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1. What are the barriers towards cervical cancer screening for vulnerable women? A qualitative comparative analysis of stakeholder perspectives in seven European countries

Author: Partha Basu, Martin McKee, Adriana Băban, Luke Vale, Marc Bardou, Ana Fernandes, Sadie Bell, Margarida Teixeira, Rebecca Moore, Nuno Lunet, David Ritchie, Romeu Mendes, Eric Lucas, Paolo Giorgi Rossi, Rosa Legood, Berit Andersen, Diana Taut, Keitly Mensah, João Firmino-Machado, Mariana Amorim, Mette Tranberg, Laura Bonvicini, Li Sun, Anneli Uusküla, Pia Kirkegaard, Paola Mantellini, Ines Baia, Lise Rochaix, Camilla Fiorina, Luca Ghirotto, Anna Tisler, Wendy Yared, Firmino Machado, Rikke Buus Bøje, Raquel Rico Berrocal, Noemi Auzzi, Nicoleta Jiboc, Kerli Reintamm, Raya Michaylova, Yulia Panayotova, Tatyana Kotzeva, Anna Foss, Rachel Greenley, Letizia Bartolini, Giusy Iorio, Cláudia Gouvinhas, Florian Nicula, Alexandra Tolnai, Vanessa Moore, Isabel Mosquera Metcalfe, Violette Delisle, Irina Todorova, Raya Mihaylova, Helena Ros Comesana, Meritxel Mallafré-Larrosa, Ginevra Papi, Arianna Khatchadourian, and Christiane Dascher-Nade
Subjects: Medicine
Abstract: Objectives The aim of this study was to map and compare stakeholders’ perceptions of barriers towards cervical cancer screening for vulnerable women in seven European countries.Design In Collaborative User Boards, stakeholders were invited to participate to identify barriers towards participation in cervical cancer screening.Setting The study is nested in the European Union-funded project CBIG-SCREEN which aims to tackle inequity in cervical cancer screening for vulnerable women (www.cbig-screen.eu). Data collection took place in Bulgaria, Denmark, Estonia, France, Italy, Portugal and Romania.Participants Participants represented micro-level stakeholders covering representatives of users, that is, vulnerable women, meso-level stakeholders covering healthcare professionals and social workers, and macro-level stakeholders covering programme managers and decision-makers.Methods Across the seven countries, 25 meetings in Collaborative User Boards with a duration of 2 hours took place between October 2021 and June 2022. The meetings were video recorded or audio recorded, transcribed and translated into English for a qualitative framework analysis.Results 120 participants took part in the Collaborative User Boards. Context-specific barriers were related to different healthcare systems and characteristics of vulnerable populations. In Romania and Bulgaria, the lack of a continuous screening effort and lack of ways to identify eligible women were identified as barriers for all women rather than being specific for women in vulnerable situations. The participants in Denmark, Estonia, France, Italy and Portugal identified providers’ lack of cultural and social sensitivity towards vulnerable women as barriers. In all countries, vulnerable women’s fear, shame and lack of priority to preventive healthcare were identified as psychological barriers.Conclusion The study provides an overview of stakeholders’ perceived barriers towards vulnerable women’s cervical cancer screening participation in seven European countries. The organisation of healthcare systems and the maturity of screening programmes differ between countries, while vulnerable women’s psychological barriers had several similarities.
Published: 2024
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2. Immunomodulators for immunocompromised patients hospitalized for COVID-19: a meta-analysis of randomized controlled trialsResearch in context

Author: Ilias I. Siempos, Andre C. Kalil, Drifa Belhadi, Viviane Cordeiro Veiga, Alexandre Biasi Cavalcanti, Westyn Branch-Elliman, Eleni Papoutsi, Konstantinos Gkirgkiris, Nikoleta A. Xixi, Anastasia Kotanidou, Olivier Hermine, Raphaël Porcher, Xavier Mariette, Philippe Ravaud, Serge Bureau, Maxime Dougados, Matthieu Resche-Rigon, Pierre-Louis Tharaux, Annick Tibi, Elie Azoulay, Jacques Cadranel, Joseph Emmerich, Muriel Fartoukh, Bertrand Guidet, Marc Humbert, Karine Lacombe, Matthieu Mahevas, Frédéric Pene, Valerie Pourchet-Martinez, Frédéric Schlemmer, Yazdan Yazdanpanah, Gabriel Baron, Elodie Perrodeau, Damien Vanhoye, Cécile Kedzia, Lauren Demerville, Anne Gysembergh-Houal, Alexandre Bourgoin, Nabil Raked, Lakhdar Mameri, Claire Montlahuc, Lucie Biard, St.phanie Alary, Samir Hamiria, Thinhinane Bariz, Hala Semri, Dhiaa Meriem Hai, Moustafa Benafla, Mohamed Belloul, Pernelle Vauboin, Saskia Flamand, Claire Pacheco, Anouk Walter-Petrich, Emilia Stan, Souad Benarab, Corine Nyanou, Robin Charreteur, Céline Dupre, Kévin Cardet, Blandine Lehmann, Kamyl Baghli, Claire Madelaine, Eric D'Ortenzio, Oriane Puéchal, Caroline Semaille, Laurent Savale, Anatole Harrois, Samy Figueiredo, Jacques Duranteau, Nadia Anguel, Arthur Pavot, Xavier Monnet, Christian Richard, Jean-Louis Teboul, Philippe Durand, Pierre Tissieres, Mitja Jevnikar, David Montani, Stephan Pavy, Gaétane Nocturne, Samuel Bitoun, Nicolas Noel, Olivier Lambotte, Lelia Escaut, Stephane Jauréguiberry, Elodie Baudry, Christiane Verny, Edouard Lefevre, Mohamad Zaidan, Domitille Molinari, Gaël Leprun, Alain Fourreau, Laurent Cylly, Lamiae Grimaldi, Myriam Virlouvet, Ramdane Meftali, Soléne Fabre, Marion Licois, Asmaa Mamoune, Yacine Boudali, Clotilde Le Tiec, Céline Verstuyft, Anne-Marie Roques, Sophie Georgin-Lavialle, Patricia Senet, Gilles Pialoux, Angele Soria, Antoine Parrot, Helene François, Nathalie Rozensztajn, Emmanuelle Blin, Pascaline Choinier, Juliette Camuset, Jean-Simon Rech, Antony Canellas, Camille Rolland-Debord, Nadege Lemarié, Nicolas Belaube, Marine Nadal, Martin Siguier, Camille Petit-Hoang, Julie Chas, Elodie Drouet, Matthieu Lemoine, Audrey Phibel, Lucie Aunay, Eliane Bertrand, Sylviane Ravato, Marie Vayssettes, Anne Adda, Celine Wilpotte, Pélagie Thibaut, Julie Fillon, Isabelle Debrix, Soraya Fellahi, Jean-Philippe Bastard, Guillaume Lefévre, Jacques-Eric Gottenberg, Yves Hansmann, Frédéric Blanc, Sophie Ohlmann-Caillard, Vincent Castelain, Emmanuel Chatelus, Eva Chatron, Olivier Collange, François Danion, Frédéric De Blay, Pierre Diemunsch, Sophie Diemunsch, Renaud Felten, Bernard Goichot, Valentin Greigert, Aurelien Guffroy, Bob Heger, Charlotte Kaeuffer, Loic Kassegne, Anne Sophie Korganow, Pierrick Le Borgne, Nicolas Lefebvre, Paul-Michel Mertes, Eric Noll, Mathieu Oberlin, Vincent Poindron, Julien Pottecher, Yvon Ruch, François Weill, Nicolas Meyer, Emmanuel Andres, Eric Demonsant, Hakim Tayebi, Gabriel Nisand, Stéphane Brin, Cédric Sublon, Guillaume Becker, Anne Hutt, Tristan Martin, Sophie Bayer, Catherine Metzger, Arsene Mekinian, Noémie Abisror, Amir Adedjouma, Diane Bollens, Marion Bonneton, Nathalie Bourcicaux, Anne Bourrier, Maria Chauchard Thibault Chiarabiani, Doroth.e Chopin, Jonathan Cohen, Ines Devred, Bruno Donadille, Olivier Fain, Geoffrey Hariri, Vincent Jachiet, Patrick Ingliz, Marc Garnier, Marc Gatfosse, Etienne Ghrenassia, Delphine Gobert, Jessica Krause le Garrec, Cecilia Landman, Jean Remy Lavillegrand, Benedicte Lefebvre, Thibault Mahevas, Sandie Mazerand, Jean Luc Meynard, Marjolaine Morgand, Zineb Ouaz.ne, Jerome Pacanowski, S.bastien Riviere, Philippe Seksik, Harry Sokol, Heithem Soliman, Nadia Valin, Thomas Urbina, Chloé McAvoy, Maria Pereira Miranda, Gladys Aratus, Laurence Berard, Tabassome Simon, Anne Daguenel Nguyen, Elise Girault, Cl.mentine Mayala-Kanda, Marie Antignac, Céline Leplay, Jean-Benoit Arlet, Jean-Luc Diehl, Florence Bellenfant, Anne Blanchard, Alexandre Buffet, Bernard Cholley, Antoine Fayol, Edouard Flamarion, Anne Godier, Thomas Gorget, Sophie-Rym Hamada, Caroline Hauw-Berlemont, Jean-Sébastien Hulot, David Lebeaux, Marine Livrozet, Adrien Michon, Arthur Neuschwander, Marie-Aude Pennet, Benjamin Planquette, Brigitte Ranque, Olivier Sanchez, Geoffroy Volle, Sandrine Briois, Mathias Cornic, Virginie Elisee, Jesuthasan Denis, Juliette Djadi-Prat, Pauline Jouany, Ramon Junquera, Mickael Henriques, Amina Kebir, Isabelle Lehir, Jeanne Meunier, Florence Patin, Val.rie Paquet, Anne Tréhan, Véronique Vigna, Brigitte Sabatier, Damien Bergerot, Charléne Jouve, Camille Knosp, Olivia Lenoir, Nassim Mahtal, Léa Resmini, Xavier Lescure, Jade Ghosn, Antoine Bachelard, Anne Rachline, Valentina Isernia, Bao-chau, Phung, Dorothée Vallois, Aurelie Sautereau, Catherine Neukrich, Antoine Dossier, Raphaël Borie, Bruno Crestani, Gregory Ducrocq, Philippe Gabriel Steg, Philippe Dieude, Thomas Papo, Estelle Marcault, Marhaba Chaudhry, Charléne Da Silveira, Annabelle Metois, Ismahan Mahenni, Meriam Meziani, Cyndie Nilusmas, Sylvie Le Gac, Awa Ndiaye, Fran.oise Louni, Malikhone Chansombat, Zelie Julia, Solaya Chalal, Lynda Chalal, Laura Kramer, Jeniffer Le Grand, Kafif Ouifiya, Valentine Piquard, Sarah Tubiana, Yann Nguyen, Vasco Honsel, Emmanuel Weiss, Anais Codorniu, Virginie Zarrouk, Victoire de Lastours, Matthieu Uzzan, Naura Gamany, Agathe Claveirole, Alexandre Navid, Tiffanie Fouque, Yonathan Cohen, Maya Lupo, Constance Gilles, Roza Rahli, Zeina Louis, David Boutboul, Lionel Galicier, Yaël Amara, Gabrielle Archer, Amira Benattia, Anne Bergeron, Louise Bondeelle, Nathalie de Castro, Melissa Clément, Michaël Darmon, Blandine Denis, Clairelyne Dupin, Elsa Feredj, Delphine Feyeux, Adrien Joseph, Etienne Lenglin, Pierre Le Guen, Geoffroy Liégeon, Gwenaël Lorillon, Asma Mabrouki, Eric Mariotte, Grégoire Martin de Frémont, Adrien Mirouse, Jean-Michel Molina, Régis Peffault de Latour, Eric Oksenhendler, Julien Saussereau, Abdellatif Tazi, Jean-Jacques Tudesq, Lara Zafrani, Isabelle Brindele, Emmanuelle Bugnet, Karine Celli Lebras, Julien Chabert, Lamia Djaghout, Catherine Fauvaux, Anne Lise Jegu, Ewa Kozakiewicz, Martine Meunier, Marie-Thérèse Tremorin, Claire Davoine, Isabelle Madelaine, Sophie Caillat-Zucman, Constance Delaugerre, Florence Morin, Damien Sène, Ruxandra Burlacu, Benjamin Chousterman, Bruno Mégarbanne, Pascal Richette, Jean-Pierre Riveline, Aline Frazier, Eric Vicaut, Laure Berton, Tassadit Hadjam, Miguel Alejandro Vazquez-Ibarra, Clément Jourdaine, Olivia Tran, Véronique Jouis, Aude Jacob, Julie Smati, Stéphane Renaud, Claire Pernin, Lydia Suarez, Luca Semerano, Sébastien Abad, Ruben B. nainous, Nicolas Bonnet, Celine Comparon, Yves Cohen, Hugues Cordel, Robin Dhote, Nathalie Dournon, Boris Duchemann, Nathan Ebstein, Thomas Gille, Benedicte Giroux-Leprieur, Jeanne Goupil de Bouille, Hilario Nunes, Johanna Oziel, Dominique Roulot, Lucile Sese, ClaireTantet, Yurdagul Uzunhan, Coralie Bloch-Queyrat, Vincent Levy, Fadhila Messani, Mohammed Rahaoui, Myléne Petit, Sabrina Brahmi, Vanessa Rathoin, Marthe Rigal, Nathalie Costedoat-Chalumeau, Liem Binh Luong, Zakaria Ait Hamou, Sarah Benghanem, Philippe Blanche, Nicolas Carlier, Benjamin Chaigne, Remy Gauzit, Hassan Joumaa, Mathieu Jozwiak, Marie Lachétre, Hélène Lafoeste, Odie Launay, Paul Legendre, Jonathan Marey, Caroline Morbieu, Lola-Jade Palmieri, Tali-Anne Szwebel, Hendy Abdoul, Alexandra Bruneau, Audrey Beclin-Clabaux, Charly Larrieu, Pierre Montanari, Eric Dufour, Ada Clarke, Catherine Le Bourlout, Nathalie Marin, Nathalie Menage, Samira Saleh-Mghir, Mamadou Salif Cisse, Kahina Cheref, Corinne Guerin, Jérémie Zerbit, Marc Michel, Sébastien Gallien, Etienne Crickx, Benjamin Le Vavasseur, Emmanuelle Kempf, Karim Jaffal, William Vindrios, Julie Oniszczuk, Constance Guillaud, Pascal Lim, Elena Fois, Giovanna Melica, Marie Matignon, Maud Jalabert, Jean-Daniel Lelièvre, David Schmitz, Marion Bourhis, Sylia Belazouz, Laetitia Languille, Caroline Boucle, Nelly Cita, Agnés Didier, Fahem Froura, Katia Ledudal, Thiziri Sadaoui, Alaki Thiemele, Delphine Le Febvre De Bailly, Muriel Carvhalo Verlinde, Julien Mayaux, Patrice Cacoub, David Saadoun, Mathieu Vautier, Héléne Bugaut, Olivier Benveniste, Yves Allenbach, Gaëlle Leroux, Aude Rigolet, Perrine Guillaume-Jugnot, Fanny Domont, Anne Claire Desbois, Chloé Comarmond, Nicolas Champtiaux, Segolene Toquet, Amine Ghembaza, Matheus Vieira, Georgina Maalouf, Goncalo Boleto, Yasmina Ferfar, Jean-Christophe Corvol, C.line Louapre, Sara Sambin, Louise-Laure Mariani, Carine Karachi, Florence Tubach, Candice Estellat, Linda Gimeno, Karine Martin, Aicha Bah, Vixra Keo, Sabrine Ouamri, Yasmine Messaoudi, Nessima Yelles, Pierre Faye, Sebastien Cavelot, Cecile Larcheveque, Laurence Annonay, Jaouad Benhida, Aida Zahrate-Ghoul, Soumeya Hammal, Ridha Belilita, Fanny Charbonnier, Claire Aguilar, Fanny Alby-Laurent, Carole Burger, Clara Campos-Vega, Nathalie Chavarot, Benjamin Fournier, Claire Rouzaud, Damien Vimpére, Caroline Elie, Prissile Bakouboula, Laure Choupeaux, Sophie Granville, Elodie Issorat, Christine Broissand, Marie-Alexandra Alyanakian, Guillaume Geri, Nawal Derridj, Naima Sguiouar, Hakim Meddah, Mourad Djadel, Héléne Chambrin-Lauvray, Jean-Charles Duclos-vallée, Faouzi Saliba, Sophie-Caroline Sacleux, Ilias Kounis, Sonia Tamazirt, Eric Rudant, Jean-Marie Michot, Annabelle Stoclin, Emeline Colomba, Fanny Pommeret, Christophe Willekens, Rosa Da Silva, Valérie Dejean, Yasmina Mekid, Ines Ben-Mabrouk, Florence Netzer, Caroline Pradon, Laurence Drouard, Valérie Camara-Clayette, Alexandre Morel, Gilles Garcia, Abolfazl Mohebbi, Férial Berbour, Mélanie Dehais, Anne-Lise Pouliquen, Alison Klasen, Loren Soyez-Herkert, Jonathan London, Younes Keroumi, Emmanuelle Guillot, Guillaume Grailles, Younes El amine, Fanny Defrancq, Hanane Fodil, Chaouki Bouras, Dominique Dautel, Nicolas Gambier, Thierno Dieye, Boris Bienvenu, Victor Lancon, Laurence Lecomte, Kristina Beziriganyan, Belkacem Asselate, Laure Allanic, Elena Kiouris, Marie-Héléne Legros, Christine Lemagner, Pascal Martel, Vincent Provitolo, Félix Ackermann, Mathilde Le Marchand, Aurélie Chan Hew Wai, Dimitri Fremont, Elisabeth Coupez, Mireille Adda, Frédéric Duée, Lise Bernard, Antoine Gros, Estelle Henry, Claire Courtin, Anne Pattyn, Pierre-Grégoire Guinot, Marc Bardou, Agnes Maurer, Julie Jambon, Amélie Cransac, Corinne Pernot, Bruno Mourvillier, Eric Marquis, Philippe Benoit, Damien Roux, Coralie Gernez, Cécile Yelnik, Julien Poissy, Mandy Nizard, Fanette Denies, Helene Gros, Jean-Jacques Mourad, Emmanuelle Sacco, Sophie Renet, F. Ader, Y. Yazdanpanah, F. Mentre, N. Peiffer-Smadja, F.X. Lescure, J. Poissy, L. Bouadma, J.F. Timsit, B. Lina, F. Morfin-Sherpa, M. Bouscambert, A. Gaymard, G. Peytavin, L. Abel, J. Guedj, C. Andrejak, C. Burdet, C. Laouenan, D. Belhadi, A. Dupont, T. Alfaiate, B. Basli, A. Chair, S. Laribi, J. Level, M. Schneider, M.C. Tellier, A. Dechanet, D. Costagliola, B. Terrier, M. Ohana, S. Couffin-Cadiergues, H. Esperou, C. Delmas, J. Saillard, C. Fougerou, L. Moinot, L. Wittkop, C. Cagnot, S. Le Mestre, D. Lebrasseur-Longuet, V. Petrov-Sanchez, A. Diallo, N. Mercier, V. Icard, B. Leveau, S. Tubiana, B. Hamze, A. Gelley, M. Noret, E. D’Ortenzio, O. Puechal, C. Semaille, T. Welte, J.A. Paiva, M. Halanova, M.P. Kieny, E. Balssa, C. Birkle, S. Gibowski, E. Landry, A. Le Goff, L. Moachon, C. Moins, L. Wadouachi, C. Paul, A. Levier, D. Bougon, F. Djossou, L. Epelboin, J. Dellamonica, C.H. Marquette, C. Robert, S. Gibot, E. Senneville, V. Jean-Michel, Y. Zerbib, C. Chirouze, A. Boyer, C. Cazanave, D. Gruson, D. Malvy, P. Andreu, J.P. Quenot, N. Terzi, K. Faure, C. Chabartier, V. Le Moing, K. Klouche, T. Ferry, F, Valour, B. Gaborit, E. Canet, P. Le Turnier, D. Boutoille, F. Bani-Sadr, F. Benezit, M. Revest, C. Cameli, A. Caro, MJ Ngo Um Tegue, Y. Le Tulzo, B. Laviolle, F. Laine, G. Thiery, F. Meziani, Y. Hansmann, W. Oulehri, C. Tacquard, F. Vardon-Bounes, B. Riu-Poulenc, M. Murris-Espin, L. Bernard, D. Garot, O. Hinschberger, M. Martinot, C. Bruel, B. Pilmis, O. Bouchaud, P. Loubet, C. Roger, X. Monnet, S. Figueiredo, V. Godard, J.P. Mira, M. Lachatre, S. Kerneis, J. Aboab, N. Sayre, F. Crockett, D. Lebeaux, A. Buffet, J.L. Diehl, A. Fayol, J.S. Hulot, M. Livrozet, A Mekontso- Dessap, C. Ficko, F. Stefan, J. Le Pavec, J. Mayaux, H. Ait-Oufella, J.M. Molina, G. Pialoux, M. Fartoukh, J. Textoris, M. Brossard, A. Essat, E. Netzer, Y. Riault, M. Ghislain, L. Beniguel, M. Genin, L. Gouichiche, C. Betard, L. Belkhir, A. Altdorfer, V Fraipont Centro, S. Braz, JM Ferreira Ribeiro, R Roncon Alburqueque, M. Berna, M. Alexandre, B. Lamprecht, A. Egle, R. Greil, M. Joannidis, Thomas F. Patterson, Philip O. Ponce, Barbara S. Taylor, Jan E. Patterson, Jason E. Bowling, Heta Javeri, LuAnn Larson, Angela Hewlett, Aneesh K. Mehta, Nadine G. Rouphael, Youssef Saklawi, Nicholas Scanlon, Jessica J. Traenkner, Ronald P. Trible, Jr., Emmanuel B. Walter, Noel Ivey, Thomas L. Holland, Guillermo M. Ruiz-Palacios, Alfredo Ponce de León, Sandra Rajme, Lanny Hsieh, Alpesh N. Amin, Miki Watanabe, Helen S. Lee, Susan Kline, Joanne Billings, Brooke Noren, Hyun Kim, Tyler D. Bold, Victor Tapson, Jonathan Grein, Fayyaz Sutterwala, Nicole Iovine, Lars K. Beattie, Rebecca Murray Wakeman, Matthew Shaw, Mamta K. Jain, Satish Mocherla, Jessica Meisner, Amneris Luque, Daniel A. Sweeney, Constance A. Benson, Farhana Ali, Robert L. Atmar, Hana M. El Sahly, Jennifer Whitaker, Ann R. Falsey, Angela R. Branche, Cheryl Rozario, Justino Regalado Pineda, José Arturo Martinez-Orozco, David Chien Lye, Sean WX. Ong, Po Ying Chia, Barnaby E. Young, Uriel Sandkovsky, Mezgebe Berhe, Clinton Haley, Emma Dishner, Valeria D. Cantos, Colleen F. Kelley, Paulina A. Rebolledo Esteinou, Sheetal Kandiah, Sarah B. Doernberg, Pierre-Cedric B. Crouch, Hannah Jang, Anne F. Luetkemeyer, Jay Dwyer, Stuart H. Cohen, George R. Thompson, 3rd, Hien H. Nguyen, Robert W. Finberg, Jennifer P. Wang, Juan Perez-Velazquez, Mireya Wessolossky, Patrick E.H. Jackson, Taison D. Bell, Miranda J. West, Babafemi Taiwo, Karen Krueger, Johnny Perez, Triniece Pearson, Catharine I. Paules, Kathleen G. Julian, Danish Ahmad, Alexander G. Hajduczok, Henry Arguinchona, Christa Arguinchona, Nathaniel Erdmann, Paul Goepfert, Neera Ahuja, Maria G. Frank, David Wyles, Heather Young, Myoung-don Oh, Wan Beom Park, Chang Kyung Kang, Vincent Marconi, Abeer Moanna, Sushma Cribbs, Telisha Harrison, Eu Suk Kim, Jongtak Jung, Kyoung-Ho Song, Hong Bin Kim, Seow Yen Tan, Humaira Shafi, MF Jaime Chien, Raymond KC. Fong, Daniel D. Murray, Jens Lundgren, Henrik Nielsen, Tomas Jensen, Barry S. Zingman, Robert Grossberg, Paul F. Riska, Otto O. Yang, Jenny Ahn, Rubi Arias, Rekha R. Rapaka, Naomi Hauser, James D. Campbell, William R. Short, Pablo Tebas, Jillian T. Baron, Susan L.F. McLellan, Lucas S. Blanton, Justin B. Seashore, C. Buddy Creech, Todd W. Rice, Shannon Walker, Isaac P. Thomsen, Diego Lopez de Castilla, Jason W. Van Winkle, Francis X. Riedo, Surinder Kaur Pada, Alvin DY. Wang, Li Lin, Michelle Harkins, Gregory Mertz, Nestor Sosa, Louis Yi Ann Chai, Paul Anantharajah Tambyah, Sai Meng Tham, Sophia Archuleta, Gabriel Yan, David A. Lindholm, Ana Elizabeth Markelz, Katrin Mende, Richard Mularski, Elizabeth Hohmann, Mariam Torres-Soto, Nikolaus Jilg, Ryan C. Maves, Gregory C. Utz, Sarah L. George, Daniel F. Hoft, James D. Brien, Roger Paredes, Lourdes Mateu, Cora Loste, Princy Kumar, Sarah Thornton, Sharmila Mohanraj, Noreen A. Hynes, Lauren M. Sauer, Christopher J. Colombo, Christina Schofield, Rhonda E. Colombo, Susan E. Chambers, Richard M. Novak, Andrea Wendrow, Samir K. Gupta, Tida Lee, Tahaniyat Lalani, Mark Holodniy, Aarthi Chary, Nikhil Huprikar, Anuradha Ganesan, Norio Ohmagari, Ayako Mikami, D. Ashley Price, Christopher J.A. Duncan, Kerry Dierberg, Henry J. Neumann, Stephanie N. Taylor, Alisha Lacour, Najy Masri, Edwin Swiatlo, Kyle Widmer, James D. Neaton, Mary Bessesen, David S. Stephens, Timothy H. Burgess, Timothy M. Uyeki, Robert Walker, G. Lynn Marks, Anu Osinusi, Huyen Cao, Anabela Cardoso, Stephanie de Bono, Douglas E. Schlichting, Kevin K. Chung, Jennifer L. Ferreira, Michelle Green, Mat Makowski, Michael R. Wierzbicki, Tom M. Conrad, Jill Ann El-Khorazaty, Heather Hill, Tyler Bonnett, Nikki Gettinger, Theresa Engel, Teri Lewis, Jing Wang, John H. Beigel, Kay M. Tomashek, Varduhi Ghazaryan, Tatiana Beresnev, Seema Nayak, Lori E. Dodd, Walla Dempsey, Effie Nomicos, Marina Lee, Rhonda Pikaart-Tautges, Mohamed Elsafy, Robert Jurao, Hyung Koo, Michael Proschan, Tammy Yokum, Janice Arega, Ruth Florese, Jocelyn D. Voell, Richard Davey, Ruth C. Serrano, Zanthia Wiley, Varun K. Phadke, Paul A. Goepfert, Carlos A. Gomez, Theresa A. Sofarelli, Laura Certain, Hannah N. Imlay, Cameron R. Wolfe, Emily R. Ko, John J. Engemann, Nora Bautista Felix, Claire R. Wan, Sammy T. Elmor, Laurel R. Bristow, Michelle S. Harkins, Nicole M. Iovine, Marie-Carmelle Elie-Turenne, Victor F. Tapson, Pyoeng Gyun Choe, Richard A. Mularski, Kevin S. Rhie, Rezhan H. Hussein, Dilek Ince, Patricia L. Winokur, Jin Takasaki, Sho Saito, Kimberly McConnell, PharmD, David L. Wyles, Ellen Sarcone, Kevin A. Grimes, Katherine Perez, Charles Janak, Jennifer A. Whitaker, Paulina A. Rebolledo, John Gharbin, Allison A. Lambert, Diego F. Zea, Emma Bainbridge, David C. Hostler, Jordanna M. Hostler, Brian T. Shahan, Evelyn Ling, Minjoung Go, Fleesie A. Hubbard, Melony Chakrabarty, Maryrose Laguio-Vila, Edward E. Walsh, Faheem Guirgis, Vincent C. Marconi, Christian Madar, Scott A. Borgetti, Corri Levine, Joy Nock, Keith Candiotti, Julia Rozman, Fernando Dangond, Yann Hyvert, Andrea Seitzinger, Kaitlyn Cross, Stephanie Pettibone, Seema U. Nayak, and Gregory A. Deye
Subjects: Acute respiratory distress syndrome, Acute hypoxemic respiratory failure, Pneumonia, Critically ill, Cancer, Medicine (General), R5-920
Abstract: Summary: Background: Although immunomodulators have established benefit against the new coronavirus disease (COVID-19) in general, it is uncertain whether such agents improve outcomes without increasing the risk of secondary infections in the specific subgroup of previously immunocompromised patients. We assessed the effect of immunomodulators on outcomes of immunocompromised patients hospitalized for COVID-19. Methods: The protocol was prospectively registered with PROSPERO (CRD42022335397). MEDLINE, Cochrane Central Register of Controlled Trials and references of relevant articles were searched up to 01-06-2022. Authors of potentially eligible randomized controlled trials were contacted to provide data on immunocompromised patients randomized to immunomodulators vs control (i.e., placebo or standard-of-care). Findings: Eleven randomized controlled trials involving 397 immunocompromised patients hospitalized for COVID-19 were included. Ten trials had low risk of bias. There was no difference between immunocompromised patients randomized to immunomodulators vs control regarding mortality [30/182 (16.5%) vs 41/215 (19.1%); RR 0.93, 95% CI 0.61–1.41; p = 0.74], secondary infections (RR 1.00, 95% CI 0.64–1.58; p = 0.99) and change in World Health Organization ordinal scale from baseline to day 15 (weighed mean difference 0.27, 95% CI -0.09–0.63; p = 0.15). In subgroup analyses including only patients with hematologic malignancy, only trials with low risk of bias, only trials administering IL-6 inhibitors, or only trials administering immunosuppressants, there was no difference between comparators regarding mortality. Interpretation: Immunomodulators, compared to control, were not associated with harmful or beneficial outcomes, including mortality, secondary infections, and change in ordinal scale, when administered to immunocompromised patients hospitalized for COVID-19. Funding: Hellenic Foundation for Research and Innovation.
Published: 2024
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3. Post-traumatic stress disorders in women victims-survivors of intimate partner violence: a mixed-methods pilot study in a French coordinated structure

