie-Aline, Achino, Chloé, Delignette, Marie-Charlotte, Mazard, Tessa, Aubrun, Frédéric, Bouchet, Bruno, Frérou, Aurélien, Muller, Laura, Quentin, Charlotte, Degoul, Samuel, Stihle, Xavier, Sumian, Claude, Bergero, Nicoletta, Lanaspre, Bernard, Quintard, Hervé, Maiziere, Eve Marie, Egreteau, Pierre-Yves, Leloup, Guillaume, Berteau, Florin, Cottrel, Marjolaine, Bouteloup, Marie, Jeannot, Matthieu, Blanc, Quentin, Saison, Julien, Geneau, Isabelle, Grenot, Romaric, Ouchike, Abdel, Hazera, Pascal, Masse, Anne-Lyse, Demiri, Suela, Vezinet, Corinne, Baron, Elodie, Benchetrit, Deborah, Monsel, Antoine, Trebbia, Grégoire, Schaack, Emmanuelle, Lepecq, Raphaël, Bobet, Mathieu, Vinsonneau, Christophe, Dekeyser, Thibault, Delforge, Quentin, Rahmani, Imen, Vivet, Bérengère, Paillot, Jonathan, Hierle, Lucie, Chaignat, Claire, Valette, Sarah, Her, Benoït, Brunet, Jennifier, Page, Mathieu, Boiste, Fabienne, Collin, Anthony, Bavozet, Florent, Garin, Aude, Dlala, Mohamed, Mhamdi, Kais, Beilouny, Bassem, Lavalard, Alexandra, Perez, Severine, Veber, Benoit, Guitard, Pierre-Gildas, Gouin, Philippe, Lamacz, Anna, Plouvier, Fabienne, Delaborde, Bertrand, Kherchache, Aïssa, Chaalal, Amina, Ricard, Jean-Damien, Amouretti, Marc, Freita-Ramos, Santiago, Roux, Damien, Constantin, Jean-Michel, Assefi, Mona, Lecore, Marine, Selves, Agathe, Prevost, Florian, Lamer, Christian, Shi, Ruiying, Knani, Lyes, Pili Floury, Sébastien, Vettoretti, Lucie, Levy, Michael, Marsac, Lucile, Dauger, Stéphane, Guilmin-Crépon, Sophie, Winiszewski, Hadrien, Piton, Gael, Soumagne, Thibaud, Capellier, Gilles, Putegnat, Jean-Baptiste, Bayle, Frédérique, Perrou, Maya, Thao, Ghyslaine, Géri, Guillaume, Charron, Cyril, Repessé, Xavier, Vieillard-Baron, Antoine, Guilbart, Mathieu, Roger, Pierre-Alexandre, Hinard, Sébastien, Macq, Pierre-Yves, Chaulier, Kevin, Goutte, Sylvie, Chillet, Patrick, Pitta, Anaïs, Darjent, Barbara, Bruneau, Amandine, Lasocki, Sigismond, Leger, Maxime, Gergaud, Soizic, Lemarie, Pierre, Terzi, Nicolas, Schwebel, Carole, Dartevel, Anaïs, Galerneau, Louis-Marie, Diehl, Jean-Luc, Hauw-Berlemont, Caroline, Péron, Nicolas, Guérot, Emmanuel, Mohebbi Amoli, Abolfazl, Benhamou, Michel, Deyme, Jean-Pierre, Andremont, Olivier, Lena, Diane, Cady, Julien, Causeret, Arnaud, de la Chapelle, Arnaud, Cracco, Christophe, Rouleau, Stéphane, Schnell, David, Foucault, Camille, Lory, Cécile, Chapelle, Thibault, Bruckert, Vincent, Garcia, Julie, Sahraoui, Abdlazize, Abbosh, Nathalie, Bornstain, Caroline, Pernet, Pierre, Poirson, Florent, Pasem, Ahmed, Karoubi, Philippe, Poupinel, Virginie, Gauthier, Caroline, Bouniol, François, Feuchere, Philippe, Heron, Anne, Carreira, Serge, Emery, Malo, Le Floch, Anne Sophie, Giovannangeli, Luana, Herzog, Nicolas, Giacardi, Christophe, Baudic, Thibaut, Thill, Chloé, Lebbah, Said, Palmyre, Jessica, Tubach, Florence, Bonnet, Nicolas, Ebstein, Nathan, Gaudry, Stéphane, Cohen, Yves, Noublanche, Julie, Lesieur, Olivier, Sément, Arnaud, Roca-Cerezo, Isabel, Pascal, Michel, Sma, Nesrine, Colin, Gwenhaël, Lacherade, Jean-Claude, Bionz, Gauthier, Maquigneau, Natacha, Bouzat, Pierre, Durand, Michel, Hérault, Marie-Christine, Payen, Jean-Francois, Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), 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)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), REanimation et Soins intensifs du Patient en Insuffisance Respiratoire aigüE [CHU Pitié-Salpêtrière] (GRC RESPIRE), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Neurophysiologie Respiratoire Expérimentale et Clinique (UMRS 1158), Département Médico-Universitaire APPROCHES, CHU Tenon [AP-HP], Groupe de recherche clinique CARMAS (Cardiovascular and Respiratory Manifestations of Acute lung injury and Sepsis) (CARMAS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Henri Mondor, Laboratoire d'Imagerie Biomédicale (LIB), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), INSERM UMRS-1144, Université Paris Cité, Réanimation Médicale et Toxicologique, Hôpital Lariboisière, and Mégarbane, Bruno
Subjects: [SDV.MHEP.ME] Life Sciences [q-bio]/Human health and pathology/Emerging diseases, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, Acute respiratory distress syndrome, RC86-88.9, Research, COVID-19, Medical emergencies. Critical care. Intensive care. First aid, Critical Care and Intensive Care Medicine, Predictive survival model, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.TOX] Life Sciences [q-bio]/Toxicology, Mechanical ventilation, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, [SDV.TOX]Life Sciences [q-bio]/Toxicology, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, [SDV.MHEP.PSR] Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Outcome
Abstract: Background Predicting outcomes of critically ill intensive care unit (ICU) patients with coronavirus-19 disease (COVID-19) is a major challenge to avoid futile, and prolonged ICU stays. Methods The objective was to develop predictive survival models for patients with COVID-19 after 1-to-2 weeks in ICU. Based on the COVID–ICU cohort, which prospectively collected characteristics, management, and outcomes of critically ill patients with COVID-19. Machine learning was used to develop dynamic, clinically useful models able to predict 90-day mortality using ICU data collected on day (D) 1, D7 or D14. Results Survival of Severely Ill COVID (SOSIC)-1, SOSIC-7, and SOSIC-14 scores were constructed with 4244, 2877, and 1349 patients, respectively, randomly assigned to development or test datasets. The three models selected 15 ICU-entry variables recorded on D1, D7, or D14. Cardiovascular, renal, and pulmonary functions on prediction D7 or D14 were among the most heavily weighted inputs for both models. For the test dataset, SOSIC-7’s area under the ROC curve was slightly higher (0.80 [0.74–0.86]) than those for SOSIC-1 (0.76 [0.71–0.81]) and SOSIC-14 (0.76 [0.68–0.83]). Similarly, SOSIC-1 and SOSIC-7 had excellent calibration curves, with similar Brier scores for the three models. Conclusion The SOSIC scores showed that entering 15 to 27 baseline and dynamic clinical parameters into an automatable XGBoost algorithm can potentially accurately predict the likely 90-day mortality post-ICU admission (sosic.shinyapps.io/shiny). Although external SOSIC-score validation is still needed, it is an additional tool to strengthen decisions about life-sustaining treatments and informing family members of likely prognosis.
Published: 2021
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12. Safety and Persistence of Nalmefene Treatment for Alcohol Dependence. Results from Two Post-authorisation Safety Studies

Author: S. Guillo, Florence Tubach, Massoud Toussi, Frank Andersohn, Kavitha Kuppan, Elin Heldbo Reines, Jennifer S. Haas, Jonathan Chick, K. Borchert, Sebastian Braun, Ole Lemming, Castle Craig Hospital [Peeblesshire, UK] (CCH), Frank Andersohn Consulting and Research Services [Berlin, Germany] (FACRS), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Xcenda GmbH [Hannover, Germany], IQVIA, H. Lundbeck A/S [Valby, Denmark], HAL-SU, Gestionnaire, Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Subjects: Adult, Male, medicine.medical_specialty, Nausea, Narcotic Antagonists, alcohol dependence, safety nalmefene, Article, older adult, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Outcome Assessment, Health Care, medicine, follow-up, Humans, AcademicSubjects/MED00860, Prospective Studies, start trial, Nalmefene, Retrospective Studies, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, business.industry, Alcohol dependence, Retrospective cohort study, General Medicine, Middle Aged, medicine.disease, Comorbidity, Naltrexone, psychiatry, 030227 psychiatry, 3. Good health, Discontinuation, Alcoholism, comorbidity, Tolerability, Female, medicine.symptom, business, 030217 neurology & neurosurgery, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Cohort study, medicine.drug
Abstract: Aims Two post-authorisation studies assessed the safety and persistence of patients’ use of nalmefene. Methods The START study (EUPAS5678) was a non-interventional, multi-country, prospective, 18-month (8 follow-up visits) cohort study including outpatients initiating nalmefene for the first time. The multi-database retrospective cohort study (MDRC, EUPAS14083) included baseline and follow-up data from German, Swedish and UK healthcare databases. Both studies permitted ‘all comers’ without explicit exclusion criteria; predefined subgroups of interest included the elderly (≥65 years) as well as patients with significant psychiatric and/or somatic comorbidities. Results START study: Overall, the mean duration of nalmefene treatment was 10.3 ± 7.3 months (N = 1348), with 49.0% of patients treated for ≥1 year; frequent reasons for treatment discontinuation were ‘goal reached’ and ‘drug cost’. The most frequently reported adverse drug reactions (ADRs) were nausea (4.7%), dizziness (3.2%) and insomnia (2.0%). ADR rates appeared higher in the elderly subpopulation (18.6% reported ≥1 ADR vs. 12.0% in the total population) but were not higher in the other predefined subgroups. MDRC study: The database follow-up analysis followed 2892 patients over 18 months for whom the duration of nalmefene treatment was between 2 and 3 months and, Short Summary: Two studies were used to evaluate the safety and persistence of nalmefene in the routine management of alcohol dependence in Europe as part of the overall risk management plan. Although adverse events appeared more common in over 65-year olds, there were no major differences in safety outcomes between the total population, and those with psychiatric and somatic comorbidities or those with a history of seizures. Findings were in line with those from previous clinical studies. The differing rates of persistence beyond 1 year (49% in the prospective study and
Published: 2021
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13. Chimeric antigen receptor T ‐cells safety: A pharmacovigilance and meta‐analysis study

Author: Dolladille, Charles, Ederhy, Stéphane, Ezine, Emilien, Choquet, Sylvain, Nguyen, Lee, Alexandre, Joachim, Moslehi, Javid, Dechartres, Agnès, Salem, Joe-Elie, Picard, Diane, Leroy, Rebecca, Poussy, Tifany, Tankere, Frederic, Gatignol, Peggy, Université de Caen Normandie - UFR Santé (UNICAEN Santé), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU), Service de Cardiologie [CHU Saint-Antoine], CHU Saint-Antoine [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), Groupe de REcherche en Cardio Oncologie [CHU Saint-Antoine] (GRC 27 GRECO), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Service d'Hématologie clinique [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CMC Ambroise Paré [Neuilly-sur-Seine, France], Département de Pharmacologie [CHU Caen], Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Vanderbilt University Medical Center [Nashville], Vanderbilt University [Nashville], Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Université Pierre et Marie Curie - Paris 6 - UFR de Médecine Pierre et Marie Curie (UPMC), Université Pierre et Marie Curie - Paris 6 (UPMC), Physiologie et physiopathologie de la motricité chez l'homme, Université Pierre et Marie Curie - Paris 6 (UPMC)-IFR70-Institut National de la Santé et de la Recherche Médicale (INSERM), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and Gestionnaire, Hal Sorbonne Université
Subjects: [SDV.MHEP.HEM] Life Sciences [q-bio]/Human health and pathology/Hematology, medicine.medical_specialty, Drug-Related Side Effects and Adverse Reactions, MESH: Bayes Theorem, MESH: Pharmacovigilance, Antigens, CD19, Receptors, Antigen, T-Cell, Immunotherapy, Adoptive, MESH: Nervous System Diseases, Pharmacovigilance, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, MESH: Incidence, MESH: Receptors, Chimeric Antigen, Biological Products, Receptors, Chimeric Antigen, Lung, MESH: Humans, MESH: Antigens, CD19, business.industry, Incidence, Incidence (epidemiology), Bayes Theorem, MESH: Receptors, Antigen, T-Cell, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, Hematology, medicine.disease, MESH: Hematologic Diseases, Hematologic Diseases, MESH: Drug-Related Side Effects and Adverse Reactions, 3. Good health, Cytokine release syndrome, medicine.anatomical_structure, Respiratory failure, 030220 oncology & carcinogenesis, Meta-analysis, MESH: Cytokine Release Syndrome, MESH: Immunotherapy, Adoptive, Observational study, Nervous System Diseases, Cytokine Release Syndrome, business, 030215 immunology, Cohort study
Abstract: International audience; Chimeric-antigen-receptor T cells directed against CD19 (CAR-T) are emerging hematological therapeutics with scarce data on its overall safety profile spectrum. To determine the clinical features and incidence of adverse-drug reactions (ADR) associated with CAR-T. This observational, cross-sectional, pharmacovigilance cohort study examined individual case safety reports from the World Health Organization database VigiBase and meta-analysis of data from CAR-T trials and cohorts in the literature was also performed through March, 2020. The primary objective was to identify ADR associated with approved CAR-T (axicabtagene-ciloleucel; tisagenlecleucel). We conducted a Bayesian disproportionate analysis with the 95% lower credibility-interval of information component (IC025 , significance > 0). We also performed a systematic-review and meta-analysis of CAR-T trials and cohorts in the literature to evaluate ADR incidence. Nine ADR classes were associated with CAR-T: Cytokine release syndrome (CRS, n = 1378, IC025 = 4.24), neurological disorders (n = 963, IC025 = 2.42), hematological disorders (n = 532, IC025 = 3.32), infections (n = 287, IC025 = 2.38), cardiovascular disorders (n = 256, IC025 = 2.81), pulmonary disorders (n = 186, IC025 = 3.80), reno-metabolic disorders (n = 123, IC025 = 1.89), hemophagocytic-lymphohistiocytosis (n = 36, IC025 = 5.01) and hepatic disorders (n = 32, IC025 = 2.49). ADR-related fatalities accounted for 99/1783 (5.5%) of the reports and 262/1783 (14.7%) for all-cause mortality. These ADR-related fatalities were associated with hemophagocytic-lymphohistiocytosis, cerebral vascular disorder, infections, and respiratory failure. In meta-analyses, the most frequent any-grade ADRs were CRS, hematological disorders, and neurological disorders. Fatal ADR were most found with neurological disorders, CRS, and infections. Note, CAR-T infusion may be associated with severe ADR mainly following the week of administration, though rarely fatal. Infections, hemophagocytic-lymphohistiocytosis and end organ failures including neurological or lung involvements require scrutiny.
Published: 2021
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14. Refracture And Mortality Following Hospitalization For Severe Osteoporotic Fractures: The Fractos Study

