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8. Parents’ decision whether or not to enrol their infant in a clinical trial: towards a patient centred approach? A qualitative study

Author

Cornu, Catherine, primary, Carle, Quentin, additional, Poite, Maylis, additional, Erpeldinger, Sylvie, additional, Meunier-Beillard, Nicolas, additional, Binquet, Christine, additional, Ginhoux, Tiphanie, additional, Saidi, Manel, additional, Lamotte-Félin, Alexandra, additional, Supper, Irène, additional, Moreau, Alain, additional, Verriere, Virginie, additional, Tisserand, Elodie, additional, Berard, Anick, additional, Paris, Adeline, additional, Lamort-Bouché, Marion, additional, Kieffer, François, additional, and Wallon, Martine, additional

Published
2022
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9. Population pharmacokinetics of micafungin in ICU patients with sepsis and mechanical ventilation

Author

Jullien, Vincent, Azoulay, Elie, Schwebel, Carole, Le Saux, Thomas, Charles, Pierre Emmanuel, Cornet, Muriel, Souweine, Bertrand, Klouche, Kadda, Jaber, Samir, Trouillet, Jean-Louis, Bruneel, Fabrice, Cour, Martin, Cousson, Joel, Meziani, Ferhat, Gruson, Didier, Paris, Adeline, Darmon, Michael, Garrouste-Orgeas, Maité, Navellou, Jean-Christophe, Foucrier, Arnaud, Allaouchiche, Bernard, Das, Vincent, Gangneux, Jean-Pierre, Ruckly, Stéphane, Wolff, Michel, Timsit, Jean-François, Timsit, Jean François, Hamidfar-Roy, Rebecca, Ciroldi, Magalie, Paugam-Burtz, Catherine, Foucrier, Arnaud, Navellou, Jean Christophe, Wolff, Michel, Timsit, Jean-Francois, Bouadma, Lila, Mourvillier, Bruno, Sonneville, Romain, Chemam, Sarah, Gruson, Didier, Souweine, Bertrand, Lautrette, Alexandre, Charles, Pierre Emmanuel, Bruyere, Rémi, Hamet, Maël, Allaouchiche, Bernard, Christian, Guillaume, Ber, Charles-Eric, Prothet, Johanne, Rimmele, Thomas, Argaud, Laurent, Simon, Marie, Cour, Martin, Hernu, Romain, Jaber, Samir, Jung, Boris, Conseil, Mathieu, Coisel, Yannael, Belafia, Fouad, Klouche, Kada, Amigues, Laurent, Machado, Sonia, Serveaux, Marianne, Chastre, Jean, Trouillet, Jean-Louis, Cousson, Joël, Raclot, Pascal, Floch, Thierry, Zeni, Fabrice, Darmon, Michael, Pichon, Matthias, Coudrot, Maud, Ninet, Sebastien, Diconne, Eric, Schlemmer, Benoit, Azoulay, Elie, Lemiale, Virginie, Maziers, Nicolas, Meziani, Ferhat, Schnell, David, Boisrame-Helms, Julie, Neagu-Anca, Raluca, Delabranche, Xavier, Martinet, Olivier, Garrouste-orgeas, Maité, Misset, Benoit, Bruneel, Fabrice, Laurent, Virginie, Lacave, Guillaume, Bedos, Jean-Pierre, Hammi, Khadija, Styfalova, Lenka, Fritzsch, Joelle, Letrou, Sophie, Estevez, Lucie, Adda, Mireille, Devaux, Therese, Dubien, Celine, Bayarassou, Soumia, Faure, Catherine Jouvene, de La Salle, Sylvie, Prades, Albert, Rodriguez, Annie, Meur, Pierre, Warchol, Magda, El Haouari, Hanane, Theodose, Igor, Fournier, Julien, Cavelot, Sebastien, Kodja, Lilia Bakir, Faure, Marie Joyeux, Maurisot, Sophie, Labat, Carole, Tacco, Frédéric, Roos, Sonia, Dupre, Karima, Abazid, Malek, Essert, Michele, Arnaud, Philippe, Papy, Emmanuelle, Ghezzoul, Bellabes, Gerbouin, Olivier, Peccoux, Sandrine Corny, Fagnoni, Philippe, Millaret, Anne, Pivot, Christine, Gerard, Cecile, Breuker, Cyril, Castet, Audrey, Charbonnier, Fanny, Legrand, Maryline, Mordini, Julia, Chambrin, Isabelle Madelaine, Clauss, Anne Hutt, Cherifi, Mohamed, Pattyn, Anne, Pichard, Camille, Cornet, Murielle, Zumbo, Christian, Smets, Aurélie, Benveniste, Eliane, Grenouillet, Fréderic, Chochillon, Christian, Accoberry, Isabelle, Pons, Denis, Mrozek, Natacha, Dalle, Frédéric, Bienvenu, Anne-lise, Picot, Stephane, Beyerle, Francoise, Bourgeois, Nathalie, Fekkar, Arnaud, Toubas, Dominique, Raberin, Hélène, Candolfi, Ermanno, Bru, Valérie, Kitzis, Marie Dominique, Senghor, Yaye, Palette, Catherine, Eloy, Odile, Ruckly, Stéphane, Vesin, Aurélien, Mira, Jean-Paul, Zahar, Jean-Ralph, Shir, Edith, Larrey, Dominique, and Zarskii, Jean-Pierre

Published
2017
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13. High-risk exposure without personal protective equipment and infection with SARS-CoV-2 in-hospital workers - The CoV-CONTACT cohort

Author

Tubiana, Sarah, Burdet, Charles, Houhou, Nadhira, Thy, Michael, Manchon, Pauline, Blanquart, François, Charpentier, Charlotte, Guedj, Jérémie, Alavoine, Loubna, Behillil, Sylvie, Leclercq, Anne, Lucet, Jean-Christophe, Yazdanpanah, Yazdan, Attia, Mikaël, Demeret, Caroline, Rose, Thierry, Bielicki, Julia Anna, Bruijning-Verhagen, Patricia, Goossens, Herman, Descamps, Diane, van der Werf, Sylvie, Lina, Bruno, Duval, Xavier, Abad, Fanny, Abry, Dominique, Allain, Jean-Sébastien, Amiel-Taieb, Karline, Audoin, Pierre, Augustin, Shana, Ayala, Sandrine, Bansard, Hélène, Bertholon, Fréderique, Boissel, Nolwenn, Botelho-Nevers, Elisabeth, Bouiller, Kévin, Bourgeon, Marilou, Boutrou, Mathilde, Brick, Lysiane, Bruneau, Léa, Caumes, Eric, Chabouis, Agnès, Chan Thien, Eric, Chirouze, Catherine, Coignard, Bruno, Costa, Yolande, Costenoble, Virginie, Cour, Sylvie, Cracowski, Claire, Cracowski Jean, Luc, Deplanque, Dominique, Dequand, Stéphane, Desille-Dugast, Mireille, Desmarets, Maxime, Detoc, Maelle, Dewitte, Marie, Djossou, Felix, Ecobichon, Jean-Luc, Elrezzi, Elise, Faurous, William, Fortuna, Viviane, Fouchard, Julie, Gantier, Emilie, Gautier, Céline, Gerardin, Patrick, Gerset, Sandrine, Gilbert, Marie, Gissot, Valérie, Guillemin, Francis, Hartard, Cédric, Hazevis, Béatrice, Hocquet, Didier, Hodaj, Enkelejda, Ilic-Habensus, Emila, A, Jeudy, Jeulin, Helene, Kane, Maty, Kasprzyk, Emmanuelle, Kikoine, John, Laine, Fabrice, Laviolle, Bruno, Lebeaux, David, Ledru, Eric, Lefevre, Benjamin, Legoas, Carole, Legrand, Amélie, Legrand, Karine, Lehacaut, Jonathan, Lehur, Claire, Lemouche, Dalila, Lepiller, Quentin, Lepuil, Sévérine, Letienne, Estelle, Lucarelli, Aude, Madeline, Isabelle, Maillot, Adrien, Malapate, Catherine, Malvy, Denis, Mandic, Milica, Marty-Quinternet, Solène, Meghadecha, Mohamed, Mergeay-Fabre, Mayka, Mespoulhe, Pauline, Meunier, Alexandre, Migaud, Maria-Claire, Motiejunaite, Justina, Nathalie, Gay, Nguyen, Duc, Oubbea, Soumaya, Pagadoy, Maïder, Paris, Adeline, Paris, Christophe, Payet, Christine, Peiffer-Smadja, Nathan, Perez, Lucas, Perreau, Pauline, Pierrez, Nathalie, Pistone, Thierry, Postolache, Andreea, Rasoamanana, Patrick, Reminiac, Cécile, Rexah, Jade, Roche-Gouanvic, Elise, Rousseau, Alexandra, Schoemaecker, Betty, Simon, Sandrine, Soler, Catherine, Somers, Stéphanie, Sow, Khaly, Tardy, Bernard, Terzian, Zaven, Tournier, Anne, Tyrode, Sandrine, Vauchy, Charline, Verdon, Renaud, Vernet, Pauline, Vignali, Valérie, Waucquier, Nawal, Do Thi Thu, Huong, Laouénan, Cédric, Mentre, France, Pauline, Manchon, Dechanet, Aline, Letrou, Sophie, Quintin, Caroline, Frezouls, Wahiba, Le Hingrat, Quentin, Damond, Florence, Descamps, Dianes, Visseaux, Benoit, Vabret, Astrid, Bouscambert, Maud, Gaillanne, Laurence, Benmalek, Nabil, Attia, Mikael, Barbet, Marion, Petres, Stéphane, Escriou, Nicolas, Goyard, Sophie, Kafif, Ouifiya, Piquard, Valentine, Mailles, Alexandra, Simondon, Anne, Dreyere, Marion, Morel, Bruno, Vesval, Thiphaine, Amat, Karine, Ammour, Douae, Aqourras, Khadija, Couffin-Cadiergues, Sandrine, Delmas, Christelle, Desan, Vristi, Jean, Michel Doute, Esperou, Hélène, Hendou, Samia, Kouakam, Christelle, Le Meut, Guillaume, Lemestre, Soizic, Leturque, Nicolas, Marcoul, Emmanuelle, Nguefang, Solange, Roufai, Layidé, Abel, Laurent, Caillat-Zucman, Sophie, Study Group, Covcontact, Centre d'investigation Clinique [CHU Bichat] - Épidémiologie clinique (CIC 1425), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM), 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, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre interdisciplinaire de recherche en biologie (CIRB), Labex MemoLife, École normale supérieure - Paris (ENS-PSL), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Collège de France (CdF (institution))-Ecole Superieure de Physique et de Chimie Industrielles de la Ville de Paris (ESPCI Paris), Université Paris sciences et lettres (PSL)-École normale supérieure - Paris (ENS-PSL), Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Génétique Moléculaire des Virus à ARN - Molecular Genetics of RNA Viruses (GMV-ARN (UMR_3569 / U-Pasteur_2)), Institut Pasteur [Paris] (IP)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Centre National de Référence des virus des infections respiratoires (dont la grippe) - National Reference Center Virus Influenzae [Paris] (CNR - laboratoire coordonnateur), Institut Pasteur [Paris] (IP), Hôpital Beaujon [AP-HP], Physique des fonctions biologiques / Physics of Biological Functions, Institut Pasteur [Paris] (IP)-Centre National de la Recherche Scientifique (CNRS), Biologie Cellulaire des Lymphocytes - Lymphocyte Cell Biology, Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM), St George's, University of London, University Children’s Hospital Basel = Hôpital pédiatrique universitaire des deux Bâle [Bâle, Suisse] (UKBB), University Medical Center [Utrecht], Universiteit Antwerpen = University of Antwerpen [Antwerpen], Virology and human respiratory Pathologies - Virology and human respiratory Pathologies (VirPath), 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)-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), Centre National de Référence des Virus des Infections Respiratoires (dont la Grippe) [Lyon] (CNR - laboratoire associé), Institut des Agents Infectieux [Lyon] (IAI), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), CHU Pontchaillou [Rennes], Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), ANR-20-COVI-0002,CORaDiag,COVID 19 Rapid diagnosis test (development and clinical validation in 7 weeks)(2020), École normale supérieure - Paris (ENS Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Ecole Superieure de Physique et de Chimie Industrielles de la Ville de Paris (ESPCI Paris), Université Paris sciences et lettres (PSL)-Collège de France (CdF (institution))-École normale supérieure - Paris (ENS Paris), Université Paris sciences et lettres (PSL)-Collège de France (CdF (institution))-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université Paris sciences et lettres (PSL)-Collège de France (CdF (institution))-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Microbiology (medical), medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Health Personnel, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), [SDV]Life Sciences [q-bio], Pneumonia, Viral, Sars-cov-2, Betacoronavirus, 03 medical and health sciences, Health personnel, 0302 clinical medicine, High-risk exposure, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Personal protective equipment, medicine, Humans, Risk exposure, Transmission, 030212 general & internal medicine, Letter to the Editor, Pandemics, ComputingMilieux_MISCELLANEOUS, 0303 health sciences, 030306 microbiology, Transmission (medicine), business.industry, COVID-19, 3. Good health, Infectious Diseases, Cohort, Emergency medicine, In-hospital workers, Human medicine, Coronavirus Infections, business
Abstract