Author: Marc Bardou, Fabienne El Khoury, Ghada Hatem, Noemie Roland, Noëlla Delmas, Alice Bardou, Leila Yacini, Laure Feldmann, and Sarah Mahdjoub
Subjects: Medicine
Abstract: Objectives This study aimed to examine the prevalence of post-traumatic stress disorder (PTSD) in victims-survivors of intimate partner violence (IPV) consulting at the specialised and original facility ‘Maison des Femmes’ (MdF) or in two close municipal health centres (MHCs).Design A mixed-methods study using a convergent parallel design from July 2020 to June 2021.Setting/participants A questionnaire was proposed to women aged 18 years and over having suffered from IPV, in the MdF and in two MHCs. We also conducted qualitative interviews with a subsample of the women, asking for victim-survivors’ perceptions of the effect of the MdF’s care.Primary and secondary outcome measures The presence of a PTSD using the PTSD self-report checklist of symptoms, possibility of reaching women by phone 6 months after the inclusion visit, level of self-rated global health, number of emergency visits in the past 6 months, substances use, readiness to change and safety behaviours.Results A total of 67 women (mean age: 34 years (SD=9.7)) responded to our questionnaire. PTSD diagnosis was retained for 40 women (59.7%). Around 30% of participants self-rated their global health as bad. Less than 30% (n=18) of women were regular smokers, and only 7.5% of participants had a problematic alcohol use (Alcohol Use Disorders Identification Test-Consumption score ≥4), 19.4% women used psychotropic drugs. Six months after inclusion, half of participants had been reached by phone. Analysis of the qualitative interviews clarified victim-survivors’ perceptions of the MdF’s specific care: social networking, multidisciplinary approach, specialised listening, healthcare facilities, evasion and ‘feeling at home’.Conclusions The high prevalence of PTSD at inclusion was nearly the same between the three centres. This mixed-methods comparison will serve as a pilot study for a larger comparative trial to assess the long-term impact of the MdF’s specialised care on victims-survivors’ mental health, compared with the care of uncoordinated structures.Trial registration number NCT04304469.
Published: 2024
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4. Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) study

Author: Yannick Béjot, Marc Bardou, Mathieu Boulin, Yves Cottin, Maurice Giroud, Anne-Laure Soilly, Gauthier Duloquin, Thibaut Pommier, Gabriel Laurent, Lucie Vadot, and Héloïse Adam
Subjects: Medicine
Abstract: Introduction The ongoing ageing population is associated with an increase in the number of patients suffering a stroke, transient ischaemic attack (TIA) or myocardial infarction (MI). In these patients, implementing secondary prevention is a critical challenge and new strategies need to be developed to close the gap between clinical practice and evidence-based recommendations. We describe the protocol of a randomised clinical trial that aims to evaluate the efficiency and effectiveness of an intensive multidisciplinary follow-up of patients compared with standard care.Methods and analysis The DiVa study is a randomised, prospective, controlled, multicentre trial including patients >18 years old with a first or recurrent stroke (ischaemic or haemorrhagic) or TIA, or a type I or II MI, managed in one of the participating hospitals of the study area, with a survival expectancy >12 months. Patients will be randomised with an allocation ratio of 1:1 in two parallel groups: one group assigned to a multidisciplinary, nurse-based and pharmacist-based 2-year follow-up in association with general practitioners, neurologists and cardiologists versus one group with usual follow-up. In each group for each disease (stroke/TIA or MI), 430 patients will be enrolled (total of 1720 patients) over 3 years. The primary outcome will be the incremental cost–utility ratio at 24 months between intensive and standard follow-up in a society perspective. Secondary outcomes will include the incremental cost–utility ratio at 6 and 12 months, the incremental cost-effectiveness ratio at 24 months, reduction at 6, 12 and 24 months of the rates of death, unscheduled rehospitalisation and iatrogenic complications, changes in quality of life, net budgetary impact at 5 years of the intensive follow-up on the national health insurance perspective and analysis of factors having positive or negative effects on the implementation of the project in the study area.Ethics and dissemination Ethical approval was obtained and all patients receive information about the study and give their consent to participate before randomisation. Results of the main trial and each of the secondary analyses will be submitted for publication in a peer-reviewed journal.Trial registration number ClinicalTrials.gov Identifier: NCT04188457. Registered on 6 December 2019.
Published: 2023
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5. Women and health professionals’ perspectives on a conditional cash transfer programme to improve pregnancy follow-up: a qualitative analysis of the NAITRE randomised controlled study

Author: Celine Chauleur, Jacob Hannigsberg, Philippe Merviel, Marc Bardou, Franck Perrotin, Thomas Schmitz, Olivier Picone, Jeanne Sibiude, Karine Chemin, Dominique Dallay, Frédéric Coatleven, Loïc Sentilhes, Céline Brochot, Astrid Eckman-Lacroix, Elise Thellier, Frédérique Falchier, Philippe Deruelle, Muriel Doret, Xavier Carcopino-Tusoli, Nicolas Meunier-Beillard, Hervé Fernandez, Vincent Villefranque, Caroline Diguisto, Damien Subtil, Clémence Houssin, Philippe Gillard, Laurent Mandelbrot, Aurelie Godard-Marceau, Nathalie Lesavre, Claude Virtos, Elodie Debras, Aude Bourtembourg, Claire Toubin, Danièle Addes, Véronique Uguen, Cleo Tourbot, Caroline Lelievre, Christophe Tremouilhac, Anne-Hélène Saliou, Aurelie Derrieu, Stephanie Auget, Anne Legourrierec, Anne Leroux, Julie Fort-Jacquier, Marion Serclerat, Nathalie Laurenceau, Audrey Renouleau, Eliane Catteau, Julie Blanc, Candice Ronin, Laurence Piechon, Séverine Puppo, Fanny Greco, Sandrine Pettazzoni, Muriel Athlani, Amina Desvignes, Annie Petiteau, Amina El Yaakoubi, Valérie Bechadergue, Valérie Vaugirard, Marie-Emmanuelle Neveu, Caroline Geyl, Marie-Victoire Senat, Claire Colmant, Marie Houllier, Myriam Virlouet, Marion Mir, Yasmina Bejaoui, Hélène Le Cornu, Lauriane Nikel, Elodie Gustave, Amandine Stadler, Ahmad Mehdi, Tiphaine Barjat, Suzanne Lima, Thomas Corsini, Anne Genod, Charlotte Vermesch, Cécile Fanget, Marianne Perrot, Manuela Munoz, Sylvie Pitaval, Fanny Magand, Françoise Baldi, Stephanie Bret, Anne-Lise Verdier, Christelle Denis, Carine Arlicot, Jérôme Potin, Stéphanie Chretien, Julie Paternotte, Nathalie Trignol, Élisabeth Blin, Camille Mathieu, Anne Dubreuil, Anne Viallon Pelletier, Catherine Guerin, Chloé Arthuis, Christophe Vayssieres, Olivier Parant, Marion Groussolles, Maria Denis, M Mathieu Morin, Marie-Thérèse Bavoux, Juliette Pelloux, Anne-Claire Jambon, Madeleine Santraine, Veronique Lebuffe, Pascale Broux, Thierry Dzukou, Magloire Gnansounou, Didier Hubert, Claire Djazet, Ludivine Destoop, Marine Derue, Pierrick Theret, Dominique Delzenne, Stéphanie Daussin, Alice Fraissinet, Mélanie Vannerum, Cyril Faraguet, Laurence Landais, Mariana Radu, Anne Rouget, Sena Al Sudani, Bernard Guillon, Estelle Wucher, Véronique Selva, Sandrine Reviron, Francis Schwetterlé, Cécile Chassande, Véronique Grandin, Eliane Krtoliza, Patrick Becher, Marie Sarrau, Claire Lecoq, Elsa Lutringer, Denis Roux, Noémie Berge, Clémentine Barbier, Anne Heron, Audrey Farina-Bracquart, Marie-Paule Curtet, Evelyne Lefebure, Marie-Hélène Le Douarin, Hassan Al Rayes, Émilie Magne, Nathalie Destampes, Émilie Ricard, Pascale Ghezzi, Catherine Guillen, Fanny Alazard, Marie-Thé Campanaro, Florence Mojard, Magalie David-Reynard, Patricia Fuma, Remy De Montgolfier, Capucine Neel, Guillaume Legendre, Isabelle Andre, Sylvie Nordstrom, Brigitte Guionnet, Catherine Crenn Hebert, Chloé Dussaux, Karine Achaintre, Anne Wagner, Martine Werveake, Eloïse De Gouville, George Theresin, Marie Pierre Couetoux, Lydia Caillaud, Marie-Pierre Fernandez, Sabrina Bottet, M Alain Almodovar, Elisa Etienne, Véronique Guiteras, Angélique Torres, N. Roche, Myriam Nassef, Christine Abel-Faure, Marie Louvet, Carole Ettori, Guillaume Ducarme, Valérie Bonnenfant-Mezeray, Laurence Szezot-Renaudeau, Marie-Pierre Berte, Elodie Netier-Herault, Stéphanie Manson-Gallone, Franck Mauviel, Nathalie Agostini, Marine Mazeaud, Jean-Claude Dausset, Isabelle De Murcia, Emilie Alliot, Anne-Marie Bes, Magali Biferi Magali, Hélène Heckenroth, Sophie Morange, Gersende Chiuot, Audrey Gnisci, Annie Allegre, Laetitia Lecq, Eva Balenbois, Claire Tourette, Aude Figarella, Dio Andriamanjay, Pauline Vignoles, Catherine Cazelles, Véronique Lejeune Saada, Benafsheh Kashani, Isabelle Chevalier, Muriel Terrieres, Audrey Cointement, Valérie Benhaïm, Najat Lindoune, Anne-Sophie Maisonneuve, M Frédéric Daubercy, Guilia Mencattini, Vanessa Combaud, Isabelle Moya, Xavier-Côme Donato, Raoul Desbriere, Marie Lafon, and Véronique Baudet
Subjects: Medicine
Abstract: Objectives Women of low socioeconomic status have been described as having suboptimal prenatal care, which in turn has been associated with poor pregnancy outcomes. Many types of conditional cash transfer (CCT) programmes have been developed, including programmes to improve prenatal care or smoking cessation during pregnancy, and their effects demonstrated. However, ethical critiques have included paternalism and lack of informed choice. Our objective was to determine if women and healthcare professionals (HPs) shared these concerns.Design Prospective qualitative research.Setting We included economically disadvantaged women, as defined by health insurance data, who participated in the French NAITRE randomised trial assessing a CCT programme during prenatal follow-up to improve pregnancy outcomes. The HP worked in some maternities participating in this trial.Participants 26 women, 14 who received CCT and 12 who did not, mostly unemployed (20/26), and - 7 HPs.Interventions We conducted a multicentre cross-sectional qualitative study among women and HPs who participated in the NAITRE Study to assess their views on CCT. The women were interviewed after childbirth.Results Women did not perceive CCT negatively. They did not mention feeling stigmatised. They described CCT as a significant source of aid for women with limited financial resources. HP described the CCT in less positive terms, for example, expressing concern about discussing cash transfer at their first medical consultation with women. Though they emphasised ethical concerns about the basis of the trial, they recognised the importance of evaluating CCT.Conclusions In France, a high-income country where prenatal follow-up is free, HPs were concerned that the CCT programme would change their relationship with patients and wondered if it was the best use of funding. However, women who received a cash incentive said they did not feel stigmatised and indicated that these payments helped them prepare for their baby’s birth.Trial registration number NCT02402855
Published: 2023
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6. Combined incentive actions, focusing on primary care professionals, to improve cervical cancer screening in women living in socioeconomically disadvantaged geographical areas: a study protocol of a hybrid cluster randomised effectiveness and implementation trial- RESISTE