Author: Laure Perrin, Frédérique Maurel, Florence Tubach, Christian Roux, Magali Lemaitre, Anne Crochard, Geoffray Bizouard, Julien Paccou, Thierry Thomas, E Toth, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Biologie Intégrative du Tissu Osseux (LBTO), Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Rhumatologie [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Université Jean Monnet - Saint-Étienne (UJM), Marrow Adiposity & Bone Lab - Adiposité Médullaire et Os - ULR 4490 (MABLab (ex-pmoi)), Université du Littoral Côte d'Opale (ULCO)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), IQVIA, UCB Pharma S.A.[Braine-l'Alleud], UCB Pharma [Brussels], Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Biologie intégrative du tissu osseux, Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Rhumatologie [Saint-Etienne], CHU Saint-Etienne-Hôpital de Bellevue, Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de Biostatistique, Santé Publique et Information Médicale [CHU Pitié-Salpêtrière] (BIOSPIM ), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi)
Subjects: medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, [SDV]Life Sciences [q-bio], Osteoporosis, 030209 endocrinology & metabolism, Diseases of the musculoskeletal system, OSTEOPOROSIS, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Internal medicine, Medicine, Orthopedics and Sports Medicine, 030212 general & internal medicine, Orthopedic surgery, FRACTURE RISK ASSESSMENT, business.industry, Proportional hazards model, Mortality rate, Hazard ratio, Retrospective cohort study, Original Articles, medicine.disease, FRACTURE PREVENTION, Confidence interval, 3. Good health, RC925-935, THERAPEUTICS, Cohort, Original Article, GENERAL POPULATION STUDIES, business, RD701-811
Abstract: Severe osteoporotic fractures (hip, proximal humerus, pelvic, vertebral and multiple rib fractures) carry an increased risk of mortality. This retrospective cohort study in the French national healthcare database aimed to estimate refracture and mortality rates after severe osteoporotic fractures at different sites, and to identify mortality‐related variables. A total of 356,895 patients hospitalized for severe osteoporotic fracture between 2009 and 2014 inclusive were analyzed. The cohort was followed for 2 to 8 years up to the study end or until the patient died. Data were extracted on subsequent hospitalizations, refracture events, treatments, comorbidities of interest and survival. Time to refracture and survival were described using Kaplan‐Meier analysis by site of fracture and overall. Mortality risk factors were identified using a Cox model. Hip fractures accounted for 60.4% of the sample (N = 215,672). In the 12 months following fracture, 58,220 patients (16.7%) received a specific osteoporosis treatment, of whom 21,228 were previously treatment‐naïve. The 12‐month refracture rate was 6.3% (95% confidence interval [CI], 6.2%–6.3%), ranging from 4.0% (95% CI, 3.7%–4.3%) for multiple rib fractures to 7.8% (95% CI, 7.5%–8.1%) for pelvic fractures. Twelve‐month all‐cause mortality was 12.8% (95% CI, 12.7%–12.9%), ranging from 5.0% (95% CI, 4.7%–5.2%) for vertebral fractures to 16.6% (95% CI, 16.4%–16.7%) for hip fractures. Osteoporosis‐related mortality risk factors included fracture site, previous osteoporotic fracture (hazard ratio 1.21; 95% CI, 1.18–1.23), hip refracture (1.74; 95% CI, 1.71–1.77), and no prior osteoporosis treatment (1.24; 95% CI, 1.22–1.26). Comorbid cancer (3.15; 95% CI, 3.09–3.21) and liver disease (2.54; 95% CI, 2.40–2.68) were also strongly associated with mortality. In conclusion, severe osteoporotic fractures, including certain non‐hip nonvertebral fractures, carry a high burden in terms of mortality and refracture risk. However, most patients received no anti‐osteoporotic treatment. The findings emphasize the importance of better management of patients with severe fractures, and of developing effective strategies to reduce fracture risk in patients with osteoporosis. © 2021 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.
Published: 2021
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15. Prognosis of Rash and Chilblain-like Lesions among Outpatients with COVID-19: A Large Cohort Study

Author: Hélène, Mascitti, Patrick, Jourdain, Alexandre, Bleibtreu, Luc, Jaulmes, Agnès, Dechartres, Xavier, Lescure, Youri, Yordanov, Aurélien, Dinh, Pascaline, Villie, Hôpital Raymond Poincaré [AP-HP], Université Paris-Saclay, AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Paris Diderot - Paris 7 (UPD7), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Saint-Antoine [AP-HP], Université Sorbonne Paris Cité (USPC), AP-HP/Universities/INSERM COVID-19 research collaboration: Caroline Apra, Arthur Mensch, Amélie Aime-Eusebi, Erwan Debuc, Agnes Dechartres, Laurène Deconinck, Christine Katlama, Josselin Lebel, François-Xavier Lescure, Yves Artigou, Amélie Banzet, Elodie Boucheron, Christiane Boudier, Edouard Buzenac, Marie-Claire Chapron, Dalhia Chekaoui, Laurent De Bastard, Alexandre Grenier, Pierre-Etienne Haas, Julien Hody, Michèle Jarraya, Louis Lacaille, Aurélie Le Guern, Jeremy Leclert, Fanny Male, Jerôme Marchand-Arvier, Emmanuel Martin-Blondet, Apolinne Nassour, Oussama Ourahou, Thomas Penn, Ambre Ribardiere, Nicolas Robin, Camille Rouge, Nicolas Schmidt, Pascaline Villie, and HAL UPMC, Gestionnaire
Subjects: Adult, Male, Microbiology (medical), myalgia, medicine.medical_specialty, COVID19, Chilblain-like lesion, [SDV]Life Sciences [q-bio], Population, Anosmia, Chest pain, Cohort Studies, Rash, Outpatients, Humans, Medicine, education, Aged, education.field_of_study, SARS-CoV-2, business.industry, Brief Report, digestive, oral, and skin physiology, COVID-19, General Medicine, Exanthema, Middle Aged, Ageusia, Prognosis, Dermatology, Chilblains, Hospitalization, [SDV] Life Sciences [q-bio], Infectious Diseases, Risk factors, Vomiting, Female, medicine.symptom, business, Cohort study
Abstract: In a large regional observational cohort study of adult (≥ 18 years), outpatients with COVID-19, prevalence, characteristics, and outcome of patients with rash and/or chilblain-like lesions (CLL), compared with population without cutaneous features, were studied. In total, 28,957 outpatients were included; the prevalence of rash and CCL were 9.5% and 3.7%, respectively. Presence of rash was significantly associated with presence of asthenia, shivers or myalgia, respiratory and gastro-intestinal symptoms, and anosmia/ageusia. The presence of CCL was associated with chest pain, chest oppression, nausea/vomiting, and anosmia/ageusia. Patients with CCL were significantly less prone to an unfavourable outcome (hospitalization or death). Supplementary Information The online version contains supplementary material available at 10.1007/s10096-021-04305-3.
Published: 2021
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16. Novel Composite Endpoint for Assessing Outcomes in Liver Transplantation: Arterial and Biliary Complication–Free Survival

Author: Joan Fabregat, Josefina Lopez-Dominguez, Olivier Scatton, Emilio Ramos, Alba Cachero, Pierre Rufat, Daniel Azoulay, Claire Goumard, Fabiano Perdigao, Yann De Rycke, Chetana Lim, Eric Savier, Laura Lladó, Geraldine Rousseau, Chady Salloum, Service d'Hépato-Gastro-Entérologie [CHU Pitié-Salpêtrière], 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 de Recherche Saint-Antoine (CR Saint-Antoine), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Service de Département de santé publique, Service de Chirurgie Digestive, Hépato-Bilio-pancréatique et Transplantation Hépatique [CHU Pitié-Salpétrière], Service de Département d'Information Médicale [CHU Pitié-Salpêtrière] (DIM), Hôpital Paul Brousse, Institut d'Investigació Biomèdica de Bellvitge [Barcelone] (IDIBELL), Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Service de Département de santé publique [CHU Pitié-Salpêtrière], and HAL-SU, Gestionnaire
Subjects: medicine.medical_specialty, Multivariate analysis, [SDV.MHEP.CHI] Life Sciences [q-bio]/Human health and pathology/Surgery, medicine.medical_treatment, Biliary complication, [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery, 030230 surgery, Liver transplantation, Gastroenterology, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Medicine, Humans, Proportional Hazards Models, Retrospective Studies, Transplantation, Hepatology, business.industry, Hazard ratio, Graft Survival, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Circulatory death, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, 3. Good health, Liver Transplantation, Clinical trial, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Cohort, 030211 gastroenterology & hepatology, Surgery, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Complication, business
Abstract: International audience; Transplant and patient survival are the validated endpoints to assess the success of liver transplantation (LT). This study evaluates arterial and biliary complication-free survival (ABCFS) as a new metric. ABC, considered as an event, was an arterial or biliary complication of Dindo-Clavien grade ≥III complication dated at the interventional, endoscopic, or surgical treatment required to correct it. ABCFS was defined as the time from the date of LT to the dates of first ABC, death, relisting, or last follow-up (transplant survival is time from LT to repeat LT or death). Following primary whole LT (n = 532), 106 ABCs occurred and 99 (93%) occurred during the first year after LT. An ABC occurring during the first year after LT (overall rate 19%) was an independent factor associated with transplant survival (hazard ratio [HR], 3.17; P < 0.001) and patient survival (HR, 2.7; P = 0.002) in univariate and multivariate analyses. This result was confirmed after extension of the cohort to splitliver graft, donation after circulatory death, or re-LT (n = 658). Data from 2 external cohorts of primary whole LTs (n = 249 and 229, respectively) confirmed that the first-year ABC was an independent prognostic factor for transplant survival but not for patient survival. ABCFS was correlated with transplant and patient survival (ρ = 0.85 [95% CI, 0.78-0.90] and 0.81 [95% CI, 0.71-0.88], respectively). Preoperative factors known to influence 5-year transplant survival influenced ABCFS after 1 year of follow-up. The 1-year ABCFS was indicative of 5-year transplant survival. ABCFS is a reproducible metric to evaluate the results of LT after 1 year of follow-up and could serve as a new endpoint in clinical trials.
Published: 2021
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17. Weaning-Related Shock in Patients With ECMO: Incidence, Mortality, and Predisposing Factors

Author: Adrien Bouglé, Nadia Aissat, Guillaume Lebreton, Baptiste Duceau, Camille Piat, Joanna Tohme, Ahmed Charfeddine, Amandine Baptiste, Institut de cardiologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service d'Anesthésie réanimation [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sorbonne Université - Faculté de Médecine (SU FM), Sorbonne Université (SU), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Service de Chirurgie cardiaque et thoracique [CHU Pitié-Salpêtrière], Département de Biostatistique, Santé Publique et Information Médicale [CHU Pitié-Salpêtrière] (BIOSPIM ), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CCSD, Accord Elsevier, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Subjects: medicine.medical_specialty, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Shock, Cardiogenic, cardiac surgical procedure, 030204 cardiovascular system & hematology, extracorporeal life support, law.invention, Sepsis, 03 medical and health sciences, 0302 clinical medicine, Extracorporeal Membrane Oxygenation, 030202 anesthesiology, law, Cardiopulmonary bypass, medicine, Extracorporeal membrane oxygenation, Humans, Hospital Mortality, Retrospective Studies, business.industry, Mortality rate, Cardiogenic shock, Incidence, cardiogenic shock, medicine.disease, Intensive care unit, 3. Good health, Cardiac surgery, [SDV] Life Sciences [q-bio], Anesthesiology and Pain Medicine, surgical procedures, operative, Anesthesia, Shock (circulatory), medicine.symptom, Cardiology and Cardiovascular Medicine, business, cardiopulmonary bypass
Abstract: Objective Venoarterial extracorporeal membrane oxygenation (VA-ECMO) commonly is used to manage refractory cardiogenic shock after cardiac surgery, with 31% to 76% of patients successfully weaned off their ECMO. However, it is associated with high mortality rates, and 20% to 65% of weaned patients do not survive to hospital discharge. This study aimed to assess the incidence of ECMO weaning-related shock, the risk factors, and prognosis in the intensive care unit (ICU). Design Retrospective observational cohort study. Setting Surgical ICU of Cardiology Institute of Pitie-Salpetriere University Hospital (Paris-France). Participants Patients who were assisted with a peripheral VA-ECMO from January 2015 to December 2017 were included. Patients with venovenous, central, or right ECMO were excluded. Measurements The authors collected data on patients’ characteristics, during and after surgery. The indications for VA-ECMO implantation were ventricular dysfunction, primary graft dysfunction, and refractory cardiac arrest. Weaning-related shock was defined as the need to introduce or increase the dose of catecholamine at ECMO explantation or in the following week. Results After weaning off VA-ECMO, 56 of 146 patients (38.4%) presented weaning-related shock: 55% were septic shocks, 12.5 % were caused by right ventricle failure, and 7.1% by hemorrhage. ICU mortality was 42% versus 8% in patients who did not present shock. Multivariate analysis showed that patients with pulmonary hypertension and those with norepinephrine before weaning were more likely to develop shock. Conclusion ECMO weaning-related shock is frequent in patients with refractory cardiogenic shock after cardiac surgery. This is most commonly caused by sepsis and causes higher mortality rates, calling for further evaluation.
Published: 2021
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18. Consistency of causal claims in observational studies : a review of papers published in a general medical journal

