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3,428 results on '"MESH: Aged"'

1. Nursing home residents’ perspectives on oral health: An in-depth interview study

Author: Patricia A․ I․ Vandenbulcke, Johanna de Almeida Mello, Valerie Cornette, Marijke Brabants, Emilie Schoebrechts, Jan De Lepeleire, Anja Declercq, Dominique Declerck, and Joke Duyck
Subjects: Mesh: aged, Behavior, Dental care, Interviews as topic, Long-term care, Nursing homes, Nursing, RT1-120
Abstract: Background: Oral health is associated with general health and care dependency, but is often neglected in nursing homes. Integration of oral care into general care is necessary, but is hampered by multiple barriers at different levels. This study is part of research into the implementation of the new Oral Health Section for use within the interRAI Long-Term Care Facilities instrument, which is used to assess care needs of nursing home residents. This new Oral Health Section evaluates nine aspects of oral health and results in two Collaborative Action Points. Objective: To identify residents' perspectives on oral health, oral care, and on the assessment of their oral health using the new Oral Health Section Design: Qualitative design using in-depth interviews. Setting(s): Three nursing homes Participants: Residents were selected using purposeful sampling in nursing homes participating in research evaluating the use of the new Oral Health Section. The selection was based on their oral status for maximum variation and on their cognitive performance score. Twenty-two residents from three Flemish nursing homes agreed to participate. Methods: Residents’ oral health was assessed using the new Oral Health Section and dental indices. In-depth interviews were conducted, including the validated short-form Oral Health Impact Profile to evaluate the impact of oral conditions on residents’ well-being. The interviews were coded and analysed by three researchers and mapped into a model to understand participants’ oral health behaviours. Results: Low Oral Health Impact Profile scores indicated a low impact of oral health issues on participants’ lives. However, despite 77.3 % of the participants reporting satisfaction with their oral health, 86.4 % had poor oral hygiene and 68.2 % required referral to a dentist, suggesting a tendency to overestimate their oral health. Their oral health behaviour was determined by a lack of oral health knowledge (Capability), positive attitudes towards oral health and autonomy (Motivation), upbringing and social support (Opportunity). Participants considered assessments with the new Oral Health Section acceptable. Conclusions: This study shows how older people perceive their oral health and oral healthcare. Understanding their wishes and needs will not only facilitate their involvement in their oral care, but is also likely to enable the improvement of their oral hygiene and the development of effective oral care strategies for the future. Policy makers and managers of care organisations may use these results to foster integration of oral care guidelines into care protocols within nursing homes, including collaboration with dentists and dental hygienists. Tweetable abstract: Oral health assessments with the new Oral Health Section for use within interRAI were positively perceived by nursing home residents.
Published: 2024
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2. Nursing home residents' perspectives on oral health: An in-depth interview study.

Author: Vandenbulcke PAI, de Almeida Mello J, Cornette V, Brabants M, Schoebrechts E, De Lepeleire J, Declercq A, Declerck D, and Duyck J
Abstract: Background: Oral health is associated with general health and care dependency, but is often neglected in nursing homes. Integration of oral care into general care is necessary, but is hampered by multiple barriers at different levels. This study is part of research into the implementation of the new Oral Health Section for use within the interRAI Long-Term Care Facilities instrument, which is used to assess care needs of nursing home residents. This new Oral Health Section evaluates nine aspects of oral health and results in two Collaborative Action Points., Objective: To identify residents' perspectives on oral health, oral care, and on the assessment of their oral health using the new Oral Health Section., Design: Qualitative design using in-depth interviews., Settings: Three nursing homes., Participants: Residents were selected using purposeful sampling in nursing homes participating in research evaluating the use of the new Oral Health Section. The selection was based on their oral status for maximum variation and on their cognitive performance score. Twenty-two residents from three Flemish nursing homes agreed to participate., Methods: Residents' oral health was assessed using the new Oral Health Section and dental indices. In-depth interviews were conducted, including the validated short-form Oral Health Impact Profile to evaluate the impact of oral conditions on residents' well-being. The interviews were coded and analysed by three researchers and mapped into a model to understand participants' oral health behaviours., Results: Low Oral Health Impact Profile scores indicated a low impact of oral health issues on participants' lives. However, despite 77.3 % of the participants reporting satisfaction with their oral health, 86.4 % had poor oral hygiene and 68.2 % required referral to a dentist, suggesting a tendency to overestimate their oral health. Their oral health behaviour was determined by a lack of oral health knowledge (Capability), positive attitudes towards oral health and autonomy (Motivation), upbringing and social support (Opportunity). Participants considered assessments with the new Oral Health Section acceptable., Conclusions: This study shows how older people perceive their oral health and oral healthcare. Understanding their wishes and needs will not only facilitate their involvement in their oral care, but is also likely to enable the improvement of their oral hygiene and the development of effective oral care strategies for the future. Policy makers and managers of care organisations may use these results to foster integration of oral care guidelines into care protocols within nursing homes, including collaboration with dentists and dental hygienists., Tweetable Abstract: Oral health assessments with the new Oral Health Section for use within interRAI were positively perceived by nursing home residents., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors. Published by Elsevier Ltd.)
Published: 2024
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3. Impact of Mitral Regurgitation Etiology on Mitral Surgery After Transcatheter Edge-to-Edge Repair

Author: Zaid, Syed, Avvedimento, Marisa, Vitanova, Keti, Akansel, Serdar, Bhadra, Oliver, Ascione, Guido, Saha, Shekhar, Noack, Thilo, Tagliari, Ana Paula, Pizano, Alejandro, Donatelle, Marissa, Squiers, John, Goel, Kashish, Leurent, Guillaume, Asgar, Anita, Ruaengsri, Chawannuch, Wang, Lin, Leroux, Lionel, Flagiello, Michele, Algadheeb, Muhanad, Werner, Paul, Ghattas, Angie, Bartorelli, Antonio, Dumonteil, Nicholas, Geirsson, Arnar, van Belle, Eric, Massi, Francesco, Wyler von Ballmoos, Moritz, Goel, Sachin, Reardon, Michael, Bapat, Vinayak, Nazif, Tamim, Kaneko, Tsuyoshi, Modine, Thomas, Denti, Paolo, Tang, Gilbert, Tang, Gilbert H.L., Houston Methodist Hospital [Houston, TX, USA], Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], CHU Bordeaux [Bordeaux], Hospices Civils de Lyon (HCL), Clinique Pasteur, Clinique Pasteur [Toulouse], CHU Lille, Mount Sinai Health System, Dr Bhadra has received travel compensation from Edwards Lifesciences. Dr Tagliari has received research support from the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. Dr Leurent has been a consultant and physician proctor for and has received speaker honoraria from Abbott. Dr Asgar has been a consultant for Medtronic, Abbott, Edwards Lifesciences, and W. L. Gore & Associates, and has received research grants from Abbott. Dr Leroux has been a physician proctor for Medtronic and Abbott, and a consultant for Edwards Lifesciences. Dr Dumonteil has received speaker honoraria and travel reimbursement by Edwards Lifesciences, and has been a physician proctor and consultant for Edwards Lifesciences. Dr Geirsson has been a member of the Medtronic Strategic Surgical Advisory Board. Dr Wyler von Ballmoos has served as a consultant for LivaNova, Medtronic, and Boston Scientific. Dr Reardon has been a consultant for Medtronic, Boston Scientific, Abbott, and W. L. Gore & Associates. Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. Dr Nazif has equity in Venus Medtech, and has received consulting fees or honoraria from Keystone Heart, Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Kaneko has been a speaker for Edwards Lifesciences, Medtronic, Abbott, and Baylis Medical, and has been a consultant for 4C Medical. Dr Modine has been a physician proctor and consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences, and has been a consultant for InnovHeart. Dr Tang has been a physician proctor for Medtronic, a consultant for Medtronic, Abbott, and NeoChord, and a physician advisory board member for Abbott, Boston Scientific and JenaValve, and and has received speaker honoraria from Siemens Healthineers and East End Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Subjects: MESH: Aged, MESH: Mitral Valve Insufficiency, MESH: Humans, MESH: Middle Aged, MESH: Registries, transcatheter edge-to-edge repair, MESH: Retrospective Studies, MESH: Mitral Valve, mitral valve replacement, mitral valve repair, MESH: Aged, 80 and over, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Cardiology and Cardiovascular Medicine, mitral valve surgery, MESH: Treatment Outcome
Abstract: International audience; Background: Although >150,000 mitral TEER procedures have been performed worldwide, the impact of MR etiology on MV surgery after TEER remains unknown.Objectives: The authors sought to compare outcomes of mitral valve (MV) surgery after failed transcatheter edge-to-edge repair (TEER) stratified by mitral regurgitation (MR) etiology.Methods: Data from the CUTTING-EDGE registry were retrospectively analyzed. Surgeries were stratified by MR etiology: primary (PMR) and secondary (SMR). MVARC (Mitral Valve Academic Research Consortium) outcomes at 30 days and 1 year were evaluated. Median follow-up was 9.1 months (IQR: 1.1-25.8 months) after surgery.Results: From July 2009 to July 2020, 330 patients underwent MV surgery after TEER, of which 47% had PMR and 53.0% had SMR. Mean age was 73.8 ± 10.1 years, median STS risk at initial TEER was 4.0% (IQR: 2.2%-7.3%). Compared with PMR, SMR had a higher EuroSCORE, more comorbidities, lower LVEF pre-TEER and presurgery (all P < 0.05). SMR patients had more aborted TEER (25.7% vs 16.3%; P = 0.043), more surgery for mitral stenosis after TEER (19.4% vs 9.0%; P = 0.008), and fewer MV repairs (4.0% vs 11.0%; P = 0.019). Thirty-day mortality was numerically higher in SMR (20.4% vs 12.7%; P = 0.072), with an observed-to-expected ratio of 3.6 (95% CI: 1.9-5.3) overall, 2.6 (95% CI: 1.2-4.0) in PMR, and 4.6 (95% CI: 2.6-6.6) in SMR. SMR had significantly higher 1-year mortality (38.3% vs 23.2%; P = 0.019). On Kaplan-Meier analysis, the actuarial estimates of cumulative survival were significantly lower in SMR at 1 and 3 years.Conclusions: The risk of MV surgery after TEER is nontrivial, with higher mortality after surgery, especially in SMR patients. These findings provide valuable data for further research to improve these outcomes.
Published: 2023

4. Post-vaccination SARS-CoV-2 antibody kinetics and protection duration against Omicron in elderly population

Author: Chloé Dimeglio, Pauline Trémeaux, Fabrice Herin, Isabelle Da-Silva, Marion Porcheron, Guillaume Martin-Blondel, Caroline Gernigon, Sabine Chapuy-Regaud, Hélène Villars, Jacques Izopet, Laboratoire Virologie [CHU Toulouse], Institut Fédératif de Biologie (IFB), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Pôle Biologie [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Institut Toulousain des Maladies Infectieuses et Inflammatoires (Infinity), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre d'Epidémiologie et de Recherche en santé des POPulations (CERPOP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Service Maladies Professionnelles et Environnementales [CHU Toulouse], Pôle Santé publique et médecine publique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Service Maladies infectieuses et tropicales [CHU Toulouse], Pôle Inflammation, infection, immunologie et loco-moteur [CHU Toulouse] (Pôle I3LM Toulouse), Pôle Gériatrie [CHU Toulouse], and Benson-Rumiz, Alicia
Subjects: MESH: Aged, Microbiology (medical), [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, MESH: COVID-19* / prevention & control, MESH: Kinetics, SARS-CoV-2, Vaccination, COVID-19, MESH: Vaccination, Antibodies, Viral, Kinetics, Infectious Diseases, MESH: SARS-CoV-2, Humans, MESH: Antibodies, Viral, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Aged
Abstract: International audience; Coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 is particularly severe in older individuals because of an impaired immune response.1 The vaccines presently available are less efficacious in older individuals, because of the senescence of their immune systems.2 A recent letter in Journal of Infection showed the need of a third vaccine dose due to a waning antibody response against new SARS-CoV-2 variants in healthy and immunocompromised individuals.3 In this study, we analysed the protection against Omicron provided by the immune responses of nursing home residents (NHRs) and a population of healthcare workers (HCWs).
Published: 2022

5. Infant BCG vaccination and risk of pulmonary and extrapulmonary tuberculosis throughout the life course: a systematic review and individual participant data meta-analysis

Author: Leonardo Martinez, Olivia Cords, Qiao Liu, Carlos Acuna-Villaorduna, Maryline Bonnet, Greg J Fox, Anna Cristina C Carvalho, Pei-Chun Chan, Julio Croda, Philip C Hill, Elisa Lopez-Varela, Simon Donkor, Katherine Fielding, Stephen M Graham, Marcos A Espinal, Beate Kampmann, Arthur Reingold, Helena Huerga, Julian A Villalba, Louis Grandjean, Giovanni Sotgiu, Uzochukwu Egere, Sarman Singh, Limei Zhu, Christian Lienhardt, Justin T Denholm, James A Seddon, Christopher C Whalen, Alberto L García-Basteiro, Rina Triasih, Cheng Chen, Jitendra Singh, Li-Min Huang, Surendra Sharma, Djohar Hannoun, Helena del Corral, Anna M Mandalakas, LaShaunda L Malone, Du-Lin Ling, Afrânio Kritski, Catherine M Stein, Richa Vashishtha, Fadila Boulahbal, Chi-Tai Fang, W Henry Boom, Eduardo Martins Netto, Antonio Carlos Lemos, Anneke C Hesseling, Alexander Kay, Edward C Jones-López, C Robert Horsburgh, Christoph Lange, Jason R Andrews, Boston University [Boston] (BU), University of California (UC), Recherches Translationnelles sur le VIH et les maladies infectieuses endémiques et émergentes (TransVIHMI), Institut de Recherche pour le Développement (IRD)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Fundação Oswaldo Cruz / Oswaldo Cruz Foundation (FIOCRUZ), Réseau International des Instituts Pasteur (RIIP), University of Nottingham, UK (UON), Infectious Diseases Epidemiology Unit, London School of Hygiene and Tropical Medicine (LSHTM), Medical Research Council Unit The Gambia (MRC), Imperial College London, and Universidad Peruana Cayetano Heredia (UPCH)
Subjects: Adult, Adolescent, MESH: Child, Humans, Tuberculosis, MESH: Tuberculosis, Child, Tuberculosis, Pulmonary, Aged, Retrospective Studies, MESH: Adolescent, MESH: Tuberculosis, Pulmonary, MESH: Aged, MESH: Humans, Vaccination, MESH: Child, Preschool, MESH: Infant, Newborn, Infant, Newborn, Infant, MESH: Adult, MESH: Retrospective Studies, MESH: Vaccination, General Medicine, MESH: Infant, MESH: BCG Vaccine, Child, Preschool, BCG Vaccine, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
Abstract: BACKGROUND: BCG vaccines are given to more than 100 million children every year, but there is considerable debate regarding the effectiveness of BCG vaccination in preventing tuberculosis and death, particularly among older children and adults. We therefore aimed to investigate the age-specific impact of infant BCG vaccination on tuberculosis (pulmonary and extrapulmonary) development and mortality. METHODS: In this systematic review and individual participant data meta-analysis, we searched MEDLINE, Web of Science, BIOSIS, and Embase without language restrictions for case-contact cohort studies of tuberculosis contacts published between Jan 1, 1998, and April 7, 2018. Search terms included "mycobacterium tuberculosis", "TB", "tuberculosis", and "contact". We excluded cohort studies that did not provide information on BCG vaccination or were done in countries that did not recommend BCG vaccination at birth. Individual-level participant data for a prespecified list of variables, including the characteristics of the exposed participant (contact), the index case, and the environment, were requested from authors of all eligible studies. Our primary outcome was a composite of prevalent (diagnosed at or within 90 days of baseline) and incident (diagnosed more than 90 days after baseline) tuberculosis in contacts exposed to tuberculosis. Secondary outcomes were pulmonary tuberculosis, extrapulmonary tuberculosis, and mortality. We derived adjusted odds ratios (aORs) using mixed-effects, binary, multivariable logistic regression analyses with study-level random effects, adjusting for the variable of interest, baseline age, sex, previous tuberculosis, and whether data were collected prospectively or retrospectively. We stratified our results by contact age and Mycobacterium tuberculosis infection status. This study is registered with PROSPERO, CRD42020180512. FINDINGS: We identified 14 927 original records from our database searches. We included participant-level data from 26 cohort studies done in 17 countries in our meta-analysis. Among 68 552 participants, 1782 (2·6%) developed tuberculosis (1309 [2·6%] of 49 686 BCG-vaccinated participants vs 473 [2·5%] of 18 866 unvaccinated participants). The overall effectiveness of BCG vaccination against all tuberculosis was 18% (aOR 0·82, 95% CI 0·74-0·91). When stratified by age, BCG vaccination only significantly protected against all tuberculosis in children younger than 5 years (aOR 0·63, 95% CI 0·49-0·81). Among contacts with a positive tuberculin skin test or IFNγ release assay, BCG vaccination significantly protected against tuberculosis among all participants (aOR 0·81, 95% CI 0·69-0·96), participants younger than 5 years (0·68, 0·47-0·97), and participants aged 5-9 years (0·62, 0·38-0·99). There was no protective effect among those with negative tests, unless they were younger than 5 years (0·54, 0·32-0·90). 14 cohorts reported on whether tuberculosis was pulmonary or extrapulmonary (n=57 421). BCG vaccination significantly protected against pulmonary tuberculosis among all participants (916 [2·2%] in 41 119 vaccinated participants vs 334 [2·1%] in 16 161 unvaccinated participants; aOR 0·81, 0·70-0·94) but not against extrapulmonary tuberculosis (106 [0·3%] in 40 318 vaccinated participants vs 38 [0·2%] in 15 865 unvaccinated participants; 0·96, 0·65-1·41). In the four studies with mortality data, BCG vaccination was significantly protective against death (0·25, 0·13-0·49). INTERPRETATION: Our results suggest that BCG vaccination at birth is effective at preventing tuberculosis in young children but is ineffective in adolescents and adults. Immunoprotection therefore needs to be boosted in older populations. FUNDING: National Institutes of Health.
Published: 2022

6. Semen Cryopreservation in Adolescents and Young Adults with Hematologic Diseases: from Bed to Benchside

Author: Xavier Pollet-Villard, Aurélie Cabannes-Hamy, Annalisa Andreoli, Elise Ricadat, Isabelle Berthaut, Raphael Itzykson, Etienne Lengliné, Nicolas Boissel, David Beauvais, Virginie Barraud-Lange, Catherine Poirot, Nathalie Dhedin, Rachel Levy, Hélène Behal, Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut de Recherche Saint-Louis - Hématologie Immunologie Oncologie (Département de recherche de l’UFR de médecine, ex- Institut Universitaire Hématologie-IUH) (IRSL), Université Paris Cité (UPCité), CHU Lille, Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Institut Cochin (IC UM3 (UMR 8104 / U1016)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Hôpital Cochin [AP-HP], M-Lab, Université Paris Dauphine-PSL, Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL), Institut Humanités, Sciences et Sociétés [Paris] (UPCité IHSS), Sorbonne Université (SU), and Levy, Rachel
Subjects: Male, MESH: Premature Birth, MESH: Pre-Eclampsia, [SDV]Life Sciences [q-bio], MESH: Pregnancy, MESH: Obesity, media_common, MESH: Aged, MESH: Semen Preservation, human immunodeficiency virus, Obstetrics, MESH: Sperm Motility, Assisted reproductive technology, MESH: Hematologic Diseases, Semen cryopreservation, MESH: Postpartum Hemorrhage, [SDV] Life Sciences [q-bio], sperm banking, Oncology, MESH: Pregnancy Complications, MESH: Young Adult, Sperm Motility, Adult, Infertility, MESH: Pandemics, endocrine system, medicine.medical_specialty, Adolescent, fertility preservation, media_common.quotation_subject, Fertility, Semen collection, Young Adult, Semen quality, Semen, MESH: Cryopreservation, medicine, Humans, MESH: SARS-CoV-2, MESH: Semen, Aged, Retrospective Studies, Cryopreservation, MESH: Adolescent, MESH: Humans, urogenital system, business.industry, hematological diseases, MESH: Adult, MESH: Retrospective Studies, MESH: Pregnancy Outcome, medicine.disease, Sperm bank, Hematologic Diseases, Sperm, MESH: Male, Semen Analysis, quality of life, Oligospermia, MESH: Semen Analysis, Pediatrics, Perinatology and Child Health, in vitro fertilization outcomes, MESH: Pregnant Women, business, Semen Preservation
Abstract: International audience; Purpose: Infertility in adolescents and young adult (AYA) survivors of malignant disease remains a major long-term adverse effect, but semen collection for fertility preservation in fertility centers is not always feasible and makes AYAs uncomfortable. We evaluated the feasibility of collecting sperm samples on the ward versus in fertility centers. Methods: Consecutive hospitalized AYA-aged male patients in the Hematology AYA unit (Saint-Louis Hospital, France) between August 2010 and June 2016 with hematological disease and indication of semen collection (n = 95) were included in this retrospective study. Semen quality was analyzed according to World Health Organization guidelines and was compared according to semen collection place: on the ward (n = 46) or in fertility center (n = 49). Results: The median age was median age 19.1 years (range: 13.7-33.3; interquartile range: 17.1-22.8) and 85 patients successfully collected semen. Sperm collection failure was ∼11% and was comparable between the two modalities as were main sperm quality characteristics (semen volume, sperm concentration, total sperm count, progressive motility and vitality, sperm morphology, and multiple anomalies index). Oligospermia was significantly higher in the samples obtained in fertility center (47.7%) than on the ward (26.8%), p = 0.047. Average frozen straws were comparable, 12.2 ± 6.4 on the ward versus 11.9 ± 6.3 in fertility center. Conclusion: Semen collection on the ward is feasible and would be particularly interesting for AYA male patients without altering semen quality characteristics.
Published: 2022