International audience

Published
2021
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14. Detection of SARS-CoV-2 N-antigen in blood during acute COVID-19 provides a sensitive new marker and new testing alternatives

Author

Marcoul Emmanuelle, Benoit Visseaux, Minh Patrick Lê, Alphonsine Diouf, Mergeay-Fabre Mayka, Kasprzyk Emmanuelle, Hazevis Beatrice, Houhou Nadhira, Christophe Choquet, Laviolle Bruno, Benedicte Rossignol, Verdon Renaud, Aqourras Khadija, Bourgeon Marilou, Lehur Claire, Ikram Houas, Ventzislava Petrov-Sanchez, Jeremie Guedj, Aurelie Veislinger, Amina Meziane, Brick Lysiane, Salma Jaafoura, Alexandre Hoctin, Visseaux Benoit, Oriane Puéchal, Alavoine Loubna, Denis Malvy, Gautier Celine, Letienne Estelle, Djossou Felix, Amiel-Taieb Karline, Esperou Helene, Thy Michael, Alpha Diallo, Bertholon Frederique, Sow Khaly, Boutrou Mathilde, Somers Stephanie, Tardy Bernard, Descamps Dianes, Rose Thierry, Morgane Gilg, Lucarelli Aude, Kikoine John, Charles Burdet, Barbet Marion, Kafif Ouifiya, Yazdan Yazdanpanah, Perez Lucas, Justine Pages, Laurent Abel, Florence Damond, Kouakam Christelle, Guillemin Francis, Dominique Deplanque, Marie Pierre Debray, Camille Couffignal, Botelho-Nevers Elisabeth, Jean Sebastien Hulot, Desmarets Maxime, Meunier Alexandre, Legrand Amelie, Maillot Adrien, Marine Beluze, Hartard Cedric, Bansard Helene, Legoas Carole, Gantier Emilie, Ledru Eric, Noemie Mercier, Sylvie van der Werf, Philippine Eloy, Guillaume Lingas, Coralie Tardivon, Fouchard Julie, Dewitte Marie, Bruno Lina, Alexandra Coelho, Boissel Nolwenn, Demeret Caroline, Marty-Quinternet Solene, Cédric Laouénan, Nassima Si Mohammed, Meghadecha Mohamed, Reminiac Cecile, Isabelle Gorenne, Chabouis Agnes, Paris Adeline, Sabrina Kali, Pierrez Nathalie, Mathilde Desvallee, Cracowski Jean Luc, Nathan Peiffer-Smadja, Tournier Anne, Abry Dominique, Marina Esposito-Farese, Lucet Jean-Christophe, Tristan Gigante, Abad Fanny, Olivier Picone, Lefevre Benjamin, Soizic Le Mestre, Ecobichon Jean-Luc, Manuel Rosa-Calatrava, Morel Bruno, Leturque Nicolas, Nguyen Duc, Nathalie Gault, Simon Sandrine, Jade Ghosn, Letrou Sophie, Elrezzi Elise, Ilic-Habensus Emila, Hodaj Enkelejda, Quintin Caroline, Doute Jean Michel, Schoemaecker Betty, Escriou Nicolas, Francois Dubos, A. Jeudy, Gilles Peytavin, Nadhira Houhou-Fidouh, Aurelie Papadopoulos, Noemie Vanel, Aurélie Wiedemann, Vincent Enouf, Rasoamanana Patrick, Behillil Sylvie, Le Hingrat Quentin, Vernet Pauline, Eric D'Ortenzio, Couffin-Cadiergues Sandrine, Damond Florence, Rousseau Alexandra, Jimmy Mullaert, Lemestre Soizic, Cracowski Claire, Malapate Catherine, Hocquet Didier, Francois Teoule, Hervé Le Nagard, Krishna Bhavsar, Mandic Milica, Postolache Andreea, Yves Levy, Caroline Semaille, Perreau Pauline, Frezouls Wahiba, Malvy Denis, Bouscambert Maud, Nadège Néant, Soler Catherine, Dreyere Marion, Nabil Benmalek, Diane Descamps, Allain Jean-Sebastien, Gerardin Patrick, Lila Bouadma, Charlotte Charpentier, Roufai Layide, Caillat-Zucman Sophie, Sandrine Couffin-Cardiergues, Sylvie Behilill, François Angoulvant, Coignard Bruno, Marina Mambert, Petres Stephane, Jean-François Timsit, Dehbia Benkerrou, Coralie Khan, Goyard Sophie, Motiejunaite Justina, Le Meut Guillaume, Burdet Charles, Christelle Paul, Catherine Chirouze, Pagadoy Maider, Hugo Mouquet, Hendou Samia, Fortuna Viviane, Dechanet Aline, Claire Andrejak, Marion Schneider, Claire Levy-Marchal, Christelle Tual, Olivier Terrier, Gerset Sandrine, J.-C. Lucet, Ammour Douae, Quentin Le Hingrat, Madeline Isabelle, Piquard Valentine, Costenoble Virginie, Paris Christophe, Lepiller Quentin, Manuel Etienne, Vignali Valerie, Oubbea Soumaya, Kane Maty, Hélène Espérou, François-Xavier Lescure, Desan Vristi, Vauchy Charline, Francois Bompart, Simondon Anne, Xavier Duval, Delphine Bachelet, Tyrode Sandrine, Rexah Jade, Bruneau Lea, Carine Roy, Gilbert Marie, Amat Karine, Augustin Shana, Gissot Valerie, Lehacaut Jonathan, Do Thi Thu Huong, Antoine Khalil, Marie Capucine Tellier, Pauline Manchon, Ouifiya Kafif, Bouiller Kevin, Jeulin Helene, Faurous William, Tubiana Sarah, Cour Sylvie, Detoc Maelle, Van Der Werf Sylvie, Mailles Alexandra, Audoin Pierre, Nguefang Solange, Mespoulhe Pauline, Caumes Eric, Alexandre Gaymard, Pistone Thierry, Laouenan Cedric, Delmas Christelle, Lepuil Severine, Ayala Sandrine, Lemouche Dalila, Dequand Stephane, Céline Dorival, Lina Bruno, Minerva Cervantes-Gonzalez, Duval Xavier, Costa Yolande, Leclercq Anne, Vabret Astrid, Theo Trioux, Samira Laribi, Roche-Gouanvic Elise, Houria Ichou, Deplanque Dominique, Isabelle Hoffmann, Marion Noret, Benmalek Nabil, Gaillanne Laurence, Mélanie Bertine, Lysa Tagherset, Peiffer-Smadja Nathan, Migaud Maria-Claire, Waucquier Nawal, Desille-Dugast Mireille, Nadia Ettalhaoui, Sarah Tubiana, Payet Christine, Romain Basmaci, Laine Fabrice, Attia Mikael, Patrick Rossignol, Charlene Da Silveira, Legrand Karine, Florentia Kaguelidou, Chirouze Catherine, Chan Thien Eric, Lebeaux David, Maude Bouscambert, Vesval Thiphaine, Charpentier Charlotte, Terzian Zaven, 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, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Pasteur [Paris] (IP), Qiagen, BioMérieux, Gilead, Theratechnologie, Hologic, ViiV Healthcare, Abbvie, BMS, J&J, Pfizer, Beckton Dickinson, REACTing, 20-0424, Ministry of Health, ANRS, AAZ, Inserm, Sanofi Pasteur, Da Volterra, Biomerieux, Mylan, MSD, Medimune, Gilead Sciences, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, 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), and Jonchère, Laurent

Subjects
0301 basic medicine, Microbiology (medical), Serum, medicine.medical_specialty, Saliva, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), [SDV]Life Sciences [q-bio], 030106 microbiology, Antigenemia, Gastroenterology, 03 medical and health sciences, Plasma, 0302 clinical medicine, Antigen, Internal medicine, Medicine, Sampling (medicine), 030212 general & internal medicine, Symptom onset, Diagnostic, business.industry, SARS-CoV-2, COVID-19, General Medicine, Serum samples, 3. Good health, [SDV] Life Sciences [q-bio], Research Note, Infectious Diseases, Blood, business, Viral load
Abstract