Author: Camila Olarte Parra, Agnès Dechartres, Els Goetghebeur, Lorenzo Bertizzolo, Sara Schroter, Universiteit Gent = Ghent University [Belgium] (UGENT), University of Amsterdam [Amsterdam] (UvA), The BMJ, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], and Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
Subjects: Statement (logic), statistics & research methods, medical education & training), 03 medical and health sciences, 0302 clinical medicine, Consistency (negotiation), Research Methods, Medicine and Health Sciences, Medicine, Humans, 030212 general & internal medicine, Medical journal, education & training (see, Association (psychology), Language, Data source, 030505 public health, business.industry, Publications, Outcome measures, WORD, General Medicine, education & training (see medical education & training), Compendium, Causality, Mathematics and Statistics, Observational study, epidemiology, 0305 other medical science, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Clinical psychology
Abstract: ObjectiveTo evaluate the consistency of causal statements in observational studies published in The BMJ.DesignReview of observational studies published in a general medical journal.Data sourceCohort and other longitudinal studies describing an exposure-outcome relationship published in The BMJ in 2018. We also had access to the submitted papers and reviewer reports.Main outcome measuresProportion of published research papers with ‘inconsistent’ use of causal language. Papers where language was consistently causal or non-causal were classified as ‘consistently causal’ or ‘consistently not causal’, respectively. For the ‘inconsistent’ papers, we then compared the published and submitted version.ResultsOf 151 published research papers, 60 described eligible studies. Of these 60, we classified the causal language used as ‘consistently causal’ (48%), ‘inconsistent’ (20%) and ‘consistently not causal’(32%). Eleven out of 12 (92%) of the ‘inconsistent’ papers were already inconsistent on submission. The inconsistencies found in both submitted and published versions were mainly due to mismatches between objectives and conclusions. One section might be carefully phrased in terms of association while the other presented causal language. When identifying only an association, some authors jumped to recommending acting on the findings as if motivated by the evidence presented.ConclusionFurther guidance is necessary for authors on what constitutes a causal statement and how to justify or discuss assumptions involved. Based on screening these papers, we provide a list of expressions beyond the obvious ‘cause’ word which may inspire a useful more comprehensive compendium on causal language.
Published: 2021
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19. Venoarterial extracorporeal membrane oxygenation to rescue sepsis-induced cardiogenic shock: a retrospective, multicentre, international cohort study

Author: Antoine Kimmoun, Guillaume Lebreton, Alain Combes, Elie Zogheib, Nicolas Bréchot, Cara Agerstrand, Guillaume Hékimian, David Hajage, Pierre Asfar, Julien Demiselle, Matthieu Schmidt, Arthur S. Slutsky, Daniel Brodie, Santiago Montero, Bruno Levy, Charles-Edouard Luyt, Erwan Flecher, Centre interdisciplinaire de recherche en biologie (CIRB), Labex MemoLife, École normale supérieure - Paris (ENS Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Ecole Superieure de Physique et de Chimie Industrielles de la Ville de Paris (ESPCI Paris), Université Paris sciences et lettres (PSL)-Collège de France (CdF (institution))-École normale supérieure - Paris (ENS Paris), Université Paris sciences et lettres (PSL)-Collège de France (CdF (institution))-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Défaillance Cardiovasculaire Aiguë et Chronique (DCAC), Université de Lorraine (UL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Service de Réanimation Médicale [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Columbia University Medical Center (CUMC), Columbia University [New York], New York Presbyterian Hospital, Hopital Universitario Germans Trias i Pujol, Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut de cardiologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Service de chirurgie thoracique cardiaque et vasculaire [Rennes] = Thoracic and Cardiovascular Surgery [Rennes], CHU Pontchaillou [Rennes], CHU Amiens-Picardie, University of Toronto, École normale supérieure - Paris (ENS-PSL), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Collège de France (CdF (institution))-Ecole Superieure de Physique et de Chimie Industrielles de la Ville de Paris (ESPCI Paris), Université Paris sciences et lettres (PSL)-École normale supérieure - Paris (ENS-PSL), Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), 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 Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], and CCSD, Accord Elsevier
Subjects: Inotrope, medicine.medical_specialty, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Cardiac index, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Extracorporeal membrane oxygenation, Medicine, 030212 general & internal medicine, Ejection fraction, business.industry, Septic shock, Cardiogenic shock, Retrospective cohort study, General Medicine, medicine.disease, 3. Good health, [SDV] Life Sciences [q-bio], surgical procedures, operative, Shock (circulatory), Cardiology, medicine.symptom, business
Abstract: Background Patients with sepsis-induced cardiomyopathy with cardiogenic shock have a high mortality. This study assessed venoarterial extracorporeal membrane oxygenation (VA-ECMO) support for sepsis-induced cardiogenic shock refractory to conventional treatments. Methods In this retrospective, multicentre, international cohort study, we compared outcomes of 82 patients (aged >= 18 years) with septic shock who received VA-ECMO at five academic ECMO centres, with 130 controls (not receiving ECMO) obtained from three large databases of septic shock. All patients had severe myocardial dysfunction (cardiac index 3 L/min per m(2) or less or left ventricular ejection fraction [LVEF] 35% or less) and severe haemodynamic compromise (inotrope score at least 75 mu g/kg per min or lactic acidaemia at least 4 mmol/L) at time of inclusion. The primary endpoint was survival at 90 days. A propensity score-weighted analysis was done to control for confounders. Findings At baseline, patients treated with VA-ECMO had more severe myocardial dysfunction (mean cardiac index 1.5 L/min per m(2) vs 2.2 L/min per m(2), LVEF 17% vs 27%), more severe haemodynamic impairment (inotrope score 279 mu g/kg per min vs 145 mu g/kg per min, lactataemia 8.9 mmol/L vs 6.5 mmol/L), and more severe organ failure (Sequential Organ Failure Assessment score 17 vs 13) than did controls, with p
Published: 2020
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20. Long-Term Disabilities of Survivors of Out-of-Hospital Cardiac Arrest

Author: Anne Peskine, Alain Cariou, David Hajage, Nicolas Deye, Emmanuel Guérot, Martin Dres, Romain Sonneville, Alexandre Lafourcade, Vincent Navarro, Hélène Robert, Philippe Azouvi, Tarek Sharshar, Eleonore Bayen, Charles-Edouard Luyt, Guillaume Hékimian, Nicolas Bréchot, Mathieu Schmidt, Alain Combes, Alexandre Demoule, Julien Mayaux, Pascale Pradat-Diehl, Eléonore Bayen, Damien Galanaud, Nathalie Marin, Julien Charpentier, Jean-Paul Mira, Olivier Vignaud, Jean-Luc Diehl, Jean-Yves Fagon, Bruno Mégarbane, Jean-Pierre Guichard, Nathalie Kubis, Alain Yelnik, Lila Bouadma, Jean-François Timsit, Isabelle Klein, Robert Carlier, Florence Colle, Service de médecine physique et de réadaptation [CHU Pitié-Salpêtrière], Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de réanimation médicale polyvalente [CHU Cochin], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Département de Biostatistique, Santé Publique et Information Médicale [CHU Pitié-Salpêtrière] (BIOSPIM ), Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Service de Pneumologie et Réanimation Médicale [CHU Pitié-Salpêtrière] (Département ' R3S '), CIC - CHU Bichat, Institut National de la Santé et de la Recherche Médicale (INSERM), Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute (ICM), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Hôpital Raymond Poincaré [AP-HP], Hôpital d'Instruction des Armées Sainte Anne, Service de Santé des Armées, Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut de cardiologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], and Service de Médecine Physique et de Réadaptation [CHU Pitié-Salpêtrière] (MPR)
Subjects: Pulmonary and Respiratory Medicine, Pediatrics, medicine.medical_specialty, SF-36, [SDV]Life Sciences [q-bio], Population, cardiac arrest, 030204 cardiovascular system & hematology, Critical Care and Intensive Care Medicine, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Medicine, education, Depression (differential diagnoses), Coma, education.field_of_study, Mini–Mental State Examination, medicine.diagnostic_test, business.industry, Glasgow Coma Scale, 3. Good health, disability, Anxiety, prognosis, medicine.symptom, Cardiology and Cardiovascular Medicine, business, 030217 neurology & neurosurgery
Abstract: Background Long-term outcomes of awakened survivors of out-of-hospital cardiac arrest (OHCA) are poorly known. Research Question What are the month (M) 18 outcomes of survivors of out-of-hospital cardiac arrest (OHCA) who awakened during the first 2 weeks’ post-OHCA and their poor-outcome risk factors? Study Design and Methods All OHCA survivors with a Glasgow Coma Scale score ≥12 during the first 2 weeks’ post-OHCA were enrolled in six ICUs and followed up at M3, M6, M12, and M18. The primary outcome measure was Glasgow Outcome Scale-Extended (GOS-E) score at M18. Secondary outcome measures included evaluation at M18 of neurologic, behavioral, and cognitive disabilities; health-related quality of life (HR-QOL), anxiety and depression; and poor-outcome risk factors (GOS-E score ≤ 6). Results Among the 139 included patients, 98 were assessable for the primary outcome measure. At M18, 64 (65%) had full recovery or minor disabilities (GOS-E score > 6), 18 (18%) had moderate disabilities but were autonomous for daily-life activities (GOS-E score = 6), 12 (12%) had poor autonomy (GOS-E score 1), and four had died. Percentages of patients with GOS-E scores > 6 increased significantly over the 18-month study period. At M18, no patients had major neurologic disabilities, 20% had cognitive disabilities, 32% had anxiety symptoms, 25% had depression symptoms, and their HR-QOL was impaired compared with a sex- and age-matched population. Low-flow time, Sequential Organ Failure Assessment score at admission, coma duration > 3 days after cardiac arrest, and mechanical ventilation on days 3 and 7 were associated with poor functional outcome. Interpretation Among patients who awoke (Glasgow Coma Scale score ≥12) in the 14 days following OHCA, 35% had moderate to severe disabilities or had died at M18. Interestingly, patients improved until M18 post-OHCA. Risk factors associated with poor functional outcome were low-flow time, clinical severity at ICU admission, prolonged coma duration, and mechanical ventilation. Clinical Trial Registration ClinicalTrials.gov ; No.: NCT02292147; URL: www.clinicaltrials.gov .
Published: 2020
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21. External factors may influence Cochrane reviewers when classifying the risk of bias of original reports

Author: Bertizzolo, Lorenzo, Bossuyt, Patrick M., Atal, Ignacio, Ravaud, Philippe, Dechartres, Agnès, Graduate School, APH - Methodology, APH - Personalized Medicine, Epidemiology and Data Science, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Subjects: Research on research, Reporting, [SDV]Life Sciences [q-bio], Matched case-control, Systematic reviews, Risk of bias
Abstract: Objective: The objective of the study was to explore contextual factors associated with high or low risk-of-bias judgment in case of incomplete or unclear information in study reports. Study Design and Setting: Research-on-research study, using matched case–control design, with a sample of 304 randomized controlled trials (RCTs) included in two Cochrane reviews for which there was disagreement on the risk-of-bias judgment related to incomplete or unclear information in the study report. A case was defined as an RCT judged at high or low risk of bias; a control was the same RCT judged at unclear risk. We used a conditional logistic regression model for analysis. Results: Review authors being also authors of the RCT were more likely to assess an item at low risk of bias than unclear (OR: 11.71; 95% CI: 1.39–98.76). Earlier trials in a review were more often assigned a low risk (OR: 0.37; [0.15–0.96]). Review groups and authors that had completed a lower number of reviews slightly more often assigned a low risk, whereas others reported “unclear” (OR: 0.97, [95% CI: 0.95–0.99] for groups) and 0.97 (95% CI: 0.95–0.998) for authors). Conclusions: Risk-of-bias assessment of RCTs in case of incomplete or unclear information may be affected by contextual factors.
Published: 2020
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22. Plasma oxysterols: biomarkers for diagnosis and treatment in spastic paraplegia type 5