7. Breast reconstruction and quality of life five years after cancer diagnosis: VICAN French National cohort

Author: Memoli Victoria, Bannier Marie, Rey Dominique, Alleaume Caroline, Ben Diane Marc-Karim, Mancini Julien, Lauzier Sophie, Bouhnik Anne-Déborah, Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut des sciences de la santé publique [Marseille] (ISSPAM), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Santé publique France, Ile de France, Paris, France (SpF-Ile de France), Biostatistique et technologies de l'information et de la communication (BioSTIC) - [Hôpital de la Timone - APHM] (BiosTIC ), Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Université Laval [Québec] (ULaval), and Centre de recherche Université Laval Robert Giffard (CRULRG)
Subjects: MESH: Aged, Cancer Research, MESH: Humans, MESH: Mastectomy, [SDV]Life Sciences [q-bio], Mammaplasty, MESH: Quality of Life, Breast Neoplasms, MESH: Cancer Survivors, Breast cancer, Cancer Survivors, Oncology, Psychosocial outcomes, Quality of Life, MESH: Mammaplasty, Humans, Breast reconstruction, Female, MESH: Female, MESH: Breast Neoplasms, Mastectomy, Aged
Abstract: International audience; Purpose: Women with breast cancer (BC) who have a mastectomy may subsequently undergo breast reconstruction (BR). This study aimed to identify (1) factors associated with having BR, (2) factors associated with immediate BR (IBR) and delayed BR (DBR), and (3) associations between no BR, IBR and DBR and physical and mental quality of life (QoL) 5 years after diagnosis.Methods: Analyses were based on data from the national French cancer cohort VICAN, which followed a representative sample of cancer survivors, including BC survivors, for 5 years after diagnosis. BR and BR type (IBR/DBR) were identified using medico-administrative databases. The SF12 scale was used to measure mental and physical QoL. Multivariate logistic regressions were used to identify factors associated with BR, and linear models to evaluate associations between BR and BR type with QoL.Results: Of the 1192 BC survivors in VICAN, 32.6% (n = 388) had a mastectomy. Among them, 60.1% (n = 233) had BR. Of these, 38.6% (n = 90) and 61.4% (n = 143) had IBR and DBR, respectively. Compared with women who had BR, women who did not were more likely to be older and to have a lower level of health literacy. Compared with women who did not have BR, those with IBR had better mental QoL, while those who had either IBR or DBR had better physical QoL.Conclusion: Older women and those with inadequate health literacy were less likely to have BR. This may reflect women's preferences, inequalities in care options offered after a mastectomy, and socioeconomic barriers to accessing BR. These issues need further exploration. Furthermore, BR was associated with a better long-term physical QoL. IBR was associated with better mental QoL and should be promoted when possible.
Published: 2022

8. A network analysis of rest-activity rhythms in young people with emerging bipolar disorders

Author: Jan, Scott, Bruno, Etain, Ashlee, Grierson, Sharon, Naismith, Elizabeth, Scott, Ian, Hickie, Newcastle University [Newcastle], The University of Sydney, Optimisation thérapeutique en Neuropsychopharmacologie (OPTeN (UMR_S_1144 / U1144)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), St. Vincent's Hospital, Sydney, and Etain, Bruno
Subjects: Male, Sleep Wake Disorders, Bipolar Disorder, Youth, MESH: Actigraphy, Adolescent, MESH: Sleep, [SDV.MHEP.PSM] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, MESH: Bipolar Disorder, Bipolar disorders, Humans, MESH: Circadian Rhythm, Aged, MESH: Adolescent, MESH: Aged, MESH: Humans, Circadian, Actigraphy, MESH: Sleep Wake Disorders, MESH: Male, Circadian Rhythm, Psychiatry and Mental health, Clinical Psychology, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, MESH: Biomarkers, Female, Network analysis, Sleep, MESH: Female, Biomarkers
Abstract: International audience; Aims: Actigraphy studies of individuals with bipolar disorders (BD) suggest that illness progression may be associated with a range of progressive disruptions in 24-hour rest-activity rhythms (RAR). However, those longitudinal studies were undertaken in older adults with extended histories or illness and treatment rather than young people with emerging BD. To our knowledge, this is the first study to use network modelling to examine the statistical associations between clinical phenotypes of BD and different subsets of RAR markers.Methods: This study of adolescents and young adults (mean age 22 years; 69% female) uses network modelling to examine which self-rated or actigraphic markers of RAR are more strongly associated with full threshold BD (referred to as Stage 2; N = 15) compared with BD-at risk syndromes (subthreshold presentations referred to as Stage 1; N = 25).Results: Network analysis demonstrated that some RAR are associated with both stage of BD and a family history of BD (such as longer sleep duration and higher levels of daytime impairment). Markers of circadian rhythmicity indicated that regulation of this system is weaker in Stage 2 compared with Stage 1 of BD.Limitations: The small subgroup samples may have undermined the ability to detect some associations between phenotypes and RAR.Conclusions: Network modelling may offer a useful strategy for visualizing and analysing patterns of association between RAR and clinical phenotypes defined by stage of illness, familial loading or symptom profile. This could prove useful in understanding the underlying pathophysiology of sleep-wake cycle and circadian rhythm disturbances in BD.
Published: 2022

9. Timing of Kidney Clamping and Deceased Donor Kidney Transplant Outcomes

Author: Simon, Ville, Marine, Lorent, Clarisse, Kerleau, Anders, Asberg, Christophe, Legendre, Emmanuel, Morelon, Fanny, Buron, Valérie, Garrigue, Moglie, Le Quintrec, Sophie, Girerd, Marc, Ladrière, Laetitia, Albano, Antoine, Sicard, Denis, Glotz, Carmen, Lefaucheur, Julien, Branchereau, David, Jacobi, Magali, Giral, Etienne, Sicard, Institut de Transplantation et de Recherche en Transplantation [CHU Nantes] (ITERT), Centre hospitalier universitaire de Nantes (CHU Nantes), European cohort for Kidney Transplantation Epidemiology (EKiTE), Centre de Recherche en Transplantation et Immunologie - Center for Research in Transplantation and Translational Immunology (U1064 Inserm - CR2TI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ), Oslo University Hospital [Oslo], Réseau CENTAURE, Service Néphrologie et transplantation rénale Adultes [CHU Necker], CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), Hôpital Lapeyronie [Montpellier] (CHU), Service de Néphrologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Département de Néphrologie - Hôpital Pasteur [Nice], Hôpital Pasteur [Nice] (CHU), Service d'Urologie [CHU Saint-Louis], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité), Institut de transplantation urologie-néphrologie (ITUN), Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes), unité de recherche de l'institut du thorax UMR1087 UMR6291 (ITX), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), and Salvy-Córdoba, Nathalie
Subjects: Graft Rejection, Male, Time Factors, Databases, Factual, Epidemiology, Kidney, Critical Care and Intensive Care Medicine, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, Organ transplantation, MESH: Kidney Transplantation, MESH: Delayed Graft Function, Kidney transplantation / nephrology, MESH: Incidence, Prospective Studies, Kidney transplantation, MESH: Aged, MESH: Middle Aged, Norway, Ischemia-reperfusion, Incidence, Graft Survival, Hazard ratio, Middle Aged, Constriction, medicine.anatomical_structure, Nephrology, Cardiology, Female, France, Adult, medicine.medical_specialty, MESH: Circadian Clocks, MESH: Graft Survival, Delayed Graft Function, MESH: Graft Rejection, Cadaver organ transplantation, MESH: Norway, Circadian Clocks, Internal medicine, medicine, Humans, Circadian rhythm, Aged, Transplantation, MESH: Humans, business.industry, MESH: Time Factors, MESH: Adult, Original Articles, Odds ratio, medicine.disease, Organ transplant, MESH: Databases, Factual, [SDV.MHEP.UN] Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, Kidney Transplantation, MESH: Male, MESH: Prospective Studies, Confidence interval, MESH: France, business, MESH: Female
Abstract: International audience; Background and objectives The fact that metabolism and immune function are regulated by an endogenous molecular clock that generates circadian rhythms suggests that the magnitude of ischemia reperfusion, and subsequent inflammation on kidney transplantation, could be affected by the time of the day. Design, setting, participants, & measurements We evaluated 5026 individuals who received their first kidney transplant from deceased heart-beating donors. In a cause-specific multivariable analysis, we compared delayed graft function and graft survival according to the time of kidney clamping and declamping. Participants were divided into those clamped between midnight and noon ( ante meridiem [ am ] clamping group; 65%) or clamped between noon and midnight ( post meridiem [ pm ] clamping group; 35%), and, similarly, those who underwent am declamping (25%) or pm declamping (75%). Results Delayed graft function occurred among 550 participants (27%) with am clamping and 339 (34%) with pm clamping (adjusted odds ratio, 0.81; 95% confidence interval, 0.67 to 0.98; P =0.03). No significant association was observed between clamping time and overall death-censored graft survival (hazard ratio, 0.92; 95% confidence interval, 0.77 to 1.10; P =0.37). No significant association of declamping time with delayed graft function or graft survival was observed. Conclusions Clamping between midnight and noon was associated with a lower incidence of delayed graft function, whereas declamping time was not associated with kidney graft outcomes.
Published: 2021

10. Management of anaphylaxis due to COVID-19 vaccines in the elderly

Author: Paulo Augusto Moreira Camargos, Radolslaw Gawlik, Mirko Petrovic, Gunter J. Sturm, Kristof Nekam, Sergio Bonini, Zhanat Ispayeva, Marilyn Urrutia Pereira, Jean Bousquet, Antti Lauerma, Menachem Rottem, Arzu Yorgancioglu, Hubert Blain, Antonio Cherubini, Mário Morais-Almeida, Nathalie Salles, Charlotte G. Mortz, Sylwia Smolinska, Davor Plavec, A. Bedbrook, Torsten Zuberbier, Helga Kraxner, M. Beatrice Bilò, Sinthia Bosnic-Anticevich, Gaëtan Gavazzi, Finbarr C. Martin, Alvaro A. Cruz, K. S. Bennoor, Isabella Annesi-Maesano, Mohamed H. Shamji, Karin Hoffmann-Sommergruber, Marina Atanaskovic-Markovic, Carsten Bindslev-Jensen, Lan Tt Le, Isabel Skypala, Ana Todo-Bom, Vincenzo Patella, Lorenzo Cecchi, Charlotte Suppli Ulrik, Oscar Palomares, Joaquin Sastre, Hans Jürgen Hoffmann, Knut Brockow, Eva Untersmayr, Martin Hrubisko, Bernadette Eberlein, Aziz Sheikh, Milan Sova, Osman M. Yusuf, Violeta Kvedariene, G. Walter Canonica, Dana Wallace, Ioana Agache, Milena Sokolowska, Jos M. G. A. Schols, Susan Waserman, Stéphanie Miot, Carla Irani, Regina E Roller-Winsberger, Michael Levin, Yves Rolland, Emma Montella, Bilun Gemicioglu, Bolesław Samoliński, Stefano Del Giacco, Madda lenaIllario, Yehia El-Gamal, Olga Lourenço, Jean-Christoph Roger J-P Caubet, Luisa Brussino, Marysia Recto, De Yun Wang, Igor Kaidashev, Renaud Louis, Antonino Romano, Mario E. Zernotti, Jacques Reynes, Pedro Carreiro-Martins, Alexandra F. Santos, Marek Niedoszytko, M. Gotua, Musa Khaitov, Thomas B. Casale, Andrea Matucci, Bernardo Sousa-Pinto, Rafael Stelmach, Dejan Dokic, Joana Vitte, Motohiro Ebisawa, Maria Teresa Ventura, Joaquim Mullol, Tomas Chivato, Petr Panzner, Oliver Pfaar, Sanna Toppila-Salmi, Ioanna Tsiligianni, Wytske Fokkens, Alessandra Vultaggio, H. Neffen, Juan Carlos Ivancevich, Ya-dong Gao, Anna Sediva, Maja Hofmann, Ana Maria Carriazo, João Fonseca, Marek Jutel, A. Benetos, Nhân Pham-Thi, Mona Al-Ahmad, Arunas Valiulis, Mihaela Zidarn, Elizabeth Angier, Yoshitaka Okamoto, Montserrat Fernandez-Rivas, Cezmi A. Akdis, Philip W. Rouadi, Olivier Guérin, John Farrell, Mikaela Odemyr, George Christoff, Vera Mahler, Claus Bachert, Edward F. Knol, Wienczyslawa Czarlewski, Robyn E O'Hehir, Victoria Cardona, Ludger Klimek, Tari Haahtela, Vincent Le Moing, Branislava Milenkovic, Carmen Rondon, Kaja Julge, Jolanta Walusiak-Skorupa, Nikolaos G. Papadopoulos, Aslı Gelincik, Markus Ollert, Piotr Kuna, Leyla Namazova-Baranova, Margitta Worm, Annick Barbaud, Elena Camelia Berghea, Todor A. Popov, Derek K. Chu, María José Torres, Faradiba Sarquis Serpa, Nicola Scichilone, Amir Hamzah Abdul Latiff, Frederico S. Regateiro, Gianni Passalacqua, Humboldt-Universität zu Berlin, Microbes évolution phylogénie et infections (MEPHI), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Institut Hospitalier Universitaire Méditerranée Infection (IHU Marseille), Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Center for Rhinology and Allergology Wiesbaden, University Hospital Mannheim, Humboldt University Of Berlin, Contre les MAladies Chroniques pour un VIeillissement Actif en Languedoc-Roussillon (MACVIA-LR), Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-European Innovation Partnership on Active and Healthy Ageing Reference Site (EIP on AHA), Commission Européenne-Commission Européenne-Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Transylvania University, Wrocław Medical University, Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro (UNIBA), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], University of Cagliari, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Università Politecnica delle Marche [Ancona] (UNIVPM), Medical Consulting Czarlewski, Universiti Putra Malaysia, University of Southampton, Institut Desbrest de santé publique (IDESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), University of Belgrade [Belgrade], Ghent University Hospital, CHU Tenon [AP-HP], 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), Dhaka Shishu Hospital [Bangladesh], University of Medicine and Pharmacy 'Carol Davila' Bucharest (UMPCD), Odense University Hospital (OUH), Italian National Research Council, National Research Council [Italy] (CNR), The University of Sydney, Technische Universität München = Technical University of Munich (TUM), Università degli studi di Torino = University of Turin (UNITO), Universidade Federal de Minas Gerais = Federal University of Minas Gerais [Belo Horizonte, Brazil] (UFMG), IRCCS Research Hospital, Milan, Vall d'Hebron University Hospital [Barcelona], Centro Hospitalar de Lisboa Central E.P.E, University of South Florida [Tampa] (USF), Geneva University Hospital (HUG), Azienda Usl Toscana centro [Firenze], Софийски университет = Sofia University, McMaster University [Hamilton, Ontario], State University of Bahia, Institute of Public Health of Republic of North Macedonia [Skopje], Ain Shams University (ASU), Sagamihara National Hospital [Kanagawa, Japan], Instituto de Investigación Sanitaria del Hospital Clínico San Carlos [Madrid, Spain] (IdISSC), Amsterdam UMC - Amsterdam University Medical Center, Universidade do Porto = University of Porto, Wuhan University [China], CHU Grenoble, Silesian University of Medicine, Istanbul Faculty of Medicine, Cerrahpasa Faculty of Medicine, Istanbul University, Centre Hospitalier Universitaire de Nice (CHU Nice), Helsinki University Hospital [Helsinki, Finlande], Helsingin yliopisto = Helsingfors universitet = University of Helsinki, Medizinische Universität Wien = Medical University of Vienna, Aarhus University [Aarhus], Oncology Institute of St Elisabeth, University of Naples Federico II = Università degli studi di Napoli Federico II, St Joseph University, Hôtel-Dieu de France (HDF), Université Saint-Joseph de Beyrouth (USJ), Kazakh National Medical University, Servicio de Alergia e ImmunologiaBuenos Aires (Clinica Santa Isabel), Tartu University Institute of Clinical Medicine, Ukrainina Medical Stomatological Academy [Poltava, Ukraine], Federal Medicobiological Agency [Moscow, Russian Federation], University Medical Center [Utrecht], Semmelweis University [Budapest], Medical University of Łódź (MUL), Vilnius University [Vilnius], University of Medicine and Pharmacy (VIETNAM), University of Cape Town, CHU Sart Tilman, Université de Liège, University of Beira Interior [Portugal] (UBI), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), uBibliorum, Ear, Nose and Throat, AII - Inflammatory diseases, CHU Montpellier, Wroclaw Medical University [Wrocław, Pologne], University of Bari Aldo Moro (UNIBA), Service de Médecine Interne = Hôpital de jour de médecine [CHU Tenon], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sagamihara National Hospital, Recherches Translationnelles sur le VIH et les maladies infectieuses endémiques er émergentes (TransVIHMI), Institut de Recherche pour le Développement (IRD)-Université de Yaoundé I-Université Cheikh Anta Diop [Dakar, Sénégal] (UCAD)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), CHU Toulouse [Toulouse], RS: CAPHRI - R1 - Ageing and Long-Term Care, Health Services Research, Bousquet J., Agache I., Blain H., Jutel M., Ventura M.T., Worm M., Del Giacco S., Benetos A., Bilo B.M., Czarlewski W., Abdul Latiff A.H., Al-Ahmad M., Angier E., Annesi-Maesano I., Atanaskovic-Markovic M., Bachert C., Barbaud A., Bedbrook A., Bennoor K.S., Berghea E.C., Bindslev-Jensen C., Bonini S., Bosnic-Anticevich S., Brockow K., Brussino L., Camargos P., Canonica G.W., Cardona V., Carreiro-Martins P., Carriazo A., Casale T., Caubet J.-C., Cecchi L., Cherubini A., Christoff G., Chu D.K., Cruz A.A., Dokic D., El-Gamal Y., Ebisawa M., Eberlein B., Farrell J., Fernandez-Rivas M., Fokkens W.J., Fonseca J.A., Gao Y., Gavazzi G., Gawlik R., Gelincik A., Gemicioglu B., Gotua M., Guerin O., Haahtela T., Hoffmann-Sommergruber K., Hoffmann H.J., Hofmann M., Hrubisko M., Illario M., Irani C., Ispayeva Z., Ivancevich J.C., Julge K., Kaidashev I., Khaitov M., Knol E., Kraxner H., Kuna P., Kvedariene V., Lauerma A., Le L.T.T., Le Moing V., Levin M., Louis R., Lourenco O., Mahler V., Martin F.C., Matucci A., Milenkovic B., Miot S., Montella E., Morais-Almeida M., Mortz C.G., Mullol J., Namazova-Baranova L., Neffen H., Nekam K., Niedoszytko M., Odemyr M., O'Hehir R.E., Okamoto Y., Ollert M., Palomares O., Papadopoulos N.G., Panzner P., Passalacqua G., Patella V., Petrovic M., Pfaar O., Pham-Thi N., Plavec D., Popov T.A., Recto M.T., Regateiro F.S., Reynes J., Roller-Winsberger R.E., Rolland Y., Romano A., Rondon C., Rottem M., Rouadi P.W., Salles N., Samolinski B., Santos A.F., S Sarquis F., Sastre J., M. G. A. Schols J., Scichilone N., Sediva A., Shamji M.H., Sheikh A., Skypala I., Smolinska S., Sokolowska M., Sousa-Pinto B., Sova M., Stelmach R., Sturm G., Suppli Ulrik C., Todo-Bom A.M., Toppila-Salmi S., Tsiligianni I., Torres M., Untersmayr E., Urrutia Pereira M., Valiulis A., Vitte J., Vultaggio A., Wallace D., Walusiak-Skorupa J., Wang D.-Y., Waserman S., Yorgancioglu A., Yusuf O.M., Zernotti M., Zidarn M., Chivato T., Akdis C.A., Zuberbier T., Klimek L., HUS Inflammation Center, University of Helsinki, and Department of Dermatology, Allergology and Venereology
Subjects: Male, Allergy, Pediatrics, Eaaci Position Paper, COVID-19 vaccines, older (adults, GUIDELINES, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Medicine and Health Sciences, Immunology and Allergy, Medicine, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, Geriatrics, MESH: Aged, RISK, Vaccines, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, people), EPINEPHRINE, Epinephrine, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, COVID -19 vaccines, Anaphylaxis, medicine.drug, older (adults/people), medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), MESH: Covid-19, MESH: Epinephrine, Immunology, adrenaline, anaphylaxis, Aged, COVID-19 Vaccines, Humans, SARS-CoV-2, COVID-19, Settore MED/10 - Malattie Dell'Apparato Respiratorio, 03 medical and health sciences, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Diabetes mellitus, Anaphylaxis/etiology, MESH: SARS-CoV-2, [SDV.MP.PAR]Life Sciences [q-bio]/Microbiology and Parasitology/Parasitology, COVID‐19 vaccines, Older - Adults/people, Asthma, MESH: Humans, business.industry, adrenaline, anaphylaxis, COVID-19 vaccines, older (adults/people), medicine.disease, Obesity, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, MESH: Male, MESH: Anaphylaxis, Older, 3121 General medicine, internal medicine and other clinical medicine, business, MESH: Covid-19 vaccines, 030215 immunology
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Published: 2021

11. Efficacy and safety of prostate artery embolization for patients with lower urinary tract symptoms and indwelling urinary catheter: A retrospective multicenter study

Author: Julien Frandon, Asmaa Belaouni, Olivier Pellerin, Nicolas Thiounn, Chris Serrand, Stéphane Droupy, François Petitpierre, Hélène Vernhet-Kovacsik, Thibaut Murez, Vincent Vidal, Julien Ghelfi, Gaele Pagnoux, Ricardo Codas, Hélène de Forges, Jean-Paul Beregi, Marc Sapoval, Initial MAnagement and prevention of acute orGan failures IN critically ill patiEnts (IMAGINE), Université de Montpellier (UM), Paris-Centre de Recherche Cardiovasculaire (PARCC (UMR_S 970/ U970)), 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)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Laboratoire de Biostatistique, Epidémiologie clinique, Santé Publique Innovation et Méthodologie [CHU Nîmes] (BESPIM), Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Hôpital Pellegrin, CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, Hôpital Arnaud de Villeneuve [CHRU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital de la Timone [CHU - APHM] (TIMONE), Centre Européen de Recherche en Imagerie médicale (CERIMED), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-École Centrale de Marseille (ECM)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Centre National de la Recherche Scientifique (CNRS), Laboratoire d'Imagerie Interventionnelle Expérimentale (LIIE), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire [Grenoble] (CHU), Institute for Advanced Biosciences / Institut pour l'Avancée des Biosciences (Grenoble) (IAB), Centre Hospitalier Universitaire [Grenoble] (CHU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang - Auvergne-Rhône-Alpes (EFS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), Hospices Civils de Lyon (HCL), Service d'urologie [Centre Hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), and Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL)
Subjects: Male, MESH: Catheters, Indwelling, Urinary Catheters, MESH: Prostate, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, Catheters, Indwelling, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [INFO.INFO-IM]Computer Science [cs]/Medical Imaging, Humans, Radiology, Nuclear Medicine and imaging, Lower urinary tract symptoms, MESH: Arteries, Aged, Retrospective Studies, MESH: Aged, MESH: Lower Urinary Tract Symptoms / therapy, Benign prostatic hyperplasia, MESH: Humans, MESH: Middle Aged, Radiological and Ultrasound Technology, Prostate, MESH: Urinary Catheters, MESH: Quality of Life, MESH: Retrospective Studies, General Medicine, Arteries, Middle Aged, MESH: Lower Urinary Tract Symptoms / etiology, MESH: Male, Prostatic artery embolization, Quality of Life, MESH: Urinary Catheterization, Urinary Catheterization, Predictive factors
Abstract: International audience; Purpose: the purpose of this multicenter study was to evaluate the clinical success at three months of prostate artery embolization (PAE), assess PAE safety in centers with various experiences and identify factors associated with PAE success.Patients and methods: this multicenter, retrospective study included patients who underwent PAE for lower urinary tract symptoms (LUTS) including those with indwelling urinary catheter. PAE clinical success was defined as either 25% improvement of the International Prostate Symptom Score (IPSS) or 1-point improvement of quality of life (QoL) score, or catheter removal at three months. Multivariable analyses were performed using a logistic regression adjusted on patient variables, technical parameters and center experience in PAE.Results: a total of 383 men (mean age, 68.4±9.7 [standard deviation] years; range: 46-94) with LUTS, including 99 (25.8%) patients with indwelling urinary catheter, were included in seven centers from January 2017 to March 2019. Five patients reported major complications (1.3%), three (0.8%) penile ulceration, three (0.8%) acute urinary retention, one (0.3%) prostatic abscess, and 56 (14.6%) minor complications. Follow up data were available for 271 patients (center 1: n= 159; other centers: n= 112). Clinical success was reported in 232 patients (85.6%). In multivariable analyses, presence of cardiovascular comorbidities (diabetes, stroke history, myocardial infarction and lower limb artery disease) was the single independent variable inversely associated with PAE clinical success (odds ratio= 0.396; 95% confidence interval: 0.17-0.91; P= 0.029). There was no center effect.Conclusion: our results show that PAE is safe and effective in centers with various PAE experiences. Cardiovascular comorbidity is the single independent variable associated with PAE failure.
Published: 2022