Author: Marc Bardou, Alexandre Dumont, Dolorès Pourette, Jean-Luc Fanon, Laurence Fagour, Guillemette Antoni, Nicolas Traversier, Amir Hassine, Muriel Fender, Katia Slama, François-Xavier Léandri, Christelle Auvray, Marie Christine Jaffar Bandjee, Lise Rochaix, Camilla Fiorina, Eric Opigez, and Resiste Study Group
Subjects: Medicine
Abstract: Introduction Cervical cancer (CC) causes thousands of deaths each year. Nearly 100% of cases are caused by oncogenic strains of human papillomavirus (HPV). In most industrialised countries, CC screening (CCS) is based on the detection of HPV infections. For many reasons including lower adherence to CCS, underserved women are more likely to develop CC, and die from it. We aim to demonstrate that the use of incentives could improve screening rates among this population.Methods and analysis Our cluster randomised, controlled trial will include 10 000 women aged 30–65 years eligible for CCS, living in deprived areas in four French departments, two mainlands and two overseas, and who did not perform physician-based HPV testing within the framework of the nationally organised screening programme. HPV self-sampling kit (HPVss) will be mailed to them. Two interventions are combined in a factorial analysis design ending in four arms: the possibility to receive or not a financial incentive of €20 and to send back the self-sampling by mail or to give it to a health professional, family doctor, gynaecologist, midwife or pharmacist. The main outcome is the proportion of women returning the HPVss, or doing a physician-based HPV or pap-smear test the year after receiving the HPVss. 12-month follow-up data will be collected through the French National Health Insurance database. We expect to increase the return rate of HPV self-samples by at least 10% (from 20% to 30%) compared with the postal return without economic incentive.Ethics and dissemination Ethics approval was first obtained on 2 April 2020, then on July 29 2022. The ethics committee classified the study as interventional with low risk, thus no formal consent is required for inclusion. The use of health insurance data was approved by the Commission Nationale Informatique et Libertés on 14 September 2021 (ref No 920276). An independent data security and monitoring committee was established. The main trial results will be submitted for publication in a peer-reviewed journal.Trial registration number NCT04312178.
Published: 2022
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7. First use of Simulation in Therapeutic Patient Education (S-TPE) in adults with diabetes: a pilot study

Author: Marc Bardou, Rémi Gagnayre, Christelle Pennecot, Maxime Luu, Claire Marchand, Nathalie Dechannes, Sabine Rudoni, Anne-Marie Hilaire, Aurore Demongeot, and Delphine Capelle
Subjects: Medicine
Published: 2022
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8. Leptin-Induced HLA-G Inhibits Myometrial Contraction and Differentiation

Author: Maeva Wendremaire, Tatiana E. Lopez, Marina Barrichon, Hang Zhang, Tarik Hadi, Xiang-Yang Ye, Fabrice Neiers, Marc Bardou, Paul Sagot, Carmen Garrido, and Frédéric Lirussi
Subjects: leptin, differentiation, labour, macrophage, myometrium, oxidative stress, Cytology, QH573-671
Abstract: Maternal obesity is associated with a wide spectrum of labour disorders, including preterm birth. Leptin, a pro-inflammatory adipokine and a key factor of obesity, is suspected to play a major role in these disorders. OB-R, its receptor, is expressed on macrophages and myocytes, two cell types critical for labour onset. Macrophages secrete reactive oxygen species/pro-inflammatory cytokines, responsible for myometrial differentiation while myocytes control uterine contractions. In this study, we assessed the effect of leptin on myometrial contraction and differentiation using our validated co-culture model of human primary macrophages and myocytes. We demonstrated that leptin had a different effect on myocytes and macrophages depending on the dose. A low leptin concentration induced a tocolytic effect by preventing myocytes’ contraction, differentiation, and macrophage-induced ROS production. Additionally, leptin led to an increase in HLA-G expression, suggesting that the tocolytic effect of leptin may be driven by HLA-G, a tolerogenic molecule. Finally, we observed that recombinant HLA-G also prevented LPS-induced ROS production by macrophages. Altogether, these data provide a putative molecular mechanism by which leptin may induce immune tolerance and therefore interfere with labour-associated mechanisms. Therefore, HLA-G represents a potential innovative therapeutic target in the pharmacological management of preterm labour.
Published: 2022
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9. Monitoring HSP70 exosomes in cancer patients’ follow up: a clinical prospective pilot study

Author: Gaëtan Chanteloup, Marine Cordonnier, Nicolas Isambert, Aurélie Bertaut, Alice Hervieu, Audrey Hennequin, Maxime Luu, Sylvie Zanetta, Bruno Coudert, Leila Bengrine, Isabelle Desmoulins, Laure Favier, Aurélie Lagrange, Pierre-Benoit Pages, Ivan Gutierrez, Jeanine Lherminier, Laure Avoscan, Clémentine Jankowski, Cédric Rébé, Angélique Chevriaux, Marie-Martine Padeano, Charles Coutant, Sylvain Ladoire, Sylvain Causeret, Laurent Arnould, Céline Charon-Barra, Vanessa Cottet, Julie Blanc, Christine Binquet, Marc Bardou, Carmen Garrido, and Jessica Gobbo
Subjects: exosomes, hsp70, diagnosis, liquid biopsy, cancer, Cytology, QH573-671
Abstract: Exosomes are nanovesicles released by all cells that can be found in the blood. A key point for their use as potential biomarkers in cancer is to differentiate tumour-derived exosomes from other circulating nanovesicles. Heat shock protein-70 (HSP70) has been shown to be abundantly expressed by cancer cells and to be associated with bad prognosis. We previously showed that exosomes derived from cancer cells carried HSP70 in the membrane while those from non-cancerous cells did not. In this work, we opened a prospective clinical pilot study including breast and lung cancer patients to determine whether it was possible to detect and quantify HSP70 exosomes in the blood of patients with solid cancers. We found that circulating exosomal HSP70 levels, but not soluble HSP70, reflected HSP70 content within the tumour biopsies. Circulating HSP70 exosomes increased in metastatic patients compared to non-metastatic patients or healthy volunteers. Further, we demonstrated that HSP70-exosome levels correlated with the disease status and, when compared with circulating tumour cells, were more sensitive tumour dissemination predictors. Finally, our case studies indicated that HSP70-exosome levels inversely correlated with response to the therapy and that, therefore, monitoring changes in circulating exosomal HSP70 might be useful to predict tumour response and clinical outcome.
Published: 2020
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10. Small Molecule Drugs in Inflammatory Bowel Diseases

Author: Inès Ben Ghezala, Maëva Charkaoui, Christophe Michiels, Marc Bardou, and Maxime Luu
Subjects: inflammatory bowel diseases, ulcerative colitis, Crohn’s disease, small molecule drugs, Medicine, Pharmacy and materia medica, RS1-441
Abstract: Inflammatory bowel diseases (IBDs), mainly represented by Crohn’s disease (CD) and Ulcerative Colitis (UC), are chronic disorders with an unclear pathogenesis. This incurable and iterative intestinal mucosal inflammation requires the life-long use of anti-inflammatory drugs to prevent flares or relapses, which are the major providers of complications, such as small bowel strictures and intestinal perforations. The introduction of tumor necrosis factor (TNF)-alpha inhibitors and other compounds, such as anti-IL12/23 and anti-alpha4/beta7 integrin monoclonal antibodies, has considerably improved the clinical management of IBDs. They are now the standard of care, being the first-line therapy in patients with aggressive disease and in patients with moderate to severe disease with an inadequate response to conventional therapy. However, for approximately one third of all patients, their efficacy remains insufficient by a lack or loss of response due to the formation of anti-drug antibodies or compliance difficulties with parenteral formulations. To address these issues, orally administered Small Molecules Drugs (SMDs) that use a broad range of novel pharmacological pathways, such as JAK inhibitors, sphingosine-1-phosphate receptor modulators, and phosphodiesterase 4 inhibitors, have been developed for CD and UC. This article provides an updated and complete review of the most recently authorized SMDs and SMDs in phase II/III development.
Published: 2021
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11. First nationwide web-based surveillance system for influenza-like illness in pregnant women: participation and representativeness of the French G-GrippeNet cohort

Author: Paul Loubet, Caroline Guerrisi, Clément Turbelin, Béatrice Blondel, Odile Launay, Marc Bardou, Thierry Blanchon, Isabelle Bonmarin, François Goffinet, Pierre-Yves Ancel, Vittoria Colizza, Thomas Hanslik, and Solen Kernéis
Subjects: Pregnancy, Influenza, Incidence, Surveillance, Web-based study, Public aspects of medicine, RA1-1270
Abstract: Abstract Background Pregnancy is a risk factor for severe influenza resulting in increased risks of hospitalisation and death in mothers and their new-borns. Our objective was to assess the representativeness and participation of French women to a new web-based collaborative tool for data collection and monitoring of Influenza Like Illness (ILI) during pregnancy. Methods During the 2014/2015 influenza season, pregnant women living in metropolitan France were enrolled through a web platform ( https://www.grippenet.fr/ ). Then throughout the season, participants were asked to report, on a weekly basis, if they had experienced symptoms of ILI. Representativeness was assessed by comparing the characteristics of participants to those of the French National Perinatal Survey. For each participant, the participation rate was the number of weekly questionnaires completed, divided by the length of follow-up (in weeks). Predictors of active participation (participation rate >15 %) were assessed by multivariate logistic regression. Results A total of 153 women were enrolled. Participants were older (mean age 34 years vs. 29 years) and more highly educated (high school level 89 % versus 52 %) than the general population of pregnant women in France, but the sample did not differ on pregnancy-related characteristics (parity, history of hospitalisation during a previous pregnancy). The median rate of participation was high (78 %, interquartile range: 34–96). Higher educational level and participation to a previous GrippeNet.fr season were associated with active participation. Conclusion Despite small sample size and lack of representativeness, the retention rate was high, suggesting that pregnant women are prone to adhere to a longitudinal follow-up of their health status via the Internet.
Published: 2016
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12. Approaches to manage ‘affordability’ of high budget impact medicines in key EU countries

Author: Mathias Flume, Marc Bardou, Stefano Capri, Oriol Sola-Morales, David Cunningham, Lars-Ake Levin, Maarten J. Postma, and Nicolas Touchot
Subjects: Budget impact, affordability, cost effectiveness, market access, funding, expensive therapies, health technology assessment, price negotiation, Public aspects of medicine, RA1-1270, Business, HF5001-6182
Abstract: Background: The launch of hepatitis C (HCV) drugs such as sofosbuvir or ledipasvir has fostered the question of affordability of novel high budget impact therapies even in countries with high domestic product. European countries have developed a variety of mechanisms to improve affordability of such therapies, including ‘affordability thresholds’, price volume agreements or caps on individual product sales, and special budgets for innovative drugs. While some of these mechanisms may help limit budget impact, there are still significant progresses to be made in the definition and implementation of approaches to ensure affordability, especially in health systems where the growth potential in drug spending and/or in the patient contribution to health insurance are limited. Objectives: In this article, we will review how seven countries in western Europe are approaching the question of affordability of novel therapies and are developing approaches to continue to reward new sciences while limiting budget impact. We will also discuss the question of affordability of cost-effective but hugely expensive therapies and the implications for payers and for the pharmaceutical industry. Results: There is clearly not one solution that is used consistently across countries but rather a number of ‘tools’ that are combined differently in each country. This illustrates the difficulty of managing affordability within different legal frameworks and within different health care system architectures.
Published: 2018
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13. Can the Presence of Endoscopic High-Risk Stigmata be Bredicted before Endoscopy? A Multivariable Analysis Using the RUGBE Database

Author: Yen-I Chen, Jonathan Wyse, Alan Barkun, Marc Bardou, Ian M Gralnek, and Myriam Martel
Subjects: Diseases of the digestive system. Gastroenterology, RC799-869
Abstract: BACKGROUND: Many aspects in the management of acute upper gastrointestinal bleeding rely on pre-esophagogastroduodenoscopy (EGD) stratification of patients likely to exhibit high-risk stigmata (HRS); however, data predicting the presence of HRS are lacking.
Published: 2014
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14. Review article: obesity and colorectal cancer

Author: Marc Bardou, Alexia Rouland, Myriam Martel, Romaric Loffroy, Alan N. Barkun, and Nicolas Chapelle
Subjects: Male, Hepatology, Rectal Neoplasms, Gastroenterology, Bariatric Surgery, Overweight, Body Mass Index, Pregnancy, Humans, Female, Pharmacology (medical), Obesity, Child, Colorectal Neoplasms
Abstract: Obesity is a growing global public health problem. More than half the European and North American population is overweight or obese. Colon and rectum cancers are still the second leading cause of cancer death worldwide, and epidemiological data support an association between obesity and colorectal cancers (CRCs).To review the literature on CRC epidemiology in obese subjects, assessing the effects of obesity, including childhood or maternal obesity, on CRC, diagnosis, management, and prognosis, and discussing targeted prophylactic measures.We searched PubMed for obesity/overweight/metabolic syndrome and CRC. Other key words included 'staging', 'screening', 'treatment', 'weight loss', 'bariatric surgery' and 'chemotherapy'.In Europe, about 11% of CRCs are attributed to overweight and obesity. Epidemiological data suggest that obesity is associated with a 30%-70% increased risk of colon cancer in men, the association being less consistent in women. Visceral fat or abdominal obesity seems to be of greater concern than subcutaneous fat obesity, and any 1 kg/mDespite a growing body of evidence linking obesity to CRC, many questions remain unanswered, including whether we should screen patients with obesity earlier or propose prophylactic bariatric surgery for certain patients with obesity.
Published: 2022

15. Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): An open-label randomised controlled trial