Author: Cecilia Marelli, Alexandra Durr, Patrick J. Babin, David Hajage, Elodie Petit, Elisabeth Ollagnon, Isabelle Coupry, Giovanni Castelnovo, Claire Ewenczyk, Christel Thauvin-Robinet, Urielle Ullmann, Gaetan Lesca, Foudil Lamari, Marie-Lorraine Monin, Sylvie Odent, Claude Wolf, Pierre Labauge, Dominique Rainteau, Cyril Goizet, Julie Pilliod, Alexandre Lafourcade, Julie Lavie, Fanny Mochel, Guillaume Banneau, Imen Benyounes, Claire Guissart, Rabab Debs, Lydie Humbert, Giovanni Stevanin, Département de neurologie [Montpellier], Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Gui de Chauliac [Montpellier]-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de Biochimie Métabolique [CHU Pitié-Salpêtrière], 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), Université Pierre et Marie Curie - Paris 6 (UPMC), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Service de Biochimie Métabolique et Centre de Génétique moléculaire et chromosomique [CHU Pitié Salpêtrière], 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), Unité de neurophysiologie [CHU Saint-Antoine], Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute (ICM), 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)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Service des Maladies du Système Nerveux [CHU Pitié-Salpêtrière], Service de Neurologie [CHU Nimes] (Pôle NIRR), Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL), Laboratoire Maladies Rares: Génétique et Métabolisme (Bordeaux) (U1211 INSERM/MRGM), Université de Bordeaux (UB)-Groupe hospitalier Pellegrin-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de génétique des maladies rares. Pathologie moleculaire, etudes fonctionnelles et banque de données génétiques (LGMR), IFR3, Université Montpellier 1 (UM1)-Université Montpellier 1 (UM1)-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de génétique - Centre de référence des maladies rares, anomalies du développement et syndromes malformatifs (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Hôpital Gui de Chauliac, Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Universitaire [Rennes], Service de pharmacologie - Dosage de médicaments [CHU Saint-Antoine], École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL), Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables (ECEVE (U1123 / UMR_S_1123)), Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université de Paris (UP), and Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-CHU Pitié-Salpêtrière [AP-HP]
Subjects: Male, 0301 basic medicine, spastic paraplegia type 5, Atorvastatin, Gastroenterology, Cohort Studies, chemistry.chemical_compound, 0302 clinical medicine, Chenodeoxycholic acid, Spastic, Medicine, Child, Neurologic Examination, Anticholesteremic Agents, Deoxycholic acid, atorvastatin, Middle Aged, Magnetic Resonance Imaging, 3. Good health, Cholesterol, oxysterols, Female, chenodeoxycholic acid, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Deoxycholic Acid, medicine.drug, Adult, medicine.medical_specialty, Adolescent, Oxysterol, CYP7B1, Cytochrome P450 Family 7, Bile Acids and Salts, Young Adult, 03 medical and health sciences, Internal medicine, Humans, Spastic Paraplegia, Hereditary, business.industry, Infant, biomarkers, Crossover study, Hydroxycholesterols, 030104 developmental biology, ROC Curve, chemistry, Resveratrol, Mutation, Steroid Hydroxylases, sense organs, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract: IF 10.292; International audience; The hereditary spastic paraplegias are an expanding and heterogeneous group of disorders characterized by spasticity in the lower limbs. Plasma biomarkers are needed to guide the genetic testing of spastic paraplegia. Spastic paraplegia type 5 (SPG5) is an autosomal recessive spastic paraplegia due to mutations in CYP7B1, which encodes a cytochrome P450 7α-hydroxylase implicated in cholesterol and bile acids metabolism. We developed a method based on ultra-performance liquid chromatography electrospray tandem mass spectrometry to validate two plasma 25-hydroxycholesterol (25-OHC) and 27-hydroxycholesterol (27-OHC) as diagnostic biomarkers in a cohort of 21 patients with SPG5. For 14 patients, SPG5 was initially suspected on the basis of genetic analysis, and then confirmed by increased plasma 25-OHC, 27-OHC and their ratio to total cholesterol. For seven patients, the diagnosis was initially based on elevated plasma oxysterol levels and confirmed by the identification of two causal CYP7B1 mutations. The receiver operating characteristic curves analysis showed that 25-OHC, 27-OHC and their ratio to total cholesterol discriminated between SPG5 patients and healthy controls with 100% sensitivity and specificity. Taking advantage of the robustness of these plasma oxysterols, we then conducted a phase II therapeutic trial in 12 patients and tested whether candidate molecules (atorvastatin, chenodeoxycholic acid and resveratrol) can lower plasma oxysterols and improve bile acids profile. The trial consisted of a three-period, three-treatment crossover study and the six different sequences of three treatments were randomized. Using a linear mixed effect regression model with a random intercept, we observed that atorvastatin decreased moderately plasma 27-OHC (∼30%, P < 0.001) but did not change 27-OHC to total cholesterol ratio or 25-OHC levels. We also found an abnormal bile acids profile in SPG5 patients, with significantly decreased total serum bile acids associated with a relative decrease of ursodeoxycholic and lithocholic acids compared to deoxycholic acid. Treatment with chenodeoxycholic acid restored bile acids profile in SPG5 patients. Therefore, the combination of atorvastatin and chenodeoxycholic acid may be worth considering for the treatment of SPG5 patients but the neurological benefit of these metabolic interventions remains to be evaluated in phase III therapeutic trials using clinical, imaging and/or electrophysiological outcome measures with sufficient effect sizes. Overall, our study indicates that plasma 25-OHC and 27-OHC are robust diagnostic biomarkers of SPG5 and shall be used as first-line investigations in any patient with unexplained spastic paraplegia.
Published: 2017
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23. A two-stage design for phase II trials with time-to-event endpoint using restricted follow-up

Author: Philippe Broët, Yann De Rycke, Lisa Belin, Institut Curie [Paris], Université Pierre et Marie Curie - Paris 6 (UPMC), Centre d'investigation clinique Paris Est [CHU Pitié Salpêtrière] (CIC Paris-Est), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Paris-Saclay, Hôpital Paul Brousse, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse, University of Montreal, CIC Paris Est, Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Paul Brousse-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11), HAL-UPMC, Gestionnaire, Centre d'investigation clinique pluridisciplinaire [CHU Pitié Salpêtrière] (CIC-P 1421), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Subjects: Pharmacology, Protocol (science), lcsh:R5-920, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Computer science, Entry time, General Medicine, 01 natural sciences, Article, 3. Good health, Clinical trial, 010104 statistics & probability, 03 medical and health sciences, 0302 clinical medicine, Sample size determination, Statistics, Cytostatic drugs, 030212 general & internal medicine, 0101 mathematics, Stage (cooking), lcsh:Medicine (General), [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Type I and type II errors, Event (probability theory)
Abstract: International audience; In phase II oncology trials, the use of new cytostatic drugs raises some questions regarding the endpoint. Time-to-event endpoints such as Progression-Free Survival have been recommended and led to new designs. In 2003, Case and Morgan proposed a design based on the comparison of the cumulative hazards at a clinically relevant timepoint. In 2013, Kwak proposed a design based on the one-sample log-rank test. If all the patients are followed from their entry time to the analysis date, the Kwak and Jung's design leads to a smaller sample size as compared to the Case-Morgan's design. However, the Case and Morgan's design requires less information since it only needs to follow every patient during a fixed interval of time. We propose a trade-off between these two approaches that corresponds to an adaptation of Kwak and Jung's design when the follow-up is expected to be restricted. Our proposal is based on the one-sample log-rank test as the Kwak and Jung's design but it uses the same follow-up information as the Case-Morgan's design. Simulation study shows that our proposal allows reducing the sample size as compared to the Case-Morgan's design (median difference of 23% [15%-33%]). Type I and type II error rates are close to their nominal rates planned in the protocol. A real phase II clinical trial in cervical cancer illustrated the interest of this new design. Thus, our proposal can be recommended as an alternative to the Kwak's design when patients' follow-up is restricted.
Published: 2017
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24. Predictive factors of tumour necrosis inhibitor treatment persistence for rheumatoid arthritis: An observational study in 8052 patients

Author: Eric Van Ganse, Christophe Hudry, Manon Belhassen, Marie-Christine Woronoff-Lemsi, Laurie Levy-Bachelot, Florence Tubach, Bruno Fautrel, Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Health Service and Performance Research (HESPER), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CIC Paris Est, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)
Subjects: Male, medicine.medical_specialty, Necrosis, Gout, [SDV]Life Sciences [q-bio], Gout Suppressants, Arthritis, Rheumatoid, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Neoplasms, Internal medicine, medicine, Treatment persistence, Humans, Prospective Studies, 030212 general & internal medicine, Prospective cohort study, Aged, 030203 arthritis & rheumatology, business.industry, Tophus, Middle Aged, Symptom Flare Up, medicine.disease, Uric Acid, 3. Good health, Rheumatoid arthritis, Antirheumatic Agents, Female, Observational study, Tumor Necrosis Factor Inhibitors, medicine.symptom, Ultrasonography, business
Abstract: Objectives To determine whether changes in ultrasonography (US) features of monosodium urate crystal deposition is associated with the number of gouty flares after stopping gout flare prophylaxis. Methods We performed a 1-year multicentre prospective study including patients with proven gout and US features of gout. The first phase of the study was a 6-month US follow-up after starting urate-lowering therapy (ULT) with gout flare prophylaxis. After 6 months of ULT, gout flare prophylaxis was stopped, followed by a clinical follow-up (M6 to 12) and ULT was maintained. Outcomes were the proportion of relapsing patients between M6 and M12 according to changes of US features of gout and determining a threshold decrease in tophus size according to the probability of relapse. Results We included 79 gouty patients (mean [± SD] age 61.8 ± 14 years, 91% males, median disease duration 4 [IQR 1.5; 10] years). Among the 49 completers at M12, 23 (47%) experienced relapse. Decrease in tophus size ≥ 50% at M6 was more frequent without than with relapse (54% vs. 26%, P = 0.049). On ROC curve analysis, a threshold decrease of 50.8% in tophus size had the best sensitivity/specificity ratio to predict relapse. Probability of relapse was increased for patients with a decrease in tophus size Conclusion A high reduction in US tophus size is associated with low probability of relapse after stopping gout prophylaxis. US follow-up may be useful for managing ULT and gout flare prophylaxis.
Published: 2020
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25. Impact of Point-of-care Testing on Length of Stay of Patients in the Emergency Department: A Cluster-randomized Controlled Study

Author: Alexandre Lafourcade, Bruno Riou, David Hajage, Isabelle Durand-Zaleski, Michel Arock, Pierre Hausfater, Pauline Canavaggio, Julie Bulsei, Nathalie Oueidat, Anne Laure Paquet, Service des Urgences [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Département de Biostatistique, Santé Publique et Information Médicale [CHU Pitié-Salpêtrière] (BIOSPIM ), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Unité de recherche clinique en économie de la santé d'Ile-de-France (URC Eco), Hôpital Hôtel-Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Unité de Recherche Clinique [CHU Pitié-Salpêtrière], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sorbonne Université - Faculté de Médecine (SU FM), Sorbonne Université (SU), and French Ministry of Health (Programme de recherche sur la performance du systeme des soins) PREPS-16-42Assistance Publique-Hopitaux de Paris
Subjects: Adult, Male, medicine.medical_specialty, Point-of-care testing, [SDV]Life Sciences [q-bio], Population, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Clinical endpoint, Medicine, Blood test, Cluster Analysis, Humans, Prospective Studies, education, Aged, education.field_of_study, medicine.diagnostic_test, business.industry, 030208 emergency & critical care medicine, General Medicine, Emergency department, Length of Stay, Middle Aged, Confidence interval, Crowding, Point-of-Care Testing, Emergency medicine, Emergency Medicine, Female, business, Emergency Service, Hospital, Blood sampling
Abstract: International audience; Objectives: Crowding is a frequent concern in the emergency department (ED). Laboratory point-of-care testing (POCT) has been proposed to decrease patients' length of stay (LOS). Our objective was to determine whether an extended panel of POCT solutions could reduce LOS.Methods: This was a single-center, prospective, open-label, controlled cluster-randomized study. Blood test processing was randomized into 1-week inclusion periods: interventional arm (laboratory analyses performed on POCT analyzers implemented in the ED) or control arm (central laboratory). The primary endpoint was LOS of patients in the ED. Secondary endpoints were time to result (TTR), ED crowding surrogates, and average total cost of an ED visit in each arm.Results: A total of 23,231 patients were included and 20,923 were analyzed for the main outcome measure. Mean ± SD age was 46 ± 20 years, and 7,905 (36%) underwent blood sampling. Mean ± SD LOSs were 203 ± 161 and 210 ± 168 minutes in the POCT and control arms, respectively. LOS reduction for the entire ED population was -9 minutes (95% confidence interval [CI] = -22 to 5, p = 0.22) compared to the control arm and -17 minutes (95% CI = -34.0 to 0.6, p = 0.06) for patients undergoing blood sampling. The mean ± SD TTRs were 28 ± 31 and 79 ± 34 minutes in the POCT and control arms, respectively (TTR reduction = -51 minutes, 95% CI = -54 to -48 minutes, p < 0.001).Conclusions: The implementation of an extended panel of POCT solutions in an ED did not significantly reduce the LOS, but reduced the TTR.
Published: 2020
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26. Covidom, a Telesurveillance Solution for Home Monitoring Patients With COVID-19