12. A stratified adaptive two-stage design with co-primary endpoints for phase II clinical oncology trials

Author: Bastien Cabarrou, Eve Leconte, Patrick Sfumato, Jean-Marie Boher, Thomas Filleron, Biostatistique et science des données de santé/Biostatistics & Health Data Science Unit [Toulouse] (ICR), Institut Claudius Regaud-Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université de Toulouse (UT), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, and Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: MESH: Aged, MESH: Humans, Epidemiology, [SDV]Life Sciences [q-bio], Phase II clinical oncology trials, MESH: Research Design, Health Informatics, Medical Oncology, Research Design, Neoplasms, Sample Size, Adaptive stratified design, MESH: Biomarkers, Humans, MESH: Neoplasms, Co-primary endpoints, Heterogeneity, Biomarkers, MESH: Sample Size, Aged, MESH: Medical Oncology
Abstract: Background Given the inherent challenges of conducting randomized phase III trials in older cancer patients, single-arm phase II trials which assess the feasibility of a treatment that has already been shown to be effective in a younger population may provide a compelling alternative. Such an approach would need to evaluate treatment feasibility based on a composite endpoint that combines multiple clinical dimensions and to stratify older patients as fit or frail to account for the heterogeneity of the study population to recommend an appropriate treatment approach. In this context, stratified adaptive two-stage designs for binary or composite endpoints, initially developed for biomarker studies, allow to include two subgroups whilst maintaining competitive statistical performances. In practice, heterogeneity may indeed affect more than one dimension and incorporating co-primary endpoints, which independently assess each individual clinical dimension, would therefore appear quite pertinent. The current paper presents a novel phase II design for co-primary endpoints which takes into account the heterogeneity of a population. Methods We developed a stratified adaptive Bryant & Day design based on the Jones et al. and Parashar et al. algorithm. This two-stage design allows to jointly assess two dimensions (e.g. activity and toxicity) in two different subgroups. The operating characteristics of this new design were evaluated using examples and simulation comparisons with the Bryant & Day design in the context where the study population is stratified according to a pre-defined criterion. Results Simulation results demonstrated that the new design minimized the expected and maximum sample sizes as compared to parallel Bryant & Day designs (one in each subgroup), whilst controlling type I error rates and maintaining a competitive statistical power as well as a high probability of detecting heterogeneity. Conclusions In a heterogeneous population, this two-stage stratified adaptive phase II design provides a useful alternative to classical one and allows to identify a subgroup of interest without dramatically increasing sample size. As heterogeneity is not limited to older populations, this new design may also be relevant to other study populations such as children or adolescents and young adults or the development of targeted therapies based on a biomarker.
Published: 2022

13. Evolution of the prevalence of obesity in the adult population in France, 2013–2016: the Constances study

Author: Sébastien, Czernichow, Adeline, Renuy, Claire, Rives-Lange, Claire, Carette, Guillaume, Airagnes, Emmanuel, Wiernik, Anna, Ozguler, Sofiane, Kab, Marcel, Goldberg, Marie, Zins, Joane, Matta, Demarquay, Sandrine, 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), Université Paris Cité (UPCité), 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), Cohortes épidémiologiques en population (CONSTANCES), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université Paris Cité (UPCité), CIC - HEGP (CIC 1418), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and the Constances cohort is supported by the National Health Insurance Fund ('Caisse nationale d'assurance maladie des travailleurs salariés', CNAMTS), the ministry of health, the ministry of research and the Nationale Institute for Health and Medical research. The Constances Cohort benefits from a grant from ANR (ANR-11-INBS-0002). Constances is also partly funded by MSD, AstraZeneca, Lundbeck and l'Oréal handled by INSERM.
Subjects: Adult, Male, MESH: Smoking, Adolescent, [SDV]Life Sciences [q-bio], Science, MESH: Logistic Models, Article, MESH: Multivariate Analysis, Body Mass Index, MESH: Body Mass Index, Young Adult, MESH: Health Surveys, Odds Ratio, Prevalence, Humans, MESH: Obesity, Nutrition disorders, Obesity, Exercise, MESH: Prevalence, Aged, MESH: Adolescent, MESH: Aged, MESH: Humans, MESH: Middle Aged, Smoking, MESH: Adult, Middle Aged, MESH: Income, Health Surveys, MESH: Male, MESH: Odds Ratio, [SDV] Life Sciences [q-bio], MESH: France, Logistic Models, MESH: Young Adult, MESH: Exercise, Multivariate Analysis, Income, Educational Status, Medicine, Female, France, MESH: Educational Status, MESH: Female
Abstract: International audience; Abstract This study provides trends in obesity prevalence in adults from 2013 to 2016 in France. 63,582 men and women from independent samples upon inclusion from the Constances cohort were included. Anthropometrics were measured at Health Screening Centers and obesity defined as a Body mass index (BMI) ≥ 30 kg/m 2 ; obesity classes according to BMI are as follows: class 1 [30–34.9]; class 2 [35–39.9]; class 3 [≥ 40 kg/m 2 ]. Linear trends across obesity classes by sex and age groups were examined in regression models and percentage point change from 2013 to 2016 for each age category calculated. All analyses accounted for sample weights for non-response, age and sex-calibrated to the French population. Prevalence of obesity ranged from 14.2 to 15.2% and from 14 to 15.3% in women and men respectively from 2013 to 2016. Class 1 obesity category prevalence was the only one to increase significantly across survey years in both men and women ( p for linear trend = 0.04 and 0.01 in women and men respectively). The only significant increase for obesity was observed in the age group 18–29 y in both women and men (+ 2.71% and + 3.26% point increase respectively, equivalent to an approximate rise of 50% in women and 93% in men, p = 0.03 and 0.02 respectively). After adjustment for survey non-response and for age and sex distribution, the results show that class 1 obesity prevalence has significantly increased in both women and men from 2013 to 2016, and only in young adults in a representative sample of the French population aged 18–69 years old.
Published: 2021

14. Effect of Tocilizumab on Disease Activity in Patients With Active Polymyalgia Rheumatica Receiving Glucocorticoid Therapy

Author: Devauchelle-Pensec, Valérie, Carvajal-Alegria, Guillermo, Dernis, Emmanuelle, Richez, Christophe, Truchetet, Marie-Elise, Wendling, Daniel, Toussirot, Eric, Perdriger, Aleth, Gottenberg, Jacques-Eric, Felten, Renaud, Fautrel, Bruno Jean, Chiche, Laurent, Hilliquin, Pascal, Le Henaff, Catherine, Dervieux, Benjamin, Direz, Guillaume, Chary-Valckenaere, Isabelle, Cornec, Divi, Guellec, Dewi, Marhadour, Thierry, Nowak, Emmanuel, Saraux, Alain, Inserm UMR 1227 Immunothérapies et Pathologies Lymphocytaires B, Hôpital Morvan - CHRU de Brest (CHU - BREST ), Centre d'Investigation Clinique de Besançon (Inserm CIC 1431), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), CHU Pontchaillou [Rennes], Université de Rennes (UR), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, and The funders of this study were the French National Program for Clinical Research and the study sponsor (ie, the Brest University Hospital). Roche-Chugai Pharmaceutical provided an unconditional grant for the study and donated the tocilizumab used for the study.
Subjects: MESH: Aged, MESH: Humans, MESH: Administration, Intravenous, [SDV]Life Sciences [q-bio], MESH: Giant Cell Arteritis, MESH: Interleukin-6, MESH: Male, MESH: Drug Tapering, MESH: Polymyalgia Rheumatica, MESH: Antibodies, Monoclonal, Humanized, MESH: Anti-Inflammatory Agents, MESH: Administration, Oral, MESH: C-Reactive Protein, MESH: Double-Blind Method, MESH: Glucocorticoids, MESH: Prednisone, MESH: Female
Abstract: International audience; Importance: Few treatments are available for patients with glucocorticoid-dependent polymyalgia rheumatica. IL-6 antagonists may reduce disease activity in patients with active glucocorticoid-dependent polymyalgia rheumatica.Objective: To compare the efficacy of tocilizumab vs placebo in patients with glucocorticoid-dependent polymyalgia rheumatica.Design, setting, and participants: This double-blind, parallel-group, placebo-controlled randomized clinical trial enrolled 101 patients with polymyalgia rheumatica at 17 hospitals in France from February 2017 to October 2019. Final follow-up occurred in November 2020. Inclusion criteria were persistent disease activity (polymyalgia rheumatica activity score computed using the C-reactive protein level [CRP PMR-AS] >10) and prednisone dose greater than or equal to 10 mg per day.Interventions: Patients were randomly assigned to receive intravenous tocilizumab (8 mg/kg; n = 51) or placebo (n = 50) every 4 weeks for 24 weeks, combined with predefined standardized tapering of oral prednisone.Main outcomes and measures: The primary efficacy end point was CRP PMR-AS less than 10 (range, 0-100; higher values indicate greater activity; no minimal clinically important difference defined) combined with either prednisone dose less than or equal to 5 mg per day or a decrease in prednisone dose greater than or equal to 10 mg from baseline at week 24. There were 11 secondary outcomes assessed at week 24 included in this report, including disease activity (measured by CRP PMR-AS) and the proportion of patients no longer taking prednisone.Results: Of the 101 randomized patients (mean age, 67.2 years; 68 [67.3%] women), 100 (99%) received at least 1 infusion and 100 completed the trial. The primary end point was achieved in 67.3% of patients in the tocilizumab group and 31.4% of patients in the placebo group (adjusted difference, 36.0% [95% CI, 19.4%-52.6%]; adjusted relative risk, 2.3 [95% CI, 1.5-3.6]; P < .001). Of 11 reported secondary end points at 24 weeks, 7 showed significant differences favoring tocilizumab, including mean CRP PMR-AS score (7.5 [95% CI, 5.4-9.6] vs 14.9 [95% CI, 11.4-18.4]; adjusted difference, -7.5 [95% CI, -11.2 to -3.8]; P < .001) and the percentage of patients no longer receiving prednisone (49.0% vs 19.6%; adjusted difference, 29.3% [95% CI, 18.9%-39.7%]; adjusted relative risk, 2.5 [95% CI, 1.8-3.5]; P < .001). The most frequent adverse events were infections, experienced by 23 patients (46.9%) in the tocilizumab group and 20 (39.2%) in the placebo group.Conclusions and relevance: Among patients with active polymyalgia rheumatica despite prednisone therapy, tocilizumab, compared with placebo, resulted in a significantly greater percentage of patients with a CRP PMR-AS less than 10 with reduced prednisone requirements at week 24. Further research is needed to confirm efficacy and to determine the balance of potential benefits and harms.
Published: 2022

15. Trends in the relation between hyperglycemia correction and active Charcot neuroarthropathy: results from the EPICHAR study

Author: Dured Dardari, Sophie Schuldiner, Carole-Anne Julien, Georges Ha Van, Jocelyne M’Bemba, Muriel Bourgeon, Ariane Sultan, Marc Lepeut, Sylvie Grandperret-Vauthier, Florence Baudoux, Maud François, Sylvaine Clavel, Jacques Martini, Julien Vouillarmet, Paul Michon, Myriam Moret, Arnaud Monnier, Vaneva Chingan-Martino, Vincent Rigalleau, Isabelle Dumont, Laurence Kessler, Ionela Stifii, Benjamin Bouillet, Pierre Bonnin, Amal Lemoine, Enrique Da Costa Correia, Marie Martine Bonello Faraill, Marie Muller, Marie Cazaubiel, Mohammed Zakarya Zemmache, Agnes Hartemann, Laboratoire de Biologie de l'Exercice pour la Performance et la Santé (LBEPS), Université d'Évry-Val-d'Essonne (UEVE)-Université Paris-Saclay-Institut de Recherche Biomédicale des Armées [Brétigny-sur-Orge] (IRBA), Centre Hospitalier Sud Francilien, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de diabétologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), CHU Roubaix, Service de Génétique Biologique, Histologie Biologie du Développement et de la reproduction, Centre Hospitalier Régional universitaire Jean Minjoz (Service de Génétique Biologique, Histologie Biologie du Développement et de la reproduction, Centre Hospitalier Régional universitaire Jean Minjoz), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Hôpital Claude Huriez [Lille], CHU Lille, Hôpital Robert Debré, Hôpital Robert Debré-Centre Hospitalier Universitaire de Reims (CHU Reims), Hôpital Hôtel-Dieu [Paris], Service Diabétologie [CHU Toulouse], Pôle Cardiovasculaire et Métabolique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Hôpital Louis Pradel [CHU - HCL], CHU Pointe-à-Pitre/Abymes [Guadeloupe], 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), Les Hôpitaux Universitaires de Strasbourg (HUS), Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Agro Dijon, 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), Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois], Hôpital Lucien Hussel Vienne [Vienne, France] (HLHV), Centre Hospitalier de Vichy (CH Vichy), Hôpital Archet 2 [Nice] (CHU), Hôpital Michallon, Centre Hospitalier de Tourcoing, and BESPIM
Subjects: Male, HbA1c, MESH: Glycated Hemoglobin, Endocrinology, Diabetes and Metabolism, MESH: Diabetic Neuropathies / epidemiology, Cohort Studies, Diabetic Neuropathies, Diabetes complications, Diagnosis, MESH: Diabetes Mellitus, Type 2 / complications, Humans, Aged, MESH: Hyperglycemia / complications, Glycated Hemoglobin, MESH: Aged, MESH: Humans, Middle Aged, [SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism, MESH: Male, MESH: Middle aged, Diabetes Mellitus, Type 2, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Hyperglycemia, MESH: Cohort studies, Neuroarthropathy, Female, MESH: Female, MESH: Diabetic Neuropathies / etiology
Abstract: IntroductionThe pathophysiology of Charcot neuroarthropathy (CN) remains unclear. There are a number of hypotheses but these are not exclusive. In its clinical presentation, this complication intersects with the semiology of diabetic-induced neuropathy, such as peripheral hypervascularization and the appearance of arteriovenous shunt. The EPICHAR study is as yet an unpublished cohort of people living with diabetes complicated by CN (in active or chronic phase). Based on the findings of the EPICHAR study, this study aimed to investigate whether a reduction in the rate of hyperglycemia accompanies the onset of an active phase of CN.Research design and methodsHemoglobin A1c (HbA1c) levels were assessed 3 months (M3) and 6 months (M6) before the diagnosis of active CN (M0).Results103 patients living with diabetes and presenting active CN were included between January and December 2019 from the 31 centers participating in this study (30 in France and 1 in Belgium). The mean age of the participants was 60.2±12.2 years; the vast majority were men (71.8%) living with type 2 diabetes (75.5%). Mean HbA1c levels significantly declined between M6 (median 7.70; Q1, Q3: 7.00, 8.55) and M3 (median 7.65; Q1, Q3: 6.90, 8.50) (p=0.012), as well as between M6 and M0 (median 7.40; Q1, Q3: 6.50, 8.50) (p=0.014). No significant difference was found between M3 and M0 (p=0.072).ConclusionsA significant reduction in HbA1c levels seems to accompany the onset of the active phase of CN.Trial registration numberNCM03744039.
Published: 2022

16. What can lead to late diagnosis of HIV in an illegal gold mining environment? A qualitative study at the French Guiana’s border with Brazil

Author: Floersheim, Charlotte, Musso, Sandrine, Eubanks, August, Douine, Maylis, Spire, Bruno, Sagaon-Teyssier, Luis, Parriault, Marie, Girard, Gabriel, Mosnier, Emilie, Département des Centres Délocalisés de Prévention et de Soins [Cayenne, Guyane Française], Centre Hospitalier Andrée Rosemon [Cayenne, Guyane Française], Centre population et développement (CEPED - UMR_D 196), Institut de Recherche pour le Développement (IRD)-Université Paris Cité (UPCité), Centre Norbert Elias (CNELIAS), École des hautes études en sciences sociales (EHESS)-Avignon Université (AU)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut des sciences de la santé publique [Marseille] (ISSPAM), Centre d'Investigation Clinique Antilles-Guyane (CIC - Antilles Guyane), Université des Antilles et de la Guyane (UAG)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pointe-à-Pitre/Abymes [Guadeloupe] -CHU de Fort de France-Centre Hospitalier Andrée Rosemon [Cayenne, Guyane Française], and Service des maladies infectieuses et tropicales [Cayenne, Guyane Française]
Subjects: MESH: Aged, Public health, MESH: Humans, MESH: Middle Aged, Epidemiology, [SDV]Life Sciences [q-bio], HIV & AIDS, MESH: Adult, MESH: HIV Infections, MESH: Mining, MESH: Male, MESH: Delayed Diagnosis, MESH: French Guiana, MESH: Gold, MESH: Brazil, MESH: Female
Abstract: International audience; Objective The present study aimed to understand what factors can lead to late HIV diagnosis of illegal gold miners at French Guiana's border with Brazil. Design An exploratory qualitative study with in-depth interviews and observations was conducted between November 2019 and February 2020. Setting The study was conducted in the main medical healthcare service and two non-governmental organisation premises in the Oyapock border region, which is a supply area for illegal gold mining sites. Participants Fifteen people living with HIV diagnosed with CD4 count
Published: 2022

17. Acceptance, efficacy, and safety of COVID-19 vaccination in older patients with cancer

Author: Anne-Laure Couderc, Laetitia Ninove, Emilie Nouguerède, Dominique Rey, Marina Rebroin, Aurélie Daumas, Pascale Tomasini, Laurent Greillier, Sebastien Salas, Florence Duffaud, Laetitia Dahan, Muriel Duluc, Marie-Eve Garcia, Johan Pluvy, Solène Chaléat, Laure Farnault, Geoffroy Venton, Toscane Fourié, Elif Nurtop, Xavier de Lamballerie, Patrick Villani, Remi Charrel, Florian Correard, Anthropologie bio-culturelle, Droit, Ethique et Santé (ADES), Aix Marseille Université (AMU)-EFS ALPES MEDITERRANEE-Centre National de la Recherche Scientifique (CNRS), Assistance Publique - Hôpitaux de Marseille (APHM), Unité des Virus Emergents (UVE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Hospitalier Universitaire Méditerranée Infection (IHU Marseille), Unité de coordination en oncogériatrie (UCOG Paca ouest), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Multidisciplinary Oncology and Therapeutic Innovations Unit, Hôpital Nord [CHU - APHM], Méthodes computationnelles pour la prise en charge thérapeutique en oncologie : Optimisation des stratégies par modélisation mécaniste et statistique (COMPO), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Aix Marseille Université (AMU), Service d’Oncologie Médicale [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Hôpital de la Timone [CHU - APHM] (TIMONE), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Marseille, Theories and Approaches of Genomic Complexity (TAGC), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Timone [CHU - APHM] (TIMONE)
Subjects: Male, COVID-19 Vaccines, Medical oncology, Second-line, Drug-related side effects and adverse reactions, MESH: Aged, 80 and over, Neoplasms, Humans, Lenvatinib, MESH: COVID-19, Thymic epithelial tumors, MESH: Neoplasms, MESH: BNT162 Vaccine, BNT162 Vaccine, Aged, Aged, 80 and over, MESH: Aged, Vaccines, MESH: Humans, Vaccination, COVID-19, MESH: Vaccination, Geriatric assessment, MESH: Male, MESH: Vaccines, Oncology, MESH: COVID-19 Vaccines, Female, Immunotherapy, Geriatrics and Gerontology, Pembrolizumab, MESH: Female, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: The COVID-19 vaccination campaign began in December 2020, in France, and primarily targeted the oldest people. Our study aimed to determine the level of acceptance of vaccination in a population of older patients with cancer.From January 2021, we offered vaccination with the BNT162b2 COVID-19 vaccine to all patients 70 years and older referred to our geriatric oncology center in Marseille University Hospital (AP-HM) for geriatric assessment before initiation of an oncological treatment. Objectives were to evaluate acceptance rate of COVID-19 vaccination and to assess vaccine safety, reactogenicity, and efficacy two months after the first dose.Between January 18, 2021 and May 7, 2021, 150 older patients with cancer were offered vaccination after a geriatric assessment. The majority were men (61.3%), with a mean age of 81 years. The two most frequent primary tumors were digestive (29.4%) and thoracic (18%). The vaccine acceptance rate was 82.6% and the complete vaccination rate (2 doses) reached 75.3%. Among the vaccinated patients, 15.9% reported mild side effects after the first dose and 23.4% after the second dose, mostly arm pain and fatigue. COVID-19 cases were observed in 5.1% of vaccinated patients compared with 16.7% in unvaccinated patients. Of the 22 vaccinated patients who agreed to have their serum tested, 15 had antibodies against the spike protein at day 21 after the first dose.Our study showed a high acceptance rate of COVID-19 vaccination, with good tolerance in this frail population. These results highlight the benefits of organizing vaccination campaigns at the very beginning of oncological management in older patients.This study was registered May 23, 2019 in ClinicalTrials.gov (NCT03960593).
Published: 2022

18. Most randomized controlled trials for psoriasis used placebo comparators despite the availability of effective treatments