Objectives Molecular assays on nasopharyngeal swabs remain the cornerstone of COVID-19 diagnostics. The high technicalities of nasopharyngeal sampling and molecular assays, as well as scarce resources of reagents, limit our testing capabilities. Several strategies failed, to date, to fully alleviate this testing process (e.g. saliva sampling or antigen testing on nasopharyngeal samples). We assessed the clinical performances of SARS-CoV-2 nucleocapsid antigen (N-antigen) ELISA detection in serum or plasma using the COVID-19 Quantigene® (AAZ, France) assay. Methods Performances were determined on 63 serum samples from 63 non-COVID patients and 227 serum samples (165 patients) from the French COVID and CoV-CONTACT cohorts with RT-PCR-confirmed SARS-CoV-2 infection, including 142 serum samples (114 patients) obtained within 14 days after symptom onset. Results Specificity was 98.4% (95% CI 95.3–100). Sensitivity was 79.3% overall (180/227, 95% CI, 74.0–84.6) and 93.0% (132/142, 95% CI, 88.7–97.2) within 14 days after symptom onset. Ninety-one of the included patients had serum samples and nasopharyngeal swabs collected in the same 24 hr. Among those with high nasopharyngeal viral loads, i.e. Ct value below 30 and 33, only 1/50 and 4/67 tested negative for N-antigenaemia, respectively. Among those with a negative nasopharyngeal RT-PCR, 8/12 presented positive N-antigenaemia; the lower respiratory tract was explored for six of these eight patients, showing positive RT-PCR in five cases. Discussion This is the first evaluation of a commercially available serum N-antigen detection assay. It presents a robust specificity and sensitivity within the first 14 days after symptoms onset. This approach provides a valuable new option for COVID-19 diagnosis, only requiring a blood draw and easily scalable in all clinical laboratories.

Published
2021

23. On-Demand Sildenafil as a Treatment for Raynaud Phenomenon

Author

Roustit, Matthieu, Giai, Joris, Gaget, Olivier, Khouri, Charles, Mouhib, Myriam, Lotito, Adrien, Blaise, Sophie, Seinturier, Christophe, Subtil, Fabien, Paris, Adeline, Cracowski, Claire, Imbert, Bernard, Carpentier, Patrick, Vohra, Sunita, Cracowski, Jean-Luc, Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire [Grenoble] (CHU), Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Hospices Civils de Lyon (HCL), Université de Lyon, and University of Alberta

Subjects
[STAT.AP]Statistics [stat]/Applications [stat.AP], [STAT.ME]Statistics [stat]/Methodology [stat.ME], ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2018

26. Incidence of Asymptomatic and Symptomatic Influenza Among Healthcare Workers: A Multicenter Prospective Cohort Study.

Author

Bénet, Thomas, Amour, Sélilah, Valette, Martine, Saadatian-Elahi, Mitra, Aho-Glélé, Ludwig Serge, Berthelot, Philippe, Denis, Marie-Agnès, Grando, Jacqueline, Landelle, Caroline, Astruc, Karine, Paris, Adeline, Pillet, Sylvie, Lina, Bruno, Vanhems, Philippe, and Group, AFP Study

Subjects
INFLUENZA epidemiology, RESEARCH, ACADEMIC medical centers, CONFIDENCE intervals, MEDICAL personnel, CROSS infection, MEDICAL cooperation, DISEASE incidence, PSYCHOSOCIAL factors, DESCRIPTIVE statistics, POLYMERASE chain reaction, LONGITUDINAL method
Abstract

Background Influenza is an important cause of viral hospital-acquired infection involving patients, healthcare workers (HCW), and visitors. The frequency of asymptomatic influenza among HCW with possible subsequent transmission is poorly described. The objective is to determine the cumulative incidence of asymptomatic, paucisymptomatic, and symptomatic influenza among HCW. Method A multicenter prospective cohort study was done in 5 French university hospitals, including 289 HCW during the 2016–2017 influenza season. HCW had 3 physical examinations (time [T] 0, before epidemic onset; T.1, before epidemic peak; T.2, T.3, after epidemic peak). A blood sample was taken each time for influenza serology and a nasal swab was collected at T1 and T2 for influenza detection by polymerase chain reaction (PCR). Positive influenza was defined as either a positive influenza PCR, and/or virus-specific seroconversion against influenza A, the only circulating virus, with no vaccination record during follow-up. Symptoms were self-reported daily between T1 and T2. Cumulative incidence of influenza was stratified by clinical presentation per 100 HCW. Results Of the 289 HCW included, 278 (96%) completed the entire follow-up. Overall, 62 HCW had evidence of influenza of whom 46.8% were asymptomatic, 41.9% were paucisymptomatic, and 11.3% were symptomatic. Cumulative influenza incidence was 22.3% (95% confidence interval [CI]: 17.4%–27.2%). Cumulative incidence of asymptomatic influenza was 5.8% (95% CI: 3.3%–9.2%), 13.7% (95% CI: 9.9%–18.2%) for paucisymptomatic influenza, and 2.9% (95% CI: 1.3%–5.5%) for symptomatic influenza. Conclusions Asymptomatic and paucisymptomatic influenza were frequent among HCW, representing 47% and 42% of the influenza burden, respectively. These findings highlight the importance of systematic implementation of infection control measures among HCW regardless of respiratory symptoms from preventing nosocomial transmission of influenza. Clinical Trials Registration NCT02868658. [ABSTRACT FROM AUTHOR]

Published
2021
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27. Effect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban

Author

MARLU, Raphaël, Hodaj, Enkelejda, Paris, Adeline, Albaladejo, Pierre, Crackowski, Jean, Pernod, Gilles, Université Grenoble Alpes (UGA), Thérapeutique Recombinante Expérimentale (TIMC-IMAG-TheREx), Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525 (TIMC-IMAG), Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP)-IMAG-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA)-Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP)-IMAG-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), Xénobiotiques, Institut National de la Recherche Agronomique (INRA)-Ecole Nationale Vétérinaire de Toulouse (ENVT), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, Service d'anesthésie-réanimation, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-Hôpital Michallon, Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP)-IMAG-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Ecole Nationale Vétérinaire de Toulouse (ENVT), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Recherche Agronomique (INRA), and Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])

Subjects
[SDV]Life Sciences [q-bio], [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, ComputingMilieux_MISCELLANEOUS, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience

Published
2017

28. Quality of written information in biomedical research in France

Author

Kerlan-Paris, Adeline, Kerlan-Paris, Adeline, Centre d'Investigation Clinique [Grenoble] (CIC Grenoble), Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-Hôpital Michallon-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Joseph-Fourier - Grenoble I, Jean-Luc CRACOWSKI(Jean-Luc.cracowski@ujf-grenoble.fr), CIC Lyon, CIC Strasbourg, CIC Nancy, CIC Toulouse, CIC Saint-Etienne, and URC Créteil

Subjects
[SDV.OT]Life Sciences [q-bio]/Other [q-bio.OT], biomedical research, compréhension, [SDV.OT] Life Sciences [q-bio]/Other [q-bio.OT], questionnaire, informed consent, lisibilité, readability, Recherche biomédicale, Consentement, information
Abstract

The Informed Consent Form (ICF) is very important in biomedical research, so its quality is crucial. However, many publications emphasize its low readability and the difficulties to understand it. We studied the French documents. In a first step, we showed that the lexicosyntactic readability of the informed consent forms was lower than a university level. We then described that ethic committees did not improve lexicosyntactic readability and that they increased the length and complexity of the document. We after compared the readability and the density of ICF and pieces of popular science. The ICF have a low readability level and a low density. Thanks to our questionnaire validated, the QCFic, we showed that improving the lexicosyntactic readability or asking a working group to correct the ICF allows a better understanding in healthy volunteers . However, in patients, we tested the two techniques but no one Has an effect on comprehension. It therefore seems necessary to conduct a study in a real situation, in factorial plan, to evaluate on the one hand the lexicosyntactic modification of ICF, on the other hand, the intervention of a third person in the process of Information., Le document écrit d'information et de consentement éclairé (DICE) en recherche biomédicale a une très grande importance, c'est pourquoi sa qualité est primordiale. Cependant, nombreuses publications soulignent sa faible lisibilité et la difficulté à le comprendre. Nous avons souhaité étudier les documents d'information et de consentement français. Dans un premier temps, nous avons montré que la lisibilité lexicosyntaxique des formulaires d'information et de consentement était plus faible que celle de sujets d'agrégation par exemple. Nous avons ensuite décrit que les comités de protection des personnes n'amélioraient pas la lisibilité lexicosyntaxique et qu'ils augmentaient la longueur et la complexité du document. Nous avons ensuite comparé la lisibilité et la densité d'information de documents d'information et de textes de vulgarisation scientifique. Les formulaires d'information et de consentement sont peu lisibles et peu denses. Puis, grâce à notre questionnaire QCFic validé, nous avons pu montrer qu'améliorer la lisibilité lexicosyntaxique ou demander à un groupe de travail de corriger le document d'information permet une meilleure compréhension des formulaires d'information et de consentement chez des volontaires sains. Cependant, chez des malades, , nous avons testé les deux techniques d'amélioration des formulaires d'information mais aucune des deux n'a d'effet. Il semble donc nécessaire de réaliser une étude en situation réelle, en plan factoriel où seraient évalués d'une part la modification lexicosyntaxique des formulaires d'information et de consentement, d'autre part l'intervention d'une tierce personne dans le processus d'information

Published
2008

29. Population pharmacokinetics of micafungin in ICU patients with sepsis and mechanical ventilation

Author

Jullien, Vincent, primary, Azoulay, Elie, additional, Schwebel, Carole, additional, Le Saux, Thomas, additional, Charles, Pierre Emmanuel, additional, Cornet, Muriel, additional, Souweine, Bertrand, additional, Klouche, Kadda, additional, Jaber, Samir, additional, Trouillet, Jean-Louis, additional, Bruneel, Fabrice, additional, Cour, Martin, additional, Cousson, Joel, additional, Meziani, Ferhat, additional, Gruson, Didier, additional, Paris, Adeline, additional, Darmon, Michael, additional, Garrouste-Orgeas, Maité, additional, Navellou, Jean-Christophe, additional, Foucrier, Arnaud, additional, Allaouchiche, Bernard, additional, Das, Vincent, additional, Gangneux, Jean-Pierre, additional, Ruckly, Stéphane, additional, Wolff, Michel, additional, and Timsit, Jean-François, additional

Published
2016
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30. [Readability of informed consent forms for subjects participating in biomedical research: updating is required]