Author: Youri Yordanov, Aurelien Dinh, Patrick Jourdain, Erwan Debuc, Xavier Lescure, Agnès Dechartres, Caroline Apra, Pascaline Villie, Jerome Marchand-Arvier, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Neurochirurgie [CHU Pitié-Salpêtrière], Service d'Urgences Adultes [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Service des Maladies Infectieuses et Tropicales [CHU Raymond Poincaré], Hôpital Raymond Poincaré [AP-HP], AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), HAL-SU, Gestionnaire, Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service des Urgences [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)
Subjects: Male, MESH: Coronavirus Infections, Health Status, MESH: Monitoring, Physiologic, 030204 cardiovascular system & hematology, 0302 clinical medicine, MESH: Health Surveys, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Pandemic, Health care, Outpatients, Medicine, MESH: COVID-19, 030212 general & internal medicine, app, MESH: Health Status, [SDV.MHEP.ME] Life Sciences [q-bio]/Human health and pathology/Emerging diseases, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, MESH: Middle Aged, lcsh:Public aspects of medicine, MESH: Paris, Middle Aged, Telemedicine, 3. Good health, coronavirus disease, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, lcsh:R858-859.7, MESH: Betacoronavirus, Female, [SDV.IB]Life Sciences [q-bio]/Bioengineering, Medical emergency, patient, Coronavirus Infections, Adult, 2019-20 coronavirus outbreak, Paris, MESH: Pandemics, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), infectious disease, Pneumonia, Viral, telesurveillance, Health Informatics, lcsh:Computer applications to medicine. Medical informatics, 03 medical and health sciences, Betacoronavirus, Viewpoint, Humans, home monitoring, MESH: SARS-CoV-2, Pandemics, Rapid response, Monitoring, Physiologic, [SDV.IB] Life Sciences [q-bio]/Bioengineering, MESH: Humans, business.industry, SARS-CoV-2, COVID-19, lcsh:RA1-1270, MESH: Adult, medicine.disease, Health Surveys, MESH: Male, MESH: Outpatients, monitoring, MESH: Pneumonia, Viral, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, MESH: Telemedicine, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, MESH: Female
Abstract: International audience; In a matter of months, COVID-19 has escalated from a cluster of cases in Wuhan, China, to a global pandemic. As the number of patients with COVID-19 grew, solutions for the home monitoring of infected patients became critical. This viewpoint presents a telesurveillance solution-Covidom-deployed in the greater Paris area to monitor patients with COVID-19 in their homes. The system was rapidly developed and is being used on a large scale with more than 65,000 registered patients to date. The Covidom solution combines an easy-to-use and free web application for patients (through which patients fill out short questionnaires on their health status) with a regional control center that monitors and manages alerts (triggered by questionnaire responses) from patients whose health may be deteriorating. This innovative solution could alleviate the burden of health care professionals and systems while allowing for rapid response when patients trigger an alert.
Published: 2020
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27. Closed-form variance estimator for weighted propensity score estimators with survival outcome

Author: Guillaume Chauvet, Lisa Belin, Florence Tubach, Alexandre Lafourcade, David Hajage, Yann De Rycke, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut de Recherche Mathématique de Rennes (IRMAR), AGROCAMPUS OUEST, Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université de Rennes 2 (UR2), Université de Rennes (UNIV-RENNES)-École normale supérieure - Rennes (ENS Rennes)-Centre National de la Recherche Scientifique (CNRS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA), Institut Curie [Paris], CIC epidémiologie clinique/ essais cliniques, Hôpital Bichat - Claude Bernard, Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Biostatistique, French National Health Insurance (CNAMTS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-École normale supérieure - Rennes (ENS Rennes)-Université de Rennes 2 (UR2)-Centre National de la Recherche Scientifique (CNRS)-INSTITUT AGRO Agrocampus Ouest, Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro), and ANR-11-LABX-0020,LEBESGUE,Centre de Mathématiques Henri Lebesgue : fondements, interactions, applications et Formation(2011)
Subjects: Statistics and Probability, Biometry, Average treatment effect, Population, 01 natural sciences, survival analysis, 010104 statistics & probability, 03 medical and health sciences, 0302 clinical medicine, [MATH.MATH-ST]Mathematics [math]/Statistics [math.ST], variance estimator, Statistics, 030212 general & internal medicine, 0101 mathematics, causal inference, education, Survival analysis, ComputingMilieux_MISCELLANEOUS, propensity score, Proportional Hazards Models, Mathematics, Analysis of Variance, education.field_of_study, Estimator, General Medicine, Variance (accounting), Standard error, Causal inference, Propensity score matching, observational study, Statistics, Probability and Uncertainty, Software
Abstract: Propensity score (PS) methods are widely used in observational studies for evaluating marginal treatment effects. PS-weighting is a popular PS-based method that allows for estimating both the average treatment effect on the overall population (ATE) and the average treatment effect on the treated population (ATT). Previous research has shown that the variance of the treatment effect is accurately estimated only if the variance estimator takes into account the fact that the propensity score is itself estimated from the available data in a first step of the analysis. In 2016, Austin showed that the bootstrap-based variance estimator was the only existing estimator resulting in approximately correct estimates of standard errors when evaluating a survival outcome and a Cox model was used to estimate a marginal hazard ratio (HR). This author stressed the need to develop a closed-form variance estimator of the marginal HR accounting for the estimation of the PS. In the present research, we developed such variance estimators both for the ATE and ATT. We evaluated their performance with an extensive simulation study and compared them to bootstrap-based variance estimators and to naive variance estimators that do not account for the estimation step. We found that the performance of the proposed variance estimators was similar to that of the bootstrap-based estimators. The proposed variance estimators provide an alternative to the bootstrap estimator, particularly interesting in situations in which time-consumption and/or reproducibility are an important issue. An implementation has been developed for the R software and is freely available (package hrIPW).
Published: 2018
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28. Comparison of high flow nasal cannula oxygen and conventional oxygen therapy on ventilatory support duration during acute-on-chronic respiratory failure: study protocol of a multicentre, randomised, controlled trial. The 'HIGH-FLOW ACRF' study

Author: Jean-Damien, Ricard, Fadia, Dib, Marina, Esposito-Farese, Jonathan, Messika, Christophe, Girault, Lise, Piquilloud, Ecologie et Evolution des Microorganismes (EEM), Université Paris Diderot - Paris 7 (UPD7)-Université Paris 13 (UP13)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Louis Mourier - AP-HP [Colombes], CHU Rouen, Normandie Université (NU), Hémodynamique, Interaction Fibrose et Invasivité tumorales Hépatiques (HIFIH), and Université d'Angers (UA)
Subjects: Adult, Lung Diseases, Male, medicine.medical_specialty, [SDV]Life Sciences [q-bio], medicine.medical_treatment, Population, medicine.disease_cause, law.invention, Hypercapnia, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Oxygen therapy, medicine, Humans, 030212 general & internal medicine, education, Monitoring, Physiologic, education.field_of_study, Noninvasive Ventilation, business.industry, Oxygen Inhalation Therapy, General Medicine, Intensive care unit, 3. Good health, Outcome and Process Assessment, Health Care, 030228 respiratory system, Emergency medicine, Good clinical practice, Breathing, Female, business, Respiratory Insufficiency, Nasal cannula, Respiratory care
Abstract: IntroductionThis study protocol describes a trial designed to investigate whether high-flow heated and humidified nasal oxygen (HFHO) therapy in patients with hypercapnic acute respiratory failure (ARF) reduces the need of non-invasive ventilation (NIV).Methods and analysisThis is an open-label, superiority, international, parallel-group, multicentre randomised controlled two-arm trial, with an internal feasibility pilot phase. 242 patients with hypercapnic ARF requiring NIV admitted to an intensive care unit, an intermediate care or a respiratory care unit will be randomised in a 1:1 ratio to receive HFHO or standard oxygen in between NIV sessions. Randomisation will be centralised and stratified by centre and pH at admission (pH ≤7.25 or >7.25). The primary outcome will be the number of ventilator-free days (VFDs) and alive at day 28 postrandomisation. The secondary outcomes will encompass parameters related to the VFDs, comfort and tolerance variables, hospital length of stay and mortality. VFDs at 28 days postrandomisation will be compared between the two groups by Wilcoxon-Mann-Whitney two-sample rank-sum test in the intention-to-treat population. A sensitivity analysis will be conducted in the population of patients for whom the criteria of switching from NIV to spontaneous breathing, or conversely, are not strictly verified.Ethics and disseminationThe protocol has been approved by theComité de Protection des Personnes(CPP)Sud-Ouest & Outre-Mer IV(ref CPP17-049a/2017-A01830-53) and will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. A trial steering committee will oversee the progress of the study. Findings will be disseminated through national and international scientific conferences, and publication in peer-reviewed journals.Trial registration numberNCT03406572.
Published: 2018
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29. Effect of cumulative exposure to corticosteroid and DMARD on radiographic progression in rheumatoid arthritis: results from the ESPOIR cohort

Author: Bruno Fautrel, Baptiste Louveau, Alain Saraux, Francis Guillemin, Yann De Rycke, Alexandre Lafourcade, Florence Tubach, David Hajage, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), Centre National de Référence CERAINO, Service de Rhumatologie (Hôpital de la Cavale Blanche), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université de Lorraine (UL), Université Pierre et Marie Curie - Paris 6 - UFR de Médecine Pierre et Marie Curie (UPMC), Université Pierre et Marie Curie - Paris 6 (UPMC), Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables (ECEVE (U1123 / UMR_S_1123)), Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Department of Biostatistics, Institut Curie [Paris], CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), CIC epidémiologie clinique/ essais cliniques, Hôpital Bichat - Claude Bernard, 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)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre de Pharmacoépidémiologie (Cephepi), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Institut Curie, Service de Rhumatologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], and Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris]-Université Paris Diderot - Paris 7 (UPD7)
Subjects: Adult, Male, medicine.medical_specialty, Adolescent, [SDV]Life Sciences [q-bio], Cumulative Exposure, Arthritis, Administration, Oral, Logistic regression, Arthritis, Rheumatoid, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Rheumatology, Internal medicine, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Young adult, Glucocorticoids, ComputingMilieux_MISCELLANEOUS, Aged, Retrospective Studies, 030203 arthritis & rheumatology, Dose-Response Relationship, Drug, business.industry, Retrospective cohort study, Middle Aged, medicine.disease, 3. Good health, Radiography, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Rheumatoid arthritis, Antirheumatic Agents, Cohort, Disease Progression, Population study, Female, Joints, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Follow-Up Studies, Forecasting
Abstract: Objectives Several authors have tried to predict the risk of radiographic progression in RA according to baseline characteristics, considering exposure to treatment only as a binary variable (Treated: Yes/No). This study aims to model the risk of 5-year radiographic progression taking into account both baseline characteristics and the cumulative time-varying exposure to corticosteroids or DMARDs. Methods The study population consisted of 403 patients of the Etude et Suivi des Polyarthrites Indifferenciees Recentes cohort meeting the 1987 ACR or 2010 ACR/EULAR criteria for RA at inclusion and having complete radiographic data at baseline and 5 years. Radiographic progression was defined at 5 years as a significant increase of the Sharp/van der Heidje score (smallest detectable difference ⩾5). The best logistic regression model was selected from the following: model including only clinico-biological baseline characteristics; model considering baseline characteristics and treatments as binary variables; and model considering baseline characteristics and treatments as weighted cumulative exposure variables. Results Radiographic progression occurred in 143 (35.5%) patients. The best model combined anti-citrullinated peptide antibody positivity, ESR, swollen joint count >14 and erosion score at baseline, as well as corticosteroids, MTX/LEF (MTX or LEF) and biologic DMARDs (bDMARDs) as weighted cumulative exposure variables. Recent cumulative exposure to high doses of corticosteroids (⩽ 3months) was significantly associated with the risk of 5-year radiographic progression and a significant protective association was highlighted for a 36-month exposure to bDMARDs. Conclusion Corticosteroids and bDMARDs play an important role in radiographic progression. Accounting for treatment class and intensity of exposure is a major concern in predictive models of radiographic progression in RA patients.
Published: 2018
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30. Short-course antibiotic therapy for critically ill patients treated for postoperative intra-abdominal infection: the DURAPOP randomised clinical trial

Author: Gaëtan Plantefève, Benoit Veber, Philippe Seguin, Catherine Paugam, Joel Cousson, Karim Asehnoune, Claude Meistelman, Alain Lepape, Antoine Tesniere, Samir Jaber, Gilles Blasco, Florence Tubach, Thomas Lescot, Sigismond Lasocki, Hervé Dupont, Philippe Montravers, Marina Esposito-Farèse, Département d'Anesthésie Réanimation, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Département d'épidémiologie, biostatistique et recherche clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de réanimation médicale [CHU Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Pontchaillou [Rennes], Hôpital Beaujon [AP-HP], Hospices Civils de Lyon (HCL), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre Hospitalier Universitaire de Reims (CHU Reims), Hôpital Cochin [AP-HP], CH Argenteuil, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Thérapeutiques cliniques et expérimentales des infections (EA 3826) (EA 3826), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Pôle d'Anesthésie Réanimation, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), PRES Université Nantes Angers Le Mans (UNAM), Mécanismes physiologiques et conséquences des calcifications cardiovasculaires: rôle des remodelages cardiovasculaires et osseux, and Université de Picardie Jules Verne (UPJV)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: medicine.medical_specialty, Multidrug-resistant bacteria, Peritonitis, Duration of therapy, Critical Care and Intensive Care Medicine, Postoperative intra-abdominal infection, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Anesthesiology, Antibiotic therapy, Intensive care, Internal medicine, medicine, Clinical endpoint, Antimicrobial stewardship, Short course, 030212 general & internal medicine, business.industry, 030208 emergency & critical care medicine, medicine.disease, 3. Good health, Clinical trial, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business
Abstract: International audience; Purpose: Shortening the duration of antibiotic therapy (ABT) is a key measure in antimicrobial stewardship. The optimal duration of ABT for treatment of postoperative intra-abdominal infections (PIAI) in critically ill patients is unknown.Methods: A multicentre prospective randomised trial conducted in 21 French intensive care units (ICU) between May 2011 and February 2015 compared the efficacy and safety of 8-day versus 15-day antibiotic therapy in critically ill patients with PIAI. Among 410 eligible patients (adequate source control and ABT on day 0), 249 patients were randomly assigned on day 8 to either stop ABT immediately (n = 126) or to continue ABT until day 15 (n = 123). The primary endpoint was the number of antibiotic-free days between randomisation (day 8) and day 28. Secondary outcomes were death, ICU and hospital length of stay, emergence of multidrug-resistant (MDR) bacteria and reoperation rate, with 45-day follow-up.Results: Patients treated for 8 days had a higher median number of antibiotic-free days than those treated for 15 days (15 [6–20] vs 12 [6–13] days, respectively; P < 0.0001) (Wilcoxon rank difference 4.99 days [95% CI 2.99–6.00; P < 0.0001). Equivalence was established in terms of 45-day mortality (rate difference 0.038, 95% CI − 0.013 to 0.061). Treatments did not differ in terms of ICU and hospital length of stay, emergence of MDR bacteria or reoperation rate, while subsequent drainages between day 8 and day 45 were observed following short-course ABT (P = 0.041).Conclusion: Short-course antibiotic therapy in critically ill ICU patients with PIAI reduces antibiotic exposure. Continuation of treatment until day 15 is not associated with any clinical benefit
Published: 2018
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31. Differential effect of corticosteroids and biological Dmards on five-year radiographic progression in rheumatoid arthritis: results from a weighted cumulative exposure model developed on the Espoir Cohort