Author: Nadia Oubaya, Laurence Le Cleach, Emilie Sbidian, Theodoros Evrenoglou, Sivem Afach, Epidemiology in Dermatology and Evaluation in Therapeutics (EpiDermE), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Equipe 5 : METHODS - Méthodes de l’évaluation thérapeutique des maladies chroniques (CRESS - U1153), 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)-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), French Cochrane Centre, Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Hôpital Henri Mondor, IMRB - CEPIA/'Clinical Epidemiology And Ageing : Geriatrics, Primary Care and Public Health' [Créteil] (U955 Inserm - UPEC), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Université Paris-Est Créteil Val-de-Marne - Faculté de médecine (UPEC Médecine), Service de dermatologie [Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), 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), and CCSD, Accord Elsevier
Subjects: medicine.medical_specialty, Epidemiology, education, MESH: Placebos, Placebo, Placebo group, law.invention, 03 medical and health sciences, MESH: Aged, 80 and over, 0302 clinical medicine, Randomized controlled trial, law, Psoriasis, Internal medicine, medicine, Clinical Trials, 030212 general & internal medicine, Ethics, MESH: Aged, MESH: Psoriasis, MESH: Humans, MESH: Middle Aged, business.industry, MESH: Biomedical Research, MESH: Research Design, MESH: Guidelines as Topic, Linear Regression, MESH: Adult, medicine.disease, Therapeutic trial, MESH: Male, Clinical trial, Meta-analysis, MESH: Randomized Controlled Trials as Topic, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, MESH: Anti-Inflammatory Agents, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, MESH: Female, 030217 neurology & neurosurgery
Abstract: International audience; Background: The availability of effective treatments for psoriasis raises ethical questions about the use of a placebo group in therapeutic trials. We evaluated the use of the placebo over time in such trials.Methods: From trials in a living Cochrane review and network meta-analysis for psoriasis, we included trials comparing a biologic to a placebo or other systemic treatment. First, we tested the changes in placebo rate from 2001 to 2019 by linear regression, then constructed networks for 2004-2019 and evaluated the contribution of the placebo to the network meta-analysis estimates per trial and per comparison.Results: We included 81 trials (36,774 patients). The placebo rate did not decrease significantly over time. The proportion contribution of trials with a placebo decreased from 100% in 2004 to 86% in 2008 and 75% in 2019. However, the proportion contribution of trials without a placebo remained low (from 0% in 2004 to 25% in 2019).Conclusion: The design of future psoriasis trials should be reviewed to improve the number of patients to be included in a placebo group.
Published: 2021

19. Impact of prone position in non-intubated spontaneously breathing patients admitted to the ICU for severe acute respiratory failure due to COVID-19

Author: Alexandre Demoule, Jean-Jacques Tudesq, Alexandra Beurton, Muriel Fartoukh, Guillaume Geri, Romain Jouffroy, Safaa Nemlaghi, Antoine Vieillard-Baron, Michael Darmon, Elie Azoulay, Foucauld Isnard, Hôpital Ambroise Paré [AP-HP], Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Service des Urgences [CHU Tenon], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Tenon [AP-HP], Service d'Anesthésie réanimation [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
Subjects: Male, medicine.medical_treatment, Hemodynamics, Critical Care and Intensive Care Medicine, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Prone position, 0302 clinical medicine, Mechanical ventilation, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, MESH: Cannula, Intubation, MESH: COVID-19, MESH: Aged, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, MESH: Middle Aged, MESH: Paris, MESH: Patient Positioning, Middle Aged, Intensive Care Units, Anesthesia, MESH: Survival Analysis, High-flow nasal cannula, Breathing, Female, Respiratory Insufficiency, Paris, MESH: Hemodynamics, MESH: Blood Gas Analysis, Patient Positioning, Article, 03 medical and health sciences, medicine, Cannula, Humans, MESH: SARS-CoV-2, Propensity Score, Aged, Retrospective Studies, MESH: Humans, SARS-CoV-2, Proportional hazards model, business.industry, COVID-19, 030208 emergency & critical care medicine, Retrospective cohort study, MESH: Retrospective Studies, MESH: Prone Position, MESH: Propensity Score, Survival Analysis, MESH: Male, 030228 respiratory system, Respiratory failure, MESH: Intensive Care Units, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Blood Gas Analysis, business, MESH: Female, MESH: Respiratory Insufficiency
Abstract: Purpose Studies performed in spontaneously breathing patients with mild to moderate respiratory failure suggested that prone position (PP) in COVID-19 could be beneficial. Materials and methods Consecutive critically ill patients with COVID-19 were enrolled in four ICUs. PP sessions lasted at least 3 h each and were performed twice daily. A Cox proportional hazard model identified factors associated with the need of intubation. A propensity score overlap weighting analysis was performed to assess the association between spontaneous breathing PP (SBPP) and intubation. Results Among 379 patients, 40 underwent SBPP. Oxygenation was achieved by high flow nasal canula in all but three patients. Duration of proning was 2.5 [1.6;3.4] days. SBPP was well tolerated hemodynamically, increased PaO2/FiO2 (78 [68;96] versus 63 [53;77] mm Hg, p = 0.004) and PaCO2 (38 [34;43] versus 35 [32;38] mm Hg, p = 0.005). Neither day-28 survival (HR 0.51, 95% CI 0.16–1.16] nor risk of invasive ventilation [sHR 0.96; 95% CI 0.49;1.88] differed between patients who underwent PP and others. Conclusions SBPP in COVID-19 is feasible and well tolerated in severely hypoxemic patients. It did not induce any effect on risk of intubation and day-28 mortality.
Published: 2021

20. Speech Biomarkers in Rapid Eye Movement Sleep Behavior Disorder and Parkinson Disease

Author: Jacques Montplaisir, Paul C. Timm, Erik K. St. Louis, Evi Holzknecht, Petr Dusek, Klaus Seppi, Evžen Růžička, Luke N. Teigen, Tereza Tykalová, Sara Marelli, Ronald B. Postuma, Andrea Galbiati, Karel Sonka, Michal Novotný, Amélie Pelletier, Mahboubeh Habibi, Yves Dauvilliers, Annette Janzen, Wolfgang H. Oertel, Jan Rusz, Luigi Ferini-Strambi, Jan Hlavnička, Birgit Högl, Ambra Stefani, Jean Gagnon, Elisa Evangelista, Anna Laura Rassu, Rusz, Jan, Hlavnička, Jan, Novotný, Michal, Tykalová, Tereza, Pelletier, Amelie, Montplaisir, Jacque, Gagnon, Jean-Francoi, Dušek, Petr, Galbiati, Andrea, Marelli, Sara, Timm, Paul C, Teigen, Luke N, Janzen, Annette, Habibi, Mahboubeh, Stefani, Ambra, Holzknecht, Evi, Seppi, Klau, Evangelista, Elisa, Rassu, Anna Laura, Dauvilliers, Yve, Högl, Birgit, Oertel, Wolfgang, St Louis, Erik K, Ferini-Strambi, Luigi, Růžička, Evžen, Postuma, Ronald B, Šonka, Karel, Czech Technical University in Prague (CTU), First Faculty of Medicine Charles University [Prague], Hôpital du Sacré-Coeur de Montréal, McGill University Health Center [Montreal] (MUHC), Universita Vita Salute San Raffaele = Vita-Salute San Raffaele University [Milan, Italie] (UniSR), Mayo Clinic [Rochester], Philipps Universität Marburg = Philipps University of Marburg, Innsbruck Medical University = Medizinische Universität Innsbruck (IMU), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut des Neurosciences de Montpellier (INM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), and Retiveau, Nolwenn
Subjects: 0301 basic medicine, Male, Disease, REM Sleep Behavior Disorder, Audiology, Behavior disorder, Dysarthria, MESH: Aged, 80 and over, 0302 clinical medicine, Research Articles, MESH: Aged, Aged, 80 and over, MESH: Middle Aged, MESH: Speech, Parkinsonism, Parkinson Disease, Middle Aged, Europe, Neurology, Disease Progression, Biomarker (medicine), MESH: Disease Progression, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Female, medicine.symptom, Research Article, medicine.medical_specialty, Rapid eye movement sleep, Prodromal Symptoms, REM sleep behavior disorder, 03 medical and health sciences, medicine, Humans, Speech, [SDV.NEU] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], MESH: Prodromal Symptoms, Aged, MESH: Humans, business.industry, Disease progression, medicine.disease, MESH: Male, 030104 developmental biology, MESH: REM Sleep Behavior Disorder, MESH: Biomarkers, MESH: Europe, Neurology (clinical), business, MESH: Female, MESH: Parkinson Disease, 030217 neurology & neurosurgery, Biomarkers
Abstract: International audience; Objective: This multilanguage study used simple speech recording and high-end pattern analysis to provide sensitive and reliable noninvasive biomarkers of prodromal versus manifest α-synucleinopathy in patients with idiopathic rapid eye movement sleep behavior disorder (iRBD) and early-stage Parkinson disease (PD).Methods: We performed a multicenter study across the Czech, English, German, French, and Italian languages at 7 centers in Europe and North America. A total of 448 participants (337 males), including 150 with iRBD (mean duration of iRBD across language groups 0.5-3.4 years), 149 with PD (mean duration of disease across language groups 1.7-2.5 years), and 149 healthy controls were recorded; 350 of the participants completed the 12-month follow-up. We developed a fully automated acoustic quantitative assessment approach for the 7 distinctive patterns of hypokinetic dysarthria.Results: No differences in language that impacted clinical parkinsonian phenotypes were found. Compared with the controls, we found significant abnormalities of an overall acoustic speech severity measure via composite dysarthria index for both iRBD (p = 0.002) and PD (p < 0.001). However, only PD (p < 0.001) was perceptually distinct in a blinded subjective analysis. We found significant group differences between PD and controls for monopitch (p < 0.001), prolonged pauses (p < 0.001), and imprecise consonants (p = 0.03); only monopitch was able to differentiate iRBD patients from controls (p = 0.004). At the 12-month follow-up, a slight progression of overall acoustic speech impairment was noted for the iRBD (p = 0.04) and PD (p = 0.03) groups.Interpretation: Automated speech analysis might provide a useful additional biomarker of parkinsonism for the assessment of disease progression and therapeutic interventions. ANN NEUROL 2021;90:62-75.
Published: 2021

21. 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

22. Health-related quality of life and utility outcomes with selinexor in relapsed/refractory diffuse large B-cell lymphoma

Author: Agnes Nagy, Rene-Olivier Casasnovas, Sameer Bakhshi, Sharon Shacham, Juan-Manuel Sancho, Ronit Gurion, Josée M. Zijlstra, Jatin P. Shah, Miklos Egyed, Brian T. Hill, Krzysztof Warzocha, Gabriel Tremblay, Michael W. Schuster, Fritz Offner, Reda Bouabdallah, Dimitrios Tomaras, Paolo Caimi, Andre Goy, Priyanka Samal, Catherine Thieblemont, Joost S.P. Vermaat, Matthew Ku, Ulrich Jäger, John Kuruvilla, Nagesh Kalakonda, George A Follows, Eric Van Den Neste, Miguel Ángel Canales Albendea, Michael Kauffman, Nada Hamad, Fatima De la Cruz, Patrick Daniele, Marie Maerevoet, Theodoros Vasilakopoulos, Federica Cavallo, Sylvain Choquet, Karyopharm Therapeutics Inc., Newton, MA, U918, Service d'Hématologie Clinique (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Amsterdam UMC, Addenbrooke's Hospital, Cambridge University NHS Trust, Leiden University Medical Center (LUMC), Institute of Translational Medicine, University of Liverpool, Hackensack University Medical Center [Hackensack], 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), Université Catholique de Louvain = Catholic University of Louvain (UCL), Cleveland Clinic, Service d'Hémato-oncologie [CHU Saint-Louis], Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), University of Turin, Hospital Universitario Virgen del Rocío [Sevilla], University Health Network, St Vincent's Hospital Melbourne [Australia], Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Medizinische Universität Wien = Medical University of Vienna, University Hospitals Case Medical Center, Tel Aviv University [Tel Aviv], Institute of Hematology and Transfusion Medicine[Warsaw, Poland] (IHTM), Germans Trias i Pujol Hospital, Barcelona Autonomous University, Stony Brook University [SUNY] (SBU), State University of New York (SUNY), Ghent University Hospital, National and Kapodistrian University of Athens (NKUA), Semmelweis University [Budapest], Hospital Universitario La Paz, UCL - SSS/DDUV - Institut de Duve, UCL - SSS/DDUV/BCHM - Biochimie-Recherche métabolique, and UCL - (SLuc) Service d'hématologie
Subjects: Male, Oncology, Cancer Research, Health utility, FACT-Lym, patient reported outcomes, MESH: Patient Reported Outcome Measures, MESH: Aged, 80 and over, 0302 clinical medicine, Quality of life, Recurrence, Medicine and Health Sciences, Aged, 80 and over, MESH: Aged, MESH: Middle Aged, health, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, General Medicine, Middle Aged, MESH: Drug Resistance, Neoplasm, 3. Good health, health-related quality of life, Hydrazines, EQ-5D-5L, patient-reported outcomes, 030220 oncology & carcinogenesis, Female, health utility, Lymphoma, Large B-Cell, Diffuse, MESH: Hydrazines, Adult, disutility of adverse events, medicine.medical_specialty, diffuse large B-cell lymphoma, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, Refractory, Internal medicine, medicine, Humans, health state utility, selinexor, Patient Reported Outcome Measures, Aged, Health related quality of life, MESH: Humans, business.industry, MESH: Quality of Life, MESH: Adult, Triazoles, medicine.disease, MESH: Male, MESH: Recurrence, Lymphoma, MESH: Triazoles, utility, Drug Resistance, Neoplasm, Relapsed refractory, Quality of Life, MESH: Lymphoma, Large B-Cell, Diffuse, business, MESH: Female, Diffuse large B-cell lymphoma, Progressive disease, 030215 immunology
Abstract: Aim: Evaluate health-related quality of life (HRQoL) and health utility impact of single-agent selinexor in heavily pretreated patients with relapsed/refractory diffuse large B-cell lymphoma. Patients & methods: Functional Assessment of Cancer Therapy (FACT) - Lymphoma and EuroQoL five-dimensions five-levels data collected in the single-arm Phase IIb trial SADAL (NCT02227251) were analyzed with mixed-effects models. Results: Treatment responders maintained higher FACT - Lymphoma (p = 3 adverse events and serious adverse events were not associated with clinically meaningful negative QoL impacts.
Published: 2021

23. Prevalence of Hearing Loss and Hearing Aid Use Among Adults in France in the CONSTANCES Study

Author: Quentin Lisan, Marcel Goldberg, Ghizlene Lahlou, Anna Ozguler, Sylvie Lemonnier, Xavier Jouven, Marie Zins, Jean-Philippe Empana, Hôpital Foch [Suresnes], Paris-Centre de Recherche Cardiovasculaire (PARCC (UMR_S 970/ U970)), 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)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Cohortes épidémiologiques en population (CONSTANCES), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université Paris Cité (UPCité), UMS 011, Institut National de la Santé et de la Recherche Médicale (INSERM), UFR Médecine [Santé] - Université Paris Cité (UFR Médecine UPCité), Université Paris Cité (UPCité), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Technologies et thérapie génique pour la surdité - Technologies and Gene Therapy for Deafness (TGTD), Institut de l'Audition [Paris] (IDA), Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Service de cardiologie [CHU HEGP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), The CONSTANCES cohort study was funded by the Caisse Nationale d’Assurance Maladie (CNAM), the Ministry of Health, the Council of the Ile de France Region, and the Cohorts TGIR IReSP-ISP INSERM (Ministère de la santé et des sports, Ministère délégué à la recherche, Institut national de la santé et de la recherche médicale, Institut national du cancer et Caisse nationale de solidarité pour l’autonomie). The CONSTANCES cohort study is an Infrastructure nationale en Biologie et Santé and benefits from a grant from the Agence Nationale de la Recherche (ANR-11-INBS-0002)., and ANR-11-INBS-0002,CONSTANCES,La cohorte CONSTANCES - Infrastructure épidémiologique ouverte pour la recherche et la surveillance(2011)
Subjects: Adult, Male, Adolescent, [SDV]Life Sciences [q-bio], MESH: Deafness, Deafness, MESH: Hearing Aids, Cohort Studies, Young Adult, Hearing Aids, MESH: Cross-Sectional Studies, Prevalence, Humans, [SDV.MHEP.OS]Life Sciences [q-bio]/Human health and pathology/Sensory Organs, Hearing Loss, MESH: Hearing Loss, MESH: Cohort Studies, MESH: Prevalence, Aged, MESH: Adolescent, MESH: Aged, MESH: Humans, MESH: Middle Aged, MESH: Adult, General Medicine, Middle Aged, MESH: Male, Cross-Sectional Studies, MESH: Young Adult, Female, MESH: Female
Abstract: International audience; Importance Although hearing loss is common in the population worldwide, the prevalence of hearing loss and hearing aid use is not known.Objective To estimate the prevalence of hearing loss and hearing aid use in the adult French population.Design, Setting, and Participants This cohort study used data from the CONSTANCES cohort, a representative sample of the French population. Volunteers aged 18 to 75 years were recruited at 21 preventive health centers between January 1, 2012, and December 31, 2019. The present study included participants with audiometric data.Main Outcomes and Measures The main outcomes were prevalence of hearing loss and disabling hearing loss overall and by sex and age group and prevalence of self-reported hearing aid use among those with disabling hearing loss. Hearing loss was defined as a pure-tone average (PTA) in the better ear of 20 dB or higher, and disabling hearing loss was defined as a PTA in the better ear of 35 dB or higher.Results Of 200 870 participants in the CONSTANCES study, 186 460 had full audiometric data and were included in this study (mean [SD] age, 47.1 [13.5] years); 100 330 (53.8%) were female, and 86 130 (46.2%) were male. Of these participants, 24.8% (95% CI, 24.6%-25.0%) had hearing loss and 4.3% (95% CI, 4.2%-4.4%) had disabling hearing loss. The prevalence rates of hearing loss increased from 3.4% (95% CI, 2.8%-3.9%) at age 18 to 25 years to 73.3% (95% CI, 69.5%-77.2%) at age 71 to 75 years among men and from 4.4% (95% CI, 3.9%-5.0%) at age 18 to 25 years to 64.1% (95% CI, 59.7%-68.4%) at age 71 to 75 years among women. The prevalence of disabling hearing loss increased from 0.3% (95% CI, 0.2%-0.4%) among participants aged 18 to 25 years to 23.3% (95% CI, 20.7%-26.0%) among participants aged 71 to 75 years. Among the 8050 participants with disabling hearing loss, 36.8% (95% CI, 35.8%-37.9%) reported using hearing aids, including 56.7% (95% CI, 38.9%-74.4%) aged 18 to 25 years and 32.9% (95% CI, 26.8%-39.2%) aged 71 to 75 years.Conclusions and Relevance In this cohort study, hearing loss was prevalent in France, and the prevalence of hearing loss increased with age among both men and women. Hearing aids were underused, particularly among older individuals. These findings suggest that hearing loss prevention and screening in the French population are needed.
Published: 2022

24. Bladder cancer, inflammageing and microbiomes

Author: Austin Martin, Benjamin L. Woolbright, Shahid Umar, Molly A. Ingersoll, John A. Taylor, University of Kansas Medical Center [Kansas City, KS, USA], Inflammation et immunité des muqueuses - Mucosal Inflammation and Immunity, Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), and This work is funded in part by the Albert Charitable Trust (J.A.T. III), American Urological Association Research Scholar Award (B.L.W.) and National Institutes of Health (R01CA185322 (S.U.)).
Subjects: MESH: Aged, Aging, MESH: Humans, MESH: Immune System, Urology, Microbiota, [SDV.CAN]Life Sciences [q-bio]/Cancer, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, MESH: Gastrointestinal Microbiome, MESH: Urinary Bladder Neoplasms, Gastrointestinal Microbiome, Urinary Bladder Neoplasms, Immune System, MESH: Microbiota, [SDV.IMM]Life Sciences [q-bio]/Immunology, Humans, MESH: Aging, Aged
Abstract: International audience; Ageing is correlated with elevated bladder cancer incidence, morbidity and mortality. Advanced age is also associated with elevated markers of chronic inflammation and perturbations in gut and urinary tract microbiota. One reason for the increased incidence and mortality of bladder cancer in the elderly might be that age-associated changes in multiple microbiomes induce systemic metabolic changes that contribute to immune dysregulation with potentially tumorigenic effects. The gut and urinary microbiomes could be dysregulated in bladder cancer, although the effect of these changes is poorly understood. Each of these domains - the immune system, gut microbiome and urinary microbiome - might also influence the response of patients with bladder cancer to treatment. Improved understanding of age-related alterations to the immune system and gut and urinary microbiomes could provide possible insight into the risk of bladder cancer development and progression in the elderly. In patients with bladder cancer, improved understanding of microbiota might also provide potential targets for therapeutic intervention.
Published: 2022

25. Negative susceptibility vessel sign might be predictive of complete reperfusion in patients with acute basilar artery occlusion managed with thrombectomy