Author

Paris , Adeline, Cracowski , Jean-Luc, Ravanel , Nadia, Cornu , Catherine, Gueyffier , François, Deygas , Béatrice, Guillot , Karine, Bosson , Jean-Luc, Hommel , Marc, Centre d'Investigation Clinique [Grenoble] (CIC Grenoble), Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-Hôpital Michallon-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC CHU Lyon (inserm), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Saint Etienne, Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, Adeline, CIC - Grenoble, Université Joseph Fourier - Grenoble 1 ( UJF ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ), and Université Jean Monnet [Saint-Étienne] ( UJM ) -Institut National de la Santé et de la Recherche Médicale ( INSERM )

Subjects
MESH: Human Experimentation, MESH : Single-Blind Method, MESH: Random Allocation, lisibilité, MESH: Consent Forms, MESH: Comprehension, Consent Forms, Random Allocation, MESH : Child, MESH: Child, MESH: Informed Consent, MESH: Double-Blind Method, Single-Blind Method, Textbooks as Topic, MESH : Consent Forms, MESH: Qualitative Research, Child, Qualitative Research, MESH: Statistics, Nonparametric, Informed Consent, MESH: Research Design, Age Factors, MESH : Comprehension, MESH : Adult, MESH : Research Design, Research Design, MESH: Research Subjects, [ SDV.ETH ] Life Sciences [q-bio]/Ethics, Educational Status, France, Comprehension, Adult, Adolescent, recherche biomédicale, Research Subjects, education, MESH : Textbooks as Topic, Statistics, Nonparametric, MESH : Random Allocation, Double-Blind Method, MESH : Human Experimentation, MESH : Adolescent, MESH : Qualitative Research, MESH : Double-Blind Method, Humans, MESH : France, MESH : Statistics, Nonparametric, MESH: Adolescent, MESH: Age Factors, formulaire d'information et de consentement, MESH: Humans, MESH : Humans, MESH: Adult, [SDV.ETH] Life Sciences [q-bio]/Ethics, MESH: Single-Blind Method, MESH: Textbooks as Topic, [SDV.ETH]Life Sciences [q-bio]/Ethics, MESH: France, MESH : Informed Consent, Human Experimentation, MESH : Age Factors, MESH: Educational Status, MESH : Educational Status, MESH : Research Subjects
Abstract

National audience; OBJECTIVE: We compared informed consent forms of subjects participating in biomedical research with those of references texts in order to determine the factors that influence readability. METHODS: We assessed the readability of 73 informed consent forms of research protocols conducted in the clinical investigation centres in the Rhone-Alpes area, and then compared them with 33 reference texts corresponding to 5 French school grades (first year infant, primary school, GCS level, high school, and classics aggregation), using the Flesch test and Cordial" analyser. RESULTS: Median Flesch scores were 66 for the first year infant level, 62 for the primary school level, 58 for the GCS level, 42 for the high school level, and 43 for the aggregation level. It was 22 for the informed consent forms. Median Cordial scores were 86 for the first year infant level, 77 for the second, 74 for the third, 49 for the fourth, 43 for the fifth. It was 1 for the informed consent forms. No methodological factor correlated with Flesch and Cordial" results. CONCLUSION: The quantitative readability scores for informed consent forms for subjects participating in biomedical research are low, lower than those proposed to aggregation candidates, whatever the type of protocol. Some thought must be given to the impact of the reduced readability on patients' understanding, and steps should be taken to improve the readability of the forms.

Published
2005

31. Pulmonary Langerhans histiocytosis and Hodgkin's lymphoma

Author

Paris, Adeline, Dib, Mamoun, Rousselet, Marie-Christine, Urban, Thierry, Tazi, A., Gagnadoux, Frédéric, CIC - Grenoble, Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'hématologie [Angers], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Hémodynamique, Interaction Fibrose et Invasivité tumorales Hépatiques (HIFIH), Université d'Angers (UA), Micro et Nanomédecines Translationnelles (MINT), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Stress Oxydant et Pathologies Métaboliques (SOPAM), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Mitochondrie : Régulations et Pathologie

Subjects
Lung Diseases, Mitoguazone, Vindesine, [SDV]Life Sciences [q-bio], Marijuana Smoking, Vinblastine, Methylprednisolone, Bleomycin, Young Adult, immune system diseases, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, Traffic, Humans, Ifosfamide, Langerhans-Cell, Bronchioles, Lymphatic Diseases, Melphalan, Tomography, Etoposide, Incidental Findings, Remission Induction, Smoking, Cytarabine, Carmustine, Hodgkin Disease, X-Ray Computed, Dacarbazine, Doxorubicin, Accidents, Female, Histiocytosis
Abstract

International audience; Pulmonary Langerhans histiocytosis (PLH) is a rare disease due to the accumulation of Langerhans cells at the level of the bronchioles. These dendritic immunocytes form granulomata and destroy the wall of the airway. We report a case of PLH developing at the same time as Hodgkin's lymphoma in a young woman who smoked tobacco and cannabis. We observed a complete remission of the PLH lesions parallel to the remission of the Hodgkin's lymphoma after chemotherapy, in the absence of any change in the consumption of tobacco and cannabis. This observation leads us to discuss the potential relationships between PLH on one hand, and smoking, the lymphoma and its treatment on the other.

Published
2011

32. Qualité de l'information écrite aux personnes se prêtant à une recherche biomédicale en France. Etudes QuIPs

Author

Kerlan-Paris, Adeline, Centre d'Investigation Clinique [Grenoble] (CIC Grenoble), Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-Hôpital Michallon-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Joseph-Fourier - Grenoble I, Jean-Luc CRACOWSKI(Jean-Luc.cracowski@ujf-grenoble.fr), CIC Lyon, CIC Strasbourg, CIC Nancy, CIC Toulouse, CIC Saint-Etienne, and URC Créteil

Subjects
[SDV.OT]Life Sciences [q-bio]/Other [q-bio.OT], biomedical research, compréhension, questionnaire, informed consent, lisibilité, readability, Recherche biomédicale, Consentement, information
Abstract

The Informed Consent Form (ICF) is very important in biomedical research, so its quality is crucial. However, many publications emphasize its low readability and the difficulties to understand it. We studied the French documents. In a first step, we showed that the lexicosyntactic readability of the informed consent forms was lower than a university level. We then described that ethic committees did not improve lexicosyntactic readability and that they increased the length and complexity of the document. We after compared the readability and the density of ICF and pieces of popular science. The ICF have a low readability level and a low density. Thanks to our questionnaire validated, the QCFic, we showed that improving the lexicosyntactic readability or asking a working group to correct the ICF allows a better understanding in healthy volunteers . However, in patients, we tested the two techniques but no one Has an effect on comprehension. It therefore seems necessary to conduct a study in a real situation, in factorial plan, to evaluate on the one hand the lexicosyntactic modification of ICF, on the other hand, the intervention of a third person in the process of Information.; Le document écrit d'information et de consentement éclairé (DICE) en recherche biomédicale a une très grande importance, c'est pourquoi sa qualité est primordiale. Cependant, nombreuses publications soulignent sa faible lisibilité et la difficulté à le comprendre. Nous avons souhaité étudier les documents d'information et de consentement français. Dans un premier temps, nous avons montré que la lisibilité lexicosyntaxique des formulaires d'information et de consentement était plus faible que celle de sujets d'agrégation par exemple. Nous avons ensuite décrit que les comités de protection des personnes n'amélioraient pas la lisibilité lexicosyntaxique et qu'ils augmentaient la longueur et la complexité du document. Nous avons ensuite comparé la lisibilité et la densité d'information de documents d'information et de textes de vulgarisation scientifique. Les formulaires d'information et de consentement sont peu lisibles et peu denses. Puis, grâce à notre questionnaire QCFic validé, nous avons pu montrer qu'améliorer la lisibilité lexicosyntaxique ou demander à un groupe de travail de corriger le document d'information permet une meilleure compréhension des formulaires d'information et de consentement chez des volontaires sains. Cependant, chez des malades, , nous avons testé les deux techniques d'amélioration des formulaires d'information mais aucune des deux n'a d'effet. Il semble donc nécessaire de réaliser une étude en situation réelle, en plan factoriel où seraient évalués d'une part la modification lexicosyntaxique des formulaires d'information et de consentement, d'autre part l'intervention d'une tierce personne dans le processus d'information

Published
2008

33. [Satisfaction of subjects enrolled in clinical studies]

Author

Huot, Laure, Paris, Adeline, Bosson, Jean-Luc, Boignard, Aude, Hommel, Marc, Labarère, José, Cracowski, Jean-Luc, TIMB, Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525 (TIMC-IMAG), VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Centre National de la Recherche Scientifique (CNRS)-Université Joseph Fourier - Grenoble 1 (UJF)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Centre National de la Recherche Scientifique (CNRS)-Université Joseph Fourier - Grenoble 1 (UJF)-CIC - Grenoble, Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC - Grenoble, Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM), Unité neurovasculaire - Service de neurologie, CHU Grenoble, VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Centre National de la Recherche Scientifique (CNRS)-Université Joseph Fourier - Grenoble 1 (UJF)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Centre National de la Recherche Scientifique (CNRS)-Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble, and Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-CHU Grenoble

Subjects
[SDV.EE.SANT]Life Sciences [q-bio]/Ecology, environment/Health, Male, Clinical Trials as Topic, MESH: Humans, MESH: Middle Aged, MESH: Clinical Trials as Topic, Research Subjects, MESH: Questionnaires, Data Collection, MESH: Hospitals, Teaching, Consumer Behavior, Middle Aged, MESH: Consumer Satisfaction, MESH: Male, MESH: France, MESH: Research Subjects, Surveys and Questionnaires, Humans, MESH: Data Collection, Female, France, Hospitals, Teaching, MESH: Female
Abstract

OBJECTIVE: The Grenoble clinical research centre carried out a prospective satisfaction survey of subjects taking part in clinical studies undertaken in its buildings. MATERIALS AND METHODS: A questionnaire adapted from Grenoble teaching hospital's inpatient satisfaction survey was sent to 198 subjects. It comprised 24 items pooled in categories on which were calculated average scores. The participation rate of the survey was 82.6%. On the whole, 94.4% of the questioned subjects would accept to take part in a new study if we requested them, and 72.2% were satisfied or very satisfied with their stay; 24% had no opinion. The mean overall satisfaction score was 8.6 (95% confidence interval: 7.6-9.6) out of 10. CONCLUSION: This investigation shows that the assumption of responsibility of the subjects by specific personnel and in an adapted place, within the framework of clinical protocol of research, is associated with a high satisfaction of the subjects. However, we still have to improve the transmission of the clinical study results to the patients.

Published
2006

34. Empirical Micafungin Treatment and Survival Without Invasive Fungal Infection in Adults With ICU-Acquired Sepsis, Candida Colonization, and Multiple Organ Failure: The EMPIRICUS Randomized Clinical Trial.