Author: Louveau, Baptiste, De Rycke, Yann, Lafourcade, Alexandre, Saraux, Alain, Guillemin, Francis, Tubach, Florence, Fautrel, Bruno, Hajage, David, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), University of Nancy, Nancy, France, Université Pierre et Marie Curie - Paris 6 (UPMC), Université Pierre et Marie Curie - Paris 6 - UFR de Médecine Pierre et Marie Curie (UPMC), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Lymphocytes B, Autoimmunité et Immunothérapies (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-LabEX IGO Immunothérapie Grand Ouest, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Institut Brestois Santé Agro Matière (IBSAM), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), and Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL)
Subjects: [SDV]Life Sciences [q-bio], ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2017

32. The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rationale

Author: Dominique Malgrange, Laurence Baillet-Blanco, Dured Dardari, Gilberto Velho, Teresa Crea Avila, Roxane Ducloux, Ariane Sultan, Dominique-François Eveno, Vincent Rigalleau, Estelle Nobecourt-Dupuy, Marilyne Feron, Florence Tubach, Kamel Mohammedi, Abdelkader Chibani, Ronan Roussel, Louis Potier, Manuel Dolz, Maud François, Michel Marre, Jean-Claude Dupré, Service d'endocrinologie, diabétologie et nutrition [CHU Bichat], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Centre de Recherche des Cordeliers (CRC), Université Paris Diderot - Paris 7 (UPD7)-École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Endocrinologie - Diabète - Nutrition [Reims], Université de Reims Champagne-Ardenne (URCA)-Hôpital Robert Debré-Centre Hospitalier Universitaire de Reims (CHU Reims), Centre Hospitalier Sud Francilien, CH Evry-Corbeil, Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital d'Instruction des Armées Begin, Service de Santé des Armées, Hôpital Corentin Celton [Issy-les-Moulineaux], Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier de Gonesse, Centre hospitalier régional Metz-Thionville (CHR Metz-Thionville), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Université de Bordeaux (UB), Département d'épidémiologie, biostatistique et recherche clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CIC Bichat (CIC1425), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Pierre et Marie Curie - Paris 6 (UPMC)-École Pratique des Hautes Études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Herrada, Anthony, Université Pierre et Marie Curie - Paris 6 (UPMC)-École pratique des hautes études (EPHE), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Subjects: medicine.medical_specialty, Randomization, Healing, medicine.medical_treatment, Foot Orthoses, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, Amputation, Surgical, law.invention, Weight-Bearing, 03 medical and health sciences, Study Protocol, 0302 clinical medicine, Patient satisfaction, Randomized controlled trial, law, Informed consent, Clinical endpoint, Pressure, Medicine, Humans, Device, Orthopedics and Sports Medicine, Single-Blind Method, Wound Healing, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Rehabilitation, Off-loading, business.industry, Wound, Equipment Design, medicine.disease, Diabetic foot, 3. Good health, Treatment Outcome, Amputation, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Patient Satisfaction, Research Design, Physical therapy, business
Abstract: Background Off-loading is essential for diabetic foot management, but remains understudied. The evaluation of Off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) trial aims to evaluate the efficacy of a new removable device “Orthèse Diabète” in the healing of diabetic foot. Methods/design ORTHODIAB is a French multi-centre randomized, open label trial, with a blinded end points evaluation by an adjudication committee according to the Prospective Randomized Open Blinded End-point. Main endpoints are adjudicated based on the analysis of diabetic foot photographs. Orthèse Diabète is a new removable off-loading orthosis (PROTEOR, France) allowing innovative functions including real-time evaluation of off-loading and estimation of patients’ adherence. Diabetic patients with neuropathic plantar ulcer or amputation wounds (toes or transmetatarsal) are assigned to one of 2 parallel-groups: Orthèse Diabète or control group (any removable device) according to a central computer-based randomization. Study visits are scheduled for 6 months (days D7 and D14, and months M1, M2, M3, and M6). The primary endpoint is the proportion of patients whose principal ulcer is healed at M3. Secondary endpoints are: the proportion of patients whose principal ulcer is healed at M1, M2 and M6; the proportion of patients whose initial ulcers are all healed at M1, M2, M3, and M6; principal ulcer area reduction; time-related ulcer-free survival; development of new ulcers; new lower-extremity amputation; infectious complications; off-loading adherence; and patient satisfaction. The study protocol was approved by the French National Agency for Medicines and Health Products Safety, and by the ethics committee of Saint-Louis Hospital (Paris). Comprehensive study information including a Patient Information Sheet has been provided to each patient who must give written informed consent before enrolment. Monitoring, data management, and statistical analyses are providing by UMANIS Life Science (Paris), independently to the sponsor. Since 27/10/2013, 13 centres have agreed to participate in this study, 117 participants were included, and 70 have achieved the study schedules. The study completion is expected for the end of 2016, and the main results will be published in 2017. Conclusion ORTHODIAB trial evaluates an innovating removable off-loading device, seeking to improve diabetic foot healing (ClinicalTrials.gov identifier: NCT01956162). Electronic supplementary material The online version of this article (doi:10.1186/s13047-016-0163-4) contains supplementary material, which is available to authorized users.
Published: 2016
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33. Impact on Professional Relationships of the Presence of an Itinerant Night Nurse: A Qualitative Study of Care Homes for Older People

Author: Picot-Ngo, Clément, Bonnet-Zamponi, Dominique, Tubach, Florence, Teixeira, Maria, Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables (ECEVE (U1123 / UMR_S_1123)), Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), OMEDIT Ile-de-France, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Inserm CIC 1425, Hôpital Bichat, Département d'épidémiologie, biostatistique et recherche clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and Picot-Ngo, Clément
Subjects: [SHS.ANTHRO-SE] Humanities and Social Sciences/Social Anthropology and ethnology, Care homes for older people, [SHS.SOCIO]Humanities and Social Sciences/Sociology, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SHS.SOCIO] Humanities and Social Sciences/Sociology, Geriatrics, Mobile night nurses, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Interprofessional relationship, Nursing, Qualitative study, [SHS.ANTHRO-SE]Humanities and Social Sciences/Social Anthropology and ethnology, Experimentation
Abstract: International audience; Background: A trial scheme to improving night-time nursing in residential care homes for dependent older people in the Ile de France region of France involved appointing degree-qualified nursing staff to circulate between three or four care homes. In most old age care homes, the absence of a qualified nurse to carry out health procedures during the night leads to night-duty care teams having to deal with urgent medical complications. This study aims to identify the factors which may impede the building of cooperative relationships between night staff and mobile nurses working in a number of medical settings.Design: An inductive approach was used, based on analysis of in-depth interviews, observations and informal conversations to elicit the key themes. The field study was carried out over a four-month period from February to May 2015 in a number of selected residential care homes.Methods: 35 semi-structured interviews were conducted with health professionals representing a range of paramedical categories, and 7 night-time participant observation sessions, in which the researcher accompanied mobile nurses during their night-duty work. 22 care homes were visited in total. The participant observation sessions included informal conversations to complete the data collection process.Results: The findings demonstrate the importance of shared understandings of the organization of work among health professionals of different categories. Representations concerning mobile nurses by health care teams and their managers may have counter-productive effects and give rise to status tensions in relationships between care home staff. For their part, nurses who are not permanently present within care establishments have to employ strategies to maintain the cohesion with colleagues that their professional actions require, especially for managing emergency situations.
Published: 2016
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34. Online training on skin cancer diagnosis in rheumatologists: results from a nationwide randomized web-based survey

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

Author: Bernard Fraysse, O. Sterkers, Florence Tubach, Vincent Darrouzet, Alexis Bozorg Grayeli, Christian Dubreuil, M. Kalamrides, Evelyne Ferrary, I Bernat, Sandra Zaouche, Olivier Deguine, Mathieu Marx, Alain Robier, Laboratoire Electronique, Informatique et Image [UMR6306] (Le2i), Université de Bourgogne (UB)-École Nationale Supérieure d'Arts et Métiers (ENSAM), Arts et Métiers Sciences et Technologies, HESAM Université (HESAM)-HESAM Université (HESAM)-Arts et Métiers Sciences et Technologies, HESAM Université (HESAM)-HESAM Université (HESAM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Centre National de la Recherche Scientifique (CNRS), Service Oto-Rhino-Laryngologie [CHU de Dijon] (ORL [CHU de Dijon]), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Université de Bourgogne (UB), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Réhabilitation Chirurgicale mini-Invasive et Robotisée de l'Audition, Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Toulouse [Toulouse], CHU de Bordeaux Pellegrin [Bordeaux], Service ORL et chirurgie cervico-faciale [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau, Centre de recherche cerveau et cognition (CERCO), Institut des sciences du cerveau de Toulouse. (ISCT), Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre National de la Recherche Scientifique (CNRS), Service d'oto-rhino-laryngologie et d'oto-neurologie, Service de Neurochirurgie [CHU Pitié-Salpêtrière], Centre de Recherche de l'Institut du Cerveau et de la Moelle épinière (CRICM), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Unité d’Otologie, implants auditifs et chirurgie de la base du crâne [CHU Pitié-Salpêtrière], Service d'Oto-Rhino-Laryngologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Université de Bourgogne (UB)-Centre National de la Recherche Scientifique (CNRS)-École Nationale Supérieure d'Arts et Métiers (ENSAM), HESAM Université (HESAM)-HESAM Université (HESAM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], Centre National de la Recherche Scientifique (CNRS)-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)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Arts et Métiers Sciences et Technologies, HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Université Toulouse - Jean Jaurès (UT2J), Université de Toulouse (UT)-Université de Toulouse (UT)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Toulouse - Jean Jaurès (UT2J), Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre National de la Recherche Scientifique (CNRS), Service ORL, otoneurologie et ORL pédiatrique [CHU Toulouse], Pôle Céphalique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), and Hôpital Bretonneau-Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)
Subjects: Adult, Male, medicine.medical_specialty, Adolescent, Physiology, medicine.drug_class, Facial Paralysis, Population, Placebo, Methylprednisolone, Double blind study, Young Adult, Speech and Hearing, Postoperative Complications, Double-Blind Method, Adrenal Cortex Hormones, medicine, Humans, education, Glucocorticoids, Grading (tumors), Aged, Aged, 80 and over, Postoperative Care, education.field_of_study, Intraoperative Care, Palsy, business.industry, [SCCO.NEUR]Cognitive science/Neuroscience, Neuroma, Acoustic, Middle Aged, Cerebellopontine angle, medicine.disease, Sensory Systems, Facial paralysis, Surgery, Otorhinolaryngology, Corticosteroid, Female, Neurology (clinical), Tumor removal, business, medicine.drug
Abstract: The aim of this study was to assess the effect of corticosteroids administered intra- and postoperatively on the occurrence of facial palsy after a cerebellopontine angle (CPA) tumor resection, and to investigate pre- and intraoperative prognostic factors. A multicenter, prospective, randomized, double-blind and versus-placebo study was conducted between 2006 and 2010. Three hundred and ten patients operated on for a CPA tumor (96% vestibular schwannomas, 4% miscellaneous) were included by five participating centers. The population was stratified into patients with small (≤15 mm CPA on axial MRI views) and large tumors. In each group, patients were randomized to receive corticosteroid (1 mg/kg/day i.v. methylprednisolone intraoperatively and at postoperative days 1-5) or placebo. Steroids did not affect the facial function at postoperative days 1, 8 and 30 in patients with small or large tumors as evaluated by House and Brackmann grading.
Published: 2015
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36. Can we improve transthoracic echocardiography training in non-cardiologist residents? Experience of two training programs in the intensive care unit