Author: Anatole Harrois, Florence Patin, Anaïs Razurel, Laure Allanic, Grégoire Martin de Frémont, Vincent Jachiet, Gonçalo Boleto, Eric D'Ortenzio, Xavier Mariette, Philippe Dieudé, Etienne Canouï, Z Julia, Nathalie Dournon, Jean-Sébastien Hulot, David Lebeaux, Eric Mariotte, Dorothee Vallois, Laurence Berard, Nicolas Gambier, Christiane Verny, Mathilde Le Marchand, Mitja Jevnikar, Jean-Jacques Mourad, Marjolaine Morgand, Bertrand Guidet, Alexandre Moores, Prissile Bakouboula, Frédéric Pène, Pascal Richette, Martine Meunier, Juliette Camuset, Stéphane Jauréguiberry, Lynda Chalal, Mamadou Salif Cisse, Marie-Hélène Legros, Yann Nguyen, Damien Roux, Robin Deleris, Maxence Decavele, Patrice Cacoub, Isabelle Dusanter, Patricia Senet, Nassim Mahtal, Raphael Borie, Philippe Benoit, Blandine Denis, Luca Semerano, Sebastien Abad, Marie Dubert, Marie Lachatre, Marine Livrozet, Nathan Ebstein, Lakhdar Mameri, Adrien Michon, Olivier Sanchez, Aurélien Guffroy, Pierre Dupland, Jérôme Pacanowski, Yasmina Ferfar, Tassadit Hadjam, Anne-Marie Roques, Celine Comparon, Solaya Chalal, A Soria, Isabelle Lehir, Anne Gysembergh-Houal, Stéphanie Alary, Valérie Dejean, Elena Kiouris, Estelle Henry, Sophie Diemunsch, Jonathan London, Fanny Charbonnier, Alexandre Demoule, Louise Bondeelle, Samira Saleh-Mghir, Lise Bernard, Brigitte Sabatier, Anne Jacolot, Aurelie Sautereau, Pierre Faye, Benjamin Fournier, Noémie Abisror, Awa Ndiaye, Ruben Benainous, Damien Sène, Emmanuelle Sacco, Isabelle Debrix, Gabriel Nisand, Régis Peffault de Latour, Anne Sophie Korganow, Kévin Cardet, Perrine Guillaume-Jugnot, Soumeya Hammal, B. Duchemann, Elena Fois, Jean-Benoit Arlet, Christine Broissand, Yaël Amara, Matheus Vieira, Sophie Caillat-Zucman, Madona Sakkal, Juliette Djadi-Prat, Jean-Louis Teboul, Hélène François, Stéphane Renaud, Sylviane Ravato, Alaki Thiemele, Gabrielle Archer, Alain Fourreau, David Boutboul, Arsène Mekinian, Antoine Gros, Morgane Faure, Anne Pattyn, Camille Petit-Hoang, Jessica Krause le Garrec, Antony Canellas, Jean-Michel Molina, Zakaria Ait Hamou, Eric Oksenhendler, Ilias Koumis, Marie-Aude Penet, Catherine Boussard, Vincent Fallet, Guillaume Geri, Loic Kassegne, Bernard Cholley, Lucie Biard, Elodie Perrodeau, Tomas Urbina, David Schmitz, johann Cailhol, Elise Morawiec, Audrey Phibel, Sophie Renet, Emmanuel Weiss, Faouzi Saliba, Kristina Beziriganyan, Abdellatif Tazi, Isabelle Peigney, Bertrand Dunogue, Rémy Gauzit, Damien Bergerot, Bob Heger, Ines Ben-Mabrouk, Jade Ghosn, Benjamin Planquette, Alexis Régent, François Weill, Yasmina Mekid, Rosa Da Silva, Victor Lancon, Marc Michel, Nadia Anguel, Anne Claire Desbois, François Danion, Brigitte Ranque, Mohamed Belloul, Nadège Lemarié, Amélie Cransac, Marine Nadal, Lalia Djaghout, Anne Tréhan, Samy Figueiredo, Hakim Meddah, Aurélie Clan Hew Wai, Julie Delemazure, Soraya Fellahi, Jacques-Eric Gottenberg, Matthieu Uzzan, Jean-Charles Duclos-Vallée, Tabassome Simon, Vanessa Rathouin, Yves Hansmann, Hélène Gros, Syllia Belazouz, Nathalie Marin, Camille Rolland-Debord, Edouard Lefèvre, Sophie-Rym Hamada, Tristan Martin, Annabelle Stoclin, Frédéric Duée, Helene Chambrin-Lauvray, Ramdane Meftali, Miguel Alejandro Vasquez-Ibarra, Isabelle Madeleine, Simon Valayer, Anne Adda, Marie-Thérèse Tremorin, Nicolas Meyer, Vixra Keo, Lara Zafrani, Caroline Semaille, Maxime Dougados, Olivier Olivier, Emeline Colomba, Florence Morin, Claire Rouzaud, Paul Michel Mertes, Claire Montlahuc, Anne Blanchard, Valérie Pourchet-Martinez, Constance Delaugerre, Nicolas Carlier, Jacques Cadranel, Nicolas Noel, Kahina Cheref, Bao Phung, Moez Jallouli, Ulrich Clarac, Marthe Rigal, Mireille Adda, Lionel Galicier, Fanny Domont, Lee S. Nguyen, Férial Berbour, Fanny Pommeret, Celine Dupré, Gaël Leprun, Jean-Luc Diehl, Laetitia Languille, Philippe Blanche, Abolfazl Mohebbi, Mathilde Noaillon, Olivier Collange, Paul Jaubert, Anne Daguenel-Nguyen, Sandrine Briois, Anne-Lise Pouliquen, Coralie Bloch Queyrat, Clément Jourdaine, Cédric Pierron, Geoffrey Rossi, Chloe McAvoy, Claire Courtin, Mathias Cornic, C Rioux, Christine Lemagner, Martin Dres, Emmanuelle Guillot, Marc Garnier, Safaa Nemlaghi, Guillaume Grailles, Yazdan Yazdanpanah, Veronique Joly, Thiziri Sadaoui, Marion Bouhris, Vincent Castelain, Muriel Fartoukh, Sébastien Cavelot, Sophie Ohlmann-Caillard, Valentina Isernia, Bruno Crestani, Thinhinane Bariz, Benjamin Chaigne, Emmanuel Andrès, Frédéric Blanc, Alain Wynckel, Louise-Laure Mariani, Yasmine Messaoudi, Naima Sguiouar, Amina Kebir, Asmaa Mamoune, Caroline Gaudefroy, Victoire De Lastours, Pierre Diemunsch, Etienne Lengliné, Claire Tantet, Julien Mayaux, Benjamin G. Chousterman, Arthur Pavot, Anne Rachline, Gwenaël Lorillon, Hassan Joumaa, Nicolas Lefebvre, Elodie Baudry, Nicolas Bonnet, Fanny Defrancq, Véronique Vigna, Yves Cohen, Amira Benattia, Martin Siguier, Sophie Georgin-Lavialle, Emmanuelle Bugnet, Lamiae Grimaldi, Olivia Daconceicao, Olivier Hermine, Mathieu Vautier, Florence Tubach, Marion Licois, Anaïs Codorniu, Fanny Alby-Laurent, Jérémie Zerbit, Aude Jacob, Benedicte Giroux-Leprieur, Carine Karachi, Laurent Cylly, Edouard Flamarion, Gladys Aratus, Charléne Jouve, Robin Dhote, Claire Davoine, Valentin Greigert, Gaelle Leroux, Cécile Kedzia, Guillaume Lefèvre, Catherine Metzger, Olivier Benveniste, Clairelyne Dupin, Marie-Alexandra Alyanakian, Mathieu Oberlin, Julien Poissy, Linda Gimeno, Adrien Contejean, Segolene Toquet, Jeanne CHAUFFiER, Mathieu Jozwiak, Laurent Savale, Virginie Zarrouk, Cécile Yelnik, Mandy Nizard, Mourad Djadel, F-Xavier Lescure, Agnes Maurer, Geoffroy Liégeon, Arthur Neuschwander, Hélène Lafoeste, Gaëtan Deslée, Frédéric De Blay, Claire Pernin, Cloé Comarmond, Anne Hutt, Ridha Belilita, Laurence Lecomte, Sophie-Caroline Sacleux, Nathalie Rozensztajn, Jean-Jacques Tudesq, Benjamin Terrier, Solène Fabre, Lelia Escaut, Eva Chatron, Emmanuelle Blin, Pauline Jouany, Sara Sambin, Chistophe Willekens, Nabil Raked, Jean-Simon Rech, Serge Bureau, Boris Bienvenu, Elisabeth Coupez, Tali-Anne Szwebel, Lydia Suarez, Chaouki Bouras, Kamyl Baghli, Emilia Stan, Valérie Camara-Clayette, Fanette Denies, Nathalie Menage, Paul Legendre, Axelle Fuentes, Oriane Puéchal, Charlotte Kaeuffer, Guillaume Becker, Clara Campos-Vega, Armand Mekontso-Dessaps, Pernelle Vauboin, Yurdagul Uzunhan, F Louni, Marie hélène Pari, Myriam Virlouvet, Nicolas Belaube, Hugues Cordel, Nathalie Chavarot, Olivier Sitbon, Jean-Daniel Lelievre, Matthieu Mahévas, Julie Smati, Olivier Clovet, Marc Bardou, Ada Clarke, Gilles Garcia, Anouk Walter-Petrich, Hala Semri, Vasco Honsel, Giovanna Melica, Pierre Mora, Olivier Fain, A Gervais, Marc Humbert, Yves Allenbach, Céline Verstuyft Verstuyft, Blandine Lehmann, Pascal Martel, Aida Zahrate-Ghoul, Karine Martin, Alexandre Bourgoin, Baptiste Duceau, Philippe Ravaud, Celine Wilpotte, Sylvie Le Gac, Michaël Darmont, Aurélie Durel Maurisse, Younes Keroumi, Aude Rigolet, Julie Chas, Pierre-Louis Tharaux, Caroline Morbieu, Valérie Paquet, Eric Vicaut, Pascaline Choinier, Samir Hamiria, Elsa Feredj, Frédéric Schlemmer, Gilles Pialoux, Zeina Louis, Marion Parisey, David Montani, Jean-Pierre Riveline, Jean-Marie Michot, Pascal Lim, Eliane Bertrand, Gaelle Clavere, Julie Jambon, Stéphane Brin, Saskia Flamand, Jeanne Meunier, Geoffroy Volle, Martin De Sarcus, Marie Vayssettes, Thomas Papo, Caroline Hauw-Berlemont, Gabriel Baron, Jeremy Arzoine, Loren Soyez-Herkert, Maria Pereira, Antoine Parrot, Johanna Oziel, Carole Burger, Eric Noll, Paul Vermes, Jeanne Goupil de Bouille, Xavier Monnet, Paul Crespin, Sarah Dalibey, Thierno Dieye, Renaud Felten, Jean-Philippe Bastard, Younes El Amine, Timothee Bironne, Damien Vanhoye, Amine Ghembaza, Laure Berton, Yvon Ruch, Thomas Volpe, Thomas Gorget, Jaouad Benhida, Julien Saussereau, Elodie Issorat, Virginie Elisee, Adrien Mirouse, Cecile Larcheveque, Laurène Deconinck, A. Dossier, Félix Ackermann, Greggory Ducrocq, Anne Bergeron, Laurence Annonay, Camille Knosp, Laurence Drouard, Adrien Joseph, Hilario Nunes, Hanane Fodil, Sabrine Ouamri, Belkacem Asselate, Julie Fillon, Dominique Dautel, Isabelle Brindele, Robin Charreteur, S Lariven, Elie Azoulay, Sami Kolta, Cédric Sublon, Florence Bellenfant, Melissa Clément, Lola-Jade Palmieri, Bruno Mourvillier, Ewa Kozaliewicz, Vincent Provitolo, Marie Lecronier, Julien Chabert, Matthieu Resche-Rigon, Stéphan Pavy, Naura Gamany, Dorothée Chopin, Aïcha Bah, Moustafa Benafla, Corinne Guerin, Pierre Tissieres, Nathalie Costedoat-Chalumeau, Nessima Yelles, Emmanuel Chatelus, Jean-Christophe Corvol, Luc Mouthon, Marie Gilbert, Matthieu Lemoine, Lucie Aunay, Candice Estellat, Laure Choupeaux, Dhiaa Meriem Hai, Bernard Goichot, Céline Louapre, Roza Rahli, Nathalie De Castro, Christian Richard, Malikhone Chansombat, Kamil Chitour, Joseph Emmerich, Elodie Drouet, Julien Pottecher, Eric Demonsant, Alexandra Beurton, Raphaël Porcher, Lauren Demerville, Amélie Servettaz, Annabelle Pourbaix, Philippe Manivet, Pierre-Grégoire Guinot, Nicolas Champtiaux, Caroline Pradon, Annick Tibi, Julien Le Marec, Nawal Derridj, Mohamad Zaidan, Eric Marquis, Mickael Henriques, Bruno Mégarbane, Aline Frazier, Ramon Junquera, Diane Le Pluart, Coralie Gernez, Yacine Boudali, Dimitri Fremont, Pierrick Le Borgne, Corinne Pernot, Mélanie Dehais, Claire Madelaine, Dominique Roulot, Georgina Maalouf, Constance Guillaud, Corine Nyanou, Karine Celli Lebras, Sophie Granville, Sabrina Brahmi, Catherine Le Bourlout, Hassan Tarhini, Asmaa Mabrouki, Hakim Tayebi, Sophie Ismael, Jonathan Marey, Sophie Bayer, Gabriel Steg, Antoine Fayol, Catherine Fauvaux, Delphine Feyeux, Côme Bureau, Alexandre Morel, Agathe Bounhiol, Alexandre Buffet, Souad Benarab, Luc Haudebourg, Pierre Le Guen, Damien Vimpere, Xavier Jaïs, Clotilde Le Tiec Le Tiec, Sophie Bulifon, Pélagie Thibaut, Alison Klasen, Claire Pacheco, Anne Godier, Marie Antignac, Domitille Molinari, Philippe Durand, Olivier Lambotte, Paul Henri Grisot, Anne Lise Jegu, Vincent Poindron, Ruxandra Burlacu, Denis Jesuthasan, Sarah Benghanem, Solen Kernéis, Antoine Bachelard, Jacques Duranteau, Karine Lacombe, Olivia Lenoir, Mathilde Vallet, Sara Virolle, Léa Resmini, Liem Binh Luong Nguyen, Marie Matignon, Céline Leplay, and Claire Aguilar
Subjects: medicine.medical_specialty, business.industry, Immunology, Hazard ratio, Absolute risk reduction, Articles, medicine.disease, law.invention, Clinical trial, Pneumonia, Sarilumab, Rheumatology, Randomized controlled trial, law, Internal medicine, Cohort, medicine, Immunology and Allergy, Adverse effect, business
Abstract: Summary Background Patients with COVID-19 pneumonia can have increased inflammation and elevated cytokines, including interleukin (IL)-6, which might be deleterious. Thus, sarilumab, a high-affinity anti-IL-6 receptor antibody, might improve the outcome of patients with moderate-to-severe COVID-19 pneumonia. Methods We did a multicentric, open-label, Bayesian randomised, adaptive, phase 2/3 clinical trial, nested within the CORIMUNO-19 cohort, to test a superiority hypothesis. Patients 18 years or older hospitalised with COVID-19 in six French centres, requiring at least 3L/min of oxygen but without ventilation assistance and a WHO Clinical Progression Scale [CPS] score of 5 were enrolled. Patients were randomly assigned (1:1) via a web-based system, according to a randomisation list stratified on centre and with blocks randomly selected among 2 and 4, to receive usual care plus 400 mg of sarilumab intravenously on day 1 and on day 3 if clinically indicated (sarilumab group) or usual care alone (usual care group). Primary outcomes were the proportion of patients with WHO-CPS scores greater than 5 on the 10-point scale on day 4 and survival without invasive or non-invasive ventilation at day 14. This completed trial is closed to new participants and is registered with ClinicalTrials.gov , NCT04324073 . Findings 165 patients were recruited from March 27 to April 6, 2020, and 148 patients were randomised (68 patients to the sarilumab group and 80 to the usual care group) and followed up for 90 days. Median age was 61·7 years [IQR 53·0–71·1] in the sarilumab group and 62·8 years [56·0–71·7] in the usual care group. In the sarilumab group 49 (72%) of 68 were men and in the usual care group 59 (78%) of 76 were men. Four patients in the usual care group withdrew consent and were not analysed. 18 (26%) of 68 patients in the sarilumab group had a WHO-CPS score greater than 5 at day 4 versus 20 (26%) of 76 in the usual care group (median posterior absolute risk difference 0·2%; 90% credible interval [CrI] −11·7 to 12·2), with a posterior probability of absolute risk difference greater than 0 of 48·9%. At day 14, 25 (37%) patients in the sarilumab and 26 (34%) patients in the usual care group needed ventilation or died, (median posterior hazard ratio [HR] 1·10; 90% CrI 0·69–1·74) with a posterior probability HR greater than 1 of 37·4%. Serious adverse events occurred in 27 (40%) patients in the sarilumab group and 28 (37%) patients in the usual care group (p=0·73). Interpretation Sarilumab treatment did not improve early outcomes in patients with moderate-to-severe COVID-19 pneumonia. Further studies are warranted to evaluate the effect of sarilumab on long-term survival. Funding Assistance publique—Hopitaux de Paris
Published: 2022

16. Safety and efficacy of low-dose PI3K inhibitor taselisib in adult patients with CLOVES and Klippel–Trenaunay syndrome (KTS): the TOTEM trial, a phase 1/2 multicenter, open-label, single-arm study

Author: Marc Bardou, Pierre Vabres, Laurence Faivre, Annabel Maruani, Victoria E R Parker, A. Phan, Christine Chiaverini, L. Martin, Jill Clayton-Smith, C. Fleck, Maxime Luu, Tristan Mirault, Fanny Morice-Picard, M. Carpentier, Marie-Line Jacquemont, Hervé Devilliers, Marjolaine Willems, A. Maurer, Romaric Loffroy, Didier Bessis, Florence Petit, Robert K. Semple, M. Yousfi, Centre d'Investigation Clinique 1432 (Dijon) - Epidemiologie Clinique/Essais Cliniques (CIC-EC), Université de Bourgogne (UB)-Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Institut National de la Santé et de la Recherche Médicale (INSERM), FHU TRANSLAD (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre de Référence des Maladies Génétiques à Expression Cutanée (MAGEC), Service de médecine interne et maladies systémiques (SOC 2) [CHU de Dijon], Service de radiologie et d'Imagerie médicale diagnostique et thérapeutique (CHU de Dijon), Hôpital Femme Mère Enfant [CHU - HCL] (HFME), Hospices Civils de Lyon (HCL), Institute of Applied Physics [Bern] (IAP), University of Bern, CHU Bordeaux [Bordeaux], Centre de Référence Maladies Rares Anomalies du Développement et Syndromes Malformatifs Nord, Centre Hospitalier Universitaire de Lille (CHU de Lille), Hôpital Lapeyronie [Montpellier] (CHU), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), Centre Hospitalier Universitaire de Nice (CHU Nice), Centre national de référence des maladies vasculaires rares, 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), 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 de Paris (UP), University of Manchester [Manchester], CHU Dijon, AstraZeneca [Cambridge, UK], University of Edinburgh, Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, and Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement
Subjects: Adult, Klippel-Trenaunay-Weber Syndrome, medicine.medical_specialty, Klippel-Trenaunay syndrome, Syzygium, [SDV]Life Sciences [q-bio], Population, Overgrowth syndrome, Article, Phosphatidylinositol 3-Kinases, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Internal medicine, taselisib, medicine, Humans, education, Adverse effect, Genetics (clinical), education.field_of_study, business.industry, Imidazoles, clinical trial, PIK3CA, medicine.disease, 3. Good health, Clinical trial, Oxazepines, Tolerability, 030220 oncology & carcinogenesis, Mutation, Cohort, Quality of Life, mosaic, business, PROS treatment
Abstract: International audience; ABSTRACT Purpose PIK3CA pathogenic variants in the PIK3CA-related overgrowth spectrum (PROS) activate phosphoinositide 3-kinase signaling, providing a rationale for targeted therapy, but no drug has proven efficacy and safety in this population. Our aim was to establish the six-month tolerability and efficacy of low-dose taselisib, a selective class I PI3K inhibitor, in PROS patients. Methods Patients over 16 years with PROS and PIK3CA pathogenic variants were included in a phase IB/IIA multicenter, open-label single-arm trial (six patients at 1 mg/day of taselisib, then 24 at 2 mg/day). The primary outcome was the occurrence of dose limiting toxicity (DLT). Efficacy outcomes were the relative changes after treatment of (1) tissue volume at affected and unaffected sites, both clinically and on imaging; (2) cutaneous vascular outcomes when relevant; (3) biologic parameters; (4) quality of life; and (5) patient-reported outcomes. Results Among 19 enrolled patients, 2 experienced a DLT (enteritis and pachymeningitis) leading to early trial termination (17 treated, 10 completed the study). No serious adverse reaction occurred in the 1 mg cohort ( n = 6). No significant reduction in affected tissue volume was observed (mean −4.2%; p = 0.81; SD 14.01). Thirteen (76.4%) participants reported clinical improvement (pain reduction, chronic bleeding resolution, functional improvement). Conclusion Despite functional improvement, the safety profile of low-dose taselisib precludes its long-term use.
Published: 2021

17. Combined incentive actions, focusing on primary care professionals, to improve cervical cancer screening in women living in socioeconomically disadvantaged geographical areas: a study protocol of a hybrid cluster randomised effectiveness and implementation trial- RESISTE

Author: Amir Hassine, Guillemette Antoni, Muriel Fender, Katia Slama, François-Xavier Léandri, Jean-Luc Fanon, Christelle Auvray, Marie Christine Jaffar Bandjee, Nicolas Traversier, Laurence Fagour, Lise Rochaix, Camilla Fiorina, Dolorès Pourette, Eric Opigez, Alexandre Dumont, Marc Bardou, Resiste Study Group, CIC-P INSERM 1432, 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, Regional Center for the Coordination of Cancer Screening Grand Est Region, Regional Screening for the Coordination of Cancer Screening, Réunion, Regional Center for the Coordination Screening of Cancer Screening PACA Region, Regional Centre for the Coordination of Cancer Screening Martinique Island, Laboratory of Virology, CHU Dijon Bourgogne, Laboratory of Virology, CHD Félix Guyon, Saint-Denis, Réunion, 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), Hospinomics, Paris School of Economics (PSE), Université Paris 1 Panthéon-Sorbonne (UP1)-École normale supérieure - Paris (ENS-PSL), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-École des hautes études en sciences sociales (EHESS)-École des Ponts ParisTech (ENPC)-Centre National de la Recherche Scientifique (CNRS)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Paris 1 Panthéon-Sorbonne (UP1)-École normale supérieure - Paris (ENS-PSL), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-École des hautes études en sciences sociales (EHESS)-École des Ponts ParisTech (ENPC)-Centre National de la Recherche Scientifique (CNRS)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Paris Jourdan Sciences Economiques (PJSE), Centre population et développement (CEPED - UMR_D 196), Institut de Recherche pour le Développement (IRD)-Université Paris Cité (UPCité), Santé, vulnérabilités et relations de genre au sud (SAGESUD - ERL Inserm U1244), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre population et développement (CEPED - UMR_D 196), and Institut de Recherche pour le Développement (IRD)-Université Paris Cité (UPCité)-Institut de Recherche pour le Développement (IRD)-Université Paris Cité (UPCité)
Subjects: Motivation, Primary Health Care, [SDV]Life Sciences [q-bio], Papillomavirus Infections, Uterine Cervical Neoplasms, General Medicine, Alphapapillomavirus, Health policy, Gynaecological oncology, Oncology, Humans, Female, Public Health, Preventive Medicine, Health economics, Papillomaviridae, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Early Detection of Cancer, Randomized Controlled Trials as Topic
Abstract: IntroductionCervical cancer (CC) causes thousands of deaths each year. Nearly 100% of cases are caused by oncogenic strains of human papillomavirus (HPV). In most industrialised countries, CC screening (CCS) is based on the detection of HPV infections. For many reasons including lower adherence to CCS, underserved women are more likely to develop CC, and die from it. We aim to demonstrate that the use of incentives could improve screening rates among this population.Methods and analysisOur cluster randomised, controlled trial will include 10 000 women aged 30–65 years eligible for CCS, living in deprived areas in four French departments, two mainlands and two overseas, and who did not perform physician-based HPV testing within the framework of the nationally organised screening programme. HPV self-sampling kit (HPVss) will be mailed to them. Two interventions are combined in a factorial analysis design ending in four arms: the possibility to receive or not a financial incentive of €20 and to send back the self-sampling by mail or to give it to a health professional, family doctor, gynaecologist, midwife or pharmacist. The main outcome is the proportion of women returning the HPVss, or doing a physician-based HPV or pap-smear test the year after receiving the HPVss. 12-month follow-up data will be collected through the French National Health Insurance database. We expect to increase the return rate of HPV self-samples by at least 10% (from 20% to 30%) compared with the postal return without economic incentive.Ethics and disseminationEthics approval was first obtained on 2 April 2020, then on July 29 2022. The ethics committee classified the study as interventional with low risk, thus no formal consent is required for inclusion. The use of health insurance data was approved by the Commission Nationale Informatique et Libertés on 14 September 2021 (ref No 920276). An independent data security and monitoring committee was established. The main trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04312178.
Published: 2022

18. Assessment of post-traumatic stress disorders in women victims of intimate partner violence: a mixed methods comparison at initial care in coordinated and uncoordinated care facilities in France

Author: Noémie Roland, Noëlla Delmas, Fabienne El-Khoury, Alice Bardou, Leila Yacini, Laure Feldmann, Ghada Hatem, Sarah Mahdjoub, and Marc Bardou
Abstract: Background: Intimate Partner Violence (IPV) has serious consequences on the mental health of victims-survivors such as Post-Traumatic Stress Disorder (PTSD). « La Maison des Femmes » (MdF, Women’s Home) is a French original medical and social structure specifically dedicated to provide multidisciplinary care for victims-survivors of IPV. The main objective of this study was to examine the prevalence of PTSD in victims-survivors of IPV consulting at the MdF or in two Municipal Health Centers (MHCs) located in the same area of the Paris conurbation. Methods: We conducted an observational survey from July 2020 to June 2021 in the MdF and in two MHCs. All women aged 18 years and over having suffered from IPV were eligible. PTSD diagnosis was assessed using the PTSD self-report checklist of symptoms defined in the DSM-5 (PCL-5). We solicited data on the level of self-rated global health, the substances use, and the possibility of reaching women by phone in the 6 months following the inclusion visit. We also conducted qualitative interviews with a sub-sample of the women, asking for victims-survivors’ perceptions of the effect of the care provided at MdF and perceptions of their specific needs. Results: A total of 67 women (mean age: 34 years old [Standard Deviation=9.7]) responded to our questionnaire (40 in the MdF, 12 in the MHC-1 and 15 in the MHC-2). PTSD diagnosis was retained for 40 women (59.7%) (PCL-5 score ≥33). The prevalence of PTSD was quite similar between the three groups. Around 30% of participants (n=23) self-rated their global health as bad or very bad, less than 30% (n=18) of women were regular smokers. Six months after inclusion, a half of participants (52.2%) had been reached by phone. Analysis of the nine qualitative interviews clarified victims-survivors’ perceptions of the MdF’s specific care: social networking, multidisciplinary approach, specialized listening, healthcare facilities, evasion and “feeling at home”. Conclusions The prevalence of PTSD was high among the three centers. This mixed-methods comparison will serve as a pilot study for a larger comparative trial to assess the impact of the MdF on victims-survivors’ mental health outcomes comparatively with the impact of non-dedicated structures.
Published: 2022