Author: Abdelrady, Mohamed, Derraz, Imad, Lefevre, Pierre-Henri, Cagnazzo, Federico, Gascou, Gregory, Arquizan, Caroline, Gentric, Jean-Christophe, Mourand, Isabelle, Dargazanli, Cyril, Ognard, Julien, Costalat, Vincent, Riquelme, Carlos, Mahmoudi, Mehdi, Corti, Lucas, Gaillard, Nicolas, Cheddad El Aouni, Mourad, Ben Salem, Douraied, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Neuroradiologie [Hôpital Gui de Chauliac], Hôpital Gui de Chauliac [CHU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Laboratoire de Traitement de l'Information Medicale (LaTIM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)-IMT Atlantique (IMT Atlantique), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), LaBoratoire d'Imagerie biOmédicale MultimodAle Paris-Saclay (BIOMAPS), Service Hospitalier Frédéric Joliot (SHFJ), Université Paris-Saclay-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), and Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: MESH: Aged, Ischemic stroke, MESH: Humans, MESH: Arterial Occlusive Diseases, MESH: Endovascular Procedures, [SDV.IB.IMA]Life Sciences [q-bio]/Bioengineering/Imaging, MESH: Brain Ischemia, MESH: Retrospective Studies, [SDV.IB.MN]Life Sciences [q-bio]/Bioengineering/Nuclear medicine, General Medicine, Atherosclerosis, MESH: Male, MESH: Prospective Studies, MESH: Stroke, MESH: Atherosclerosis, MESH: Reperfusion, Magnetic resonance imaging, MESH: Basilar Artery, MESH: Thrombectomy, Radiology, Nuclear Medicine and imaging, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Thrombectomy, MESH: Treatment Outcome
Abstract: International audience; Objectives: Negative susceptibility vessel sign (SVS) on pre-thrombectomy MRI has been linked to fibrin-rich thrombus and difficult retrieval in anterior ischemic stroke. However, its impact in posterior circulation-large vessel occlusion stroke (PC-LVOS) has not yet been elucidated. We aim to investigate the relationship of SVS parameters with stroke subtypes and their influence on angiographic and functional outcomes.Methods: Prospective thrombectomy registries at two-comprehensive stroke centers were retrospectively reviewed between January 2015 and December 2019 for consecutive MRI-selected patients with PC-LVOS. Two groups were assigned by two independent readers, based on the presence or absence of the SVS (SVS +, SVS -) on MRI-GRE sequence. Multivariate logistic regression analysis was utilized to study primarily the impact of the SVS on the rate of complete recanalization (defined as mTICI 2c/3) at the final series following endovascular thrombectomy (EVT) and whether or not it might influence the efficacy of the frontline EVT strategy. Secondarily, we studied whether the absence of the SVS was predictive of the rate of 90-day functional independence (defined as mRS score < 2). Lastly, both qualitative (SVS +, SVS-) and quantitative (SVS length and diameter) parameters of the SVS were analyzed in association with the puncture to recanalization interval and various stroke etiological subtypes based on TOAST criteria.Results: Among 1823 patients, 116 were qualified for final analysis (median age, 68 (59-75) years; male, 65%); SVS was detected in 62.9% (73/116) of cases. SVS length was an independent predictor of procedural duration (p = .01) whilst two-layered SVS was inversely associated with the atherosclerosis etiological subtype (aOR = 0.27, 95% CI 0.08-0.89; p = .03). Successful recanalization was achieved in 82% (60/73) vs. 86% (37/43), p = .80 of patients with SVS (+, -) respectively. Only in SVS (+), stentriever (RR 0.59 (0.4-0.88), p = .009), and contact-aspiration (RR 0.82 (0.7-0.96), p = .01) achieved a lower rate of successful recanalization compared to combined technique. SVS (-) was significantly associated with a higher rate of mTICI 2c/3 (aOR = 4.444; 95% CI 1.466-13.473; p = .008) and showed an indirect effect of 9% towards functional independence mediated by mTICI 2c/3.Conclusion: SVS parameters in PC-LVOS might predict stroke subtype and indirectly influence the functional outcome by virtue of complete recanalization.Key points: • Negative susceptibility vessel sign (SVS) in patients with basilar occlusion independently predict complete recanalization that indirectly instigated a 3-month favorable outcome following thrombectomy. • The longer the SVS, the higher likelihood of large artery atherosclerosis and the longer the thrombectomy procedure. • Two-layered SVS might be negatively associated with the presence of atherosclerosis, yet already-known limitations of TOAST classification and the absence of pathological analysis should be taken into consideration.
Published: 2022

26. MTX optimization or adding bDMARD equally improve disease activity in rheumatoid arthritis: results from the prospective study STRATEGE

Author: Elena Zinovieva, Hélène Herman-Demars, Christophe Hudry, René-Marc Flipo, Cécile Gaujoux-Viala, Salvy-Córdoba, Nathalie, Service de Rhumatologie [CHRU Nîmes], Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Institut Desbrest de santé publique (IDESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), 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), Département Médical [Paris] (Nordic Pharma SAS), Nordic Pharma SAS [Paris], Service de rhumatologie[Lille], and Hôpital Roger Salengro [Lille]-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)
Subjects: rheumatoid arthritis, Male, MESH: Antirheumatic Agents, treat-to-target, Physical function, Arthritis, Rheumatoid, Pharmacology (medical), Prospective Studies, Clinical efficacy, skin and connective tissue diseases, Prospective cohort study, AcademicSubjects/MED00360, MESH: Aged, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Arthritis, Rheumatoid, MESH: Middle Aged, Clinical Science, Middle Aged, MESH: Methotrexate, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Antirheumatic Agents, Rheumatoid arthritis, Drug Therapy, Combination, Female, optimization, management, medicine.drug, musculoskeletal diseases, Adult, medicine.medical_specialty, methotrexate, Disease activity, Rheumatology, Internal medicine, medicine, Humans, Dosing, Aged, MESH: Humans, business.industry, MESH: Adult, medicine.disease, MESH: Male, MESH: Prospective Studies, MESH: Drug Therapy, Combination, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Propensity score matching, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Methotrexate, business, MESH: Female
Abstract: Objectives The STRATEGE (Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis) study aimed to describe treatment strategies in current practice in RA biologic DMARD (bDMARD)-naïve patients with an inadequate response to MTX therapy, and to compare clinical efficacy of the different therapeutic strategies on disease activity after 6 months. Methods The main inclusion criteria of this prospective, observational, multicentre study were confirmed RA diagnosis, treatment by MTX monotherapy and need for therapeutic management modification. Results The 722 patients included had a mean (s.d.) RA duration of 5.3 (6.7) years, a mean DAS28 of 4.0 (1.1); they were all receiving MTX monotherapy, 68% oral, at a mean dose of 15.0 (4.1) mg/week. Two major strategies were identified: (i) MTX monotherapy dose and/or route optimization (72%) and (ii) bDMARD initiation ± MTX (16%). MTX dosing was modified for 70% of patients, maintained (dose and route) for 28% of patients and interrupted for 2%. bDMARDs were started when the MTX mean dose was 17.4 mg/week, 56% parenterally; MTX was maintained concomitantly for 96% of patients. Six-month follow-up results adjusted by propensity score showed that both options were equally successful in improving disease activity and physical function, with 63 and 68% of good-to-moderate EULAR responses, respectively. Conclusion The STRATEGE study shows the importance of initial MTX treatment optimization before initiation of a biological treatment and emphasizes the importance of treat-to-target strategy. Trial registration ClinicalTrials.gov NCT02288520.
Published: 2021

27. Posterior Quadratus Lumborum Block in Total Hip Arthroplasty: A Randomized Controlled Trial

Author: Xavier Capdevila, Sophie Bringuier, Helen Nguyen, Olivier Choquet, Sophia Margareta Brixel, Yassir Aarab, Philippe Biboulet, Fabien Swisser, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Université de Montpellier (UM), Hôpital Lapeyronie [Montpellier] (CHU), Institut des Neurosciences de Montpellier (INM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), and Retiveau, Nolwenn
Subjects: medicine.medical_treatment, Analgesic, MESH: Analgesia, Patient-Controlled, MESH: Analgesics, Opioid, MESH: Anesthetics, Local, MESH: Length of Stay, law.invention, Sufentanil, 03 medical and health sciences, 0302 clinical medicine, MESH: Saline Solution, Randomized controlled trial, 030202 anesthesiology, Interquartile range, law, medicine, MESH: Arthroplasty, Replacement, Hip, MESH: Double-Blind Method, MESH: Pain, Postoperative, MESH: Treatment Outcome, MESH: Aged, MESH: Middle Aged, MESH: Humans, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Ropivacaine, business.industry, Quadratus lumborum muscle, MESH: Nerve Block, Arthroplasty, MESH: Prospective Studies, MESH: Ropivacaine, MESH: Male, MESH: Morphine, Anesthesiology and Pain Medicine, Anesthesia, Morphine, business, MESH: Female, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, 030217 neurology & neurosurgery, medicine.drug
Abstract: BackgroundPain management is important for ensuring early mobilization after hip arthroplasty; however, the optimal components remain controversial. Recently, the quadratus lumborum block has been proposed as an analgesic option. The current study tested the hypothesis that the posterior quadratus lumborum block combined with multimodal analgesia decreases morphine consumption after hip arthroplasty.MethodsThis study was a prospective, randomized, double-blind, placebo-controlled trial. Before general anesthesia, 100 participating patients scheduled for elective total hip arthroplasty were randomly allocated to receive a 30-ml injection posterior to the quadratus lumborum muscle with either 0.33% ropivacaine (n = 50) or normal saline (n = 50). For all patients, multimodal analgesia included systematic administration of acetaminophen, ketoprofen, and a morphine intravenous patient-controlled analgesia. The primary outcome was total intravenous morphine consumption in the first 24 h. Secondary outcomes recorded intraoperative sufentanil consumption; morphine consumption in the postanesthesia care unit; pain scores at extubation and at 2, 6, 12, and 24 h; motor blockade; time to first standing and ambulation; hospital length of stay; and adverse events.ResultsThere was no significant difference in the 24-h total morphine consumption (ropivacaine group, median [interquartile range], 13 [7 to 21] versus saline group, 16 [9 to 21] mg; median difference, −1.5; 95% CI, −5 to 2; P = 0.337). Pain scores were not different between the groups (β = −0.4; 95% CI, −0.9 to 0.2; P = 0.199). There was no statistical difference between the two groups in intraoperative sufentanil consumption, morphine consumption in the postanesthesia care unit, motor blockade, times to first standing (median difference, 0.83 h; 95% CI, −1.7 to 3.4; P = 0.690) and ambulation (median difference, −1.85 h; 95% CI, −4.5 to 0.8; P = 0.173), hospital length of stay, and adverse events.ConclusionsAfter elective hip arthroplasty, neither morphine consumption nor pain scores were reduced by the addition of a posterior quadratus lumborum block to a multimodal analgesia regimen.Editor’s PerspectiveWhat We Already Know about This TopicWhat This Article Tells Us That Is New
Published: 2021

28. Five‐Year Lower Extremity Function is Associated with White Matter Abnormality in Older Adults

Author: Bruno Vellas, Jean-François Mangin, Philipe de Souto Barreto, Kelly Virecoulon Giudici, Audrey Gabelle, Lisa Perus, Yves Rolland, Lingxiao He, Institut du Vieillissement, Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Université de Toulouse (UT), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Neuropsychiatrie : recherche épidémiologique et clinique (PSNREC), Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Université de Montpellier (UM), CEA- Saclay (CEA), and Commissariat à l'énergie atomique et aux énergies alternatives (CEA)
Subjects: Male, Internal capsule, [SDV]Life Sciences [q-bio], MESH: Lower Extremity, Corpus callosum, Activities of Daily Living, Cingulum (brain), Correlation of Data, older adults, MESH: Aged, MESH: Correlation of Data, Physical Functional Performance, White Matter, Diffusion Tensor Imaging, medicine.anatomical_structure, Lower Extremity, Disease Progression, symbols, MESH: Disease Progression, Female, MESH: Diffusion Tensor Imaging, medicine.medical_specialty, MESH: Physical Functional Performance, Uncinate fasciculus, lower extremity function, MESH: Walking Speed, White matter, symbols.namesake, Physical medicine and rehabilitation, MESH: Mobility Limitation, Connectome, medicine, Humans, Mobility Limitation, MESH: Connectome, Aged, MESH: Humans, business.industry, MESH: Activities of Daily Living, MESH: Male, Walking Speed, Bonferroni correction, MESH: Nerve Net, MESH: White Matter, Cerebellar peduncle, Nerve Net, Geriatrics and Gerontology, business, MESH: Female, Diffusion MRI
Abstract: International audience; Objective: To explore associations between changes of lower extremity function (LEF) parameters over a 5-year period and diffusion tensor imaging (DTI) parameters of white matter tracts among community-dwelling older adults.Design: A secondary analysis on image and physical function data collected from the Multidomain Alzheimer's Preventive Trial (MAPT).Participants: 208 older adults (aged 75 ± 4 years, with spontaneous memory complaint or limited instrumental daily living activity or slow gait speed, 60% female) of the MAPT-magnetic resonance imaging (MRI) ancillary study. The time interval between a participant's enrolment and MRI scan was on average 110 ± 97 days.Measurements: Forty-eight white matter tracts (WMTs) were measured. LEF parameters (measured after the MRI scan) were assessed as the short physical performance battery (SPPB) score, gait speed, and chair stands time over a 5-year period. Mixed-effects models were performed to explore the associations between baseline DTI values and the progression of LEF parameters. Bonferroni correction was applied for multiple comparison correction.Results: The progression of LEF was associated with 35 baseline DTI parameters from 24 WMTs. Higher baseline DTI parameter values were related to more decreases in SPPB score and gait speed, and greater increases in chair stands time. Bilateral uncinate fasciculus was associated with all LEF parameters. Other WMTs in cingulum, cerebral and cerebellar peduncle, internal capsule, and corpus callosum also showed close connections with LEF changes.Conclusions: Our findings show that DTI parameters of some WMTs are associated with the 5-year decline in LEF, suggesting that alterations in WMT integrity (evaluated by DTI parameters) might be used to explore potential causes of impaired mobility in older adults when no clear explanations can be found.
Published: 2021

29. Patient-safety incidents during COVID-19 health crisis in France: An exploratory sequential multi-method study in primary care

Author: Fournier, Jean-Pascal, Amélineau, Jean-Baptiste, Hild, Sandrine, Nguyen-Soenen, Jérôme, Daviot, Anaïs, Simonneau, Benoit, Bowie, Paul, Erghf, C, Donaldson, Liam, Carson-Stevens, Andrew, Département de médecine générale [Université de Nantes - UFR de Médecine et des Techniques Médicales], Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), and Université de Nantes (UN)-Université de Nantes (UN)
Subjects: Male, Medicine (General), Delayed Diagnosis, Service delivery framework, 030204 cardiovascular system & hematology, lockdown, MESH: Infection Control, MESH: Aged, 80 and over, 0302 clinical medicine, Surveys and Questionnaires, MESH: Child, SAFER, patient safety incident, Pandemic, MESH: COVID-19, Medicine, MESH: Incidence, 030212 general & internal medicine, Young adult, Child, Referral and Consultation, Aged, 80 and over, MESH: Aged, MESH: Middle Aged, Communication, Incidence, Middle Aged, MESH: Infant, 3. Good health, covid-19, MESH: Young Adult, MESH: Patient Safety, Child, Preschool, Female, Original Article, MESH: Communication, France, Patient Safety, Medical emergency, Family Practice, Research Article, Adult, Adolescent, Coronavirus disease 2019 (COVID-19), Primary care, MESH: Primary Health Care, Young Adult, MESH: Referral and Consultation, 03 medical and health sciences, Patient safety, primary care, R5-920, Humans, MESH: Surveys and Questionnaires, Aged, MESH: Adolescent, Infection Control, MESH: Humans, Primary Health Care, business.industry, MESH: Child, Preschool, Infant, MESH: Adult, medicine.disease, MESH: Male, MESH: France, MESH: Delayed Diagnosis, Harm, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, MESH: Female
Abstract: Background\ud \ud The COVID-19 pandemic has resulted in the rapid reorganisation of health and social care services. Patients are already at significant risk of healthcare-associated harm and the wholesale disruption to service delivery during the pandemic stood to heighten those risks.\ud Objectives\ud \ud We explored the type and nature of patient safety incidents in French primary care settings during the COVID-19 first wave to make tentative recommendations for improvement.\ud Methods\ud \ud A national patient safety incident reporting survey was distributed to General Practitioners (GPs) in France on 28 April 2020. Reports were coded using a classification system aligned to the WHO International Classification for Patient Safety (incident types, contributing factors, incident outcomes and severity of harm). Analysis involved data coding, processing, iterative generation of data summaries using descriptive statistical analysis. Clinicaltrials.gov: NCT04346121.\ud Results\ud \ud Of 132 incidents, 58 (44%) related to delayed diagnosis, assessments and referrals. Cancellations of appointments, hospitalisations or procedures was reported in 22 (17%) of these incidents. Home confinement-related incidents accounted for 13 (10%) reports and inappropriate medication stopping for five (4%). Patients delayed attending or did not consult their general practitioner or other healthcare providers due to their fear of contracting COVID-19 infection at an in-person visit in 26 (10%) incidents or fear of burdening their GPs in eight (3%) incidents.\ud Conclusion\ud \ud Constraints from the first wave of the COVID-19 pandemic have contributed to patient safety incidents during non-COVID-19 care. Lessons from these incidents pinpoint where primary care services in France can focus resources to design safer systems for patients.
Published: 2021

30. Small Steatotic HCC: A Radiological Variant Associated With Improved Outcome After Ablation

Author: Eric Assenat, Chloé Guillot, Margaux Hermida, Astrid Herrero, Christophe Cassinotto, Georges-Philippe Pageaux, Fabrizio Panaro, Ancelin Preel, Boris Guiu, Lauranne Piron, José Ursic-Bedoya, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Université de Montpellier (UM), Institut de Génétique Moléculaire de Montpellier (IGMM), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Institut Desbrest de santé publique (IDESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), and Retiveau, Nolwenn
Subjects: Male, Percutaneous, Cirrhosis, [SDV.MHEP.CHI] Life Sciences [q-bio]/Human health and pathology/Surgery, medicine.medical_treatment, Gastroenterology, MESH: Magnetic Resonance Imaging, Liver disease, MESH: Liver Neoplasms, Neoplasm Metastasis, MESH: Carcinoma, Hepatocellular, MESH: Treatment Outcome, MESH: Aged, MESH: Middle Aged, medicine.diagnostic_test, Liver Neoplasms, Hazard ratio, MESH: Follow-Up Studies, Middle Aged, Ablation, Magnetic Resonance Imaging, Treatment Outcome, Hepatocellular carcinoma, Catheter Ablation, Original Article, Female, MESH: Neoplasm Recurrence, Local, medicine.medical_specialty, Carcinoma, Hepatocellular, [SDV.CAN]Life Sciences [q-bio]/Cancer, [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery, Disease-Free Survival, [SDV.CAN] Life Sciences [q-bio]/Cancer, Internal medicine, medicine, Humans, Clinical significance, lcsh:RC799-869, Aged, Retrospective Studies, MESH: Humans, MESH: Catheter Ablation, Hepatology, business.industry, MESH: Retrospective Studies, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Magnetic resonance imaging, Original Articles, medicine.disease, MESH: Neoplasm Metastasis, MESH: Male, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, digestive system diseases, MESH: Disease-Free Survival, lcsh:Diseases of the digestive system. Gastroenterology, Neoplasm Recurrence, Local, business, MESH: Female, Follow-Up Studies
Abstract: Percutaneous thermal ablation is a validated treatment option for small hepatocellular carcinoma (HCC). Steatotic HCC can be reliably detected by magnetic resonance imaging. To determine the clinical relevance of this radiological variant, we included 235 patients (cirrhosis in 92.3%, classified Child‐Pugh A in 97%) from a prospective database on percutaneous thermal ablation for 100 ng/mL (P = 0.045), and multifocality (P = 0.015). During the follow‐up (median: 28.3 months), overall mortality (3.8% vs. 23.5%; P = 0.001) and HCC‐specific mortality (0.0% vs. 14.2%; P = 0.002) rates were lower in patients with steatotic HCC. Early (, Small steatotic HCC is reliably detected by MRI and is associated with slightly less advanced liver disease and a less aggressive tumor phenotype. PTA of such radiological HCC variant results in low rate of early recurrence and HCC‐related deaths, longer time‐to‐recurrence, longer recurrence‐free and overall survivals.
Published: 2020

31. Drug induced stuttering: pharmacovigilance data

Author: Aurore Morel, Brahim Azzouz, Thierry Trenque, Agathe Trenque, Vieillissement, Fragilité (VIEFRA - EA 3797), and Université de Reims Champagne-Ardenne (URCA)
Subjects: Male, Speech production, Databases, Factual, stuttering, MESH: Pharmacovigilance, 030204 cardiovascular system & hematology, Audiology, 0302 clinical medicine, Medicine, Pharmacology (medical), media_common, MESH: Aged, MESH: Middle Aged, drug, General Medicine, Middle Aged, MESH: Drug-Related Side Effects and Adverse Reactions, 3. Good health, Vigibase, data, MESH: Young Adult, 030220 oncology & carcinogenesis, Female, medicine.symptom, Adult, Adverse event, Drug, medicine.medical_specialty, Stuttering, Adolescent, Drug-Related Side Effects and Adverse Reactions, media_common.quotation_subject, Young Adult, 03 medical and health sciences, Fluency, Pharmacovigilance, otorhinolaryngologic diseases, Adverse Drug Reaction Reporting Systems, Humans, Adverse effect, Aged, MESH: Adolescent, MESH: Humans, business.industry, MESH: Adverse Drug Reaction Reporting Systems, MESH: Adult, MESH: Stuttering, MESH: Databases, Factual, MESH: Male, nervous system diseases, pharmacovigilance, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Speech disorder, business, MESH: Female
Abstract: International audience; Background: Stuttering is a speech disorder characterized by poor fluency of speech despite the speech production organs being normal. Numerous factors contribute to stuttering, and it may also be an iatrogenic effect of certain drugs. The aim of this study was to investigate the association between stuttering and drug exposure.Research design and methods: We investigated the association between drugs and stuttering. We analyzed reports in the World Health Organization global individual case safety reports database (Vigibase) up to 31 May 2020 with the MedDRA lower level terms 'stutter' and 'stuttering.' The association between a drug and the occurrence of the adverse drug reaction was estimated by disproportionality analysis. Reporting odds ratios (ROR) were calculated with 95% confidence intervals.Results: In total, 724 notifications were identified using the MedDRA terms selected. The main drugs implicated were methylphenidate (ROR = 19.58; 95% CI: 13.3-28.8), topiramate (ROR = 12.5; 95% CI: 7.1-22.1), olanzapine (ROR = 12; 95% CI: 8-17.9) and golimumab (ROR = 10.2; 95% CI: 5.5-19.1).Conclusions: When stuttering occurs in a patient treated by drugs affecting neurotransmission, a drug-induced origin of the stutter should be considered.
Published: 2020

32. Sphincter‐saving surgery for ultra‐low rectal carcinoma initially indicated for abdominoperineal resection: Is it safe on a long‐term follow‐up?