Author: Stéphane Ederhy, Didier Dreyfuss, Blandine Pasquet, Vincent Labbé, Jean-Damien Ricard, Ariel Cohen, Cédric Rafat, David Hajage, Romain Miguel-Montanes, Muriel Fartoukh, Stéphane Gaudry, HAL-UPMC, Gestionnaire, Pôle Thorax Voies aériennes, Groupe Hospitalier des Hôpitaux Universitaires de l’Est Parisien, Service de Réanimation et USC Médico-Chirurgicale = Médecine intensive réanimation [CHU Tenon], CHU Tenon [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), Service de Cardiologie [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Service d’épidémiologie et de recherche clinique [Hôpital Louis Mourier], Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Intensive Care Department, University Hospital and University of Geneva, Service de Réanimation Médico-Chirurgicale [Hôpital Louis Mourier], Service d'Urgences néphrologiques et transplantation rénale [CHU Tenon], Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables (ECEVE (U1123 / UMR_S_1123)), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], CIC 1425, Hôpital Bichat - Claude Bernard, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), CHU Pitié-Salpêtrière [AP-HP], Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Pierre et Marie Curie - Paris 6 (UPMC), Service de Réanimation et USC Médico-Chirurgicale [CHU Tenon], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Urgences néphrologiques et transplantation rénale [CHU Tenon], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Subjects: medicine.medical_specialty, Transthoracic echocardiography, [SDV.IB.IMA]Life Sciences [q-bio]/Bioengineering/Imaging, 030204 cardiovascular system & hematology, Critical Care and Intensive Care Medicine, Inferior vena cava, law.invention, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, law, Internal medicine, Intensive care, Critical care nursing, medicine, Ejection fraction, business.industry, Research, Stroke volume, Academic training, Intensive care unit, Confidence interval, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.IB.IMA] Life Sciences [q-bio]/Bioengineering/Imaging, 030228 respiratory system, medicine.vein, SAPS II, Cardiology, Curriculum, business
Abstract: Background To evaluate the diagnostic performances of two training programs for residents with no prior ultrasound experience to reach competences in extended basic critical care transthoracic echocardiography (CCE) including Doppler capabilities. Methods This is a prospective observational study in two intensive care units of teaching hospitals. Group I (five residents) completed a short training program (4-h theory; 3-h practical); group II (six residents) completed a longer training program (6-h theory; 12-h practical). The residents and an expert examined all patients who required a transthoracic echocardiography. Their agreement studied by Cohen’s κ coefficient, concordance coefficient correlation (CCC) and Bland–Altman plots was used as an indicator of program effectiveness. Results Group I performed 136 CCEs (mean/resident 27; range 22–32; 65 in ventilated patients) in 115 patients (62 men; 64 ± 18 years; Simplified Acute Physiologic Score [SAPS] II 37 ± 18). Group II performed 158 CCEs (mean/resident 26; range 21–31; 65 in ventilated patients) in 108 patients (64 men; 58 ± 17 years; SAPS II 42 ± 22). Both groups adequately assessed left ventricular (LV) systolic function (κ 0.75, 95 % confidence interval [CI] 0.64–0.86; κ 0.77, 95 % CI 0.66–0.88, respectively) and pericardial effusion (κ 0.83, 95 % CI 0.67–0.99; κ 0.76, 95 % CI 0.60–0.93, respectively). Group II appraised severe right ventricular dilatation and significant left-sided valve disease with good to very good agreement (κ 0.80, 95 % CI 0.56–0.96; κ 0.79, 95 % CI 0.66–0.93, respectively). Regarding left ventricular ejection fraction, E/A ratio, E/e′ ratio and aortic peak velocity assessed by group II, CCCs were all >0.70 and the bias (mean difference) ±SD on Bland–Altman analysis was 1.3 ± 8.8 %, 0 ± 0.3, 0.4 ± 2.2 and 0.1 ± 0.4 m/s, respectively. Detection of paradoxical septum (κ 0.65, 95 % CI 0.37–0.93), of heterogeneous LV contraction (κ 0.49, 95 % CI 0.33–0.65) and of respiratory variation of the inferior vena cava (κ 0.27, 95 % CI 0.09–0.45), as well as stroke volume measurement (CCC 0.65, 95 % CI 0.54–0.74; bias ± SD −1.4 ± 4.7 cm), was appraised by group II with moderate agreement requiring probably more comprehensive training. Conclusions Although a training program blending 6-h theory and 12-h practical may be adapted to achieve some essential competences, it seems to be insufficiently to perform a complete extended basic critical care transthoracic echocardiography including Doppler capabilities. Electronic supplementary material The online version of this article (doi:10.1186/s13613-016-0150-8) contains supplementary material, which is available to authorized users.
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37. Some superiority trials with nonsignificant results published in high impact factor journals correspond to noninferiority situations: a research-on-research study.

Author: Rajendrabose D, Collet L, Reinaud C, Beydon M, Jiang X, Hmissi S, Vermillac A, Degonzague T, Hajage D, and Dechartres A
Subjects: Humans, Randomized Controlled Trials as Topic methods, Periodicals as Topic, Research Design, Journal Impact Factor, Equivalence Trials as Topic
Abstract: Objectives: Many negative randomized controlled trials (RCTs) report spin in their conclusions to highlight the benefits of the experimental arm, which could correspond to a noninferiority (NI) objective. We aimed to evaluate whether some negative superiority RCTs comparing 2 active interventions could correspond to an NI situation and to explore associated trial characteristics., Study Design and Setting: We searched PubMed for superiority RCTs comparing 2 active interventions with non-statistically significant results for the primary outcome that were published in 2021 in the 5 journals with the highest impact factor in each medical specialty. Three reviewers independently evaluated whether trials could correspond to an NI situation (ie, an evaluation of efficacy as the primary outcome, with the experimental intervention presenting advantages including better safety profile, ease of administration, or decreased cost as compared with the control intervention)., Results: Of the 147 trials included, 19 (12.9%, 95% CI [7.9%, 19.4%]) corresponded to a potential NI situation. As compared with trials not in a potential NI situation, they were published in a journal with a lower impact factor (median impact factor 8.7 vs 15.6), were more frequently rated at high or some concerns regarding risk of bias (n = 14, 73.7% vs n = 69, 53.9%) and reported spin in the article conclusions (n = 11, 57.9% vs n = 24, 18.8%)., Conclusion: A non-negligible proportion of superiority negative trials comparing 2 active interventions could correspond to an NI situation. These trials seemed at increased risk of bias and frequently reported spin in the conclusions, which may distort the interpretation of results., Plain Language Summary: Noninferiority trials are designed to show that a new intervention is not worse in terms of efficacy than the reference intervention. It is adapted when the new intervention has an advantage in terms of safety, ease of use or cost over the reference one. However, the literature displayed some superiority negative trials comparing 2 active interventions that could correspond to a potential noninferiority situation. Our study aimed to assess whether some superiority trials with nonsignificant results for the primary outcome could correspond to an NI situation and to explore associated trial characteristics. Our findings indicate that a non-negligible proportion of superiority negative trials could correspond to a noninferiority situation. Moreover, those trials seemed at increased risk of bias and frequently reported spin in the conclusions., Competing Interests: Declaration of competing interest There are no competing interests for any author., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
Published: 2025
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38. Clinical and Virological Characteristics and Prognostic Factors in Viral Necrotizing Retinitis.

Author: Fitoussi L, Baptiste A, Mainguy A, L'Honneur AS, Bojanova M, Dechartres A, Rozenberg F, Bodaghi B, and Touhami S
Abstract: Purpose: Describe the clinical and virological characteristics of viral necrotizing retinitis (VNR) and assess its prognostic factors. Methods: Retrospective study (Pitié Salpêtrière Hospital, Paris) of consecutive VNR patients diagnosed and monitored by qPCR on aqueous humor between 2015 and 2019. All patients received induction therapy with intravenous +/− intravitreal injections (IVI) of antivirals. Results: Forty-one eyes of 37 patients with a mean age of 56 years were included. Involved viruses were VZV (44%), CMV (37%) and HSV2 (19%). Acute retinal necrosis represented 51%, progressive outer retinal necrosis 12% and CMV retinitis 37% of eyes. Forty-six percent of patients were immunocompromised. Median BCVA was 0.7 LogMAR at baseline and 0.8 LogMAR after an average of 14.1 months. VNR bilateralized in 27% of cases after 32 months. Retinal detachment (RD) occurred in 27% of cases after a mean duration of 98 days. Factors associated with a “poor BCVA” at 1 month were: advanced age, low baseline BCVA, high vitritis grade and viral load (VL) at baseline and the “slow responder” status (i.e., VL decrease <50% after 2 weeks of treatment). Factors associated with RD were: advanced age, immunocompetence, low baseline BCVA, high vitritis grade at baseline and use of ≤5 IVIs. Conclusions: Clinical factors including advanced age, immunocompetence, low BCVA and high vitritis grade at baseline were associated with a poor prognosis. New virological factors were predictive of a poor outcome: high baseline VL and the “slow responder” status. Sequential intraocular fluid sampling might help prognosticate the outcomes of VNR.
Published: 2022
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39. Effectiveness of simulation in psychiatry for nursing students, nurses and nurse practitioners: A systematic review and meta-analysis.

Author: Piot MA, Dechartres A, Attoe C, Romeo M, Jollant F, Billon G, Cross S, Lemogne C, Layat Burn C, Michelet D, Guerrier G, Tesniere A, Rethans JJ, and Falissard B
Subjects: Computer Simulation, Humans, Manikins, Nurse Practitioners, Psychiatry, Students, Nursing
Abstract: Aims: Mental disorders constitute one of the main causes of disease and disability worldwide. While nurses are often at the frontline of mental health care, they have limited access to dedicated psychiatric training opportunities. Simulation training may foster the development of the appropriate competencies required when supporting people with mental disorders. To evaluate the effectiveness of simulation training in psychiatry for nursing students, nurses and nurse practitioners., Design: Systematic review and meta-analysis., Data Sources: Eight electronic databases, trial registries, key journals and reference lists of selected studies were searched from inception to August 20, 2020 without language restriction., Review Methods: We included randomized and non-randomized controlled studies and single group pre/post studies. Cochrane Risk of Bias tool 2.0 was used for randomized controlled study appraisal, and the Medical Education Research Study Quality instrument was completed for all other studies. Meta-analysis was restricted to randomized controlled studies. The other studies were synthesized narratively. The main outcomes were based on Kirkpatrick levels., Results: A total of 118 studies (6738 participants) were found. Interventions included simulated patients (n = 55), role-plays (n = 40), virtual reality (n = 12), manikins (n = 9) and voice simulations (n = 9). Meta-analyses based on 11 randomized controlled studies found a significant large effect size on skills at immediate post-test for simulation compared with active control; and a small and medium effect size on learners' attitudes for simulation compared with inactive control, at immediate post-test and at three-month follow-up respectively. Three quarters of non-randomized controlled studies and pre/post-tests assessing attitudes and skills showed significant differences, and three quarters of participants in randomized controlled studies and pre/post-tests showed significant differences in behaviours. Among the few studies assessing people with mental health outcomes, almost all reported significant differences., Conclusion: These findings support the effectiveness of simulation training in psychiatric nursing throughout professional development grades, despite heterogeneity in methods and simulation interventions., (© 2021 John Wiley & Sons Ltd.)
Published: 2022
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40. Prognosis of rash and chilblain-like lesions among outpatients with COVID-19: a large cohort study.

Author: Mascitti H, Jourdain P, Bleibtreu A, Jaulmes L, Dechartres A, Lescure X, Yordanov Y, and Dinh A
Subjects: Adult, Aged, Chilblains diagnosis, Cohort Studies, Exanthema diagnosis, Female, Humans, Male, Middle Aged, Outpatients, Prognosis, SARS-CoV-2 genetics, SARS-CoV-2 physiology, COVID-19 complications, Chilblains etiology, Exanthema etiology
Abstract: In a large regional observational cohort study of adult (≥ 18 years), outpatients with COVID-19, prevalence, characteristics, and outcome of patients with rash and/or chilblain-like lesions (CLL), compared with population without cutaneous features, were studied. In total, 28,957 outpatients were included; the prevalence of rash and CCL were 9.5% and 3.7%, respectively. Presence of rash was significantly associated with presence of asthenia, shivers or myalgia, respiratory and gastro-intestinal symptoms, and anosmia/ageusia. The presence of CCL was associated with chest pain, chest oppression, nausea/vomiting, and anosmia/ageusia. Patients with CCL were significantly less prone to an unfavourable outcome (hospitalization or death)., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
Published: 2021
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41. Chimeric antigen receptor T-cells safety: A pharmacovigilance and meta-analysis study.

Author: Dolladille C, Ederhy S, Ezine E, Choquet S, Nguyen LS, Alexandre J, Moslehi JJ, Dechartres A, and Salem JE
Subjects: Antigens, CD19 adverse effects, Bayes Theorem, Biological Products, Cytokine Release Syndrome etiology, Drug-Related Side Effects and Adverse Reactions etiology, Hematologic Diseases etiology, Humans, Incidence, Nervous System Diseases etiology, Pharmacovigilance, Antigens, CD19 therapeutic use, Immunotherapy, Adoptive adverse effects, Receptors, Antigen, T-Cell therapeutic use, Receptors, Chimeric Antigen therapeutic use
Abstract: Chimeric-antigen-receptor T cells directed against CD19 (CAR-T) are emerging hematological therapeutics with scarce data on its overall safety profile spectrum. To determine the clinical features and incidence of adverse-drug reactions (ADR) associated with CAR-T. This observational, cross-sectional, pharmacovigilance cohort study examined individual case safety reports from the World Health Organization database VigiBase and meta-analysis of data from CAR-T trials and cohorts in the literature was also performed through March, 2020. The primary objective was to identify ADR associated with approved CAR-T (axicabtagene-ciloleucel; tisagenlecleucel). We conducted a Bayesian disproportionate analysis with the 95% lower credibility-interval of information component (IC 025 , significance > 0). We also performed a systematic-review and meta-analysis of CAR-T trials and cohorts in the literature to evaluate ADR incidence. Nine ADR classes were associated with CAR-T: Cytokine release syndrome (CRS, n = 1378, IC 025 = 4.24), neurological disorders (n = 963, IC 025 = 2.42), hematological disorders (n = 532, IC 025 = 3.32), infections (n = 287, IC 025 = 2.38), cardiovascular disorders (n = 256, IC 025 = 2.81), pulmonary disorders (n = 186, IC 025 = 3.80), reno-metabolic disorders (n = 123, IC 025 = 1.89), hemophagocytic-lymphohistiocytosis (n = 36, IC 025 = 5.01) and hepatic disorders (n = 32, IC 025 = 2.49). ADR-related fatalities accounted for 99/1783 (5.5%) of the reports and 262/1783 (14.7%) for all-cause mortality. These ADR-related fatalities were associated with hemophagocytic-lymphohistiocytosis, cerebral vascular disorder, infections, and respiratory failure. In meta-analyses, the most frequent any-grade ADRs were CRS, hematological disorders, and neurological disorders. Fatal ADR were most found with neurological disorders, CRS, and infections. Note, CAR-T infusion may be associated with severe ADR mainly following the week of administration, though rarely fatal. Infections, hemophagocytic-lymphohistiocytosis and end organ failures including neurological or lung involvements require scrutiny., (© 2021 Wiley Periodicals LLC.)
Published: 2021
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42. Clinical characteristics and factors associated with hospital admission or death in 43 103 adult outpatients with coronavirus disease 2019 managed with the Covidom telesurveillance solution: a prospective cohort study.