Author

Timsit, Jean-Francois, Azoulay, Elie, Schwebel, Carole, Charles, Pierre Emmanuel, Cornet, Muriel, Souweine, Bertrand, Klouche, Kada, Jaber, Samir, Trouillet, Jean-Louis, Bruneel, Fabrice, Argaud, Laurent, Cousson, Joel, Meziani, Ferhat, Gruson, Didier, Paris, Adeline, Darmon, Michael, Garrouste-Orgeas, Maité, Navellou, Jean-Christophe, Foucrier, Arnaud, and Allaouchiche, Bernard

Subjects
SEPSIS, ANTIBACTERIAL agents, MYCOSES, CRITICALLY ill, ANTIFUNGAL agents, ANTIBIOTICS, PEPTIDES, CANDIDIASIS, CATASTROPHIC illness, COMPARATIVE studies, CROSS infection, DRUG administration, RESEARCH methodology, MEDICAL cooperation, MULTIPLE organ failure, PROGNOSIS, RESEARCH, TIME, EVALUATION research, RANDOMIZED controlled trials, BLIND experiment, INVASIVE candidiasis, PREVENTION, THERAPEUTICS
Abstract

Importance: Although frequently used in treating intensive care unit (ICU) patients with sepsis, empirical antifungal therapy, initiated for suspected fungal infection, has not been shown to improve outcome.Objective: To determine whether empirical micafungin reduces invasive fungal infection (IFI)-free survival at day 28.Design, Setting, and Participants: Multicenter double-blind placebo-controlled study of 260 nonneutropenic, nontransplanted, critically ill patients with ICU-acquired sepsis, multiple Candida colonization, multiple organ failure, exposed to broad-spectrum antibacterial agents, and enrolled between July 2012 and February 2015 in 19 French ICUs.Interventions: Empirical treatment with micafungin (100 mg, once daily, for 14 days) (n = 131) vs placebo (n = 129).Main Outcomes and Measures: The primary end point was survival without proven IFI 28 days after randomization. Key secondary end points included new proven fungal infections, survival at day 28 and day 90, organ failure, serum (1-3)-β-D-glucan level evolution, and incidence of ventilator-associated bacterial pneumonia.Results: Among 260 patients (mean age 63 years; 91 [35%] women), 251 (128, micafungin group; 123, placebo group) were included in the modified intent-to-treat analysis. Median values were 8 for Sequential Organ Failure Assessment (SOFA) score, 3 for number of Candida-colonized sites, and 99 pg/mL for level of (1-3)-β-D-glucan. On day 28, there were 82 (68%) patients in the micafungin group vs 79 (60.2%) in the placebo group who were alive and IFI free (hazard ratio [HR], 1.35 [95% CI, 0.87-2.08]). Results were similar among patients with a (1-3)-β-D-glucan level of greater than 80 pg/mL (n = 175; HR, 1.41 [95% CI, 0.85-2.33]). Day-28 IFI-free survival in patients with a high SOFA score (>8) was not significantly different when compared between the micafungin vs placebo groups (HR, 1.69 [95% CI, 0.96-2.94]). Use of empirical micafungin decreased the rate of new invasive fungal infection in 4 of 128 patients (3%) in the micafungin group vs placebo (15/123 patients [12%]) (P = .008).Conclusions and Relevance: Among nonneutropenic critically ill patients with ICU-acquired sepsis, Candida species colonization at multiple sites, and multiple organ failure, empirical treatment with micafungin, compared with placebo, did not increase fungal infection-free survival at day 28.Trial Registration: clinicaltrials.gov Idenitfier: NCT01773876. [ABSTRACT FROM AUTHOR]

Published
2016
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36. Comparison of nine blood tests and transient elastography for liver fibrosis in chronic hepatitis C: The ANRS HCEP-23 study

Author

Zarski, Jean-Pierre, primary, Sturm, Nathalie, additional, Guechot, Jérôme, additional, Paris, Adeline, additional, Zafrani, Elie-Serge, additional, Asselah, Tarik, additional, Boisson, Renée-Claude, additional, Bosson, Jean-Luc, additional, Guyader, Dominique, additional, Renversez, Jean-Charles, additional, Bronowicki, Jean-Pierre, additional, Gelineau, Marie-Christine, additional, Tran, Albert, additional, Trocme, Candice, additional, Ledinghen, Victor De, additional, Lasnier, Elisabeth, additional, Poujol-Robert, Armelle, additional, Ziegler, Frédéric, additional, Bourliere, Marc, additional, Voitot, Hélène, additional, Larrey, Dominique, additional, Rosenthal-Allieri, Maria Alessandra, additional, Fouchard Hubert, Isabelle, additional, Bailly, François, additional, and Vaubourdolle, Michel, additional

Published
2012
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38. Evaluation of the effect of one large dose of erythropoietin against cardiac and cerebral ischemic injury occurring during cardiac surgery with cardiopulmonary bypass: a randomized double‐blind placebo‐controlled pilot study

Author

Joyeux‐Faure, Marie, primary, Durand, Michel, additional, Bedague, Damien, additional, Protar, Daniel, additional, Incagnoli, Pascal, additional, Paris, Adeline, additional, Ribuot, Christophe, additional, Levy, Patrick, additional, and Chavanon, Olivier, additional

Published
2011
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41. Impact of French‘Comités de Protection des Personnes’ on the readability of informed consent documents (ICD) in biomedical research: more information, but not better information.

Author

Paris, Adeline, Cracowski, Jean-Luc, Maison, Patrick, Radauceanu, Anca, Cornu, Catherine, and Hommel, Marc

Subjects
*MEDICAL research, *RESEARCH, *MEDICAL care, *INFORMED consent (Medical law), *DISCLOSURE, *MEDICAL ethics
Abstract

Information is the keystone to the participation of subjects in biomedical research. Clear comprehension of the informed consent documents (ICDs) is primordial and a necessary requirement is that they are readable. While submission of a protocol to a French‘Comités de Protection des Personnes’ (CPP) is a mandatory step with regard to the French legislation on biomedical research, no published data are available concerning its influence on ICDs readability. The aim of our study was to determine the impact of French CPP on the readability of ICDs, using lexico-syntactic readability indexes and ICDs from four clinical research centres and one clinical research unit. Twenty-five ICDs were analysed. The Flesch score was not modified after CPP review, while the Cordial score was significantly lower [from 4 (1–14) to 1 (1–13),P = 0.014]. The information was longer and more complex following CPP review. No protocol characteristics had any impact on the variation before and after review for either the Flesch or the Cordial® indexes, nor on the number of syllables per word. Changes in the total number of words before and after review varied considerably between study centre, supporting heterogeneity of CPP review. Since August 2004, French CPP have to study the intelligibility of ICDs in addition to the scientific and ethic aspects of a research. We show that their current reviews do not increase the readability, while increasing the length of ICDs. [ABSTRACT FROM AUTHOR]

Published
2005
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42. Mortality from malaria in France, 2005 to 2014