Author: C. Lemanski, Denis Pezet, Philippe Rouanet, François Dravet, Eric Rullier, Marc Pocard, Jean Luc Faucheron, Sophie Gourgou, Merhdad Jafari, Laurent Mineur, Jean Michel Fabre, Jacques Balosso, Bernard Lelong, Christophe Taoum, Laurent Bresler, Michel Rivoire, Institut du Cancer de Montpellier (ICM), Centre Léon Bérard [Lyon], Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), CHU Bordeaux [Bordeaux], Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Institut Sainte Catherine [Avignon], Service de Chirurgie d'Oncologie Digestive [CHU Lariboisière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Universitaire [Grenoble] (CHU), Centre René Gauducheau, CRLCC René Gauducheau, CHU Clermont-Ferrand, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), and Centre Hospitalier Universitaire de Nancy (CHU Nancy)
Subjects: Male, [SDV]Life Sciences [q-bio], Anal Canal, law.invention, MESH: Aged, 80 and over, 0302 clinical medicine, Randomized controlled trial, intersphincteric resection, law, Prospective Studies, MESH: Aged, Aged, 80 and over, MESH: Middle Aged, Proctectomy, Abdominoperineal resection, MESH: Anal Canal, MESH: Follow-Up Studies, General Medicine, Middle Aged, Prognosis, neoadjuvant radiotherapy, Oncology, 030220 oncology & carcinogenesis, Female, 030211 gastroenterology & hepatology, Adult, medicine.medical_specialty, Randomization, Long term follow up, Adenocarcinoma, MESH: Prognosis, 03 medical and health sciences, Rectal carcinoma, Overall survival, medicine, Humans, ultra low rectal carcinoma, Aged, MESH: Humans, MESH: Organ Sparing Treatments, Rectal Neoplasms, business.industry, MESH: Proctectomy, MESH: Adenocarcinoma, MESH: Rectal Neoplasms, MESH: Adult, sphincter saving surgery, Intersphincteric resection, MESH: Male, MESH: Prospective Studies, Surgery, Sphincter saving surgery, business, MESH: Female, Organ Sparing Treatments, Follow-Up Studies
Abstract: International audience; Background: Rate of abdominoperineal resection (APR) varies from countries and surgeons. Surgical impact of preoperative treatment for ultra-low rectal carcinoma (ULRC) initially indicated for APR is debated. We report the 10-year oncological results from a prospective controlled trial (GRECCAR 1) which evaluate the sphincter saving surgery (SSR).Methods: ULRC indicated for APR were included (n = 207). Randomization was between high-dose radiation (HDR, 45 + 18 Gy) and radiochemotherapy (RCT, 45 Gy + 5FU infusion). Surgical decision was based on tumour volume regression at surgery. SSR technique was standardized as mucosectomy (M) or partial (PISR)/complete (CISR) intersphincteric resection.Results: Overall SSR rate was 85% (72% ISR), postoperative morbidity 27%, with no mortality. There were no significant differences between the HDR and RCT groups: 10-year overall survival (OS10) 70.1% versus 69.4%, respectively, 10.2% local recurrence (9.2%/14.5%) and 27.6% metastases (32.4%/27.7%). OS and disease-free survival were significantly longer for SSR (72.2% and 60.1%, respectively) versus APR (54.7% and 38.3%). No difference in OS10 between surgical approaches (M 78.9%, PISR 75.5%, CISR 65.5%) or tumour location (low 64.8%, ultralow 76.7%).Conclusion: GRECCAR 1 demonstrates the feasibility of safely changing an initial APR indication into an SSR procedure according to the preoperative treatment tumour response. Long-term oncologic follow-up validates this attitude.
Published: 2020

33. Modifying macrophages at the periphery has the capacity to change microglial reactivity and to extend ALS survival

Author: Matthieu Ribon, Lorenzo Schiaffino, Christian S Lobsiger, Michel Mallat, Pierre de la Grange, Félix Berriat, Danielle Seilhean, Delphine Bohl, Charlène Iltis, Séverine Boillée, Aude Chiot, Sakina Zaïdi, Ariane Jolly, Stéphanie Millecamps, 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), Università degli studi di Verona = University of Verona (UNIVR), GenoSplice [Paris], Département de Neuropathologie, APHP, Hôpital Pitié-Salpêtrière, Paris, France., and CHIOT, Aude
Subjects: 0301 basic medicine, Therapeutic gene modulation, MESH: Axons, Myeloid, MESH: Mice, Transgenic, [SDV]Life Sciences [q-bio], Cell, Proinflammatory cytokine, MESH: Spinal Cord, 03 medical and health sciences, 0302 clinical medicine, MESH: Mice, Inbred C57BL, medicine, MESH: Animals, Amyotrophic lateral sclerosis, MESH: Amyotrophic Lateral Sclerosis, MESH: Aged, MESH: Middle Aged, MESH: Humans, Microglia, Chemistry, General Neuroscience, Neurodegeneration, MESH: Macrophages, MESH: Adult, medicine.disease, MESH: Male, Cell biology, MESH: Microglia, [SDV] Life Sciences [q-bio], MESH: Sciatic Nerve, 030104 developmental biology, medicine.anatomical_structure, Sciatic nerve, MESH: Female, Neuroscience, MESH: Motor Neurons, 030217 neurology & neurosurgery
Abstract: International audience; Microglia and peripheral macrophages have both been implicated in amyotrophic lateral sclerosis (ALS), although their respective roles have yet to be determined. We now show that macrophages along peripheral motor neuron axons in mouse models and patients with ALS react to neurodegeneration. In ALS mice, peripheral myeloid cell infiltration into the spinal cord was limited and depended on disease duration. Targeted gene modulation of the reactive oxygen species pathway in peripheral myeloid cells of ALS mice, using cell replacement, reduced both peripheral macrophage and microglial activation, delayed symptoms and increased survival. Transcriptomics revealed that sciatic nerve macrophages and microglia reacted differently to neurodegeneration, with abrupt temporal changes in macrophages and progressive, unidirectional activation in microglia. Modifying peripheral macrophages suppressed proinflammatory microglial responses, with a shift toward neuronal support. Thus, modifying macrophages at the periphery has the capacity to influence disease progression and may be of therapeutic value for ALS.
Published: 2020

34. Atypical clinical presentation of COVID-19 infection in residents of a long-term care facility

Author: Mylène Albrand, Stéphanie Miot, Jean Bousquet, Nadia Giacosa, Yves Rolland, Hubert Blain, Athanase Benetos, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Gérontopôle, Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse], Défaillance Cardiovasculaire Aiguë et Chronique (DCAC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Service de Gériatrie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Berlin Institute of Health (BIH), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Humboldt-Universität zu Berlin, Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Humboldt University Of Berlin, and Herrada, Anthony
Subjects: Male, Pediatrics, Delayed Diagnosis, rRT-PCR, Testing for SARS-CoV-2, Disease, Polymerase Chain Reaction, Hypoxemia, MESH: Long-Term Care, MESH: Aged, 80 and over, 0302 clinical medicine, MESH: COVID-19, Medicine, Infection control, MESH: Skilled Nursing Facilities, 030212 general & internal medicine, MESH: Aged, Aged, 80 and over, [SDV.MHEP.GEG] Life Sciences [q-bio]/Human health and pathology/Geriatry and gerontology, [SDV.MHEP.GEG]Life Sciences [q-bio]/Human health and pathology/Geriatry and gerontology, Brief Report, MESH: Accidental Falls, 3. Good health, MESH: Diarrhea, Diarrhea, COVID-19 Nucleic Acid Testing, Female, medicine.symptom, Presentation (obstetrics), Long-term-care facility, MESH: Pandemics, medicine.medical_specialty, Health Personnel, Asymptomatic, MESH: COVID-19 Nucleic Acid Testing, 03 medical and health sciences, Humans, MESH: SARS-CoV-2, Pandemics, Aged, Skilled Nursing Facilities, MESH: Humans, 030214 geriatrics, SARS-CoV-2, business.industry, COVID-19, MESH: Polymerase Chain Reaction, Long-Term Care, MESH: Male, MESH: Delayed Diagnosis, Long-term care, MESH: Health Personnel, Delirium, Accidental Falls, business, MESH: Female
Abstract: Key summary points Aim To assess the magnitude of the infection in residents from—and staff working in—a long-term-care facility (LTCF) 7 days after the identification of one resident with confirmed COVID-19 infection and the clinical presentation of the infected residents. Findings Two weeks after the first case, 50.9% of residents and 27.5% of the workers were tested positive for SARS-CoV-2. Diarrhea, fall, delirium, and hypothermia can be initial symptoms of COVID-19 in LTCF residents. Message The rapid dissemination of a COVID-19 infection in a LTCF may be due to a delay in the diagnosis of the first case, whose presentation could be atypical in residents., Purpose To assess the magnitude of the infection in residents from—and staff working in—a long-term-care facility (LTCF) 7 days after the identification of one resident with confirmed COVID-19 infection and to assess the clinical presentation of the infected residents. Methods All residents and staff members of a LTCF were tested for SARS-CoV-2 by real-time reverse-transcriptase polymerase chain reaction on nasopharyngeal swab. Residents were studied clinically 4 weeks after the first COVID diagnosis. Results Thirty-eight of the 79 residents (48.1%) tested positive for SARS-CoV-2. Respiratory symptoms were preceded by diarrhea (26.3%), a fall (18.4%), fluctuating temperature with hypothermia (34.2%) and delirium in one resident. Respiratory symptoms, including cough and oxygen desaturation, appeared after those initial symptoms or as the first sign in 36.8% and 52.2%, respectively. At any time of the disease, fever was observed in 65.8%. Twelve deaths occurred among the COVID-19 residents. Among the 41 residents negative for SARS-CoV-2, symptoms included cough (21.9%), diarrhea (7.3%), fever (21.9%), hypothermia (9.7%), and transient hypoxemia (9.8%). No deaths were observed in this group. 27.5% of the workers were also COVID-19 positive. Conclusion The rapid dissemination of the COVID-19 infection may be explained by the delay in the diagnosis of the first cases due to atypical presentation. Early recognition of symptoms compatible with COVID-19 may help to diagnose COVID-19 residents earlier and test for SARS-CoV-2 symptomatic and asymptomatic staff and residents earlier to implement appropriate infection control practices.
Published: 2020

35. Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non–small cell lung cancer: IFCT-1201 MODEL trial

Author: Didier Debieuvre, Pierre-Jean Souquet, Jean-Louis Pujol, Jérôme Dauba, Jeannick Madelaine, Olivier Molinier, J. Otto, Jacques Le Treut, Fabrice Barlesi, Elisabeth Quoix, Patrick Aldo Renault, Eric Pichon, Alexandra Langlais, Virginie Westeel, L. Moreau, Franck Morin, Jacques Margery, Clarisse Audigier-Valette, Armelle Lavolé, Patrick Dumont, Denis Moro-Sibilot, CHU Strasbourg, Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer - Hôpital Sainte-Musse, CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Le Mans (CH Le Mans), Service de Pneumologie, oncologie thoracique et allergologie respiratoire [CHRU Besançon], 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), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier du Pays d'Aix, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Layné, Université Côte d'Azur (UCA), Hôpital pasteur [Colmar], Service de pneumologie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier de Chauny, Partenaires INRAE, Hôpital d'instruction des Armées Percy, Service de Santé des Armées, Groupe hospitalier de la région de Mulhouse Sud-Alsace (GHRMSA), Centre hospitalier de Pau, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Intergroupe Francophone de Cancérologie Thoracique [Paris] (IFCT), Intergroupe Francophone de Cancérologie thoracique, CHU Grenoble, Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Service de Pneumologie - Oncologie Thoracique - Maladies Pulmonaires Rares [CHU Tenon], 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)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Aix Marseille Université (AMU), and Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)
Subjects: Male, 0301 basic medicine, Oncology, Cancer Research, Lung Neoplasms, Time Factors, medicine.medical_treatment, NSCLC, Deoxycytidine, Carboplatin, chemistry.chemical_compound, Elderly, MESH: Aged, 80 and over, 0302 clinical medicine, Maintenance therapy, MESH: Progression-Free Survival, MESH: Carboplatin, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, Aged, 80 and over, MESH: Aged, MESH: Antimetabolites, Antineoplastic, Drug Substitution, Age Factors, MESH: Neoplasm Staging, Progression-Free Survival, 3. Good health, MESH: Maintenance Chemotherapy, MESH: Antineoplastic Combined Chemotherapy Protocols, Pemetrexed, 030220 oncology & carcinogenesis, Disease Progression, Female, MESH: Disease Progression, France, medicine.drug, Antimetabolites, Antineoplastic, medicine.medical_specialty, Paclitaxel, Maintenance, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH: Drug Administration Schedule, Drug Administration Schedule, Maintenance Chemotherapy, 03 medical and health sciences, Internal medicine, medicine, Carcinoma, Humans, Chemotherapy, MESH: Paclitaxel, MESH: Pemetrexed, Lung cancer, Aged, Neoplasm Staging, MESH: Age Factors, MESH: Humans, Performance status, business.industry, MESH: Time Factors, MESH: Deoxycytidine, medicine.disease, Gemcitabine, MESH: Drug Substitution, MESH: Male, MESH: Lung Neoplasms, MESH: France, 030104 developmental biology, chemistry, business, MESH: Female, MESH: Carcinoma, Non-Small-Cell Lung
Abstract: International audience; Purpose: Maintenance chemotherapy is a reasonable choice for patients with metastatic non-small cell lung carcinoma (NSCLC) not progressing after induction therapy with a platinum-based doublet. Nevertheless, there have been no studies dedicated to elderly patients.Patients and methods: We conducted a randomised trial in patients aged 70-89 years, with advanced NSCLC (with neither EGFR mutation nor ALK rearrangement), who had not progressed after four cycles of monthly carboplatin and weekly paclitaxel in order to compare maintenance with either pemetrexed (500 mg/m2 d1, 22) in patients with non-squamous cell carcinoma or gemcitabine (1,150 mg/m2 d1, 8, 22) in squamous cell carcinoma to simple observation. The patients were required to have a performance status (PS) 0-2, mini-mental score >23, and creatinine clearance ≥45 mL/min. The primary end-point was overall survival (OS).Results: 632 patients were enrolled from May 2013 to October 2016. Of the 328 (52.3%) patients randomised after induction therapy, 166 patients were assigned to the observation arm, versus 162 to the switch maintenance arm, 119 of whom received pemetrexed and 43 gemcitabine. The median OS from randomisation was 14.1 months (95% confidence interval [CI]: 12.0-17.0) in the observation arm and 14 months (95% CI: 10.9-16.9) in the maintenance arm (p = 0.72). The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6-3.1) in the observation arm versus 5.7 months (95% CI: 4.8-7.1) in the maintenance arm (p < 0.001).Conclusion: Switch maintenance therapy significantly prolonged PFS but not OS and, thus, should not be proposed to elderly patients with advanced NSCLC.
Published: 2020

36. Health Literacy and Clinical Trial Participation in French Cancer Patients: A National Survey

Author: Ousseine, Youssoufa, Bouhnik, Anne-Déborah, Mancini, Julien, Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Direction santé environnement travail - Santé Publique France, Santé publique France - French National Public Health Agency [Saint-Maurice, France], Biostatistique et technologies de l'information et de la communication (BioSTIC) - [Hôpital de la Timone - APHM] (BiosTIC ), and Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE)
Subjects: MESH: Aged, Adult, MESH: Humans, MESH: Middle Aged, [SDV]Life Sciences [q-bio], MESH: Adult, Middle Aged, MESH: Health Literacy, Health Literacy, VICAN survey, clinical trial participation, Neoplasms, Surveys and Questionnaires, cancer, Humans, MESH: Neoplasms, France, MESH: Surveys and Questionnaires, Aged
Abstract: Few studies have explored the relationship between health literacy (HL) and trial participation. In this context, we aimed to study this relationship in French cancer patients. We used data from the French national VIe après le CANcer (VICAN) survey. Two questionnaire items focused on previous invitations to participate in clinical trials and subsequent enrollment. The Single Item Literacy Screener was used to measure functional HL. In total, 1954 cancer patients responded to both VICAN surveys (two and five years after diagnosis). Mean age was 54.1 ± 12.7 years at diagnosis, and 37.6% were classified as having limited HL. One in ten (10.3%) respondents reported having been previously invited to participate in a clinical trial. Of these, 75.5% had enrolled. Limited HL was associated with fewer trial invitations but not with enrollment once invited. Multivariate analysis confirmed the negative effect of limited HL on clinical trial invitation (adjOR = 0.55 (0.39 to 0.77), p < 0.001) after adjustment for multiple characteristics. Patients with limited HL received fewer invitations to participate in trials but were likely to enroll when asked. Addressing HL is necessary to create a more inclusive health system and to reduce inequalities not only in access to innovative cancer care, but to health inequalities in general.
Published: 2022

37. Association between growth of the SARS-CoV-2 epidemic and increased coughing rate in cold temperatures: surveillance in Hokkaido, Japan

Author: Shinako Inaida, Richard Paul, Graduate School of Medicine and Faculty of Medicine Kyoto University, and Institut Pasteur [Paris] (IP)
Subjects: MESH: Aged, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, MESH: Humans, SARS-CoV-2, MESH: Cold Temperature, public health, COVID-19, General Medicine, infectious diseases, infection control, Cold Temperature, Cough, Japan, MESH: Cough, Humans, MESH: COVID-19, epidemiology, MESH: SARS-CoV-2, Aged, MESH: Japan
Abstract: ObjectiveAlthough the transmissibility of SARS-CoV-2 in winter is thought to increase through viral droplets when coughing, current epidemiological data in this regard are limited.SettingUsing the national epidemiological surveillance data in the autumn and winter seasons in Hokkaido, Japan, between February 2020 and February 2021, we analysed the relationship between case increase ratio and prevalence rate of coughing in patients with PCR-confirmed SARS-CoV-2 in two age groups (0—40s and 50—100s) with concomitant air temperature and humidity.ParticipantsThe 7893 cases of symptomatic PCR-positive patients consisted of 5361 cases in the young age group and 2532 cases in the older age group.Primary and secondary outcome measuresPearson’s correlation analysis and regression models were used to assess the relationships. Sex-adjusted OR of having cough in the young and old age groups in the autumn and winter seasons was calculated using logistic regression analysis.ResultsThe monthly prevalence rate of coughing in the young age group was negatively correlated with temperature (r=−0.77, pConclusionsThe results suggest increased rate of coughing contributes to the epidemic of SARS-CoV-2 in the winter. An effective control with a focus on these trends should be considered.
Published: 2022

38. In-hospital and midterm out-hospital complications of adults hospitalised with respiratory syncytial virus infection in France, 2017-2019: an observational study

Author: Alexandre Descamps, Nadhira Fidouh, Anne-Sophie L’Honneur, Bruno Lina, N. Lenzi, Gisèle Lagathu, Odile Launay, Corinne Merle, Fabrice Carrat, Z. Lesieur, F. Galtier, Selilah Amour, Paul Loubet, Xavier Duval, Vincent Foulongne, Philippe Vanhems, Fabrice Lainé, CIC Cochin Pasteur (CIC 1417), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu-Groupe hospitalier Broca-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), F-CRIN, Innovative clinical research network in vaccinology (I-REIVAC), CIC Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Saint Eloi (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hospices Civils de Lyon (HCL), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Pathogenesis and Control of Chronic and Emerging Infections (PCCEI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université des Antilles (UA)-Etablissement français du don du sang [Montpellier]-Université de Montpellier (UM), Centre d'investigation Clinique [CHU Bichat] - Épidémiologie clinique (CIC 1425), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-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), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Virulence Bactérienne et Infections Chroniques (VBIC), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université de Paris (UP)-Groupe hospitalier Broca-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-CHU Saint-Eloi-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre International de Recherche en Infectiologie - UMR (CIRI), Institut National de la Santé et de la Recherche Médicale (INSERM)-École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS), CHU Montpellier, Jonchère, Laurent, École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), and Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Adult, Pulmonary and Respiratory Medicine, medicine.medical_specialty, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Aftercare, Respiratory Syncytial Virus Infections, MESH: Hospitalization, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Virus, law.invention, 03 medical and health sciences, symbols.namesake, MESH: Aftercare, MESH: Respiratory Syncytial Virus Infections, 0302 clinical medicine, law, Internal medicine, Influenza, Human, Humans, Medicine, Hospital Mortality, 030212 general & internal medicine, Poisson regression, MESH: Hospital Mortality, Respiratory system, Aged, Mechanical ventilation, MESH: Aged, MESH: Humans, business.industry, MESH: Influenza, Human, MESH: Patient Discharge, virus diseases, MESH: Adult, MESH: Hospitals, Intensive care unit, Hospitals, Patient Discharge, Confidence interval, 3. Good health, [SDV] Life Sciences [q-bio], Hospitalization, 030228 respiratory system, symbols, [SDV.MHEP.PSR] Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Observational study, Complication, business
Abstract: ObjectivesThe purpose of this study was to describe the clinical characteristics and in-hospital and post-discharge outcomes of respiratory syncytial virus (RSV) infection among adults hospitalised with influenza-like illness (ILI) and compared against patients admitted for influenza.MethodsAdults hospitalised with ILI were prospectively included from five French university hospitals over two consecutive winter seasons (2017/2018 and 2018/2019). RSV and influenza virus were detected by multiplex reverse transcription PCR on nasopharyngeal swabs. RSV-positive patients were compared to RSV-negative and influenza-positive hospitalised patients. Poisson regression models were used to estimate the adjusted prevalence ratio (aPR) associated with in-hospital and post-discharge outcomes between RSV and influenza infections. The in-hospital outcome was a composite of the occurrence of at least one complication, length of stay ≥7 days, intensive care unit admission, use of mechanical ventilation and in-hospital death. Post-discharge outcome included 30- and 90-day all-cause mortality and 90-day readmission rates.ResultsOverall, 1428 hospitalised adults with ILI were included. RSV was detected in 8% (114 of 1428) and influenza virus in 31% (437 of 1428). Patients hospitalised with RSV were older than those with influenza (mean age 73.0 versus 68.8 years, p=0.015) with a higher frequency of chronic respiratory or cardiac disease (52% versus 39%, p=0.012, and 52% versus 41%, p=0.039, respectively) and longer hospitalisation duration (median stay 8 versus 6 days, pversus 66%, pConclusionRSV infection results in serious respiratory illness, with worse in-hospital outcomes than influenza and with similar midterm post-discharge outcomes.
Published: 2022

39. Combination of Trastuzumab, Pertuzumab, and Docetaxel in Patients With Advanced Non–Small-Cell Lung Cancer Harboring HER2 Mutations: Results From the IFCT-1703 R2D2 Trial