Author: Yordanov Y, Dinh A, Bleibtreu A, Mensch A, Lescure FX, Debuc E, Jourdain P, Jaulmes L, and Dechartres A
Subjects: Adult, Age Factors, COVID-19 virology, Cohort Studies, Comorbidity, Epidemiological Monitoring, Female, Health Surveys, Hospitals, Humans, Male, Middle Aged, Obesity, Outpatients, Paris epidemiology, Prospective Studies, Sex Factors, COVID-19 epidemiology, Pandemics, SARS-CoV-2 physiology, Telemedicine
Abstract: Objectives: Studies on coronavirus disease 2019 (COVID-19) have mainly focused on hospitalized patients or those with severe disease. We aim to assess the clinical characteristics, outcomes and factors associated with hospital admission or death in adult outpatients with COVID-19., Methods: This is a prospective cohort of outpatients with suspected or confirmed COVID-19, registered in the Covidom telesurveillance solution for home monitoring of patients with COVID-19 in the Greater Paris area, from March to August 2020. The primary outcome was clinical worsening, defined as hospitalization or death within 1 month after symptom onset., Results: Among 43 103 patients, mean age was 42.9 years (SD 14.3 years); 93.0% (n = 40 081) of patients were <65 years old and 61.9% (n = 26 688) were women. Of these 43 103 patients, 67.5% (n = 29 104) completed a medical questionnaire on co-morbidities and symptoms. The main reported co-morbidities were asthma (12.8%; n = 3685), hypertension (12.3%; n = 3546) and diabetes (4.8%; n = 1385). A small proportion of all eligible patients (4.1%, 95% CI 3.9-4.2; 1751/43 103) experienced clinical worsening. The rate of hospitalization was 4.0% (95% CI 3.8%-4.2%; n = 1728) and 0.1% (95% CI 0.1%-0.2%; n = 64) died. Factors associated with clinical worsening were male sex, older age, obesity and co-morbidities such as chronic renal disease or cancer under treatment. Probability of worsening was reduced with anosmia/ageusia., Conclusions: Clinical worsening was rare among outpatients. Male sex, older age and co-morbidities such as chronic renal disease, active cancers or obesity were independently associated with clinical worsening. However, our cohort may include patients younger and healthier than the general population., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Published: 2021
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43. Consistency of causal claims in observational studies: a review of papers published in a general medical journal.

Author: Olarte Parra C, Bertizzolo L, Schroter S, Dechartres A, and Goetghebeur E
Subjects: Causality, Humans, Language, Publications
Abstract: Objective: To evaluate the consistency of causal statements in observational studies published in The BMJ ., Design: Review of observational studies published in a general medical journal., Data Source: Cohort and other longitudinal studies describing an exposure-outcome relationship published in The BMJ in 2018. We also had access to the submitted papers and reviewer reports., Main Outcome Measures: Proportion of published research papers with 'inconsistent' use of causal language. Papers where language was consistently causal or non-causal were classified as 'consistently causal' or 'consistently not causal', respectively. For the 'inconsistent' papers, we then compared the published and submitted version., Results: Of 151 published research papers, 60 described eligible studies. Of these 60, we classified the causal language used as 'consistently causal' (48%), 'inconsistent' (20%) and 'consistently not causal'(32%). Eleven out of 12 (92%) of the 'inconsistent' papers were already inconsistent on submission. The inconsistencies found in both submitted and published versions were mainly due to mismatches between objectives and conclusions. One section might be carefully phrased in terms of association while the other presented causal language. When identifying only an association, some authors jumped to recommending acting on the findings as if motivated by the evidence presented., Conclusion: Further guidance is necessary for authors on what constitutes a causal statement and how to justify or discuss assumptions involved. Based on screening these papers, we provide a list of expressions beyond the obvious 'cause' word which may inspire a useful more comprehensive compendium on causal language., Competing Interests: Competing interests: SS is a full-time employee of the BMJ Publishing Group. No other competing risks to declare., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)
Published: 2021
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44. The quality of reporting general safety parameters and immune-related adverse events in clinical trials of FDA-approved immune checkpoint inhibitors.

Author: Karimian Z, Mavoungou S, Salem JE, Tubach F, and Dechartres A
Subjects: Humans, Adverse Drug Reaction Reporting Systems standards, Immune Checkpoint Inhibitors adverse effects, Immunotherapy methods
Abstract: Background: While immune-checkpoint inhibitors (ICIs) have transformed the field of oncology for advanced-stage cancers, they can lead to serious immune toxicities. Several systematic reviews have evaluated the risk of immune-related adverse events (irAEs); however, most have focused on published articles without evaluating trial registries. The objective of this methodological review was to compare the quality of reporting of safety information and in particular, serious irAEs (irSAEs), in both publications and ClinicalTrials.gov for all current FDA-approved ICIs., Methods: PubMed was searched to retrieve all published phase III randomized controlled trials (RCTs) evaluating ICIs. For each eligible trial, we searched for corresponding registration on ClinicalTrials.gov and extracted relevant safety data from both the publication and results posted on registry. We then compared the quality of reporting and the value of safety data between both sources., Results: Of 42 eligible published trials, 34 had results posted on ClinicalTrials.gov . Considerable variability was noted in the reporting of safety in both sources. SAEs were reported for all trial results in ClinicalTrials.gov compared to 23.5% of publications. An overall incidence for irAEs and irSAEs was reported in 58.8 and 8.8% of publications respectively, compared to 11.8 and 5.9% in registry results. Comparing the value of specific irSAEs was not possible between the two sources in 32/34 trials either due to different reporting formats (61.8%) or data not being reported in one or both sources (32.4%). From the 2 studies with compatible irSAE format, only 1 had matching data in both sources., Conclusions: The reporting of irAEs / irSAEs varies considerably in publications and registries, which outlines the importance of standardizing the terminologies and methodologies for reporting safety information relevant to ICIs.
Published: 2020
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45. Covidom, a Telesurveillance Solution for Home Monitoring Patients With COVID-19.

Author: Yordanov Y, Dechartres A, Lescure X, Apra C, Villie P, Marchand-Arvier J, Debuc E, Dinh A, and Jourdain P
Subjects: Adult, Betacoronavirus, COVID-19, Coronavirus Infections epidemiology, Female, Health Status, Health Surveys, Humans, Male, Middle Aged, Pandemics, Paris epidemiology, Pneumonia, Viral epidemiology, SARS-CoV-2, Coronavirus Infections diagnosis, Coronavirus Infections physiopathology, Monitoring, Physiologic methods, Outpatients, Pneumonia, Viral diagnosis, Pneumonia, Viral physiopathology, Telemedicine methods
Abstract: In a matter of months, COVID-19 has escalated from a cluster of cases in Wuhan, China, to a global pandemic. As the number of patients with COVID-19 grew, solutions for the home monitoring of infected patients became critical. This viewpoint presents a telesurveillance solution-Covidom-deployed in the greater Paris area to monitor patients with COVID-19 in their homes. The system was rapidly developed and is being used on a large scale with more than 65,000 registered patients to date. The Covidom solution combines an easy-to-use and free web application for patients (through which patients fill out short questionnaires on their health status) with a regional control center that monitors and manages alerts (triggered by questionnaire responses) from patients whose health may be deteriorating. This innovative solution could alleviate the burden of health care professionals and systems while allowing for rapid response when patients trigger an alert., (©Youri Yordanov, Agnes Dechartres, Xavier Lescure, Caroline Apra, Pascaline Villie, Jerome Marchand-Arvier, Erwan Debuc, Aurélien Dinh, Patrick Jourdain, On Behalf Of The AP-HP / Universities / Inserm COVID-19 Research Collaboration. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 22.10.2020.)
Published: 2020
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46. External factors may influence Cochrane reviewers when classifying the risk of bias of original reports.

Author: Bertizzolo L, Bossuyt PM, Atal I, Ravaud P, and Dechartres A
Subjects: Bias, Case-Control Studies, Humans, Judgment, Authorship, Randomized Controlled Trials as Topic statistics & numerical data, Systematic Reviews as Topic
Abstract: Objective: The objective of the study was to explore contextual factors associated with high or low risk-of-bias judgment in case of incomplete or unclear information in study reports., Study Design and Setting: Research-on-research study, using matched case-control design, with a sample of 304 randomized controlled trials (RCTs) included in two Cochrane reviews for which there was disagreement on the risk-of-bias judgment related to incomplete or unclear information in the study report. A case was defined as an RCT judged at high or low risk of bias; a control was the same RCT judged at unclear risk. We used a conditional logistic regression model for analysis., Results: Review authors being also authors of the RCT were more likely to assess an item at low risk of bias than unclear (OR: 11.71; 95% CI: 1.39-98.76). Earlier trials in a review were more often assigned a low risk (OR: 0.37; [0.15-0.96]). Review groups and authors that had completed a lower number of reviews slightly more often assigned a low risk, whereas others reported "unclear" (OR: 0.97, [95% CI: 0.95-0.99] for groups) and 0.97 (95% CI: 0.95-0.998) for authors)., Conclusions: Risk-of-bias assessment of RCTs in case of incomplete or unclear information may be affected by contextual factors., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)
Published: 2020
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47. Composite neonatal morbidity indicators using hospital discharge data: A systematic review.

Author: Lebreton E, Crenn-Hébert C, Menguy C, Howell EA, Gould JB, Dechartres A, and Zeitlin J
Subjects: Cross-Sectional Studies methods, Cross-Sectional Studies statistics & numerical data, Humans, Infant, Newborn, Outcome Assessment, Health Care standards, Congenital Abnormalities diagnosis, Congenital Abnormalities epidemiology, Infant, Newborn, Diseases diagnosis, Infant, Newborn, Diseases epidemiology, Patient Discharge statistics & numerical data
Abstract: Background: Neonatal morbidity is associated with lifelong impairments, but the absence of a consensual definition and the need for large data sets limit research., Objectives: To inform initiatives to define standard outcomes for research, we reviewed composite neonatal morbidity indicators derived from routine hospital discharge data., Data Sources: PubMed (updated on October 12, 2018). The search algorithm was based on three components: "morbidity," "neonatal," and "hospital discharge data.", Study Selection and Data Extraction: Studies investigating neonatal morbidity using a composite indicator based on hospital discharge data were included. Indicators defined for specific conditions (eg congenital anomalies, maternal addictions) were excluded. The target population, objectives, component morbidities, diagnosis and procedure codes, validation methods, and prevalence of morbidity were extracted., Synthesis: For each study, we assessed construct validity by describing the methods used to select the indicator components and evaluated whether the authors assessed internal and external validity. We also calculated confidence intervals for the prevalence of the morbidity composite., Results: Seventeen studies fulfilled inclusion criteria. Indicators targeted all (n = 4), low-/moderate-risk (n = 9), and very preterm (VPT, n = 4) infants. Components were similar for VPT infants, but domains and diagnosis codes within domains varied widely for all and low-/moderate-risk infants. Component selection was described for 8/17 indicators and some form of validation reported for 12/17. Neonatal morbidity prevalence ranged from 4.6% to 9.0% of all infants, 0.4% to 8.0% of low-/moderate-risk infants, and 17.8% to 61.0% of VPT infants., Conclusions: Multiple neonatal morbidity indicators based on hospital discharge data have been used for research, but their heterogeneity limits comparisons between studies. Standard neonatal outcome measures are needed for benchmarking and synthesis of research results., (© 2020 John Wiley & Sons Ltd.)
Published: 2020
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48. Meta-analyses frequently pooled different study types together: a meta-epidemiological study.

Author: Bun RS, Scheer J, Guillo S, Tubach F, and Dechartres A
Subjects: Epidemiologic Studies, Humans, Observational Studies as Topic, Randomized Controlled Trials as Topic, Epidemiologic Methods, Meta-Analysis as Topic
Abstract: Objective: To evaluate the characteristics of therapeutic meta-analyses including both observational studies and randomized controlled trials (RCTs), how these studies were combined and whether there were differences in treatment effects., Study Design and Setting: Meta-epidemiological study of meta-analyses, including both observational studies and RCTs. We searched MEDLINE for the five leading journals of each medical category according to Journal Citation Reports) and Cochrane Database of Systematic Reviews, from 2014 to 2018 for eligible meta-analyses and extracted how observational studies and RCTs were combined and results for each study., Results: Of the 102 included meta-analyses, observational studies and RCTs were combined together without a subgroup analysis in 39 (38%) and with subgroup analysis in 15 (15%); they were pooled separately for the same outcome in 11 (11%) and not for the same outcome in 9 (9%). In 28 (27%) meta-analyses, only RCTs were combined, with a qualitative description of observational studies. Treatment effect estimates did not differ between observational studies and RCTs (ratio of estimates = 0.98 [95% confidence interval 0.80-1.21]), with substantial heterogeneity (I 2 = 59%)., Conclusion: Many meta-analyses, including both observational studies and RCTs pool results from both study types. Although treatment effects did not differ between them on average, we identified situations for which estimates differed., (Copyright © 2019 Elsevier Inc. All rights reserved.)
Published: 2020
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