19. Efficacy, safety and outcomes of transcatheter arterial embolization with N-butyl cyanoacrylate glue for non-variceal gastrointestinal bleeding: A systematic review and meta-analysis

Author: Julie Pellegrinelli, Marc Bardou, Kévin Guillen, Serge Aho-Glélé, Pierre-Olivier Comby, Marco Midulla, Thomas Mouillot, Nicolas Falvo, Olivier Chevallier, and Romaric Loffroy
Subjects: Gastrointestinal bleeding, medicine.medical_specialty, Lower gastrointestinal bleeding, MEDLINE, 030218 nuclear medicine & medical imaging, law.invention, 03 medical and health sciences, 0302 clinical medicine, law, medicine, Humans, Radiology, Nuclear Medicine and imaging, GLUE, Retrospective Studies, Radiological and Ultrasound Technology, business.industry, Mortality rate, Arterial Embolization, General Medicine, Enbucrilate, medicine.disease, Embolization, Therapeutic, Surgery, Treatment Outcome, Cyanoacrylate, 030220 oncology & carcinogenesis, Meta-analysis, Gastrointestinal Hemorrhage, business, Vascular Surgical Procedures
Abstract: To perform a systematic review and meta-analysis to determine the safety, efficacy, and outcomes of transcatheter arterial embolization (TAE) with N-butyl cyanoacrylate (NBCA) as the single embolic agent for the management of non-variceal upper and lower gastrointestinal bleeding (GIB).A literature search using MEDLINE/PubMed, EMBASE, and SCOPUS databases was performed for studies published from January 1980 to December 2019. Data from eligible studies were extracted and evaluated by two independent reviewers. Exclusion criteria were sample size5, article reporting the use of NBCA with other embolic agents, no extractable data, and duplicate reports. Technical success, clinical success, 30-day rebleeding, 30-day overall and major complications, and 30-day mortality were evaluated. The estimated overall rates were calculated with their 95% confidence intervals, based on each study rate, weighted by the number of patients involved in each study. Heterogeneity across studies was assessed using the Q test and IFifteen studies with 574 patients were included. For upper GIB (331 patients), the technical and clinical success rates, and 30-day rebleeding and mortality rates, were 98.8% (328 of 331 patients) and 88.0% (237 of 300 patients), and 12.5% (69 of 314 patients) and 15.9% (68 of 331 patients), respectively. Thirty-day overall and major complications occurred in 14.3% (28 of 331 patients) and 2.7% (7 of 331 patients) of patients, respectively. For lower GIB (243 patients), the technical and clinical success rates, and 30-day rebleeding and mortality rates, were 98.8% (78 of 78 patients) and 78.0% (145 of 189 patients), and 15.7% (33 of 218 patients) and 12.7% (14 of 78 patients), respectively. Thirty-day overall and major complications occurred in 13.0% (25 of 228 patients) and 8.6% (19 of 228 patients) of patients, respectively.TAE with NBCA is safe and effective for treating non-variceal GIB, with high clinical success and very low major complication rates.
Published: 2021

20. Association between Obstetric Complications and Intravitreal Anti-Vascular Endothelial Growth Factor Agents or Intravitreal Corticosteroids

Author: Inès Ben Ghezala, Anne-Sophie Mariet, Eric Benzenine, Marc Bardou, Alain Marie Bron, Pierre-Henry Gabrielle, Florian Baudin, Catherine Quantin, Catherine Creuzot-Garcher, Service d'Ophtalmologie (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre d'Investigation Clinique 1432 (Dijon) - Epidemiologie Clinique/Essais Cliniques (CIC-EC), Université de Bourgogne (UB)-Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Dijon, Centre des Sciences du Goût et de l'Alimentation [Dijon] (CSGA), Université de Bourgogne (UB)-Centre National de la Recherche Scientifique (CNRS)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-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), Service Biostatistiques et Informatique Médicale (CHU de Dijon) (DIM), and Julien, Sabine
Subjects: corticosteroid, drug safety, pharmacoepidemiology, [SDV.MHEP.OS] Life Sciences [q-bio]/Human health and pathology/Sensory Organs, Medicine (miscellaneous), intravitreal injection, anti-vascular endothelial growth factor, pregnancy, [SDV.MHEP.OS]Life Sciences [q-bio]/Human health and pathology/Sensory Organs, obstetric complication
Abstract: International audience; This nationwide population-based cohort study aimed to describe the use of intravitreal injections (IVTs) of anti-vascular endothelial growth factor (anti-VEGF) agents and corticosteroids in pregnant women in France and to report on the incidence of obstetric and neonatal complications. All pregnant women in France who received any anti-VEGF or corticosteroid IVT during pregnancy or in the month preceding pregnancy from 1 January 2009 to 31 December 2018 were identified in the national medico-administrative databases. Between 2009 and 2018, there were 5,672,921 IVTs performed in France. Among these IVTs, 228 anti-VEGF or corticosteroid IVTs were administered to 139 women during their pregnancy or in the month preceding their pregnancy. Spontaneous abortion or the medical termination of pregnancy occurred in 10 women (16.1%) who received anti-VEGF agents and in one (3.1%) of the women who received corticosteroids (p = 0.09). This is the first national cohort study of pregnant women treated with anti-VEGF or corticosteroid IVTs. We found a high incidence of obstetric complications in pregnant women treated with anti-VEGF or corticosteroid IVTs but could not demonstrate a statistically significant association between the intravitreal agents and these complications. These agents should continue to be used with great caution in pregnant women.
Published: 2022

21. An update on drug-drug interactions associated with proton pump inhibitors

Author: Inès Ben Ghezala, Maxime Luu, and Marc Bardou
Subjects: Pharmacology, Humans, Drug Interactions, Esomeprazole, Proton Pump Inhibitors, General Medicine, Prospective Studies, Enzyme Inhibitors, Toxicology, 2-Pyridinylmethylsulfinylbenzimidazoles, Omeprazole
Abstract: Proton pump inhibitors (PPIs) block the gastric H/K-ATPase, therefore inhibiting acid gastric secretion, leading to an increased pH (4). They account for an extremely high number of prescriptions worldwide. Numerous drug-drug interactions have been described with PPIs, but all the described interactions do not have clinical significance.This review will discuss the latest updates on drug-drug interactions with PPIs, focusing on the last 10-year publications in the following areas: anti-infective agents, anticancer drugs, antiplatelet agents and anticoagulants, and antidiabetics.Although pharmacokinetic interactions of PPIs have been described with many drugs, their clinical relevance remains controversial. However, given the extremely high number of people being treated with PPIs, clinicians should remain vigilant for interactions that may be clinically significant and require dose adjustment or therapeutic monitoring. Interestingly, not all PPIs have the same pharmacokinetic and pharmacodynamic profile, with some having a strong potential to inhibit CYP2C19, such as omeprazole, esomeprazole, and lansoprazole, while others, pantoprazole, rabeprazole, and dexlansoprazole, are weak CYP2C19 inhibitors. These may be preferred depending on co-prescribed treatments.In addition, new formulations have been developed to prevent some of the gastric pH-dependent drug interactions and should be evaluated in further large-scale prospective comparative studies.
Published: 2022

22. Immunogenicity and Safety of Beta-Adjuvanted Recombinant Booster Vaccine

Author: Odile Launay, Marine Cachanado, Liem B. Luong Nguyen, Laetitia Ninove, Marie Lachâtre, Inès Ben Ghezala, Marc Bardou, Catherine Schmidt-Mutter, Karine Lacombe, Fabrice Laine, Jean-Sébastien Allain, Elisabeth Botelho-Nevers, Marie-Pierre Tavolacci, Christian Chidiac, Patricia Pavese, Bertrand Dussol, Stéphane Priet, Dominique Deplanque, Amel Touati, Laureen Curci, Eleine Konate, Nadine Ben Hamouda, Anissa Besbes, Eunice Nubret, Florence Capelle, Laurence Berard, Alexandra Rousseau, Eric Tartour, Tabassome Simon, Xavier de Lamballerie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Cochin [AP-HP], Aix Marseille Université (AMU), 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), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHU Strasbourg, Université Sorbonne Paris Nord, Hôpital Sud [CHU Rennes], CHU Pontchaillou [Rennes], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Nutrition, Inflammation et axe Microbiote-Intestin-Cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), Centre d'Investigation Clinique [CHU Rouen] (CIC Rouen), Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hospices Civil de Lyon, CHU Grenoble, CHU Marseille, CHU Lille, 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), CHU Saint-Etienne, and douville, sabine
Subjects: Vaccines, Synthetic, Immunogenicity, Vaccine, Adjuvants, Immunologic, [SDV.MHEP.PHY] Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Immunization, Secondary, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, General Medicine, Antibodies, Viral, ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2022

23. Cost-Effectiveness Analysis: Stress Ulcer Bleeding Prophylaxis with Proton Pump Inhibitors, H2 Receptor Antagonists

Author: Barkun, Alan N., Adam, Viviane, Martel, Myriam, and Marc, Bardou
Published: 2013
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24. Women and health professionals’ perspectives on a conditional cash transfer programme to improve pregnancy follow-up: a qualitative analysis of the NAITRE randomised controlled study

Author: Marc Bardou, Nicolas Meunier-Beillard, Aurélie Godard-Marceau, Philippe Deruelle, Claude Virtos, Astrid Eckman-Lacroix, Elodie Debras, and Thomas Schmitz
Subjects: General Medicine
Abstract: ObjectivesWomen of low socioeconomic status have been described as having suboptimal prenatal care, which in turn has been associated with poor pregnancy outcomes. Many types of conditional cash transfer (CCT) programmes have been developed, including programmes to improve prenatal care or smoking cessation during pregnancy, and their effects demonstrated. However, ethical critiques have included paternalism and lack of informed choice. Our objective was to determine if women and healthcare professionals (HPs) shared these concerns.DesignProspective qualitative research.SettingWe included economically disadvantaged women, as defined by health insurance data, who participated in the French NAITRE randomised trial assessing a CCT programme during prenatal follow-up to improve pregnancy outcomes. The HP worked in some maternities participating in this trial.Participants26 women, 14 who received CCT and 12 who did not, mostly unemployed (20/26), and - 7 HPs.InterventionsWe conducted a multicentre cross-sectional qualitative study among women and HPs who participated in the NAITRE Study to assess their views on CCT. The women were interviewed after childbirth.ResultsWomen did not perceive CCT negatively. They did not mention feeling stigmatised. They described CCT as a significant source of aid for women with limited financial resources. HP described the CCT in less positive terms, for example, expressing concern about discussing cash transfer at their first medical consultation with women. Though they emphasised ethical concerns about the basis of the trial, they recognised the importance of evaluating CCT.ConclusionsIn France, a high-income country where prenatal follow-up is free, HPs were concerned that the CCT programme would change their relationship with patients and wondered if it was the best use of funding. However, women who received a cash incentive said they did not feel stigmatised and indicated that these payments helped them prepare for their baby’s birth.Trial registration numberNCT02402855
Published: 2023

25. Clinical and neuroimaging findings in 33 patients with <scp>MCAP</scp> syndrome: A survey to evaluate relevant endpoints for future clinical trials

Author: Florence Petit, Fabienne Giuliano, Juliette Mazereeuw-Hautier, Marjolaine Willems, Christel Thauvin-Robinet, Patricia Blanchet, Laurence Faivre, Elodie Gautier, Anne-Claire Bursztejn, Renaud Touraine, Annick Toutain, Frederico Di Rocco, Maxime Luu, Patrick Edery, Arthur Sorlin, Jean-Luc Alessandri, Nicolas Chassaing, Alice Goldenberg, Christine Chiaverini, Fanny Morice-Picard, Aurore Garde, Stéphanie Arpin, Massimiliano Rossi, Marc Bardou, Claire Nicolas, Gilles Morin, Jenny Cornaton, Cyril Mignot, Christophe Philippe, V. Carmignac, Rodolphe Dard, Joelle Roume, Michèle Mathieu-Dramard, Philippe Khau Van Kien, Pierre Vabres, Didier Lacombe, Diane Doummar, Lucile Pinson, Christine Coubes, Laurent Guibaud, Olivia Boccara, Laboratoire Maladies Rares: Génétique et Métabolisme (Bordeaux) (U1211 INSERM/MRGM), and Université de Bordeaux (UB)-Groupe hospitalier Pellegrin-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Adult, Male, 0301 basic medicine, Pediatrics, medicine.medical_specialty, Cutis marmorata, Adolescent, Class I Phosphatidylinositol 3-Kinases, Neuroimaging, Context (language use), Skin Diseases, Vascular, 030105 genetics & heredity, Cohort Studies, Young Adult, 03 medical and health sciences, Genetics, Polymicrogyria, medicine, Humans, PROS, Abnormalities, Multiple, Telangiectasis, Megalencephaly, Child, MCAP syndrome, Genetics (clinical), Chiari malformation, Clinical Trials as Topic, business.industry, Macrocephaly, PIK3CA, medicine.disease, Magnetic Resonance Imaging, 3. Good health, Clinical trial, 030104 developmental biology, Child, Preschool, Postnatal macrocephaly, Female, medicine.symptom, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Forecasting, Ventriculomegaly
Abstract: Megalencephaly-CApillary malformation-Polymicrogyria (MCAP) syndrome results from somatic mosaic gain-of-function variants in PIK3CA. Main features are macrocephaly, somatic overgrowth, cutaneous vascular malformations, connective tissue dysplasia, neurodevelopmental delay, and brain anomalies. The objectives of this study were to describe the clinical and radiological features of MCAP, to suggest relevant clinical endpoints applicable in future trials of targeted drug therapy. Based on a French collaboration, we collected clinical features of 33 patients (21 females, 12 males, median age of 9.9 years) with MCAP carrying mosaic PIK3CA pathogenic variants. MRI images were reviewed for 21 patients. The main clinical features reported were macrocephaly at birth (20/31), postnatal macrocephaly (31/32), body/facial asymmetry (21/33), cutaneous capillary malformations (naevus flammeus 28/33, cutis marmorata 17/33). Intellectual disability was present in 15 patients. Among the MRI images reviewed, the neuroimaging findings were megalencephaly (20/21), thickening of corpus callosum (16/21), Chiari malformation (12/21), ventriculomegaly/hydrocephaly (10/21), cerebral asymmetry (6/21) and polymicrogyria (2/21). This study confirms the main known clinical features that defines MCAP syndrome. Taking into account the phenotypic heterogeneity in MCAP patients, in the context of emerging clinical trials, we suggest that patients should be evaluated based on the main neurocognitive expression on each patient.
Published: 2021

26. Subclinical proximal tubulopathy in hepatitis B: The roles of nucleot(s)ide analogue treatment and the hepatitis B virus

Author: Thierry Poynard, Guillaume Lassailly, Juliette Foucher, Manh-Thông Dao, Xavier Duval, Isabelle Hourmand-Ollivier, Séverine Hommel, Vincent Di Martino, Pierre-Henri Bernard, Dominique Larrey, Nathalie Boyer, Anais Labrunie, Marc Bardou, Paul Carrier, Marilyne Debette-Gratien, Marie Essig, Eric Nguyen-Khac, Armand Abergel, Victor de Ledinghen, Véronique Loustaud-Ratti, Claire Vanlemmens, Nathalie Ganne-Carrié, Anne Gervais, Jean-Baptiste Hiriart, Fouchard-Hubert Isabelle, Christine Aurières, Pauline Pinet, Thierry Thevenot, Jérémie Jacques, Philippe Mathurin, Dominique Thabut, Christophe Renou, Daniel Cohen, Marianne Maynard, Valérie Canva, Julien Vergniol, Bertrand Hanslik, Anaïs Brayette, Sophie Alain, Matthieu Schnee, Service d'Hépato-Gastro-Entérologie et Nutrition [CHU Limoges], CHU Limoges, Pôle Universitaire d’Addictologie en Limousin, CH Esquirol [Limoges] (CH Esquirol), Neuroépidémiologie Tropicale (NET), CHU Limoges-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Plate forme de bioinformatique et biostatistique (CEBIMER), Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Anti-infectieux : supports moléculaires des résistances et innovations thérapeutiques (RESINFIT), CHU Limoges-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL), Génomique fonctionnelle des tumeurs solides = Functional Genomics of Solid Tumors [CRC] (FunGeST), 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)-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), Groupe de Recherche sur l'alcool et les pharmacodépendances - UMR INSERM_S 1247 (GRAP), Université de Picardie Jules Verne (UPJV)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service des Maladies infectieuses et tropicales [CHU Limoges], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Hepatology, Hopital, Physiopathologie des Maladies Inflammatoires de l'Intestin, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Services de Maladies Infectieuses et Tropicales [CHU Bichat], 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), CHU Bordeaux [Bordeaux], Service d'Hépato-gastro-entérologie et oncologie digestive (CHU de Bordeaux), CHU Bordeaux [Bordeaux]-Hôpital Haut-Lévêque [CHU Bordeaux], Service d'Hépato-Gastro-Enterologie et Nutrition [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), Paris School of Economics (PSE), Université Paris 1 Panthéon-Sorbonne (UP1)-École normale supérieure - Paris (ENS-PSL), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-École des hautes études en sciences sociales (EHESS)-École des Ponts ParisTech (ENPC)-Centre National de la Recherche Scientifique (CNRS)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Paris Jourdan Sciences Economiques (PJSE), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre d'Investigation Clinique 1432 (Dijon) - Module Plurithématique : Périnatalité Cancérologie Handicap et Ophtalmologie (CIC-P803), Université de Bourgogne (UB)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Pascal (IP), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA)-Institut national polytechnique Clermont Auvergne (INP Clermont Auvergne), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), Normandie Université (NU), Service d'Hépatologie [CHRU Besançon], Hôpital Haut-Lévêque [CHU Bordeaux], Hôpital Claude Huriez [Lille], CHU Lille, Institute for Translational Research in Inflammation - U 1286 (INFINITE (Ex-Liric)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service d’Hépatologie [Hôpital Beaujon], Hôpital Beaujon [AP-HP], Université Paris Cité (UPCité), Centre de recherche sur l'Inflammation (CRI (UMR_S_1149 / ERL_8252 / U1149)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Service d'Hépato-Gastro-Entérologie, CHU Bordeaux [Bordeaux]-Hôpital Saint-André, Service de gastroentérologie (CHD Vendee - Hopital Les Oudairies, La Roche Sur Yon), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), Hôpital Saint-Éloi [Montpellier], 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), Service d'Hépato-Gastroentérologie [CHU Rouen], Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Ciblage individuel et prévention des risques de traitements immunosupresseurs et de la transplantation (IPPRITT), Épidémiologie et recherches translationnelles sur les maladies rénales et cardiovasculaires (EPREC) (U1018 (Équipe 5)), 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-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 Néphrologie/Dialyse [AP-HP Ambroise-Paré], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Ambroise Paré [AP-HP], 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 (UPC)-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 (UPC), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases [IHU ICAN], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Université Paris Cité (UPC), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPC), Service d'Hépato-Gastro-Entérologie [CHU Pitié-Salpêtrière], and Hôpital Charles Nicolle [Rouen]-CHU Rouen
Subjects: Hepatitis B virus, medicine.medical_specialty, [SDV]Life Sciences [q-bio], Population, Renal function, medicine.disease_cause, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Nucleoside analogues, Internal medicine, medicine, Cumulative incidence, Renal insufficiency, education, education.field_of_study, Hepatology, business.industry, Proximal tubulopathy, Incidence (epidemiology), Hazard ratio, Entecavir, Hepatitis B, medicine.disease, 030220 oncology & carcinogenesis, Prospective Study, 030211 gastroenterology & hepatology, business, Biomarkers, medicine.drug
Abstract: International audience; BACKGROUND The recommended monitoring tools for evaluating nucleot(s)ide analogue renal toxicity, such as estimated glomerular filtration rate (eGFR) and phosphatemia, are late markers of proximal tubulopathy. Multiple early markers are available, but no consensus exists on their use. AIM To determine the 24 mo prevalence of subclinical proximal tubulopathy (SPT), as defined with early biomarkers, in treated vs untreated hepatitis B virus (HBV)-monoinfected patients. METHODS A prospective, non-randomized, multicenter study of HBV-monoinfected patients with a low number of renal comorbidities was conducted. The patients were separated into three groups: Naive, starting entecavir (ETV) treatment, or starting tenofovir disoproxil (TDF) treatment. Data on the early markers of SPT, the eGFR and phosphatemia, were collected quarterly. SPT was defined as a maximal tubular reabsorption of phosphate/eGFR below 0.8 mmoL/L and/or uric acid fractional excretion above 10%. The prevalence and cumulative incidence of SPT at month 24 (M24) were calculated. Quantitative data were analyzed using analyses of variance or Kruskal-Wallis tests, whereas chi-squared or Fisher's exact tests were used to analyze qualitative data. Multivariate analyses were used to adjust for any potential confounding factors. RESULTS Of the 196 patients analyzed, 138 (84 naive, 28 starting ETV, and 26 starting TDF) had no SPT at inclusion. At M24, the prevalence of SPT was not statistically different between naive and either treated group (21.1% vs 30.7%, P < 0.42 and 50.0% vs 30.7%, P = 0.32 for ETV and TDF, respectively); no patient had an eGFR lower than 50 mL/min/1.73 m(2) or phosphatemia less than 0.48 mmoL/L. In the multivariate analysis, no explanatory variables were identified after adjustment. The cumulative incidence of SPT over 24 mo (25.5%, 13.3%, and 52.9% in the naive, ETV, and TDF groups, respectively) tended to be higher in the TDF group vs the naive group (hazard ratio: 2.283, P = 0.05). SPT-free survival at M24 was 57.6%, 68.8%, and 23.5% for the naive, ETV, and TDF groups, respectively. The median survival time without SPT, evaluated only in the TDF group, was 5.9 mo. CONCLUSION The prevalence and incidence of SPT was higher in TDF-treated patients compared to naive patients. SPT in the naive population suggests that HBV can induce renal tubular toxicity.
Published: 2020