Author: Julien Mazieres, Claire Lafitte, Charles Ricordel, Laurent Greillier, Elodie Negre, Gérard Zalcman, Charlotte Domblides, Jeannick Madelaine, Jaafar Bennouna, Céline Mascaux, Denis Moro-Sibilot, François Pinquie, Alexis B. Cortot, Josiane Otto, Jacques Cadranel, Alexandra Langlais, Franck Morin, Virginie Westeel, Benjamin Besse, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Services de Pneumologie, Exploration Fonctionnelle Respiratoire et Cardiologie (Hôpital Louis Pradel), Hospices Civils de Lyon (HCL), Oncogenesis, Stress, Signaling (OSS), Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CRLCC Eugène Marquis (CRLCC), Méthodes computationnelles pour la prise en charge thérapeutique en oncologie : Optimisation des stratégies par modélisation mécaniste et statistique (COMPO), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Multidisciplinary Oncology and Therapeutic Innovations Unit, Hôpital Nord [CHU - APHM], Thèses d'exercice et mémoires - UFR de Médecine Montpellier-Nîmes, Université de Montpellier (UM), Service d’oncologie thoracique et essais précoces [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), CHU Bordeaux [Bordeaux], Immunology from Concept and Experiments to Translation (ImmunoConcept), Université de Bordeaux (UB)-Centre National de la Recherche Scientifique (CNRS), Service de pneumologie [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), Hôpital Foch [Suresnes], Service de Pneumologie [Strasbourg], Université de Strasbourg (UNISTRA)-Nouvel Hôpital Civil, Hospices Civils de Strasbourg, CHU de Grenoble-Alpes, Université Côte d'Azur (UCA), Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Groupe de recherche clinique Biomarqueurs Théranostiques des Cancers Bronchiques Non à Petites Cellules (GRC 4 - Theranoscan), Sorbonne Université (SU), CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS BFC)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Institut Gustave Roussy (IGR), and Département de médecine oncologique [Gustave Roussy]
Subjects: MESH: Aged, MESH: Docetaxel, Cancer Research, MESH: Humans, MESH: Middle Aged, MESH: Mutation, MESH: Survival Rate, MESH: Non-Randomized Controlled Trials as Topic, MESH: Adult, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH: Follow-Up Studies, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, MESH: Male, MESH: Prognosis, MESH: Lung Neoplasms, MESH: Receptor, ErbB-2, MESH: Antineoplastic Combined Chemotherapy Protocols, MESH: Aged, 80 and over, Oncology, MESH: Antibodies, Monoclonal, Humanized, MESH: Trastuzumab, MESH: Female, MESH: Carcinoma, Non-Small-Cell Lung
Abstract: PURPOSE HER2 exon 20 insertions and point mutations are oncogenic drivers found in 1%-2% of patients with non–small-cell lung cancer (NSCLC). No targeted therapy is approved for this subset of patients. We prospectively evaluated the effectiveness of the combination of two antibodies against human epidermal growth factor 2 (HER2 [HER2] trastuzumab and pertuzumab with docetaxel; trastuzumab and pertuzumab) and docetaxel. METHODS The IFCT 1703-R2D2 trial is a multicenter, nonrandomized phase II study. Patients with HER2-mutated, advanced NSCLC who progressed after ≥ 1 platinum-based treatment were enrolled. Patients received pertuzumab at a loading dose of 840 mg and 420 mg thereafter; trastuzumab at an 8 mg/kg loading dose and 6 mg/kg thereafter; and docetaxel at a dose of 75 mg/m2 every 3 weeks. The primary outcome was the objective response rate (ORR). Other end points included the duration of response, progression-free survival, and safety ( NCT03845270 ). RESULTS Forty-five patients were enrolled and treated. The median age was 64.5 years (range, 31-84 years), 35% were smokers, 72% were females, 15% had an Eastern Cooperative Oncology Group performance status of 2, and 30% had brain metastases. The objective response rate was 29% (n = 13), and 58% had stable disease (n = 26). The median progression-free survival was 6.8 months (95% CI, 4.0 to 8.5). The median duration of response in patients with a confirmed response (n = 13) was 11 months (95% CI, 2.9 to 14.9). Grade 3/4 treatment-related adverse events were observed in 64% of the patients. No patient discontinued treatment because of toxicity. The most frequent grade ≥ 3 treatment-related adverse events were neutropenia (33%), diarrhea (13%), and anemia (9%). CONCLUSION Triple therapy with trastuzumab, pertuzumab, and docetaxel is feasible and effective for HER2-mutated pretreated advanced NSCLC. These results highlight the effectiveness of the HER2 antibody-based strategy, which should be considered for these patients.
Published: 2022

40. The relationship between COVID‐19 viral load and disease severity: A systematic review

Author: Omid Dadras, Amir M. Afsahi, Zahra Pashaei, Hengameh Mojdeganlou, Amirali Karimi, Pedram Habibi, Alireza Barzegary, Amirata Fakhfouri, Pegah Mirzapour, Nazanin Janfaza, Soheil Dehghani, Fatemeh Afroughi, Mohsen Dashti, Sepideh Khodaei, Esmaeil Mehraeen, Fabricio Voltarelli, Jean‐Marc Sabatier, SeyedAhmad SeyedAlinaghi, Institut de neurophysiopathologie (INP), and Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS)
Subjects: MESH: Aged, MESH: Humans, SARS-CoV-2, viruses, [SDV]Life Sciences [q-bio], Immunology, MESH: Serologic Tests, COVID-19, severity, macromolecular substances, Severity of Illness Index, viral load, MESH: Severity of Illness Index, Humans, Immunology and Allergy, MESH: COVID-19, Serologic Tests, MESH: SARS-CoV-2, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, prognosis, MESH: Viral Load, Aged
Abstract: Patients with COVID-19 may present different viral loads levels. However, the relationship between viral load and disease severity in COVID-19 is still unknown. Therefore, this study aimed to systematically review the association between SARS-CoV-2 viral load and COVID-19 severity.The relevant studies using the keywords of "COVID-19" and "viral load" were searched in the databases of PubMed, Scopus, Google Scholar, and Web of Science. A two-step title/abstract screening process was carried out and the eligible studies were included in the study.Thirty-four studies were included from the initial 1015 records. The vast majority of studies have utilized real-time reverse transcription-polymerase chain reaction of the nasopharyngeal/respiratory swabs to report viral load. Viral loads were commonly reported either as cycle threshold (CThe results were inconclusive about the relationship between COVID-19 severity and viral load, as a similar number of studies either approved or opposed this hypothesis. However, the studies denote the direct relationship between older age and higher SARS-CoV-2 viral load, which is a known risk factor for COVID-19 mortality. The higher viral load in older patients may serve as a mechanism for any possible relationships between COVID-19 viral load and disease severity. There was a positive correlation between SARS-CoV-2 viral load and its transmissibility. Nonetheless, further studies are recommended to precisely characterize this matter.
Published: 2022

41. GRAd-COV2, a gorilla adenovirus-based candidate vaccine against COVID-19, is safe and immunogenic in younger and older adults

Author: Alessandra Vitelli, Germana Grassi, Yufang Shi, Erminia Masone, Alessandra D’Abramo, Francesca Cocca, Aldo De Luca, Francesco Vaia, Laura Scorzolini, Luigi Ziviani, Dorian Bardhi, Flavia Mazzaferri, Daniele Lapa, Sandrine Ottou, Rita T. Lawlor, Irene Turrini, Federica Barra, Markus Maeurer, Francesca Colavita, Federica Mori, Alessandra M. Contino, Rita Casetti, Alessandra Vergori, Stefano Milleri, Feliciana Malescio, Marco Soriani, Ottavia Porzio, Federica Martire, Concetta Castilletti, Simone Battella, Maria M. Plazzi, Stefano Colloca, Giulia Matusali, Roberto Camerini, Enrico Girardi, Michela Gentile, Veronica Bordoni, Antonella Petrecchia, Andrea Sommella, Angelo Raggioli, Fabiana Grazioli, Alessandra Sacchi, Elisa Marchioni, Giuseppe Ippolito, Silvia Murachelli, Guido Kroemer, Chiara Agrati, Federico Napolitano, Virginia Ammendola, Roberta Gagliardini, Emanuele Nicastri, Stefania Notari, Serena Vita, Andrea Antinori, Alessandra Grillo, Daniela Zamboni, Silvia Meschi, Simone Lanini, Chiara Montaldo, Federica Poli, Mauro Piacentini, Teresa Tambasco, Emilio Scalise, Antonella Folgori, Eleonora Cimini, Maria R. Capobianchi, Licia Bordi, Stefania Capone, HAL-SU, Gestionnaire, Istituto Nazionale di Malattie Infettive 'Lazzaro Spallanzani' (INMI), ReiThera, Centro Ricerche Cliniche di Verona, Soochow University, University of Chinese Academy of Sciences [Beijing] (UCAS), Champalimaud Centre for the Unknown [Lisbon], University Medical Center of the Johannes Gutenberg-University Mainz, Department of Public Health and Cell Biology, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy, Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)), École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité), Institut Gustave Roussy (IGR), 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), Karolinska University Hospital [Stockholm], Lanini, S., Capone, S., Antinori, A., Milleri, S., Nicastri, E., Camerini, R., Agrati, C., Castilletti, C., Mori, F., Sacchi, A., Matusali, G., Gagliardini, R., Ammendola, V., Cimini, E., Grazioli, F., Scorzolini, L., Napolitano, F., Plazzi, M. M., Soriani, M., De Luca, A., Battella, S., Sommella, A., Contino, A. M., Barra, F., Gentile, M., Raggioli, A., Shi, Y., Girardi, E., Maeurer, M., Capobianchi, M. R., Vaia, F., Piacentini, M., Kroemer, G., Vitelli, A., Colloca, S., Folgori, A., and Ippolito, G.
Subjects: 2019-20 coronavirus outbreak, COVID-19 Vaccines, Settore BIO/06, Coronavirus disease 2019 (COVID-19), COVID-19 Vaccine, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Gorilla, Adenoviridae, Adenovirus Vaccines, biology.animal, Pandemic, Animals, Humans, Medicine, MESH: COVID-19, MESH: Animals, MESH: SARS-CoV-2, Aged, MESH: Adenovirus Vaccines, MESH: Aged, Gorilla gorilla, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, MESH: Humans, biology, Animal, SARS-CoV-2, business.industry, MESH: Gorilla gorilla, COVID-19, MESH: Adenoviridae, General Medicine, Virology, Adenovirus Vaccine, MESH: COVID-19 Vaccines, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Human
Abstract: International audience; Safe and effective vaccines against coronavirus disease 2019 (COVID-19) are essential for ending the ongoing pandemic. Although impressive progress has been made with several COVID-19 vaccines already approved, it is clear that those developed so far cannot meet the global vaccine demand alone. We describe a COVID-19 vaccine based on a replication-defective gorilla adenovirus expressing the stabilized prefusion severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein named GRAd-COV2. We assessed the safety and immunogenicity of a single-dose regimen of this vaccine in healthy younger and older adults to select the appropriate dose for each age group. For this purpose, a phase 1, dose-escalation, open-labeled trial was conducted including 90 healthy participants (45 aged 18 to 55 years old and 45 aged 65 to 85 years old) who received a single intramuscular administration of GRAd-COV2 at three escalating doses. Local and systemic adverse reactions were mostly mild or moderate and of short duration, and no serious adverse events were reported. Four weeks after vaccination, seroconversion to spike protein and receptor binding domain was achieved in 43 of 44 young volunteers and in 45 of 45 older participants. Consistently, neutralizing antibodies were detected in 42 of 44 younger-age and 45 of 45 older-age volunteers. In addition, GRAd-COV2 induced a robust and T helper 1 cell (T H 1)-skewed T cell response against the spike protein in 89 of 90 participants from both age groups. Overall, the safety and immunogenicity data from the phase 1 trial support the further development of this vaccine.
Published: 2022

42. Conditionality of COVID-19 vaccine acceptance in European countries

Author: Nastassia Tvardik, Nina Gobat, Sarah Tonkin-Crine, Leonardo W Heyerdahl, Tamara Giles-Vernick, Marta Wanat, Sibyl Anthierens, Benedetta Lana, Muriel Vray, Herman Goossens, Anthropologie et écologie de l’émergence des maladies - Anthropology and Ecology of Disease Emergence, Institut Pasteur [Paris] (IP)-Université Paris Cité (UPCité), Epidémiologie des Maladies Emergentes - Emerging Diseases Epidemiology, Université Paris Cité (UPCité)-Pasteur-Cnam Risques infectieux et émergents (PACRI), Institut Pasteur [Paris] (IP)-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 Paris Cité (UPCité)-Institut Pasteur [Paris] (IP)-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), University of Oxford, University of Antwerp (UA), This project is part of the output from RECOVER (Rapid European COVID-19 Emergency Research Response), which has received funding from the EU Horizon 2020 research and innovation programme under grant agreement No 101003589, European Project: 101003589, H2020-SC1-PHE-CORONAVIRUS-2020,RECOVER(2020), Institut Pasteur [Paris]-Université Paris Cité (UPC), Université Paris Cité (UPC)-Pasteur-Cnam Risques infectieux et émergents (PACRI), Institut Pasteur [Paris]-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université (HESAM)-HESAM Université (HESAM)-Université Paris Cité (UPC)-Institut Pasteur [Paris]-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université (HESAM)-HESAM Université (HESAM), and University of Oxford [Oxford]
Subjects: Vaccine safety, Mixed methods, Honesty, MESH: COVID-19, Socioeconomics, media_common, MESH: Aged, Vaccines, MESH: Middle Aged, Vaccination, Middle Aged, Europe, Infectious Diseases, MESH: Young Adult, MESH: COVID-19 Vaccines, Molecular Medicine, Adult, medicine.medical_specialty, COVID-19 Vaccines, Coronavirus disease 2019 (COVID-19), Adolescent, Short Communication, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), media_common.quotation_subject, Herd immunity, Competence (law), Young Adult, MESH: Cross-Sectional Studies, Political science, medicine, Humans, MESH: SARS-CoV-2, Vaccine hesitancy, Aged, MESH: Adolescent, MESH: Humans, General Veterinary, General Immunology and Microbiology, SARS-CoV-2, Public health, Public Health, Environmental and Occupational Health, COVID-19, MESH: Adult, Conditionality, MESH: Vaccination, MESH: Vaccines, Cross-Sectional Studies, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Human medicine, [SDV.IMM.VAC]Life Sciences [q-bio]/Immunology/Vaccinology
Abstract: The COVID-19 vaccine rollout in recent months offers a powerful preventive measure that may help control SARS-CoV-2 transmission. Nevertheless, long-standing public hesitation around vaccines has heightened public health concerns that vaccine coverage may not achieve desired public health impacts.This cross-sectional survey was conducted online in December 2020 among 7000 respondents (aged 18 to 65) in Belgium, France, Germany, Italy, Spain, Sweden, and Ukraine. The survey included open text boxes for fuller explanation of responses. Projected COVID-19 vaccine coverage varied and may not be sufficiently high among certain populations to achieve herd immunity. Overall, 56.9% would accept a COVID-19 vaccine, 19.0% would not, and 24.1% did not know or preferred not to say. By country, between 44% (France) and 66% (Italy) of respondents would accept a COVID-19 vaccine. Respondents expressed conditionality in open responses, voicing concerns about vaccine safety and mistrust of authorities. Public health campaigns must tackle these safety concerns.HighlightsMixed-method survey studied expected COVID vaccine uptake in 7 European countries.Projected COVID vaccine acceptance by country ranged from 44% to 66%.Explicit COVID vaccine acceptance or rejection was conditional.Study finds concerns about vaccine safety and authorities’ competence and honesty.Vaccine communications should address safety anxieties and target specific groups.
Published: 2022

43. Are Gadolinium-Enhanced MR Sequences Needed in Simultaneous 18F-FDG-PET/MRI for Tumor Delineation in Head and Neck Cancer?

Author: E. Chambenois, Didier Dormont, Aurélie Kas, S. Bergeret, Nadya Pyatigorskaya, R. De Laroche, G. Herve, C. Bertolus, M. Amor-Sahli, Alain Giron, G. Bera, Colliot, Olivier, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Morvan - CHRU de Brest (CHU - BREST ), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), 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), 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)-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)-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), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-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)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), 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)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-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)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), and Laboratoire d'Imagerie Biomédicale [Paris] (LIB)
Subjects: [SDV.IB.IMA]Life Sciences [q-bio]/Bioengineering/Imaging, [SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, Gadolinium, [INFO.INFO-IM] Computer Science [cs]/Medical Imaging, chemistry.chemical_element, MESH: Magnetic Resonance Imaging, 030218 nuclear medicine & medical imaging, 18f fdg pet, 03 medical and health sciences, [INFO.INFO-CV] Computer Science [cs]/Computer Vision and Pattern Recognition [cs.CV], 0302 clinical medicine, Text mining, MESH: Fluorodeoxyglucose F18, MESH: Contrast Media, [INFO.INFO-IM]Computer Science [cs]/Medical Imaging, medicine, Radiology, Nuclear Medicine and imaging, Head and neck, [SPI.SIGNAL] Engineering Sciences [physics]/Signal and Image processing, MESH: Aged, MESH: Humans, MESH: Middle Aged, business.industry, Head and neck cancer, [SDV.NEU.NB] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, [INFO.INFO-CV]Computer Science [cs]/Computer Vision and Pattern Recognition [cs.CV], MESH: Adult, MESH: Retrospective Studies, medicine.disease, Mr imaging, MESH: Male, MESH: Positron-Emission Tomography, MESH: Sensitivity and Specificity, 3. Good health, MESH: Head and Neck Neoplasms, [SDV.IB.IMA] Life Sciences [q-bio]/Bioengineering/Imaging, [INFO.INFO-TI] Computer Science [cs]/Image Processing [eess.IV], chemistry, [INFO.INFO-TI]Computer Science [cs]/Image Processing [eess.IV], Neurology (clinical), MESH: Gadolinium, business, Nuclear medicine, MESH: Female, [SPI.SIGNAL]Engineering Sciences [physics]/Signal and Image processing, MESH: Radiopharmaceuticals, 030217 neurology & neurosurgery
Abstract: International audience; PET/MRI with 18F-FDG has demonstrated the advantages of simultaneous PET and MR imaging in head and neck cancer imaging, MRI allowing excellent soft-tissue contrast, while PET provides metabolic information. The aim of this study was to evaluate the added value of gadolinium contrast-enhanced sequences in the tumor delineation of head and neck cancers on 18F-FDG-PET/MR imaging.
Published: 2020

44. PrEP Interest Among Men Who Have Sex with Men in the Netherlands

Author: van Dijk, Mart, Duken, S.B., Delabre, R.M., Stranz, R., Schlegel, V., Rojas Castro, D., Bernier, A., Zantkuijl, P., Ruiter, R.A.C., de Wit, J.B.F., Jonas, K.J., Leerstoel de Wit, Social Policy and Public Health, Maastricht University [Maastricht], University of Amsterdam [Amsterdam] (UvA), Coalition PLUS [Pantin, France] (Community Research Laboratory Pantin), AIDES [Pantin, France], Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe de Recherche en Psychologie Sociale (GRePS), Université Lumière - Lyon 2 (UL2), Soa Aids Nederland [Amsterdam, The Netherlands], Utrecht University [Utrecht], This study was funded by the Dutch Aidsfonds (Grant Numbers P-11302 and P-13301, made available to the last author). This research was conducted as a part of 'Flash PrEP in Europe,' a joint European research project coordinated by the community-based organisations AIDES and Coalition PLUS, as well as the University of Amsterdam., Klinische Psychologie (Psychologie, FMG), Psychology Other Research (FMG), Dupuis, Christine, Section Applied Social Psychology, RS: FPN WSP II, Leerstoel de Wit, and Social Policy and Public Health
Subjects: Male, MESH: Sexual Behavior, [SDV]Life Sciences [q-bio], WILLINGNESS, HIV Infections, 030312 virology, Logistic regression, law.invention, Men who have sex with men, 0302 clinical medicine, law, 030212 general & internal medicine, General Psychology, Netherlands, MESH: Aged, 0303 health sciences, CONDOM USE, MESH: Middle Aged, MESH: HIV Infections, Middle Aged, 16. Peace & justice, Explained variation, PrEP, [SDV] Life Sciences [q-bio], GAY, MESH: Risk-Taking, MESH: Young Adult, Sexual orientation, Psychology, Adult, medicine.medical_specialty, AWARENESS, Adolescent, TRANSGENDER WOMEN, Sexual Behavior, HIV prevention, Context (language use), MESH: Homosexuality, Male, Young Adult, 03 medical and health sciences, Risk-Taking, Arts and Humanities (miscellaneous), Condom, Covariate, medicine, Humans, MSM, Homosexuality, Male, Aged, MESH: Adolescent, UNPROTECTED ANAL INTERCOURSE, Original Paper, MESH: Humans, Men who have sex with men (MSM), Public health, MESH: Adult, MESH: Male, HIGH-RISK, MESH: Netherlands, BISEXUAL MEN, HIV PREEXPOSURE PROPHYLAXIS, Demography
Abstract: Despite increased availability of pre-exposure prophylaxis (PrEP), PrEP uptake has remained low. To promote uptake, factors related to PrEP interest among relevant target populations warrant investigation. The aim of this study was to provide an analysis of PrEP interest among men who have sex with men (MSM) in the Netherlands, while taking study recruitment strategies into account. We recruited 154 MSM from an LGBT research panel (AmsterdamPinkPanel) and 272 MSM from convenience sampling. Both samples were part of the Flash! PrEP in Europe Survey and were compared on their PrEP interest, usage intentions, and sexual behavior. We conducted logistic regression analyses to discover variables associated with PrEP interest and intentions. Participants from the AmsterdamPinkPanel were less likely to use PrEP, had less knowledge of PrEP, and were less interested in PrEP than participants from convenience sampling. Significant covariates of PrEP interest were being single, more prior PrEP knowledge, sexual risk behaviors, such as not having used a condom during last sex and having ever used drugs in a sexual context, and not participating in the AmsterdamPinkPanel. Adding the recruitment strategy to the regression increased explained variance on top of predictors already described in the literature. Increased sexual risk behavior is related to increased PrEP interest and it helps to identify PrEP target groups. Recruitment strategies have a substantial impact on findings regarding PrEP interest and usage intentions. This study emphasizes the importance of using multiple strategies for recruiting participants to obtain a more comprehensive view of MSM’s attitudes toward PrEP. Electronic supplementary material The online version of this article (10.1007/s10508-019-01620-x) contains supplementary material, which is available to authorized users.
Published: 2020

45. Preoperative erythropoietin within a patient blood management program decreases both blood transfusion and postoperative anemia: a prospective observational study