Author

Kendjo, Eric, Thellier, Marc, Noël, Harold, Jauréguiberry, Stéphane, Septfons, Alexandra, Mouri, Oussama, Gay, Frédérick, Tantaoui, Ilhame, Caumes, Eric, Houzé, Sandrine, Piarroux, Renaud, Musset, Lise, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre National de Référence du Paludisme [CHU Pitié-Salpétrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Santé publique France Guyane, Santé publique France - French National Public Health Agency [Saint-Maurice, France], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Mère et enfant en milieu tropical : pathogènes, système de santé et transition épidémiologique (MERIT - UMR_D 216), Institut de Recherche pour le Développement (IRD)-Université de Paris (UP), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Laboratoire de Parasitologie [Cayenne, Guyane française], Institut Pasteur de la Guyane, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP), Centre National de Référence du Paludisme [Cayenne, Guyane française] (CNR), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Mère et enfant en milieu tropical : pathogènes, système de santé et transition épidémiologique (MERIT - UMR_D 261), Institut de Recherche pour le Développement (IRD)-Université Paris Cité (UPCité), Réseau International des Instituts Pasteur (RIIP), Centre National de Référence du Paludisme [Cayenne, Guyane française] (CNR - laboratoire associé), Centre Collaborateur OMS pour la surveillance de la résistance aux antipaludiques [Cayenne, Guyane française] (CCOMS), Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), The French imported malaria Study group: C. Strady (CHU Reims), Caroline Lohmann (CH du Moenchsberg, Mulhouse), Celine Arriuberge (CH Trousseau, Paris), Emmanuel Grimprel (CH Trousseau, Paris), Jean-Marie Delarbre (CH du Moenchsberg, Mulhouse), Michel Thibault (CH René Dubos, Pontoise), Mohamadou Niang (CHR Orléans), A. Barrans (CH Sète), A. Martin (CH Périgueux), A. Spiegel (DESP Nord), A. Valentin (CHU Toulouse), A.S. Le Guern (Institut Pasteur, Paris), Adela Angoulvant (CHU Kremlin-Bicêtre, Paris), Adeline Dubois (CH Alès), Adrien Genin (CH Pays d'Aix), Agathe Lebuisson (CHU Cochin), Agnes Riche (CH Angoulême), Agnès Durand (Institut Pasteur, Paris), Agnès Fromont (CH Auxerre), Ahmed Aboubacar (CHU de Strasbourg), Ahmed Fateh Ousser (CH Louis Mourier), Aida Taieb (INTS, Paris), Alain Domergue (CH Alès - Cévennes), Alain Gravet (CH du Moenchsberg, Mulhouse), Alain Lecoustumier (CH de Cahors), Albert Faye (CHU Robert Debré, Paris), Alexander Pfaff (CHU de Strasbourg), Alexandra Faussart (CHU Bichat-Claude Bernard, Paris), Alexandre Chlilek (CHU Nîmes), Alice Borel (CHU Amiens), Alice Pérignon (CHU Pitié-Salpêtrière, Paris), Ana Mendes-Mreira (CH La Rochelle), André Gardrat (CH d’Evreux), Ange Kissila (CH Provins), Angèle LI (CH Creil (Laënnec)), Anne Cady (CH Bretagne Atlantique), Anne Debourgogne (CHU de Nancy), Anne Delaval (CHI Robert Ballanger, Aulnay-sous-Bois), Anne Goepp (CHI Villeneuve St Georges), Anne Marfaing-Koka (Hôpital Antoine-Béclère), Anne Pauline Bellanger (CHU Besançon, Jean Minjoz), Anne Vincenot-Blouin (CH Meaux), Anne-Marie Teychene-Coutet (CH Bondy-Jean Verdier), Anne-Sophie Deleplancque (CH Lille), Annick Verhaeghe (CH de Dunkerque), Annie Motard-Picheloup (CHI Fréjus St Raphaël), Antoine Berry (CHU Toulouse), Antoine Huguenin (CHU Reims), Arnaud Bouvet (CH Bretagne Atlantique), Audrey Merens (HIA Begin), Aurelie Roide (CHU Lariboisière, Paris), Aurore Sanson (CH Jacques Cœur, Bourges), Aurélie Fricot (CHU Necker), Aurélie Guigon (CHR Orléans), Benfatallah Dhouha (CHU Necker, Paris), Benjamin Wyplosz (CHU Kremlin-Bicêtre, Paris), Benoît Henri (INTS, Paris), Bernadette Buret (CH Niort), Bernadette Cuisenier (CHU Dijon), Bernadette Worms (CHU Dijon), Bernard Faugère (CH Timone, Marseille), Biligui Sylvestre (CHU Pitié-Salpêtrière, Paris), Boualem Sendid (CH Lille), Bruno Megarbane (CHU Lariboisière, Paris), Bruno Pradines (Département Microbiologie et Maladies Infectieuses, Institut de Recherche Biomédicale des Armées, 13005 Marseille, France, Aix Marseille University, IRD, SSA, AP-HM, VITROME, 13005 Marseille, France, IHU Méditerranée Infection, 13005 Marseille, France, Centre National de Référence du Paludisme, Institut de Recherche Biomédicale des Armées, 13005 Marseille, France), Béatrice Quinet (CH Trousseau, Paris), C. Braidy (CH du Sud Seine et Marne), C. Farrugia (CH de Dourdan), C. Finot (CH de Dreux), Camille Roussel (INTS, Paris), Camille Runel-Belliard (CHU de Bordeaux), Caren Brump (CHU Lariboisière, Paris), Carine Dokoula (CH Jacques Cœur, Bourges), Carmina Camal (CH Louis Mourier), Carole Mackosso (CHU Bichat-Claude Bernard, Paris), Carole Poupon (CH de Gonesse), Caroline Garandeau (CH Angoulême), Catherine Benoit (CH du Sud Seine et Marne), Catherine Branger (CH Louis Mourier), Catherine Brehant (CH La Rochelle), Catherine Desideri-Vaillant (HIA Clermont Tonnerre, Brest), Catherine Kauffmann Lacroix (CH Poitiers), Catherine Lafaurie (CH d’Epernay), Cecile Hombrouck-Alet (CH Blois), Cecile Ramade (Lyon-Croix-Rousse), Celine Damiani (CHU Amiens), Celine Gourmel (CHU Lariboisière, Paris), Chantal Duhamel (CHU Côte de Nacre), Chantal Garabedian (CH Pays d'Aix), Chralotte Chambrion (INTS, Paris), Christelle Morelle (CHU Montpellier), Christelle Pomares Estran (CH Universitaire de Nice), Christelle Prince (CH de Cayenne Andrée Rosemon), Christian Durand (CH Provins), Christian Fulleda (CHU Lariboisière, Paris), Christian Raccurt (CHU Amiens), Christine Chaigneau (GHPSO, Creil), Christine Chemla (CHRU de Reims), Christine Van batten (CH Laënnec, Creil), Christophe Martinaud (HIA Percy, Clamart), Christophe Rapp (HIA Begin), Claire Augé (CHU Bichat-Claude Bernard, Paris), Claire Malbrunot (CH Corbeil Essonne), Claudine Febvre (CH de Montbéliard), Claudine Sarfati (Hôpital Saint-Louis, Paris), Coralie l'Ollivier (CH de la Timone, Marseille), Corinne Huet (Hôpital Louis-Pasteur, Cherbourg-Octeville), Cournac Jean-Marie (HIA Percy, Clamart), Cynthia Pianetti (CH Gabriel Martin, La Réunion), Cécile Angebault (CHU Necker, Paris), Cécile Ficko (HIA Begin), Cécile Garnaud (CHU de Grenoble), Cécile Leprince (CHI Robert Ballanger, Aulnay-sous-Bois), Céliat Merat (CHU Nantes), Céline Dard (CHU de Grenoble), Céline Nourrisson (CHRU Clermont-Ferrand), Céline Tournus (Hôpital Delafontaine, Saint-Denis), Daniel Azjenberg (CHU Dupuytren, Limoges), Daniel Camus (CH Lille), Daniel Lusina (CHI Robert Ballanger, Aulnay-sous-Bois), Daniel Parzy (IMTSSA, Marseille), Denis Pons (CHRU Clermont-Ferrand), Denis Filisetti (CHU Strasbourg), Denis Malvy (CHU de Bordeaux), Didier Basset (CHU Montpellier), Didier Jan (CH Laval), Didier Poisson (CHR Orléans), Didier Raffenot (CH Chambéry), Dieudonné Bemba (CH Bondy-Jean Verdier), Dominique Maubon (CHU de Grenoble), Dominique Mazier (CHU Pitié-Salpêtrière, Paris), Dominique Popjora (CH Trousseau, Paris), Dominique Toubas (CHRU de Reims), Dorothée Quino (CHRU Morvan, Brest), Alioune Ndour (INTS, Paris), Ducout Louis (CH de la Côte Basque), Duong Thanh Hai (CHRU Bretonneau), E. Boyer (CH Le Mans), Edgar Ombandza (CH Provins), Edith Mazars (CH de Valenciennes), Elisabeth Buffet (CH de Epernay), Elodie Collin (CHI Robert Ballanger, Aulnay-sous-Bois), Elodie Meynet (CH Annecy Genevois), Emeline Scherer (CHU Besançon, Jean Minjoz), Emilie Fréalle (CH Lille), Emilie Klein (CHU Lariboisière, Paris), Emilie Sitterle (CHU Necker, Paris), Emily Ronez (CHU Lariboisière, Paris), Emmanuel Dutoit (CH Lille), Enrique Casalino (CHU Bichat-Claude Bernard, Paris), Eric Caumes (CHU Pitié-Salpêtrière, Paris), Eric Dannaoui (Hôpital Européen Georges Pompidou, Paris), Eric Gardien (CH de Draguignan, Bordeaux), Eric Kendjo (CHU Pitié-Salpêtrière, Paris),Eric d'Ortenzio (CHU Bichat-Claude Bernard, Paris), Ermanno Candolfi (CHU de Strasbourg), Estelle Perraud-Cateau (CH Poitiers), Eterne Twizeyimana (CH du Cotentin), F. Roblot (CH Poitiers), Fabienne Pateyron (CH Provins), Fabrice Bruneel (CH de Versailles, André Mignot), Fabrice Legros (CNR du paludisme), Fabrice Simon (HIA Laveran), Fakhri Jeddi (CHU Nantes), Farida M. Benaoudia (CH Troyes), Faïzi Ajana (CH Tourcoing), Felix Djossou (CH de Cayenne Andrée Rosemon), Firouze Banisadr (CHRU de Reims), Florent Morio (CHU Nantes), Francis Derouin (Hôpital Saint-Louis, Paris), Francois Moussel (CH François-Quesnay, Mantes-La-Jolie), Francoise Foulet (CHU Henri Mondor), François Peyron (Lyon-Croix-Rousse), Françoise Benoit-Vical (CHU Toulouse), Françoise Botterel (CHU Henri Mondor), Françoise Gayandrieu (CHU Nantes), Françoise Schmitt (CH du Moenchsberg, Mulhouse), Frederic Ariey (CHU Cochin, Paris), Frédéric Grenouillet (CHU Jean Minjoz, Besançon), Frédéric Sorge (CHU Necker), Frédérique Gay (CHU Pitié-Salpêtrière, Paris), Frédérique Foudrinier (CHRU de Reims), G. Courrouble (CH Blois), G. Gallou (CH de Falaise), G. Julienne (CH Belfort), G. Philippon (Centre Médical CMETE, Paris), Gauthier Pean-de-Ponfilly (CHU Lariboisière, Paris), Geneviève Grise (CH d’Elbeuf), Ghania Belkacem Belkadi (CH Tenon), Gilbert Lorre (CHD La Roche-sur-Yon), Gilles Gargala (CHU Rouen), Gilles Nevez (CHRU Morvan, Brest), Gisele Dewulf (CH de Valenciennes), Guillaume Désoubeaux (CHRU Bretonneau, Tours), Guillaume Escriou (CHU Bichat-Claude Bernard, Paris), Guillaume Le Loup (CH Tenon, Paris), Guillaume Menard (HIA Saint-Anne, Toulon), Guy Carroger (CH Jacques Cœur, Bourges), Guy Galeazzi (CH Louis Mourier), Gwénaël le Moal (CH Poitiers), Hana Talabani (CHU Cochin, Paris), Hanene Abid (CHU Necker, Paris), Helene Broutier (CHI Robert Ballanger, Aulnay-sous-Bois), Herve Pelloux (CHU de Grenoble), Houria Ichou (CH Louis Mourier), Hugo Laurent (CHU Lariboisière, Paris), Hélène Broutier (CH Meaux), Hélène Lapillonne (CH Trousseau, Paris), Hélène Yera (CHU Cochin, Paris), Hélène savini (HIA Laveran), I. Hermes (CH Saint-Malo), Ilhame Tantaoui (CHU Pitié-Salpêtrière, Paris), Isabelle Poilane (CH Bondy-Jean Verdier), Isabelle Amouroux (Hôpital Antoine-Béclère), Isabelle Mazurier (Hôpitaux Civils de Colmar), Isabelle Salimbeni (CH de Cannes), Isabelle Tawa (Centre Médical CMETE, Paris), J Cuziat (CH Saint-Nazaire), J. Bernard Poux (CH de Val d'Ariège - Foix), J. Heurtet (CH Beauvais), J. Rome (CH de Fougères), J. Truchot (CHU Lariboisière, Paris), J.M. Segalin (CHR Orleans), Jacques Gaillat (CH Annecy Genevois), Jacques Le bras (CHU Bichat-Claude Bernard, Paris), Jacques Thevenot (Centre Médical CMETE, Paris), Jacques Vaucel (CH Saint-Brieuc), Jean Dunand (Hôpital Ambroise Paré), Jean Benjamin Murat (CH de Roanne), Jean Marie Trapateau (CH Angoulême), Jean Yves Peltier (CHI Poissy-st-germain), Jean-Etienne Pilo (HIA Begin), Jean-Francois Magnaval (CHU Toulouse), Jean-François Faucher (CHU Jean Minjoz, Limoge), Jean-Paul Boutin (DESP Sud), Jean-Paul Couaillac (CH de Cahors), Jean-Philippe Breux (CH Cholet), Jean-Pierre Hurst (CH Jacques Monod, Le Havre), Jean-Yves Siriez (CHU Robert Debré, Paris), Jean-philippe Bouchara (CHU Angers), Jerome Clain (CHU Bichat-Claude Bernard, Paris), Jerome Naudin (CHU Robert Debré, Paris), Jordan Leroy (CH Lille), Josette Jehan (CH du Cotentin), Joudia Najid (CHU Pitié-Salpêtrière, Paris), Judith Gorlicki (CHU Lariboisière, Paris), Julie Bonhomme (CHU Côte de Nacre), Julie Brunet (CHU de Strasbourg), Jérome Guinard (CHR Orleans), Karima Cheikh (CHU Henri Mondor), L. Pougnet (HIA Clermont Tonnerre, Brest), Lauren Pull (CHU Robert Debré, Paris), Laurence Millon (CHU Jean Minjoz, Besançon), Laurence Campergue-Mayer (CH Avignon), Laurence Estepa (CH Blois), Laurence Lachaud (CHU Nîmes), Laurent Aaron (CH Jacques Cœur, Bourges), Laurent Bret (CHR Orléans), Laurent Guillaume (CH Blois), Liliane Ciceron (CHU Pitié-Salpêtrière, Paris), Lionnel Bertaux (CNR du paludisme), Lise Musset (Institut Pasteur, Guyane), Louise Basmacyan (CHU Dijon), Loïc Favennec (CHU Rouen), Luce Landraud (CH Louis Mourier), Lucile Cadot (CH Alès - Cévennes), Ludovic de Gentile (CHU Angers), Luis Macias (CHU Bichat-Claude Bernard, Paris), Luu-ly Pham (CHU Kremlin-Bicêtre, Paris), M. Cambon (CHRU Clermont-Ferrand), M.F. Biava (CHU de Nancy), M.H. Kiefer (CH du Moenchsberg), M.P. Carlotti (CNR du paludisme), Madeleine Fontrouge (CH de Gonesse), Marc Pihet (CHU Angers), Marc Thellier (CHU Pitié-Salpêtrière, Paris), Marie-Catherine Receveur (CHU de Bordeaux), Marie-Claire Machouart (CHU de Nancy), Marie-Elisabeth Bougnoux (CHU Necker, Paris), Marie-Laure Bigel (CH François-Quesnay, Mantes-la-Jolie), Marie-Laure Darde (CHU Dupuyrien, Limoges), Marie-Nadège Bachelier (CH Jacques Cœur, Bourges), Marion Almeras (CH Béziers), Marion Leterrier (CHU Nantes), Marion Leterrier (CHD La Roche-sur-Yon), Martin Danis (CHU Pitié-Salpêtrière, Paris), Martin G (CH du Cotentin), Martine Bloch (CH Louis Mourier), Martine Liance (CHU Henri Mondor, Paris), Marylin Madamet (IMTSSA, Marseille), Matthieu Revest (CHU Pontchaillou, Rennes),Matthieu Mechain (CHU de Bordeaux), Maxime Thouvenin (CH Troyes), Mermond Sylvain (Institut Pasteur, Nouméa), Michel Develoux (CH Tenon, Paris), Michel Miegeville (CHU Nantes), Milène Sasso (CHU Nîmes), Mohamed Diaby (CH Vernon), Monique Marty (CH La Rochelle), Monique Greze (CH Albi), Monique Lemoine (CHU Bichat-Claude Bernard, Paris), Mouri Oussama (CHU Pitié-Salpêtrière, Paris), Muriel Cornet (Hôpital Hôtel-Dieu, Paris), Muriel Mimoun Ayache (CH Trousseau), Muriel Nicolas (CHU Pointe-à-Pitre / Abymes), Muriel Roumier (CH Arles), Muriel Silva (CH Jacques Monod), Mylène Penot (CERBA), Myriam Gharbi (CHU Bichat-Claude Bernard, Paris), Nadia Guennouni (CHU Bichat-Claude Bernard, Paris), Nadine Godineau (Hôpital Delafontaine, Saint-Denis), Naima Dahane (CHU Cochin, Paris), Nathalie Bourgeois (CHU Montpellier), Nathalie Desuremain (CH Trousseau, Paris), Nathalie Fauchet (CHI de Créteil), Nathalie Parez (CH Louis Mourier), Nathalie Wilhelm (CH de Cahors), Nawel Ait-Ammar (Hôpital Ambroise Paré), Nayla Nassar (CH Auxerre), Nicolas Argy (CHU Bichat-Claude Bernard, Paris), Nicolas Blondiaux (CH Tourcoing), Nicolas Taudon (CERBA), Nicole Desbois-Nogard (CHU de la Martinique), Noura Hassouni (CHU Necker), Odile Bouret-Dubouis (CH Bretagne Atlantique), Odile Eloy (CH de Versailles, André Mignot), Odile Falguiere (CH Béziers), Odile Fenneteau (CHU Robert Debré, Paris), Olivia Bandin (Hôpital Saint-Camille/Bry-sur-Marne), Olivier Albert (CHU de Bordeaux), Olivier Bouchaud (CH Bobigny-Avicenne), Olivier Patey (CHI Villeneuve St. Georges), Olivier Rogeaux (CH Chambéry), P. Clergeau (CH Sallanches), P. Daumain (CH de Dourdan), P.H. Consigny (Institut Pasteur, Paris), Paméla Chauvin (CHU Toulouse), Pascal Delaunay (CH Universitaire de Nice), Pascal Hazera (CH Saint-Lo), Pascal Houze (Hôpital Saint Louis, Paris), Pascal Millet (CHU de Bordeaux), Pascal Pouedras (CH Bretagne Atlantique), Pascale Penn (CH Le Mans), Patrice Agnamey (CHU Amiens), Patrice Bourrée (CHU Kremlin-Bicêtre, Paris), Patricia Barbut (CH Longjumeau), Patricia Brugel (CH Antibes Juan-Les-Pins), Patricia Roux (CH Saint-Antoine, Paris), Patrick Leguen (HIA Clermont Tonnerre, Brest), Patrick Valayer (CH Notre-Dame de la Miséricorde), Pauline Caraux-Paz (CHI Villeneuve St Georges), Pauline Touroultjupin (CH Cholet), Philippe Abboud (CHU Rouen), Philippe Cormier (CH d’Evry), Philippe Minodier (CH Marseille Nord), Philippe Moskovtchenko (Hôpitaux Civils de Colmar), Philippe Parola (CH Marseille Nord), Philippe Poirier (CHRU Clermont-Ferrand), Philippe Stolidi (CH Aubagne), Pierre Patoz (CH Tourcoing), Pierre Buffet (INTS, Paris), Pierre Buffet (CHU Pitié-Salpêtrière, Paris), Pierre Flori (CH Saint-Etienne), Pierre Marty (CH Universitaire de Nice), Pierre Mornand (CH Trousseau, Paris), Pinel Claudine (CHU de Grenoble), R. Dahan (CHU de Strasbourg), R. Devallière (CH Saint-Nazaire), R. Mazataud (CH Vitry le François), Rahaf Haj Hamid (CH Louis Mourier), Regis Courtin (CHU Pitié-Salpêtrière, Paris), Renaud Blonde (CHU Robert Debré, Paris), René Nabias (CHI Poissy-st-germain), Roland Fabre (HIA Begin), Rose-Anne Lavergne (CHU Nantes), Roxane Courtois (CH Cholet), Rym Chouk Turki (CHU Henri Mondor), Rémy Durand (CH Bobigny-Avicenne), Réné Nabias (CHU Necker, Paris), Sabah Kubab (CH Corbeil Essonne), Sabine Lasserre (CH Trousseau, Paris), Samia Hamane (Hôpital Saint-Louis, Paris), Sandrine Cojean (CHU Bichat-Claude Bernard, Paris), Sandrine Houze (CHU Bichat-Claude Bernard, Paris), Sophie Matheron (CHU Bichat-Claude Bernard, Paris), Sorya Belaz (CHU Pontchaillou, Rennes), Stephane Jaureguiberry (CHU Pitié-Salpêtrière, Paris), Stephane Ranque (CH de la Timone, Marseille), Stephanie Dulucq (CHU de Bordeaux), Stéphane Bretagne (Hôpital Saint-Louis, Paris), Stéphane Pelleau (Institut Pasteur, Guyane), Stéphane Picot (Hospices Civils de Lyon), Sylvain Clauser (Hôpital Ambroise Paré), Sylviane Chevrier (CHU Pontchaillou, Rennes), Sylviane Dydymski (CHRU Clermont-Ferrand), Sylvie Lariven (CHU Bichat-Claude Bernard, Paris), Sylvie Lhopital (CH Vernon), Sylvie Maurellet Evrard (CHI Villeneuve St Georges), Sylvie Roulaud (CH Angouleme), Sébastien Larréché (HIA Begin), Thi-Hai-Chau Trinh (CHR Orléans), Thierry Ancelle (CHU Cochin, Paris), Thierry Pistone (CHU de Bordeaux), Thomas Hanslik (Hôpital Ambroise Paré), Thomas Guimard (CHD La Roche-sur-Yon), Timothée Klopfenstein (CHU Besançon, Jean Minjoz), Valerie Fuster-Dumas (CHU de Bordeaux), Veronique Blanc-Amrane (CH Antibes Juan-Les-Pins), Veronique Delcey (CHU Lariboisière, Paris), Veronique Sarrasin-Hubert (CHU Bichat-Claude Bernard, Paris), Vincent Foissaud (HIA Percy, Clamart), Virginie Mouton-Rioux (CH Bretagne Atlantique), Virginie Vitrat (CH Annecy Genevois), Véronique Jan-Lasserre (CH Lagny-sur-Marne), Xavier Nicolas (HIA Clermont Tonnerre, Brest), Y. Costa (CH Lagny-sur-Marne), Yassamine Lazrek (Institut Pasteur, Guyane), Yaye Senghor (Hôpital Saint Joseph, Paris), Yohann Le Govic (CHU Angers), Yves Guimard (CH Jacques Cœur, Bourges), Yves Poinsignon (CH Bretagne Atlantique), Claude flamand (Institut Pasteur, Guyane), C.N. guyen (CH Trousseau, Paris), G. Noël (CH Marseille Nord), G. Soula (CH Marseille Nord), J.M.Didier (CH Vesoul), M.F. Raynaud (CH Antibes Juan-Les-Pins), M. Julien (CH Béziers), M. Morillon (HIA Laveran), M.P. Carlotti (IMTSSA), P. Chantelat (CH Vesoul), P. Dussert (CH Belfort), P. Ralaimazava (CH Bobigny-Avicenne), S. Zaouche (CHU Necker, Paris), Élodie Lesteven (CHU Lariboisière, Paris)., Musset, Lise, Centre National de Référence du Paludisme [CHU Pitié-Salpétrière] (CNRpalu), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)