27. Violence against women and perceived health: An observational survey of patients treated in the multidisciplinary structure ‘The Women’s House’ and two Family Planning Centres in the metropolitan Paris area

Author: Noémie Roland, Yélian Ahogbehossou, Ghada Hatem, Leila Yacini, Laure Feldmann, Marie‐Josèphe Saurel‐Cubizolles, and Marc Bardou
Subjects: Adult, Paris, Cross-Sectional Studies, Sociology and Political Science, Risk Factors, Health Status, Health Policy, Public Health, Environmental and Occupational Health, Humans, Intimate Partner Violence, Female, Ambulatory Care Facilities, Social Sciences (miscellaneous)
Abstract: It is unknown how many women seeking care at French Family Planning Centres (FPCs) endure, or have endured intimate partner violence (IPV). To assess the prevalence of IPV, we surveyed women seeking care at three FPCs in the metropolitan Paris area (Seine-Saint-Denis). We examined the associations between IPV, socio-demographic characteristics and perceptions of health according to six indicators. Of the FPCs included in our survey, two are standalone facilities and one is located in The Women's Home, a multidisciplinary structure dedicated to serving survivors of violence. We conducted an observational survey from December 2018 to February 2019. All women aged 18 years and older were eligible. We solicited data on socio-demographic factors, general stability and history of violence. We measured health status on a 10-point scale for six different symptoms. Of the 274 women who participated, 27% had experienced IPV. Women who reported experiencing, or having experienced IPV were more likely to be between 25 and 44 years old (than under 25), temporarily documented or undocumented, unemployed or seeking employment, and experiencing housing insecurity. Women seeking care at The Women's House were more than twice as likely to report IPV (42%) than those visiting FPC-2 or FPC-3 (20% and 16%, respectively). Reports of violence increase among women with uncertain legal status, housing, employment and lower self-rated health. Results suggest that a FPC located in a structure specifically dedicated to serving women victims-survivors of violence like the Women's House may be more attractive to survivors.
Published: 2022

28. First use of Simulation in Therapeutic Patient Education (S-TPE) in adults with diabetes: a pilot study

Author: Christelle Pennecot, Maxime Luu, Claire Marchand, Rémi Gagnayre, Nathalie Dechannes, Sabine Rudoni, Anne-Marie Hilaire, Aurore Demongeot, Delphine Capelle, and Marc Bardou
Subjects: Adult, Male, Diabetes Mellitus, Type 1, Patient Education as Topic, Humans, Female, Pilot Projects, General Medicine, Self Efficacy
Abstract: ObjectiveTo pilot test the feasibility and acceptability of Simulation in Therapeutic Patient Education (S-TPE), in both adult patients with diabetes and educators.ConceptionAdult patients with insulin-dependent diabetes and who participated in a full TPE programme for the implementation of a FreeStyle were included in this monocentric pilot study. S-TPE intervention was based on a consensus conference determining the conditions and objectives of S-TPE. Main outcomes were the patients’ and educators’ perception of the usefulness of S-TPE and the patient’s satisfaction level at the conclusion of the simulation sequence, measured on validated scales. Secondary outcomes were organisational, human, material and temporal, facilitating and limiting factors for patients and educators, patient self-efficacy and anxiety scores.InterventionsThe final session of TPE used the simulation. For each group, one patient volunteered to be the simulated patient. Intervention was divided into three steps: (1) a pre-briefing, (2) a simulation of hypoglycaemia and (3) a debriefing with the group of patients and educators. The whole intervention lasted about 2 hours.ResultsWe included 23 patients (mean age ±SD 63±15 years, 14 men) and 3 educators. After S-TPE intervention, patients’ and educators’ perceived usefulness score were 20.6/25 and 37.5/40, respectively. Patient’s satisfaction score was 51.9/60. Qualitative analysis revealed no limiting factors to implementing S-TPE. Self-efficacy was stable. Decrease in anxiety score after S-TPE reached statistical significance in women (from 35.1±4.5 to 32.7±5.5, p=0.04) but not in men.ConclusionNo limiting factors that could prevent the conduct of clinical trials to assess S-TPE efficacy in patients with diabetes were identified. S-TPE appears as a promising technique to improve diabetes management.Trial registration numberRegistration N°: 2019-A00773-54 and NTC: 03956927.
Published: 2022

29. The pharmacotherapeutic management of gastroesophageal reflux disease (GERD)

Author: Marc Bardou, Alan N. Barkun, Nicolas Chapelle, and Inès Ben Ghezala
Subjects: Adult, medicine.medical_specialty, medicine.drug_class, Population, Proton-pump inhibitor, Disease, Severity of Illness Index, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, Pharmacology (medical), education, Esophagitis, Peptic, Pharmacology, education.field_of_study, business.industry, Reflux, Proton Pump Inhibitors, General Medicine, medicine.disease, humanities, digestive system diseases, Treatment Outcome, 030220 oncology & carcinogenesis, Gastroesophageal Reflux, GERD, business, Erosive esophagitis, 030217 neurology & neurosurgery
Abstract: Gastroesophageal reflux disease (GERD) is a very common worldwide condition, affecting about 15-20% of the whole population, and representing a major burden for health-care systems. Because of its frequency, health physicians - family doctors as well as specialists - should be aware of the different pharmacotherapeutic approaches in managing GERD, according to disease severity.Authors summarize the pharmacological management of GERD in adults, present the different pharmaceutical classes, and review the evidence on efficacy for each treatment according to the most common clinical scenarios: non-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE), and proton-pump inhibitor (PPI) refractory GERD. They also provide an overview of treatments under development.To date, PPIs remain the most effective treatment option for both NERD and EE. However, Potassium-Competitive Acid blockers (PCAB) may be considered, with at least similar efficacy in Asian populations. Preliminary data suggest that PCABs could be superior to classic PPIs in patients with severe EE, and may also be of particular interest in the management of PPI-refractory GERD patients. Their definitive role in GERD management, however, still remains to be determined based on properly designed and conducted randomized clinical trials.
Published: 2020

30. Recent advances in clinical practice: colorectal cancer chemoprevention in the average-risk population

Author: Alan N. Barkun, Esther Toes-Zoutendijk, Marc Bardou, Myriam Martel, Nicolas Chapelle, Gastroenterology & Hepatology, and Public Health
Subjects: Oncology, medicine.medical_specialty, Colorectal cancer, aspirin, Population, colorectal cancer, 03 medical and health sciences, 0302 clinical medicine, SDG 3 - Good Health and Well-being, Internal medicine, Recent Advances in Clinical Practice, Genetic predisposition, medicine, chemoprevention, education, education.field_of_study, Aspirin, Cancer prevention, cancer prevention, business.industry, Incidence (epidemiology), Mortality rate, Gastroenterology, Evidence-based medicine, medicine.disease, vitamins, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract: Colorectal cancer (CRC) is one of the most common and lethal malignancies in Western countries. Its development is a multistep process that spans more than 15 years, thereby providing an opportunity for prevention and early detection. The high incidence and mortality rates emphasise the need for prevention and screening. Many countries have therefore introduced CRC screening programmes. It is expected, and preliminary evidence in some countries suggests, that this screening effort will decrease CRC-related mortality rates. CRC prevention involves a healthy lifestyle and chemoprevention—more specifically, oral chemoprevention that can interfere with progression from a normal colonic mucosa to adenocarcinoma. This preventive effect is important for individuals with a genetic predisposition, but also in the general population. The ideal chemopreventive agent, or combination of agents, remains unknown, especially when considering safety during long-term use. This review evaluates the evidence across 80 meta-analyses of interventional and observational studies of CRC prevention using medications, vitamins, supplements and dietary factors. This review suggests that the following factors are associated with a decreased incidence of CRC: aspirin, non-steroidal anti-inflammatory drugs, magnesium, folate, a high consumption of fruits and vegetables, fibre and dairy products. An increased incidence of CRC was observed with frequent alcohol or meat consumption. No evidence of a protective effect for tea, coffee, garlic, fish and soy products was found. The level of evidence is moderate for aspirin, β-carotene and selenium, but is low or very low for all other exposures or interventions.
Published: 2020

31. Oral anticoagulants and risk of acute liver injury in patients with nonvalvular atrial fibrillation: a propensity-weighted nationwide cohort study

Author: Jérôme Drouin, Géric Maura, Anke Neumann, Cécile Billionnet, Marc Bardou, and Alain Weill
Subjects: Male, Epidemiology, medicine.medical_treatment, Administration, Oral, lcsh:Medicine, 030204 cardiovascular system & hematology, Liver transplantation, Cohort Studies, 0302 clinical medicine, Rivaroxaban, Atrial Fibrillation, 030212 general & internal medicine, lcsh:Science, Aged, 80 and over, education.field_of_study, Multidisciplinary, Hazard ratio, Atrial fibrillation, Middle Aged, Dabigatran, Alcoholism, Apixaban, Female, France, Cohort study, medicine.drug, Adult, Risk, medicine.medical_specialty, Adolescent, Pyridones, Population, Cardiology, Article, 03 medical and health sciences, Young Adult, Internal medicine, medicine, Humans, education, Propensity Score, Aged, Proportional Hazards Models, Hepatology, business.industry, lcsh:R, Anticoagulants, Liver Failure, Acute, medicine.disease, Pyrazoles, lcsh:Q, business
Abstract: Insufficient real-world data on acute liver injury (ALI) risk associated with oral anticoagulants (OACs) exist in patients with nonvalvular atrial fibrillation (NVAF). Using the French national healthcare databases, a propensity-weighted nationwide cohort study was performed in NVAF patients initiating OACs from 2011 to 2016, considering separately those (1) with no prior liver disease (PLD) as main population, (2) with PLD, (3) with a history of chronic alcoholism. A Cox proportional hazards model was used to estimate the hazard ratio with 95% confidence interval (HR [95% CI]) of serious ALI (hospitalised ALI or liver transplantation) during the first year of treatment, for each non-vitamin K antagonist (VKA) oral anticoagulant (NOAC: dabigatran, rivaroxaban, apixaban) versus VKA. In patients with no PLD (N = 434,015), only rivaroxaban new users were at increased risk of serious ALI compared to VKA initiation (adjusted HR: 1.41 [1.05–1.91]). In patients with chronic alcoholism history (N = 13,173), only those initiating dabigatran were at increased risk of serious ALI compared to VKA (2.88 [1.74–4.76]) but an ancillary outcome suggested that differential clinical follow-up between groups might partly explain this association. In conclusion, this study does not suggest an increase of the 1-year risk of ALI in NOAC versus VKA patients with AF.
Published: 2020

32. Kosaki overgrowth syndrome: A novel pathogenic variant in <scp> PDGFRB </scp> and expansion of the phenotype including cerebrovascular complications

Author: Diana Johnson, Jonathan Ellenbogen, Elise Schaefer, Annie Joseph, Gavin Ryan, Ange-Line Bruel, Celia Moss, Rebecca Keelagher, Bethanie Rooke, Alison Foster, Harriet Walker, Pierre Vabres, Quentin Thomas, Trevor Cole, Andrea Jester, Thalia Antoniadi, Rebecca Igbokwe, Maxime Luu, Véronique Quenardelle, Basile Chalot, Christophe Philippe, Arthur Sorlin, Laurence Faivre, Valérie Wolff, Derek Lim, Jessica Woodley, Marc Bardou, and Christel Thauvin-Robinet
Subjects: Adult, Male, 0301 basic medicine, Pathology, medicine.medical_specialty, Infantile myofibromatosis, PDGFRB, Scoliosis, 030105 genetics & heredity, Craniosynostosis, Receptor, Platelet-Derived Growth Factor beta, 03 medical and health sciences, Camptodactyly, Genetics, medicine, Humans, Joint dislocation, Stroke, Growth Disorders, Genetics (clinical), business.industry, Genetic Variation, Middle Aged, medicine.disease, Cerebrovascular Disorders, Phenotype, 030104 developmental biology, medicine.symptom, Lipodystrophy, business
Abstract: Heterozygous activating variants in platelet-derived growth factor, beta (PDGFRB) are associated with phenotypes including Kosaki overgrowth syndrome (KOGS), Penttinen syndrome and infantile myofibromatosis (IM). Here, we present three new cases of KOGS, including a patient with a novel de novo variant c.1477A > T p.(Ser493Cys), and the oldest known individual age 53 years. The KOGS phenotype includes characteristic facial features, tall stature, scoliosis, hyperelastic thin skin, lipodystrophy, variable intellectual and neurological deterioration, and abnormalities on brain imaging. Long-term outcome is unknown. Our cases confirm the phenotypic spectrum includes progressive flexion contractures, camptodactyly, widely spaced teeth, and constriction rings. We also propose novel occasional features including craniosynostosis, ocular pterygia, anterior chamber cleavage syndrome, early osteoporosis, increased pigmentation, recurrent haematomas, predisposition to cellulitis, nail dystrophy, carpal tunnel syndrome, recurrent hypoglycaemia in infancy, joint dislocation, and splenomegaly. Importantly, we report fusiform aneurysm of the basilar artery in two patients. Complications include thrombosis and stroke in the oldest reported patient and fatal rupture at the age of 21 in the patient with the novel variant. We conclude that cerebrovascular complications are part of the phenotypic spectrum of KOGS and KOGS-like disorders and suggest vascular imaging is indicated in these patients.
Published: 2020

33. Crise sanitaire : quelles opportunités pour la recherche clinique sur le médicament ?

Author: Dominique Deplanque, Stanislas Cviklinski, Marc Bardou, Florence Ader, Hervé Blanchard, Philippe Barthélémy, Isabelle David, Eric D’Ortenzio, Hélène Espérou, Odile Launay, Milan Lazarevic, Philippe Lechat, Françoise Lethiec, Yves Levy, David Pérol, Virginie Rage, Matthieu Roustit, Gabriel Thabut, CHU Lille, 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), Laboratoire Roche SAS [Boulogne Billancourt], Ministère des Solidarités et de la Santé [Paris, France], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL), Pfizer France, Pfizer, AstraZeneca [Courbevoie], SANOFI Recherche, 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), Pôle de Recherche Clinique [Paris] (PRC), Institut National de la Santé et de la Recherche Médicale (INSERM), 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), Hôpital Cochin [AP-HP], Direction de la Recherche Clinique et de l'Innovation [AP-HP] (DRCI), Agence Générale des Equipements et Produits de Santé [Paris] (AGEPS), Janssen-Cilag [Issy-les-Moulineaux], 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), Centre Léon Bérard [Lyon], Centre européen d'études et de recherche droit et santé (CEERDS), Dynamiques du droit (DD), Université Montpellier 1 (UM1)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université Montpellier 1 (UM1)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), CHU Grenoble, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble, Centre d'Investigation Clinique [Grenoble] (CIC Grenoble), and CHU Grenoble-Hôpital Michallon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA)
Subjects: Recherche clinique, HEADING: Ateliers de Giens 2021/Recherche clinique et évaluation des produits de santé, Réglementation, Partage des données, COVID-19, Pharmacology (medical), [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Médicament
Abstract: International audience; La pandémie de coronavirus disease-19 (COVID-19) a conduit au déploiement d’un effort de recherche académique et industriel sans précédent dont on peut regretter le caractère parfois redondant ainsi que le manque de pilotage tant national qu’international. Pourtant, force est de constater qu’à l’occasion de cette crise, les procédures réglementaires ont été adaptées de même que certains freins dans l’organisation de la recherche clinique ont pu être en partie levés pour contribuer au déploiement d’essais au plus près des patients et faciliter les modalités de suivi et de contrôle. La digitalisation de certains processus et la décentralisation de certaines activités ont pu être mises en œuvre sous couvert d’une mobilisation des autorités et de l’ensemble des acteurs institutionnels, académiques ou industriels. Si outre-manche, l’optimisation des ressources, au travers d’un essai de plateforme unique, a permis de montrer ou d’infirmer l’efficacité de nombreux traitements, en France la crise sanitaire a mis en lumière la fragilité de l’organisation de la recherche clinique, notamment un déficit de coordination et de financement, des difficultés dans la mise en œuvre des études ou encore une certaine frilosité concernant le partage des données. Cependant, la crise a aussi révélé les capacités d’adaptation des différents acteurs et permis l’amélioration de plusieurs processus utiles au déploiement de l’innovation thérapeutique. Gageons que les leçons tirées à l’occasion de cette crise permettront une meilleure efficacité en cas de nouvelle pandémie et surtout que les progrès obtenus continueront de s’appliquer à l’ensemble des activités de recherche clinique futures.
Published: 2022

34. Health crisis: What opportunities for clinical drug research?

Author: Dominique Deplanque, Stanislas Cviklinski, Marc Bardou, Florence Ader, Hervé Blanchard, Philippe Barthélémy, Isabelle David, Eric D’Ortenzio, Hélène Espérou, Odile Launay, Milan Lazarevic, Philippe Lechat, Françoise Lethiec, Yves Levy, David Pérol, Virginie Rage, Matthieu Roustit, Gabriel Thabut, 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), CHU Lille, Laboratoire Roche SAS [Boulogne Billancourt], Ministère des Solidarités et de la Santé [Paris, France], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL), Pfizer France, Pfizer, AstraZeneca [Courbevoie], Sanofi Aventis R&D [Chilly-Mazarin], ANRS - Maladies infectieuses émergentes (ANRS - MIE), 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, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Pôle de Recherche Clinique [Paris] (PRC), 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), Hôpital Cochin [AP-HP], Direction de la Recherche Clinique et de l'Innovation [AP-HP] (DRCI), Agence Générale des Equipements et Produits de Santé [Paris] (AGEPS), Janssen-Cilag [Issy-les-Moulineaux], 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), Vaccine Research Institute [Créteil, France] (VRI), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Centre Léon Bérard [Lyon], Université de Montpellier (UM), Centre d'Investigation Clinique [Grenoble] (CIC Grenoble), CHU Grenoble-Hôpital Michallon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), CHU Grenoble, and Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble
Subjects: Clinical Trials as Topic, Biomedical Research, [SDV]Life Sciences [q-bio], COVID-19, Article, United Kingdom, Clinical research, COVID-19 Drug Treatment, Pharmaceutical Preparations, Humans, Pharmacology (medical), Data sharing, France, Drug, Pandemics, Regulation
Abstract: International audience; The COVID-19 pandemic led to the deployment of an unprecedented academic and industrial research effort, the sometimes redundant nature of which is regrettable, as is the lack of both national and international management. However, it must be noted that during this crisis, regulatory procedures were adapted and certain obstacles in the organisation of clinical research were partly removed to contribute to the deployment of trials as close as possible to patients and to facilitate monitoring and control procedures. The digitisation of certain processes and the decentralisation of certain activities were implemented under the cover of a mobilisation of the authorities and all institutional, academic and industrial players. While in the UK, the optimisation of resources through a single platform trial has made it possible to demonstrate or invalidate the efficacy of many treatments, in France the health crisis has highlighted the fragility of the organisation of clinical research, in particular a lack of coordination and funding, difficulties in implementing studies and a certain reluctance to share data. However, the crisis has also revealed the adaptability of the various stakeholders and has led to the improvement of several processes useful for the deployment of therapeutic innovation. Let us hope that the lessons learned during this crisis will allow for greater efficiency in the event of a new pandemic and, above all, that the progress made will continue to apply to all future clinical research activities.
Published: 2021