Author: Philippe Biboulet, Pierre Smilevitch, Gaëtan Dangelser, Caroline Motais, Oliver Karam, Xavier Capdevila, Guillaume Maissiat, Sophie Bringuier, Mathieu Pencole, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), University of Richmond, Institut des Neurosciences de Montpellier - Déficits sensoriels et moteurs (INM), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)
Subjects: Male, MESH: Anemia, Blood transfusion, Arthroplasty, Replacement, Hip, medicine.medical_treatment, 030204 cardiovascular system & hematology, Postoperative Complications, MESH: Arthroplasty, Replacement, Knee, 0302 clinical medicine, MESH: Postoperative Complications, hemic and lymphatic diseases, MESH: Arthroplasty, Replacement, Hip, Immunology and Allergy, Prospective Studies, Arthroplasty, Replacement, Knee, Prospective cohort study, MESH: Aged, MESH: Iron, MESH: Middle Aged, Anemia, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, Hematology, Middle Aged, 3. Good health, Tranexamic Acid, Anesthesia, Preoperative Period, Female, Tranexamic acid, medicine.drug, Blood management, Iron, Immunology, MESH: Blood Transfusion, MESH: Preoperative Period, 03 medical and health sciences, medicine, Humans, Blood Transfusion, MESH: Erythropoietin, Erythropoietin, Aged, MESH: Humans, business.industry, Odds ratio, MESH: Tranexamic Acid, medicine.disease, Arthroplasty, MESH: Prospective Studies, MESH: Male, business, MESH: Female, 030215 immunology
Abstract: International audience; Background: In orthopedic surgery, a patient blood management program (PBM) has been proposed to reduce blood transfusion. The aim of this observational study was to assess, within a PBM, the specific efficacy of preoperative erythropoietin (EPO).Study design and methods: In a single hospital, 723 patients undergoing elective primary hip or knee arthroplasty were prospectively studied. The PBM included EPO if preoperative hemoglobin was lower than 13 g/dL, intraoperative administration of tranexamic acid, use of recommended transfusion thresholds, and postoperative infusion of iron. Blood transfusion and hemoglobin were noted until discharge. Major thromboembolic or cardiovascular events were assessed during admission and 1 month after discharge.Results: Transfusion was noted in 2.5% patients with EPO. Transfusion rate was higher in patient for whom EPO was not indicated (13.6% transfusion rate; odds ratio [OR], 13.7; 95% confidence interval [CI], 2.6-66; p = 10-3 ) or if erythropoietin was indicated but not administrated (36.8% transfusion rate; OR, 18.2; 95% CI, 3.9-84.5; p < 10-3 ). Hemoglobin was significantly higher during the postoperative period in patients with erythropoietin. At hospital discharge, 57% of patients were anemic if EPO was used compared to 88% when EPO was not indicated and 87% when EPO was indicated but not administered (p < 10-6 ). There were no significant differences in the odds of major complications between patients with or without EPO.Conclusions: Within a PBM, preoperative treatment of anemia with EPO decreased both the rate of blood transfusion and postoperative anemia. Further studies are necessary to confirm these results.
Published: 2020

46. Genome-wide whole blood transcriptome profiling in a large European cohort of systemic sclerosis patients

Author: Zuzanna Makowska, Ricard Cervera, Lorenzo Beretta, László Kovács, Marta E. Alarcón-Riquelme, Guillermo Barturen, Isabel Almeida, Divi Cornec, Javier Martín, Jacques-Olivier Pers, Ellen De Langhe, Nicolas Hunzelmann, Carlo Chizzolini, Maria Gerosa, Martin Kerick, Ralf Lesche, Chiara Bellocchi, Barbara Vigone, Rafaela Ortega Castro, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Centre for Genomics and Oncological Research Pfizer [Granada, Spain], Universidad de Granada = University of Granada (UGR)-Andalusian Regional Government [Granada, Spain], Università degli Studi di Milano = University of Milan (UNIMI), Universitätsklinikum Köln (Uniklinik Köln), Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven), University Hospitals Leuven [Leuven], Department of Clinical Sciences and Community Health [Milan, Italy], Hospital Clinic, IDIBAPS, Universidad de Barcelona, Ciberes, Barcelona, Spain., Instituto Maimonides de Investigación Biomédica de Cordoba (IMIBIC), Universidad de Córdoba = University of Córdoba [Córdoba]-Hospital Universitario Reina Sofía, University of Szeged [Szeged], CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), 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), Université de Brest (UBO), Hôpital Universitaire de Genève, Geneva, Hôpital Universitaire de Genève = University Hospitals of Geneva (HUG), Bayer Pharma AG [Berlin], Instituto de Parasitología y Biomedicina 'López-Neyra', PRECISESADS SSc substudy group, PRECISESADS Flow Cytometry study group : Doreen Belz, Eduardo Collantes-Estevez, Francesca Ingegnoli, Yolanda Jimenez Gómez, Chary Lopez Pedrera, Rik Lories, Gaia Montanelli, Silvia Piantoni, Ignasi Rodriguez Pinto, Carlos Vasconcelos, Christophe Jamin, Concepción Marañón, Lucas Le Lann, Quentin Simon, Bénédicte Rouvière, Nieves Varela, Brian Muchmore, Aleksandra Dufour, Montserrat Alvarez, Jonathan Cremer, Nuria Barbarroja, Velia Gerl, Laleh Khodadadi, Qingyu Cheng, Anne Buttgereit, Aurélie De Groof, Julie Ducreux, Elena Trombetta, Tianlu Li, Damiana Alvarez-Errico, Torsten Witte, Katja Kniesch, Nancy Azevedo, Esmeralda Neves, Sambasiva Rao, Pierre-Emmanuel Jouve., Michel, Geneviève, University of Granada [Granada]-Andalusian Regional Government [Granada, Spain], University of Milan, University Hospitals Leuven and Skeletal Biology and Engineering Research Center, KU Leuven, Leuven, Belgium, Università degli Studi di Milano [Milano] (UNIMI), Universidad de Córdoba [Cordoba]-Hospital Universitario Reina Sofía, Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Universitaire de Genève, and European Commission
Subjects: MESH: Interferon Type I, MESH: Signal Transduction, Male, 0301 basic medicine, Microarray, systemic sclerosis, Autoimmunity, Diseases, Pathogenesis, DISEASE, MESH: Scleroderma, Systemic, Cohort Studies, Transcriptome, 0302 clinical medicine, Immunophenotyping, Platelet degranulation, Gene expression, MESH: Sequence Analysis, RNA, Immunology and Allergy, Medicine, RNA-Seq, MESH: Cohort Studies, GENE-EXPRESSION, MESH: Aged, MESH: Middle Aged, Toll-Like Receptors, Middle Aged, 3. Good health, Europe, Interferon Type I, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, epidemiology, Life Sciences & Biomedicine, MESH: Toll-Like Receptors, Signal Transduction, Adult, MESH: Immunophenotyping, [SDV.IMM] Life Sciences [q-bio]/Immunology, Immunology, Context (language use), Systemic Sclerosis, Computational biology, General Biochemistry, Genetics and Molecular Biology, MESH: Gene Expression Profiling, 03 medical and health sciences, Rheumatology, MESH: Autoimmunity, Humans, autoimmune diseases, Gene, Aged, 030203 arthritis & rheumatology, Science & Technology, MESH: Humans, Scleroderma, Systemic, Sequence Analysis, RNA, business.industry, MESH: Transcriptome, Gene Expression Profiling, RNA, MESH: Adult, Microarray Analysis, Expressió gènica, MESH: Male, MESH: Microarray Analysis, Scleroderma (Disease), 030104 developmental biology, MESH: Genome-Wide Association Study, MESH: Europe, Esclerodèrmia, business, MESH: Female, Genome-Wide Association Study
Abstract: Objectives: The analysis of annotated transcripts from genome-wide expression studies may help to understand the pathogenesis of complex diseases, such as systemic sclerosis (SSc). We performed a whole blood (WB) transcriptome analysis on RNA collected in the context of the European PRECISESADS project, aiming at characterising the pathways that differentiate SSc from controls and that are reproducible in geographically diverse populations. Methods: Samples from 162 patients and 252 controls were collected in RNA stabilisers. Cases and controls were divided into a discovery (n=79+163; Southern Europe) and validation cohort (n=83+89; Central-Western Europe). RNA sequencing was performed by an Illumina assay. Functional annotations of Reactome pathways were performed with the Functional Analysis of Individual Microarray Expression (FAIME) algorithm. In parallel, immunophenotyping of 28 circulating cell populations was performed. We tested the presence of differentially expressed genes/pathways and the correlation between absolute cell counts and RNA transcripts/FAIME scores in regression models. Results significant in both populations were considered as replicated. Results: Overall, 15 224 genes and 1277 functional pathways were available; of these, 99 and 225 were significant in both sets. Among replicated pathways, we found a deregulation in type-I interferon, Toll-like receptor cascade, tumour suppressor p53 protein function, platelet degranulation and activation. RNA transcripts or FAIME scores were jointly correlated with cell subtypes with strong geographical differences; neutrophils were the major determinant of gene expression in SSc-WB samples. Conclusions: We discovered a set of differentially expressed genes/pathways validated in two independent sets of patients with SSc, highlighting a number of deregulated processes that have relevance for the pathogenesis of autoimmunity and SSc., This work was supported by eU/eFPia/innovative Medicines initiative Joint Undertaking PrecisesaDs Grant no. 115 565.
Published: 2020

47. Factors Influencing Atypical Clinical Presentations during the 2017 Madagascar Pneumonic Plague Outbreak: A Prospective Cohort Study

Author: Rindra Randremanana, Reziky Tiandraza Mangahasimbola, Rodrigue N. E. Hasiniatsy, Dominique Razafimandimby, Tiana Razafinambinintsoa, Anna L. Funk, Laurence Baril, Andrew M. Lovering, Randrianirina Frédérique, Minoarisoa Rajerison, Alex P. Salam, Arnaud Fontanet, Mihaja Raberahona, Faraniaina Andrianarintsiferantsoa, Mamy Jean de Dieu Randria, Norosoa Harline Razanajatovo, Voahangy Andrianaivoarimanana, Peter Horby, Eric Bertherat, Prisca Andriantsalama, Rado Rakotomalala, Jean-Michel Heraud, Lyndsey Castle, Bertrand Renaud, Liam Read, University of Oxford, UK Public Health Rapid Support Team [London] (UK-PHRST), London School of Hygiene and Tropical Medicine (LSHTM)-Public Health England [London], Hôpital Joseph Raseta Befelatanana, CHU d’Antananarivo, Institut Pasteur de Madagascar, Réseau International des Instituts Pasteur (RIIP), North Bristol NHS Trust [Bristol, UK], Centre Hospitalier Anti-pesteux d'Ambohimiandra [Antananarivo, Madagascar] (CHAPA), Centre Hospitalier de Soavinandriana (CENHOSOA), Institut Pasteur [Paris] (IP), Université Paris Descartes - Paris 5 (UPD5), World Health Organisation (WHO), Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM), This study was funded by the United Kingdom Public Health Rapid Support Team., University of Oxford [Oxford], and Institut Pasteur [Paris]
Subjects: Male, Pediatrics, Cohort Studies, MESH: Madagascar, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, MESH: Child, Prospective Studies, Overdiagnosis, Child, Prospective cohort study, MESH: Cohort Studies, MESH: Aged, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, MESH: Middle Aged, Articles, Middle Aged, MESH: Infant, 3. Good health, Infectious Diseases, Child, Preschool, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, Cohort, Female, medicine.symptom, Cohort study, Adult, Pneumonic plague, medicine.medical_specialty, Adolescent, 030231 tropical medicine, MESH: Plague, Bubonic plague, 03 medical and health sciences, Virology, Madagascar, medicine, Humans, Aged, MESH: Adolescent, Plague, MESH: Humans, business.industry, MESH: Child, Preschool, Infant, Outbreak, MESH: Adult, [SDV.BBM.BM]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Molecular biology, medicine.disease, MESH: Male, MESH: Prospective Studies, Sputum, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Parasitology, business, MESH: Female
Abstract: International audience; In late 2017, Madagascar experienced a large urban outbreak of pneumonic plague, the largest outbreak to date this century. During the outbreak, there were widespread reports of plague patients presenting with atypical symptoms, such as prolonged duration of illness and upper respiratory tract symptoms. Reported mortality among plague cases was also substantially lower than that reported in the literature (25% versus 50% in treated patients). A prospective multicenter observational study was carried out to investigate potential reasons for these atypical presentations. Few subjects among our cohort had confirmed or probable plague, suggesting that, in part, there was overdiagnosis of plague cases by clinicians. However, 35% subjects reported using an antibiotic with anti-plague activity before hospital admission, whereas 55% had antibiotics with anti-plague activity detected in their serum at admission. Although there may have been overdiagnosis of plague by clinicians during the outbreak, the high frequency of community antibiotic may partly explain the relatively few culture-positive sputum samples during the outbreak. Community antibiotic use may have also altered the clinical presentation of plague patients. These issues make accurate detection of patients and the development of clinical case definitions and triage algorithms in urban pneumonic plague outbreaks difficult.
Published: 2020

48. Differential levels of Neurofilament Light protein in cerebrospinal fluid in patients with a wide range of neurodegenerative disorders

Author: Delaby, Constance, Alcolea, Daniel, Carmona Iragui, María, Illán-Gala, Ignacio, Morenas Rodríguez, Estrella, Barroeta, Isabel, Altuna-Azkargorta, Miren, Estellés, T., Santos-Santos, M., Turon-Sans, J., Muñoz, L., Ribosa-Nogué, Roser, Sala-Matavera, I., Sánchez-Saudinós, María Belén, Subirana, A., Videla Toro, Laura, Benejam, Bessy, Sirisi Dolcet, Sonia, Lehmann, S., Belbin, Olivia, Clarimón, Jordi, Blesa, Rafael, Pagonabarraga Mora, Javier, Rojas-Garcia, Ricard, Fortea, Juan, Lleó, Alberto, Universitat Autònoma de Barcelona, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB), Centro de Investigacion Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Instituto de Salud Carlos III [Madrid] (ISC), German Research Center for Neurodegenerative Diseases - Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE), Ludwig-Maximilians-Universität München (LMU), CIBER de Enfermedades Raras (CIBERER), and Salvy-Córdoba, Nathalie
Subjects: 0301 basic medicine, Male, Pathology, Neurology, [SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, MESH: Neurodegenerative Diseases, Cohort Studies, 0302 clinical medicine, Cerebrospinal fluid, Neurofilament Proteins, MESH: Early Diagnosis, Medicine, Amyotrophic lateral sclerosis, MESH: Neurofilament Proteins, MESH: Cohort Studies, [SDV.BBM.BC] Life Sciences [q-bio]/Biochemistry, Molecular Biology/Biochemistry [q-bio.BM], MESH: Aged, Multidisciplinary, Neurodegeneration, Neurodegenerative Diseases, MESH: Follow-Up Studies, Disease Progression, Female, MESH: Disease Progression, Alzheimer's disease, Frontotemporal dementia, medicine.medical_specialty, Science, Neuroaxonal Dystrophies, Article, Progressive supranuclear palsy, 03 medical and health sciences, mental disorders, Humans, [SDV.BBM.BC]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Biochemistry [q-bio.BM], Aged, MESH: Humans, business.industry, Dementia with Lewy bodies, [SDV.NEU.NB] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, medicine.disease, MESH: Neuroaxonal Dystrophies, MESH: Male, 030104 developmental biology, Early Diagnosis, MESH: Biomarkers, business, MESH: Female, 030217 neurology & neurosurgery, Biomarkers, Follow-Up Studies
Abstract: Altres ajuts: "Marató TV3" grant (20141210, 044412, 20143710). Cerebrospinal fluid (CSF) biomarkers are useful in the diagnosis and the prediction of progression of several neurodegenerative diseases. Among them, CSF neurofilament light (NfL) protein has particular interest, as its levels reflect neuroaxonal degeneration, a common feature in various neurodegenerative diseases. In the present study, we analyzed NfL levels in the CSF of 535 participants of the SPIN (Sant Pau Initiative on Neurodegeneration) cohort including cognitively normal participants, patients with Alzheimer disease (AD), Down syndrome (DS), frontotemporal dementia (FTD), amyotrophic lateral sclerosis (ALS), dementia with Lewy bodies (DLB), progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS). We evaluated the differences in CSF NfL accross groups and its association with other CSF biomarkers and with cognitive scales. All neurogenerative diseases showed increased levels of CSF NfL, with the highest levels in patients with ALS, FTD, CBS and PSP. Furthermore, we found an association of CSF NfL levels with cognitive impairment in patients within the AD and FTD spectrum and with AD pathology in DLB and DS patients. These results have implications for the use of NfL as a marker in neurodegenerative diseases.
Published: 2020

49. Is the Natural Anatomical Evolution of Type B Intramural Hematomas Reliable to Identify the Patients at Risk of Aneurysmal Progression?

Author: Julien Mancini, Pierre-Antoine Barral, Arnaud Blanchard, Mariangela De Masi, Philippe Piquet, Laurence Bal, David Lagier, Marine Gaudry, Sonia Bolomey, Alexis Jacquier, Hôpital de la Timone [CHU - APHM] (TIMONE), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Biostatistique et technologies de l'information et de la communication (BioSTIC) - [Hôpital de la Timone - APHM] (BiosTIC ), Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), and Dupuis, Christine
Subjects: Male, Time Factors, Computed Tomography Angiography, [SDV]Life Sciences [q-bio], 030204 cardiovascular system & hematology, MESH: Risk Assessment, 030218 nuclear medicine & medical imaging, MESH: Aged, 80 and over, 0302 clinical medicine, Risk Factors, MESH: Risk Factors, MESH: Aneurysm, Dissecting, Computed tomography angiography, Aged, 80 and over, MESH: Aged, Aortic dissection, Hematoma, MESH: Middle Aged, medicine.diagnostic_test, General Medicine, Middle Aged, MESH: Predictive Value of Tests, Aortic Aneurysm, [SDV] Life Sciences [q-bio], Predictive value of tests, Disease Progression, cardiovascular system, Female, MESH: Disease Progression, Aortic diameter, Radiology, Cardiology and Cardiovascular Medicine, medicine.medical_specialty, Aortography, Lumen (anatomy), Risk Assessment, 03 medical and health sciences, Aneurysm, Predictive Value of Tests, medicine, Humans, MESH: Aortography, Aged, Retrospective Studies, MESH: Humans, business.industry, MESH: Time Factors, MESH: Retrospective Studies, Retrospective cohort study, medicine.disease, MESH: Male, MESH: Computed Tomography Angiography, MESH: Aortic Aneurysm, body regions, MESH: Hematoma, Aortic Dissection, Surgery, business, MESH: Female
Abstract: International audience; Background: The natural history of type B intramural hematomas is little-known. Aneurysmal progression or an aortic dissection occurs in 15 to 20% of the cases. The study of the natural anatomical evolution could help identify the patients at risk of unfavorable evolution.Methods: All the patients monitored for a type B intramural hematoma between 2009 and 2018 were included in this monocentric retrospective study. Computed tomography angiography centerline measurement of diameters was obtained in various points of aortic segmentation on day (D) 0 and at one month (M1). Aortic volumes (lumen, intramural hematoma, and total volume) were calculated. The circulating volume was calculated using the volume rendering method. The volume of the intramural hematoma was measured using a manual section-by-section segmentation tool, and the total volume was obtained by summing up the two preceding volumes. Two groups of patients were compared: group 1 (favorable anatomical evolution) and group 2 (unfavorable anatomical evolution).Results: Between January 2008 and August 2018, 25 patients were managed for a type B intramural hematoma in our center. After an average follow-up of 15.5 months (1-52), 13 patients (52%) presented a favorable evolution and 12 (48%) an unfavorable evolution. At M1, a significant increase of the luminal diameters (37 mm vs. 32 mm; P < 0.01) and a significant reduction in the longitudinal extension (19 mm vs. 26 mm; P < 0.01) were observed. The maximum aortic diameter evolved significantly between D0 and M1 in the unfavorable evolution group (49 mm vs. 44 mm, respectively; P = 0.038). Such a difference was not found in the favorable evolution group (37.4 vs. 37.1, respectively; P = 0.552). An overall significant reduction in the total aortic volume (166 cm3 vs. 219 cm3; P < 0.01), the circulating volume (124 cm3 vs. 145 cm3; P = 0,026), and the volume of the hematoma (42 cm3 vs. 39 cm3; P < 0.01) was observed. The circulating volume decreased significantly between D0 and M1 in the favorable evolution group (110 cm3 vs. 135 cm3; P = 0.05), whereas no difference was noted in the unfavorable group (142 cm3 vs, 157 cm3; P = 0.24).Conclusions: The progression of the maximum aortic diameter and of the circulating volume after one month of follow-up could be predictive factors of the poor long-term evolution of type B intramural hematomas.
Published: 2020

50. Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis

Author: Lucy Smyth, Andrea Mazzetti, Charles D. Pusey, Lorraine Harper, Donna Reidlinger, Gina Gregorini, William F. Clark, Pexivas Investigators Pexivas Investigators, Adeera Levin, Toshiko Ito-Ihara, Chen-Au Peh, Xavier Puéchal, Ulrich Specks, Carmel M. Hawley, Oliver Floßmann, Simon Carette, Alina Casian, Wojciech Szczeklik, Peter A. Merkel, Janak de Zoysa, Nader Khalidi, David Jayne, Samir Mehta, Biljana Brezina, Ron Wald, Michael Walsh, Luis Felipe Flores-Suárez, Carol A. McAlear, L. Guillevin, Louis Girard, Natalie Ives, Wladimir Szpirt, Vladimir Tesar, Elizabeth Broadhurst, Christian Pagnoux, Shouichi Fujimoto, McMaster University [Hamilton, Ontario], Royal Adelaide Hospital [Adelaide Australia], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), University of Miyazaki, McMaster University, St. Joseph’s Healthcare, Royal Berkshire Hospital, St. Michael's Hospital, University of British Columbia (UBC), Università degli Studi di Brescia [Brescia], Mount Sinai Hospital [Toronto, Canada] (MSH), Mayo Clinic [Rochester], Charles University [Prague] (CU), Instituto Nacional de Enfermedades Respiratorias [México, Mexico], University of Cambridge [UK] (CAM), Addenbrooke's Hospital, and Cambridge University NHS Trust
Subjects: MESH: Combined Modality Therapy, medicine.medical_specialty, Cyclophosphamide, medicine.medical_treatment, Azathioprine, 030204 cardiovascular system & hematology, urologic and male genital diseases, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, Gastroenterology, MESH: Dose-Response Relationship, Drug, MESH: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, 03 medical and health sciences, 0302 clinical medicine, Maintenance therapy, immune system diseases, Internal medicine, Medicine, MESH: Incidence, cardiovascular diseases, 030212 general & internal medicine, skin and connective tissue diseases, Anti-neutrophil cytoplasmic antibody, MESH: Aged, MESH: Kidney Diseases, MESH: Middle Aged, MESH: Humans, business.industry, MESH: Cyclophosphamide, MESH: Adult, Glomerulonephritis, General Medicine, MESH: Plasma Exchange, medicine.disease, MESH: Induction Chemotherapy, MESH: Male, respiratory tract diseases, 3. Good health, MESH: Kidney Failure, Chronic, MESH: Administration, Oral, Rituximab, Plasmapheresis, MESH: Immunosuppressive Agents, MESH: Rituximab, MESH: Glucocorticoids, business, Vasculitis, MESH: Female, medicine.drug
Abstract: BACKGROUND More effective and safer treatments are needed for antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis. METHODS We conducted a randomized trial with a 2-by-2 factorial design to evaluate the use of plasma exchange and two regimens of oral glucocorticoids in patients with severe ANCA-associated vasculitis (defined by an estimated glomerular filtration rate of
Published: 2020

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