Subjects
Plasmodium, Epidemiology, FNRCm, MESH: Hospitalization, Mark and recapture, 0302 clinical medicine, MESH: Aged, 80 and over, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, MESH: Child, 030212 general & internal medicine, MESH: Incidence, MESH: Travel, Imported malaria, media_common, MESH: Aged, MESH: Middle Aged, MESH: Infant, 3. Good health, MESH: Young Adult, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, surveillance, France, Sex ratio, MESH: Medical Record Linkage, MESH: Disease Notification, 030231 tropical medicine, Notifiable disease, MESH: Malaria, capture-recapture, malaria, MESH: Population Surveillance, 03 medical and health sciences, MESH: Cross-Sectional Studies, Virology, parasitic diseases, medicine, media_common.cataloged_instance, European union, MESH: Communicable Diseases, Imported, MESH: Adolescent, MESH: Hospitals, University, MESH: Humans, business.industry, MESH: Child, Preschool, Public Health, Environmental and Occupational Health, MESH: Adult, medicine.disease, Confidence interval, MESH: Male, Metropolitan France, MESH: France, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, travellers, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, MESH: Female, Malaria, Demography
Abstract

Introduction Malaria is a notifiable disease in all European Union and European Economic Area countries except Belgium and France, where only autochthonous malaria is notifiable. Although morbidity caused by malaria has been assessed, little is known about mortality incidence. Objective Our aim was to estimate the number of imported malaria-related deaths in hospital in metropolitan France. Methods We matched individual deaths reported between 1 January 2005 and 31 December 2014 to the French National Reference Centre for malaria (FNRCm) with malaria-related deaths from two other sources: the French National Registry on medical causes of death and the French national hospital discharge database. A capture–recapture method with log-linear modelling was used. Age, sex and place of death stratification were applied to remove heterogeneity. Results The estimated malaria-related deaths in metropolitan France during the study period were 205 (95% confidence interval (CI): 191–219). The annual mean number of malaria-related deaths was estimated at 21 (95% CI: 19–22). The FNRCm malaria-related deaths surveillance had a 38% sensitivity (95% CI: 32–44). Among 161 in-hospital individual malaria-related deaths reported from three data sources, the sex ratio (male to female) was 2.6. Median age of the patients was 57 years, ranging from 1 to 89 years. Conclusion The pertinent finding of this report is that malaria-related death records were significantly less* complete than case records. Therefore, data comparison of imported malaria morbidity and mortality between countries should imperatively be assessed using standard indicators weighted according to the completeness of health surveillance systems.

Published
2020

43. On-Demand Sildenafil as a Treatment for Raynaud Phenomenon: A Series of n-of-1 Trials.

Author

Roustit M, Giai J, Gaget O, Khouri C, Mouhib M, Lotito A, Blaise S, Seinturier C, Subtil F, Paris A, Cracowski C, Imbert B, Carpentier P, Vohra S, and Cracowski JL

Subjects
Adult, Cross-Over Studies, Data Interpretation, Statistical, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Prospective Studies, Treatment Outcome, Phosphodiesterase 5 Inhibitors administration & dosage, Phosphodiesterase 5 Inhibitors adverse effects, Raynaud Disease drug therapy, Sildenafil Citrate administration & dosage, Sildenafil Citrate adverse effects, Vasodilator Agents administration & dosage, Vasodilator Agents adverse effects
Abstract

Background: Treatment of Raynaud phenomenon (RP) with phosphodiesterase-5 inhibitors has shown moderate efficacy. Adverse effects decrease the risk-benefit profile of these drugs, and patients may not be willing to receive long-term treatment. On-demand single doses before or during exposure to cold may be a good alternative., Objective: To assess the efficacy and safety of on-demand sildenafil in RP., Design: Series of randomized, double-blind, n-of-1 trials. (ClinicalTrials.gov: NCT02050360)., Setting: Outpatients at a French university hospital., Participants: Patients with primary or secondary RP., Intervention: Each trial consisted of a multiple crossover study in a single patient. Repeated blocks of 3 periods of on-demand treatment were evaluated: 1 week of placebo, 1 week of sildenafil at 40 mg per dose, and 1 week of sildenafil at 80 mg per dose, with a maximum of 2 doses daily., Measurements: Raynaud Condition Score (RCS) and frequency and daily duration of attacks. Skin blood flow in response to cooling also was assessed with laser speckle contrast imaging. Mixed-effects models were used and parameters were estimated in a Bayesian framework to determine individual and aggregated efficacy., Results: 38 patients completed 2 to 5 treatment blocks. On the basis of aggregated data, the probability that sildenafil at 40 mg or 80 mg was more effective than placebo was greater than 90% for all outcomes (except for RCS with sildenafil, 80 mg). However, the aggregated effect size was not clinically relevant. Yet, substantial heterogeneity in sildenafil's efficacy was observed among participants, with clinically relevant efficacy in some patients., Limitation: The response to sildenafil was substantially heterogeneous among patients., Conclusion: Despite a high probability that sildenafil is superior to placebo, substantial heterogeneity was observed in patient response and aggregated results did not show that on-demand sildenafil has clinically relevant efficacy. In this context, the use of n-of-1 trials may be an original and relevant approach in RP., Primary Funding Source: GIRCI (Groupement Interrégional de Recherche Clinique et d'Innovation) Auvergne Rhône-Alpes (academic funding) and Pfizer.

Published
2018
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44. [Developing patient information sheets in general practice. Proposal for a methodology].

Author

Sustersic M, Meneau A, Drémont R, Paris A, Laborde L, and Bosson JL

Subjects
Feasibility Studies, Humans, Quality of Health Care, Family Practice standards, Medical Records, Patient Education as Topic methods, Patient Satisfaction
Abstract

Background: Health information is patients' wish and right. For general practitioners, it is a duty, a legal obligation and a pre-requisite in any preventive approach. Written information must complete oral information since it improves health care quality. However, in general practice, there are no patient documents which are scientifically valid, understandable and efficient in terms of communication., Objective: To develop a method for creating patient information sheets and to experiment its feasibility through the development of 125 sheets focused on the most common clinical conditions in general practice., Method: Research and literature review pour the development of specifications, and creation of 125 sheets following these specifications., Results: The specifications developed consist of the 10 following steps: selection of the topic and the objectives, literature review, selection of the sections, drafting, validation of the scientific contents, assessment among patients, validation of the layout, selection of the media, delivery to patients and update. Following these specifications, we developed 125 information sheets. Each of these was reviewed by several physicians and assessed with R. Flesh readability test (the established acceptable threshold value was 40). The 30 sheets associated with the lowest scores were selected and reviewed to improve their overall readability., Conclusion: Even though some difficulties cannot be avoided when developing patient information sheets, each physician or physician association can create its own documents following the proposed specifications and thus deliver a customized message.

Published
2008

45. [Methylphenidate in palliative care in cancer patient: a double-blind randomised trial versus placebo].

Author

Laval G and Paris A

Subjects
Adult, Aged, Asthenia etiology, Double-Blind Method, Humans, Middle Aged, Placebos, Terminal Care, Asthenia drug therapy, Central Nervous System Stimulants therapeutic use, Methylphenidate therapeutic use, Neoplasms complications, Palliative Care methods
Abstract

The amphetamine, methylphenidate (Ritaline) has been proposed as being of interest in the treatment of asthenia in patients with advanced cancer. To evaluate this hypothesis a randomised controlled double-blind parallel-group national multi-centre trial is proposed versus placebo. Three previous randomised controlled studies and one open study have suggested that the administration of methylphenidate may be of interest in the palliative care of asthenic cancer patients. However, these studies do not permit a definitive conclusion to be drawn. This article presents the protocol of our new trial. The primary objective is to evaluate the anti-asthenic effect of methylphenidate using a visual analogue scale (VAS) after 7 days of treatment of cancer patients in palliative care, i.e. when the cancer is considered to be rapidly evolving or as terminal. One hundred and ten patients are treated for 28 days at a starting dose of 20 mg/day, and adjustment of the dose is possible. It is important to stress that only the concerted efforts of an interdisciplinary team (somatologues, psychiatrists, psychologists, paramedical carers and social workers) can tackle the challenges posed by the difficult symptom of asthenia. The medical treatment is only one element of the approach to caring for these patients.

Published
2008
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47. [Readability and information density in biomedical research].

Author

Okaïs C, Paris A, and Cracowski JL

Subjects
Language, Biomedical Research, Communication, Consent Forms standards
Abstract

Objective: This study was performed in order to compare the lexicosyntactic readability, and the information density in the informed consent forms used in biomedical research, in comparison with standard scientific texts dedicated to the general population. In addition, we studied whether there is a correlation between information readability and density., Methods: Fifteen informed consent forms, 6 articles from "Sciences et Avenir" and 6 articles from "Sciences et Vie Junior" were analyzed. The lexicosyntactic readability was calculated using the Flesh score, and the information density using the number of information bits related to the number of words., Results: The lexicosyntactic readability was lower in the informed consent forms (25, 17-32) compared with "Sciences et Avenir" (32, 29-38), but even higher in "Sciences et Vie Junior" (42, 38-57). Conversely, the information density was similar in "Sciences et Vie Junior" (0.24, [0.21-0.27]) and the informed consent forms (0.24, [0.22-0.26]), but higher in "Sciences et Avenir" (0.32, [0.26-0.38])., Conclusion: Informed consent forms are less readable, but paradoxically less dense than scientific papers dedicated to the general population. There is no correlation between density and readability.

Published
2007
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49. [Satisfaction of subjects enrolled in clinical studies].

Author

Huot L, Paris A, Bosson JL, Boignard A, Hommel M, Labarère J, and Cracowski JL

Subjects
Data Collection, Female, France, Hospitals, Teaching, Humans, Male, Middle Aged, Surveys and Questionnaires, Clinical Trials as Topic standards, Consumer Behavior, Research Subjects psychology
Abstract

Objective: The Grenoble clinical research centre carried out a prospective satisfaction survey of subjects taking part in clinical studies undertaken in its buildings., Materials and Methods: A questionnaire adapted from Grenoble teaching hospital's inpatient satisfaction survey was sent to 198 subjects. It comprised 24 items pooled in categories on which were calculated average scores. The participation rate of the survey was 82.6%. On the whole, 94.4% of the questioned subjects would accept to take part in a new study if we requested them, and 72.2% were satisfied or very satisfied with their stay; 24% had no opinion. The mean overall satisfaction score was 8.6 (95% confidence interval: 7.6-9.6) out of 10., Conclusion: This investigation shows that the assumption of responsibility of the subjects by specific personnel and in an adapted place, within the framework of clinical protocol of research, is associated with a high satisfaction of the subjects. However, we still have to improve the transmission of the clinical study results to the patients.

Published
2005
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