35. Exome sequencing allows detection of relevant pharmacogenetic variants in epileptic patients

Author: Simon Verdez, Quentin Thomas, Philippine Garret, Céline Verstuyft, Emilie Tisserant, Antonio Vitobello, Frédéric Tran Mau-Them, Christophe Philippe, Marc Bardou, Maxime Luu, Abderrahmane Bourredjem, Patrick Callier, Christel Thauvin-Robinet, Nicolas Picard, Laurence Faivre, Yannis Duffourd, Equipe GAD (LNC - U1231), 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)-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), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Service de Neurologie générale, vasculaire et dégénérative (CHU de Dijon), Université Bourgogne Franche-Comté [COMUE] (UBFC), Laboratoire CERBA [Saint Ouen l'Aumône], Santé mentale et santé publique (SMSP - U1178), Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), 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, FHU TRANSLAD (CHU de Dijon), Centre d'Investigation Clinique 1432 (Dijon) - Module Plurithématique : Périnatalité Cancérologie Handicap et Ophtalmologie (CIC-P803), Université de Bourgogne (UB)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de Génétique Chromosomique et Moléculaire [CHU Dijon], Centre de référence des maladies rares des déficiences intellectuelles de causes rares (CHU Dijon) (CRMR des déficiences intellectuelles de causes rares), Ciblage individuel et prévention des risques de traitements immunosupresseurs et de la transplantation (IPPRITT), CHU Limoges-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Centre de génétique - Centre de référence des maladies rares, anomalies du développement et syndromes malformatifs (CHU de Dijon), and Duffourd, Yannis
Subjects: Pharmacology, [SDV] Life Sciences [q-bio], Epilepsy, Pharmacogenomic Variants, [SDV]Life Sciences [q-bio], Phenytoin, Genetics, Molecular Medicine, Humans, Exome, Retrospective Studies
Abstract: International audience; Beyond the identification of causal genetic variants in the diagnosis of Mendelian disorders, exome sequencing can detect numerous variants with potential relevance for clinical care. Clinical interventions can thus be conducted to improve future health outcomes for patients and their at-risk relatives, such as predicting late-onset genetic disorders accessible to prevention, treatment or identifying differential drug efficacy and safety. To evaluate the interest of such pharmacogenetic information, we designed an "in house" pipeline to determine the status of 122 PharmGKB (Pharmacogenomics Knowledgebase) variant-drug combinations in 31 genes. This pipeline was applied to a cohort of 90 epileptic patients who had previously an exome sequencing (ES) analysis, to determine the frequency of pharmacogenetic variants. We performed a retrospective analysis of drug plasma concentrations and treatment efficacy in patients bearing at least one relevant PharmGKB variant. For PharmGKB level 1A variants, CYP2C9 status for phenytoin prescription was the only relevant information. Nineteen patients were treated with phenytoin, among phenytointreated patients, none were poor metabolizers and four were intermediate metabolizers. While being treated with a standard protocol (10-23 mg/kg/30 min loading dose followed by 5 mg/kg/8 h maintenance dose), all identified intermediate metabolizers had toxic plasma concentrations (20 mg/L). In epileptic patients, pangenomic sequencing can provide information about common pharmacogenetic variants likely to be useful to guide therapeutic drug monitoring, and in the case of phenytoin, to prevent clinical toxicity caused by high plasma levels.
Published: 2021

36. Participation in faecal immunochemical testing-based colorectal cancer screening programmes in the northwest of Europe

Author: Marc Bardou, Iris Lansdorp-Vogelaar, Monique E. van Leerdam, Isabel Portillo, Philippe Perrin, Isabel De Brabander, Catherine Dubois, Esther Toes-Zoutendijk, Sarah Hoeck, and Public Health
Subjects: Male, Colorectal cancer, Health Promotion, Population based, invitation method, SDG 3 - Good Health and Well-being, Environmental health, participation, Humans, Medicine, Early Detection of Cancer, Aged, business.industry, screening, faecal immunochemical testing, Health Policy, Public Health, Environmental and Occupational Health, Original Articles, Colonoscopy, Middle Aged, Patient Acceptance of Health Care, medicine.disease, population-based, Europe, Colorectal cancer screening, Occult Blood, Female, Human medicine, Colorectal Neoplasms, business
Abstract: Objective This study compared the participation in four faecal immunochemical testing-based screening programmes for colorectal cancer in Flanders, France, Basque country and the Netherlands, to identify factors to further optimize faecal immunochemical testing programmes. Method Background information and data on performance indicators were collected and compared for the four programmes. Results Invitation method, reminders, funding, faecal immunochemical testing cut-off and follow-up after positive faecal immunochemical testing differed in the four programmes. In France, only an invitation letter is sent by mail, while the sample kit must be collected from the general practitioner. In the other programmes, an invitation letter including the sample kit is sent by mail. Participation rates vary substantially according to the method of invitation, with the highest participation rates in the Netherlands (73.0%) and Basque country (72.4%), followed by Flanders (54.5%) and France (28.6%). Basque country (92.8%) and France (88.4%), the two programmes with most active involvement of general practitioners in referral for colonoscopy, had the highest participation rates for colonoscopy. Conclusions Large differences in screening participation observed between programmes according to the invitation method used suggest that changes to the design of the programme, such as including the sample kit with the invitation, or active involvement of GPs, might increase participation.
Published: 2019

37. Secondary actionable findings identified by exome sequencing: expected impact on the organisation of care from the study of 700 consecutive tests

Author: Aurore Pélissier, Anne-Laure Mosca-Boidron, Thibaud Jouan, Elodie Cretin, Maxime Luu, Pierre Vabres, Jean-François Deleuze, Chritine Peyron, Nolwenn Jean-Marçais, Julien Thevenon, Christine Binquet, Frédéric Tran Mau-Them, Ange-Line Bruel, Patrick Callier, Elodie Gautier, Laurent Demougeot, Daphné Lehalle, Christophe Philippe, Paul Kuentz, Martin Chevarin, Sophie Nambot, Aline Chassagne, Charlotte Poe, Christel Thauvin-Robinet, Mathilde Lefebvre, Marc Bardou, Céline Verstuyft, Antonio Vitobello, Laurence Faivre, Julian Delanne, Emilie Tisserant, Arthur Sorlin, and Yannis Duffourd
Subjects: Adult, Male, Proband, PharmGKB, Genotype, Genetic counseling, Disease, Bioinformatics, Article, 03 medical and health sciences, Exome Sequencing, Genetics, Humans, Medicine, Genetic Predisposition to Disease, Genetic Testing, Child, Exome, Genetics (clinical), Exome sequencing, Retrospective Studies, Incidental Findings, 0303 health sciences, Genome, Human, business.industry, 030305 genetics & heredity, Genetic Variation, Genomics, Cohort, Female, business, Pharmacogenetics
Abstract: With exome/genome sequencing (ES/GS) integrated into the practice of medicine, there is some potential for reporting incidental/secondary findings (IFs/SFs). The issue of IFs/SFs has been studied extensively over the last 4 years. In order to evaluate their implications in care organisation, we retrospectively evaluated, in a cohort of 700 consecutive probands, the frequency and burden of introducing the search for variants in a maximum list of 244 medically actionable genes (genes that predispose carriers to a preventable or treatable disease in childhood/adulthood and genes for genetic counselling issues). We also focused on the 59 PharmGKB class IA/IB pharmacogenetic variants. We also compared the results in different gene lists. We identified variants (likely) affecting protein function in genes for care in 26 cases (3.7%) and heterozygous variants in genes for genetic counselling in 29 cases (3.8%). Mean time for the 700 patients was about 6.3 min/patient for medically actionable genes and 1.3 min/patient for genes for genetic counselling, and a mean time of 37 min/patients for the reinterpreted variants. These results would lead to all 700 pre-test counselling sessions being longer, to 55 post-test genetic consultations and to 27 secondary specialised medical evaluations. ES also detected 42/59 pharmacogenetic variants or combinations of variants in the majority of cases. An extremely low metabolizer status in genes relevant for neurodevelopmental disorders (CYP2C9 and CYP2C19) was found in 57/700 cases. This study provides information regarding the need to anticipate the implementation of genomic medicine, notably the work overload at various steps of the process.
Published: 2019

38. Increasing incidence of colorectal cancer in young adults in Europe over the last 25 years

Author: Michal F. Kaminski, Iris Lansdorp-Vogelaar, Maria José Bento, Ondřej Májek, Marc Bardou, Ernst J. Kuipers, Mário Dinis-Ribeiro, Fanny E. Vuik, Maria Pellise, Stepan Suchanek, Vesna Zadnik, Marcis Leja, Laura Esteban, Manon C.W. Spaander, Ondřej Ngo, Stella A. V. Nieuwenburg, Gastroenterology & Hepatology, and Public Health
Subjects: Adult, Male, medicine.medical_specialty, Joinpoint regression, Colorectal cancer, Young Adult, 03 medical and health sciences, 0302 clinical medicine, SDG 3 - Good Health and Well-being, Regional cancer, Epidemiology, Humans, Medicine, Young adult, Retrospective Studies, business.industry, Incidence, Incidence (epidemiology), Gastroenterology, Middle Aged, medicine.disease, Annual Percent Change, 3. Good health, Europe, Survival Rate, Younger adults, 030220 oncology & carcinogenesis, Female, 030211 gastroenterology & hepatology, Colorectal Neoplasms, business, Follow-Up Studies, Forecasting, Demography
Abstract: ObjectiveThe incidence of colorectal cancer (CRC) declines among subjects aged 50 years and above. An opposite trend appears among younger adults. In Europe, data on CRC incidence among younger adults are lacking. We therefore aimed to analyse European trends in CRC incidence and mortality in subjects younger than 50 years.DesignData on age-related CRC incidence and mortality between 1990 and 2016 were retrieved from national and regional cancer registries. Trends were analysed by Joinpoint regression and expressed as annual percent change.ResultsWe retrieved data on 143.7 million people aged 20–49 years from 20 European countries. Of them, 187 918 (0.13%) were diagnosed with CRC. On average, CRC incidence increased with 7.9% per year among subjects aged 20–29 years from 2004 to 2016. The increase in the age group of 30–39 years was 4.9% per year from 2005 to 2016, the increase in the age group of 40–49 years was 1.6% per year from 2004 to 2016. This increase started earliest in subjects aged 20–29 years, and 10–20 years later in those aged 30–39 and 40–49 years. This is consistent with an age-cohort phenomenon. Although in most European countries the CRC incidence had risen, some heterogeneity was found between countries. CRC mortality did not significantly change among the youngest adults, but decreased with 1.1%per year between 1990 and 2016 and 2.4% per year between 1990 and 2009 among those aged 30–39 years and 40–49 years, respectively.ConclusionCRC incidence rises among young adults in Europe. The cause for this trend needs to be elucidated. Clinicians should be aware of this trend. If the trend continues, screening guidelines may need to be reconsidered.
Published: 2019

39. Relative risk rather than absolute risk reduction should be preferred to sensitise the public to preventive actions

Author: Marc Bardou, Alan N. Barkun, Nicolas Chapelle, and Myriam Martel
Subjects: 0301 basic medicine, Estimation, Risk, education.field_of_study, Actuarial science, Cancer prevention, Coronavirus disease 2019 (COVID-19), Population, Gastroenterology, Absolute risk reduction, Discount points, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Intervention (counseling), Relative risk, Humans, 030211 gastroenterology & hepatology, education, Psychology, Numbers Needed To Treat
Abstract: We thank Lawrence and colleagues1 for their interest in our work,2 about which they raised some comments as the need of expressing results in absolute rather than relative risks. As they appropriately mentioned in their correspondence, absolute risk is an important parameter for the estimation of the effect of an intervention and must sometimes be preferred to relative risk. However, when discussing with health professionals and policymakers, using absolute risk reductions, expressed as percentages, may incorrectly lead to an intervention being considered unnecessary. As example, what would be the point of reducing by 30% the occurrence of an event affecting 2% of the population? This is exactly what we were confronted to with the COVID-19 pandemic, when policymakers were criticised for putting in place measures to reduce individual freedoms, which were considered excessive in relation to the …
Published: 2021

40. Effect of anakinra versus usual care in adults in hospital with COVID-19 and mild-to-moderate pneumonia (CORIMUNO-ANA-1): a randomised controlled trial

Author: Mathieu Vautier, Florence Tubach, Marion Licois, Estelle Henry, Marie-Alexandra Alyanakian, Julien Poissy, Solaya Chalal, Anne Gysembergh-Houal, Stéphanie Alary, Sophie Diemunsch, Jonathan London, Camille Petit-Hoang, Ruben Benainous, Catherine Metzger, Olivier Benveniste, Hala Semri, Charléne Jouve, Robin Dhote, johann Cailhol, Elise Morawiec, Kristina Beziriganyan, Mathieu Oberlin, Paul Legendre, Hélène François, Claire Davoine, F Louni, Myriam Virlouvet, Stéphane Renaud, Christiane Verny, Bertrand Guidet, Bob Heger, Lara Zafrani, Pierre-Louis Tharaux, Mandy Nizard, Adrien Contejean, Segolene Toquet, Ulrich Clarac, Sylviane Ravato, Gaëtan Deslée, Frédéric De Blay, Christian Richard, Raphaël Porcher, Malikhone Chansombat, Marie Lachatre, Ines Ben-Mabrouk, Matthieu Uzzan, Lauren Demerville, Amélie Servettaz, Annabelle Pourbaix, Philippe Manivet, Fanny Charbonnier, Pierre-Grégoire Guinot, Alexandre Demoule, Nicolas Champtiaux, Nicolas Belaube, Jean-Pierre Riveline, Kamil Chitour, Joseph Emmerich, Arthur Neuschwander, Mickael Henriques, Anne Hutt, Arthur Pavot, Anne Rachline, Elena Fois, Audrey Phibel, Xavier Monnet, Jean-Charles Duclos-Vallée, Félix Ackermann, Maria Pereira, Anne Sophie Korganow, Elodie Drouet, Tabassome Simon, Morgane Faure, Anne Pattyn, Aida Zahrate-Ghoul, Karine Martin, Jean-Jacques Tudesq, Gladys Aratus, Kévin Cardet, Julien Pottecher, Eric Demonsant, Arsène Mekinian, Rémy Gauzit, Julie Smati, Robin Deleris, Jean-Simon Rech, Boris Bienvenu, Nicolas Lefebvre, Elodie Baudry, Nicolas Bonnet, Alexis Régent, François Weill, Lalia Djaghout, Anne Tréhan, Isabelle Lehir, Elena Kiouris, Sophie Renet, Yasmina Mekid, Vanessa Rathouin, David Montani, Annick Tibi, Anne Blanchard, Fanette Denies, Nathalie Menage, Guillaume Becker, Valérie Camara-Clayette, Loic Kassegne, Nathalie Chavarot, Aurélie Clan Hew Wai, Jeremy Arzoine, Louise Bondeelle, Mohamad Zaidan, S Lariven, Laurent Cylly, Edouard Flamarion, Chaouki Bouras, Florence Bellenfant, Melissa Clément, Lola-Jade Palmieri, Marie hélène Pari, Lionel Galicier, Valérie Dejean, Delphine Feyeux, Naima Sguiouar, Anne Bergeron, Laurence Annonay, Anouk Walter-Petrich, Camille Knosp, Laurence Drouard, Thiziri Sadaoui, Julie Delemazure, Antoine Parrot, Carole Burger, Laurence Berard, Nicolas Gambier, Eric Marquis, Isabelle Madeleine, Gwenaël Lorillon, Matthieu Resche-Rigon, Yves Hansmann, Claire Rouzaud, Hélène Gros, Sophie Caillat-Zucman, Bernard Cholley, Celine Wilpotte, Chistophe Willekens, Lydia Suarez, Syllia Belazouz, Valérie Pourchet-Martinez, Dhiaa Meriem Hai, Olivier Collange, Paul Jaubert, Marie-Thérèse Tremorin, Nathalie Marin, Diane Le Pluart, Madona Sakkal, Juliette Djadi-Prat, Alexandre Morel, Agathe Bounhiol, Xavier Jaïs, Nicolas Meyer, Vixra Keo, Michaël Darmont, Benedicte Giroux-Leprieur, Anatole Harrois, Anne Adda, Yaël Amara, Fanny Pommeret, Antony Canellas, Matheus Vieira, Clotilde Le Tiec Le Tiec, Corinne Pernot, Bernard Goichot, Céline Louapre, Roza Rahli, Anne Jacolot, Anne Daguenel-Nguyen, Marie Dubert, Anaïs Razurel, Aurelie Sautereau, Mitja Jevnikar, Pierre Faye, Jeanne CHAUFFiER, Mathieu Jozwiak, Laurent Savale, Florence Patin, Kahina Cheref, Mélanie Dehais, Paul Michel Mertes, Caroline Morbieu, Valérie Paquet, Dominique Roulot, Giovanna Melica, Pauline Jouany, Frédéric Schlemmer, Blandine Lehmann, Pascal Martel, Tomas Urbina, Yazdan Yazdanpanah, Veronique Joly, Damien Bergerot, Claire Courtin, Benjamin Fournier, Guillaume Grailles, Asmaa Mamoune, Caroline Gaudefroy, Charlotte Kaeuffer, Bruno Crestani, Thinhinane Bariz, C Rioux, Karine Celli Lebras, Sophie Granville, Marion Bouhris, Hugues Cordel, Jean-Marie Michot, Mohamed Belloul, Nadège Lemarié, Philippe Dieudé, Sylvie Le Gac, Matthieu Mahévas, Pascal Richette, Anaïs Codorniu, Camille Rolland-Debord, Edouard Lefèvre, Sophie-Rym Hamada, Tristan Martin, Vincent Castelain, Aude Rigolet, Valentin Greigert, Gaelle Leroux, Simon Valayer, Eliane Bertrand, Eric Vicaut, Stéphane Brin, Jacques-Eric Gottenberg, Olivier Clovet, Marc Bardou, Muriel Fartoukh, Valentina Isernia, Ada Clarke, Bao Phung, Grégoire Martin de Frémont, Jeanne Meunier, Gonçalo Boleto, David Lebeaux, Hassan Tarhini, Asmaa Mabrouki, Pascaline Choinier, Etienne Canouï, Eric D'Ortenzio, Constance Guillaud, Corine Nyanou, Alexandre Moores, Linda Gimeno, Victoire De Lastours, F-Xavier Lescure, Claire Montlahuc, Sophie Georgin-Lavialle, A Soria, Xavier Mariette, Sophie Ismael, Prissile Bakouboula, Olivier Lambotte, Jérémie Zerbit, Aude Jacob, Z Julia, Nathalie Dournon, Marthe Rigal, Mireille Adda, Nathan Ebstein, Frédéric Duée, Helene Chambrin-Lauvray, Ramdane Meftali, Hélène Lafoeste, Coralie Bloch Queyrat, Sabrina Brahmi, Catherine Le Bourlout, Nicolas Noel, Emmanuelle Guillot, Hakim Tayebi, Sandrine Briois, Anne-Lise Pouliquen, Lakhdar Mameri, Sophie-Caroline Sacleux, Nathalie Rozensztajn, Lelia Escaut, Clément Jourdaine, Cédric Pierron, Marc Garnier, Yves Cohen, Abdellatif Tazi, Maxence Decavele, Paul Henri Grisot, Patrice Cacoub, Laure Allanic, Amira Benattia, Martin Siguier, Luca Semerano, Jean-Sébastien Hulot, Jean-Jacques Mourad, Sara Sambin, Miguel Alejandro Vasquez-Ibarra, Nabil Raked, Christine Lemagner, Martin Dres, Clara Campos-Vega, Tali-Anne Szwebel, Benjamin Chaigne, Emmanuel Andrès, Gabriel Steg, Frédéric Blanc, Isabelle Peigney, Catherine Fauvaux, Côme Bureau, Samira Saleh-Mghir, Julie Jambon, Pierre Dupland, Anne Lise Jegu, Mamadou Salif Cisse, Damien Roux, Moez Jallouli, Philippe Blanche, Sébastien Cavelot, Sophie Ohlmann-Caillard, Louise-Laure Mariani, Adrien Michon, Alain Wynckel, Saskia Flamand, Safaa Nemlaghi, Benjamin G. Chousterman, Geoffroy Volle, Cécile Kedzia, Fanny Domont, Lee S. Nguyen, Férial Berbour, Pierre Diemunsch, Celine Dupré, Etienne Lengliné, Claire Tantet, Gaël Leprun, Sara Virolle, Perrine Guillaume-Jugnot, Soumeya Hammal, B. Duchemann, Mathilde Le Marchand, Vincent Poindron, Victor Lancon, Ruxandra Burlacu, Guillaume Lefèvre, Kamyl Baghli, Emilia Stan, Yann Nguyen, Olivier Sanchez, Olivier Sitbon, Loren Soyez-Herkert, Fanny Defrancq, Véronique Vigna, Aurélien Guffroy, Martine Meunier, Pierre Mora, Léa Resmini, Liem Binh Luong Nguyen, Jean-Luc Diehl, Johanna Oziel, Emmanuelle Bugnet, Lamiae Grimaldi, Olivia Daconceicao, Marie Matignon, Mourad Djadel, Yasmine Messaoudi, Hassan Joumaa, Isabelle Dusanter, Sarah Benghanem, Julien Mayaux, Marc Michel, Claire Pernin, Antoine Gros, Nassim Mahtal, Philippe Benoit, Cloé Comarmond, Laurence Lecomte, Patricia Senet, Sebastien Abad, Jérôme Pacanowski, Céline Leplay, Claire Aguilar, Cédric Sublon, Jesuthasan Denis, Régis Peffault de Latour, Gabrielle Archer, Alain Fourreau, Emmanuelle Blin, Lise Bernard, Alexandra Beurton, Alexandre Buffet, Pierre Le Guen, Clairelyne Dupin, Olivier Fain, A Gervais, Marc Humbert, Yves Allenbach, Alexandre Bourgoin, Agnes Maurer, Eric Noll, Virginie Elisee, Adrien Mirouse, Cecile Larcheveque, Carine Karachi, Samy Figueiredo, Hakim Meddah, Greggory Ducrocq, Jeanne Goupil de Bouille, Awa Ndiaye, Jessica Krause le Garrec, Maxime Dougados, Yasmina Ferfar, Damien Vimpere, Olivier Olivier, Annabelle Stoclin, Jean-Louis Teboul, Ridha Belilita, Serge Bureau, Naura Gamany, Emeline Colomba, Baptiste Duceau, Philippe Ravaud, Corinne Guerin, Florence Morin, Pélagie Thibaut, Younes Keroumi, Julie Chas, Elisabeth Coupez, Laetitia Languille, Mathias Cornic, Jean-Michel Molina, Caroline Pradon, Alison Klasen, Zakaria Ait Hamou, Armand Mekontso-Dessaps, Yurdagul Uzunhan, Samir Hamiria, Anne Godier, Elsa Feredj, Nessima Yelles, Jean-Benoit Arlet, Christine Broissand, Belkacem Asselate, Jaouad Benhida, Julien Le Marec, Nawal Derridj, Laurène Deconinck, A. Dossier, Eric Oksenhendler, Eva Chatron, Lucie Aunay, Candice Estellat, Julie Fillon, Marie Antignac, Jade Ghosn, Ilias Koumis, David Schmitz, Domitille Molinari, Soraya Fellahi, Bruno Mégarbane, Aline Frazier, Ramon Junquera, Vincent Provitolo, Marie Lecronier, Dimitri Fremont, Pierrick Le Borgne, Emmanuel Weiss, Faouzi Saliba, Stéphan Pavy, Geoffrey Rossi, Chloe McAvoy, Eric Mariotte, Dorothee Vallois, Sabrine Ouamri, Pierre Tissieres, Luc Mouthon, Blandine Denis, Celine Comparon, Emmanuelle Sacco, Frédéric Pène, Marjolaine Morgand, Vasco Honsel, Laure Choupeaux, Bruno Mourvillier, Ewa Kozaliewicz, Marie-Hélène Legros, Isabelle Debrix, Gabriel Nisand, Julien Chabert, Juliette Camuset, Stéphane Jauréguiberry, Lynda Chalal, Marine Livrozet, Lucie Biard, Elodie Perrodeau, Brigitte Sabatier, Raphael Borie, Rosa Da Silva, Nathalie Costedoat-Chalumeau, Emmanuel Chatelus, Jean-Christophe Corvol, Nathalie De Castro, David Boutboul, Benjamin Planquette, Anne Claire Desbois, François Danion, Brigitte Ranque, Amélie Cransac, Marine Nadal, Coralie Gernez, Yacine Boudali, Claire Madelaine, Georgina Maalouf, Jonathan Marey, Sophie Bayer, Antoine Fayol, Souad Benarab, Luc Haudebourg, Sophie Bulifon, Claire Pacheco, Philippe Durand, Olivier Hermine, Fanny Alby-Laurent, Geoffroy Liégeon, Axelle Fuentes, Jean-Daniel Lelievre, Gilles Garcia, Céline Verstuyft Verstuyft, Marie-Aude Penet, Constance Delaugerre, Nicolas Carlier, Aurélie Durel Maurisse, Gilles Pialoux, Zeina Louis, Marion Parisey, Pascal Lim, Gaelle Clavere, Martin De Sarcus, Marie Vayssettes, Thomas Papo, Adrien Joseph, Hilario Nunes, Hanane Fodil, Solen Kernéis, Antoine Bachelard, Jacques Duranteau, Karine Lacombe, Olivia Lenoir, Mathilde Vallet, Isabelle Brindele, Robin Charreteur, Elie Azoulay, Dorothée Chopin, Aïcha Bah, Moustafa Benafla, Marie Gilbert, Matthieu Lemoine, Abolfazl Mohebbi, Mathilde Noaillon, Amina Kebir, Virginie Zarrouk, Cécile Yelnik, Benjamin Terrier, Solène Fabre, Paul Crespin, Sarah Dalibey, Thierno Dieye, Renaud Felten, Oriane Puéchal, Pernelle Vauboin, Caroline Hauw-Berlemont, Gabriel Baron, Paul Vermes, Yvon Ruch, Dominique Dautel, Tassadit Hadjam, Anne-Marie Roques, Jean-Philippe Bastard, Younes El Amine, Damien Sène, Alaki Thiemele, Catherine Boussard, Vincent Fallet, Timothee Bironne, Damien Vanhoye, Guillaume Geri, Amine Ghembaza, Bertrand Dunogue, Nadia Anguel, Laure Berton, Caroline Semaille, Thomas Volpe, Jacques Cadranel, Thomas Gorget, Julien Saussereau, Elodie Issorat, Sami Kolta, Pathologies Pulmonaires et Plasticité Cellulaire - UMR-S 1250 (P3CELL), Université de Reims Champagne-Ardenne (URCA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), 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), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Cité (UPCité), Optimisation thérapeutique en Neuropsychopharmacologie (OPTeN (UMR_S_1144 / U1144)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Service de Réanimation Médicale et Toxicologique [Hôpital Lariboisière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Centre de recherche en Myologie – U974 SU-INSERM, Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), and Porcher, Raphaël
Subjects: Male, medicine.medical_treatment, [SDV]Life Sciences [q-bio], [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, law.invention, 0302 clinical medicine, Randomized controlled trial, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, law, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, [SDV.MHEP.ME] Life Sciences [q-bio]/Human health and pathology/Emerging diseases, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, education.field_of_study, Hazard ratio, Articles, Middle Aged, Intensive care unit, Hospitals, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, 3. Good health, Hospitalization, [SDV.TOX] Life Sciences [q-bio]/Toxicology, Treatment Outcome, [SDV.TOX]Life Sciences [q-bio]/Toxicology, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Female, France, medicine.drug, Adult, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Critical Care, Population, 03 medical and health sciences, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Internal medicine, medicine, Humans, education, Critical Care Outcomes, Aged, Mechanical ventilation, Anakinra, SARS-CoV-2, business.industry, Comment, COVID-19, Bayes Theorem, Pneumonia, medicine.disease, Respiration, Artificial, COVID-19 Drug Treatment, Clinical trial, Interleukin 1 Receptor Antagonist Protein, 030228 respiratory system, [SDV.MHEP.PSR] Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, business, Interleukin-1
Abstract: International audience; Background: Patients with COVID-19 pneumonia have an excess of inflammation and increased concentrations of cytokines including interleukin-1 (IL-1). We aimed to determine whether anakinra, a recombinant human IL-1 receptor antagonist, could improve outcomes in patients in hospital with mild-to-moderate COVID-19 pneumonia.Methods: In this multicentre, open-label, Bayesian randomised clinical trial (CORIMUNO-ANA-1), nested within the CORIMUNO-19 cohort, we recruited patients from 16 University hospitals in France with mild-to-moderate COVID-19 pneumonia, severe acute respiratory syndrome coronavirus 2 infection confirmed by real-time RT-PCR, requiring at least 3 L/min of oxygen by mask or nasal cannula but without ventilation assistance, a score of 5 on the WHO Clinical Progression Scale (WHO-CPS), and a C-reactive protein serum concentration of more than 25 mg/L not requiring admission to the intensive care unit at admission to hospital. Eligible patients were randomly assigned (1:1) using a web-based secure centralised system, stratified by centre and blocked with varying block sizes (randomly of size two or four), to either usual care plus anakinra (200 mg twice a day on days 1-3, 100 mg twice on day 4, 100 mg once on day 5) or usual care alone. Usual care was provided at the discretion of the site clinicians. The two coprimary outcomes were the proportion of patients who had died or needed non-invasive or mechanical ventilation by day 4 (ie, a score of >5 on the WHO-CPS) and survival without need for mechanical or non-invasive ventilation (including high-flow oxygen) at day 14. All analyses were done on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT04341584, and is now closed to accrual.Findings: Between April 8 and April 26, 2020, we screened 153 patients. The study was stopped early following the recommendation of the data and safety monitoring board, after the recruitment of 116 patients: 59 were assigned to the anakinra group, and 57 were assigned to the usual care group. Two patients in the usual care group withdrew consent and were not analysed. In the analysable population, the median age was 66 years (IQR 59 to 76) and 80 (70%) participants were men. In the anakinra group, 21 (36%) of 59 patients had a WHO-CPS score of more than 5 at day 4 versus 21 (38%) of 55 in the usual care group (median posterior absolute risk difference [ARD] -2·5%, 90% credible interval [CrI] -17·1 to 12·0), with a posterior probability of ARD of less than 0 (ie, anakinra better than usual care) of 61·2%. At day 14, 28 (47%; 95% CI 33 to 59) patients in the anakinra group and 28 (51%; 95% CI 36 to 62) in the usual care group needed ventilation or died, with a posterior probability of any efficacy of anakinra (hazard ratio [HR] being less than 1) of 54·5% (median posterior HR 0·97; 90% CrI 0·62 to 1·52). At day 90, 16 (27%) patients in the anakinra group and 15 (27%) in the usual care group had died. Serious adverse events occurred in 27 (46%) patients in the anakinra group and 21 (38%) in the usual care group (p=0·45).Interpretation: Anakinra did not improve outcomes in patients with mild-to-moderate COVID-19 pneumonia. Further studies are needed to assess the efficacy of anakinra in other selected groups of patients with more severe COVID-19.Funding: The Ministry of Health, Programme Hospitalier de Recherche Clinique, Foundation for Medical Research, and AP-HP Foundation.
Published: 2021
Full Text: View/download PDF

41. Editorial: 'Stardust gastric mucosa' - A novel and consistent marker of vonoprazan safety during follow-up?

Author: Maxime, Luu, Ines, Ben Ghezala, and Marc, Bardou
Subjects: Sulfonamides, Gastric Mucosa, Risk Factors, Incidence, Humans, Pyrroles, Propensity Score, Follow-Up Studies
Published: 2020

42. Author response for 'Clinical and neuroimaging findings in 33 patients with MCAP syndrome: a survey to evaluate relevant endpoints for future clinical trials'

Author: Florence Petit, Juliette Mazereeuw-Hautier, Christine Coubes, Patricia Blanchet, Jenny Cornaton, Frederico Di Rocco, Fabienne Giuliano, Arthur Sorlin, Elodie Gautier, Laurent Guibaud, Renaud Touraine, Massimiliano Rossi, Christophe Philippe, Jean-Luc Alessandri, Joelle Roume, Patrick Edery, Gilles Morin, Christine Chiaverini, Diane Doummar, Michèle Mathieu-Dramard, Olivia Boccara, Philippe Khau Van Kien, Aurore Garde, Claire Nicolas, Maxime Luu, Lucile Pinson, Nicolas Chassaing, Fanny Morice-Picard, Christel Thauvin-Robinet, Rodolphe Dard, Cyril Mignot, Marc Bardou, V. Carmignac, Pierre Vabres, Alice Goldenberg, Laurence Faivre, Didier Lacombe, Annick Toutain, Stéphanie Arpin, Marjolaine Willems, and Anne-Claire Bursztejn
Subjects: Clinical trial, medicine.medical_specialty, Neuroimaging, business.industry, medicine, Intensive care medicine, business
Published: 2020

43. Comparative benefit and cost-effectiveness of mailed-out faecal immunochemical tests vs collection at the general practitioner

Author: Elisabeth F P, Peterse, Caroline B, Osoro, Marc, Bardou, and Iris, Lansdorp-Vogelaar
Subjects: General Practitioners, Cost-Benefit Analysis, Occult Blood, Humans, Mass Screening, Colonoscopy, France, Colorectal Neoplasms, Early Detection of Cancer
Abstract: Participation in the colorectal cancer screening programme in France has been well below the 45% considered acceptable by European guidelines, potentially attributable to the need to collect the faecal immunochemical test (FIT) at the general practitioner.To estimate the potential benefits and costs of including the FIT in the invitation letter.A well-established microsimulation model was used to simulate the French population 35 years and older in 2018. We estimated quality-adjusted life-years (QALY) gained, costs and cost-effectiveness of the current screening programme, and compared it to a variation of the programme where the FIT was mailed to participants and adherence was assumed to increase to 45%. We also estimated the threshold increase in participation needed to make this intervention cost-effective.Under the current programme, 53.8 colorectal cancer (CRC) cases and 25.2 CRC deaths per 1000 individuals are expected to occur over a lifetime. If sending out the FIT increases screening participation to 45%, this intervention would result in 6% fewer CRC deaths and 3% fewer CRC cases, resulting in an estimated cost-effectiveness ratio of €2149 per QALY gained. Sending out the FIT would only need to increase participation by 0.7% point for this intervention to be considered cost-effective.Including the FIT in the invitation letter is likely a very cost-effective intervention to increase participation in CRC screening. These results for France are also informative for many other countries around the world where FIT needs to be collected at pharmacies or general practitioners.
Published: 2020

44. Current role of cyanoacrylate glue transcatheter embolization in the treatment of acute nonvariceal gastrointestinal bleeding

Author: Thomas Mouillot, Marc Bardou, Olivier Chevallier, Romaric Loffroy, Equipe IFTIM [ImViA - EA7535], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER-UNICANCER-Imagerie et Vision Artificielle [Dijon] (ImViA), and Université de Bourgogne (UB)-Université de Bourgogne (UB)
Subjects: Gastrointestinal bleeding, medicine.medical_specialty, Catheters, Lower gastrointestinal bleeding, Transcatheter embolization, [SDV]Life Sciences [q-bio], law.invention, Contraindications, Procedure, 03 medical and health sciences, 0302 clinical medicine, Refractory, Recurrence, law, Adhesives, medicine, Animals, Humans, Cyanoacrylates, GLUE, ComputingMilieux_MISCELLANEOUS, Hepatology, medicine.diagnostic_test, business.industry, Patient Selection, Arterial Embolization, Gastroenterology, Interventional radiology, medicine.disease, Embolization, Therapeutic, 3. Good health, Surgery, Cyanoacrylate, 030220 oncology & carcinogenesis, Acute Disease, 030211 gastroenterology & hepatology, Gastrointestinal Hemorrhage, business
Abstract: Over the past three decades, transcatheter arterial embolization (TAE) has become the first-line therapy for the management of acute nonvariceal gastrointestinal bleeding (NVGIB) that is refractory to endoscopic hemostasis. Advances in catheter-based techniques and newer liquid embolic agents, as well as recognition of the effectiveness of minimally invasive treatment options, have expanded the role of interventional radiology in the treatment of acute NVGIB. Many embolic agents have been used successfully. However, no guidelines exist about the choice of the best embolic agent which is still controversial. Cyanoacrylate glue has gained acceptance over time. This article aims to address the current role of TAE using cyanoacrylate glue for the treatment of acute NVGIB.The authors undertook a literature review of the current evidence on the use of cyanoacrylate glue in treating patients with acute NVGIB.The evidence shows that cyanoacrylate glue is the most clinically useful embolic agent in treating patients with acute NVGIB, despite the need for learning curve, especially in case of coagulopathy. At present, research is ongoing to assess liquid embolic agents in the treatment of patients presenting with acute NVGIB. More research is needed but cyanoacrylate glue show promise for the future.
Published: 2020

45. Violence Against Women and Perceived Health: An Observational Survey of Consultants in Family Planning Centers in the Paris, France, Region

Author: Yélian Ahogbehossou, Noémie Roland, Ghada Hatem, Leila Yacini, Laure Feldmann, Marie-Josèphe Saurel-Cubizolles, and Marc Bardou
Subjects: genetic structures
Abstract: Background. Suffering violence has both short- and long-term negative effects on women’s health. We set out to study the relationship between socio-demographic characteristics of women attending three Family Planning Centers (FPCs) in France and the violence they experienced and to the association between women’s perception of their health status and their exposure to violence. Methods. We conducted an observational survey of clinical practice from December 2018 to February 2019 at three FPCs in Seine-Saint-Denis (Ile-de-France). All women patients aged 18 years or older were eligible. We solicited data on social characteristics, precariousness, and suffering violence. We measured health status on a 10-point scales for six different symptoms.Results. Of the 274 women who participated, 28% had experienced violence. This percentage was higher among women living in socially precarious situations compared to the not or slightly precarious (39.3% vs 15.8%, respectively). Experiencing violence was significantly associated with being between 25 and 44 years old, being in a temporary or irregular administrative situation, being unemployed or seeking a job, and being in a precarious to very precarious situation. The proportion of women reporting domestic violence was more than twice as high in those consulting in FPC-1 (42%) than in FPC-2 (20%) or FPC-3 (16.2%). Regardless of age, history of violence was significantly associated with poor sleep, poor diet, low morale, and poor health in general for all FPCs and all levels of precariousness. Conclusion. Our study reveals that reports of violence against women increased with migratory status and precariousness, unemployment or job-seeking, and a poorer state perception of one’s own health in a population drawn from three Family Planning Centers in Seine-Saint-Denis. It also suggests a structure specifically dedicated to the management of women victim of violence that FPC-1, may be perceived more attractive by women exposed to domestic violence. The study was retrospectively registered: ClinicalTrials.gov Identifier: NCT04304469
Published: 2020

46. Management of Nonvariceal Upper Gastrointestinal Bleeding

Author: Marc Bardou, Loren Laine, Alan N. Barkun, and Grigorios I. Leontiadis
Subjects: medicine.medical_specialty, business.industry, medicine.medical_treatment, MEDLINE, Therapeutic irrigation, General Medicine, medicine.disease, Systematic review, Internal Medicine, medicine, Intubation, Humans, Upper gastrointestinal bleeding, Intensive care medicine, business, Gastrointestinal Hemorrhage, Therapeutic Irrigation
Published: 2020

47. Ten-year experience with arterial embolization for peptic ulcer bleeding: N-butyl cyanoacrylate glue versus other embolic agents

Author: Marc Bardou, Thomas Mouillot, Marco Midulla, Julie Pellegrinelli, Nicolas Falvo, Anne-Solène Desmyttere, Olivier Chevallier, Romaric Loffroy, Pierre-Emmanuel Charles, Olivier Facy, Antoine Drouilllard, Serge Aho-Gléglé, Equipe IFTIM [ImViA - EA7535], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER-UNICANCER-Imagerie et Vision Artificielle [Dijon] (ImViA), and Université de Bourgogne (UB)-Université de Bourgogne (UB)
Subjects: medicine.medical_specialty, Peptic Ulcer, [SDV]Life Sciences [q-bio], Peptic Ulcer Hemorrhage, 030218 nuclear medicine & medical imaging, law.invention, Embolic Agent, 03 medical and health sciences, 0302 clinical medicine, Refractory, law, Medicine, Humans, Radiology, Nuclear Medicine and imaging, Cyanoacrylates, ComputingMilieux_MISCELLANEOUS, Retrospective Studies, medicine.diagnostic_test, business.industry, Arterial Embolization, Mortality rate, Interventional radiology, General Medicine, Enbucrilate, Embolization, Therapeutic, 3. Good health, Surgery, Treatment Outcome, Cyanoacrylate, 030220 oncology & carcinogenesis, Hemostasis, Radiology, business
Abstract: To compare our experience with N-butyl cyanoacrylate glue as the primary embolic agent versus other embolic agents for transcatheter arterial embolization (TAE) in refractory peptic ulcer bleeding and to identify factors associated with early rebleeding and 30-day mortality. Retrospective study of 148 consecutive patients comparing the clinical success rate in 78 patients managed with Glubran®2 N-butyl cyanoacrylate metacryloxysulfolane (NBCA-MS) alone or with other agents and 70 with other embolic agents only (coils, microspheres, ethylene-vinyl alcohol copolymer, or gelatin sponge) at a university center in 2008–2019. Univariate and multivariate logistic regression analyses were done to identify prognostic factors. The technical success rate was 95.3% and the primary clinical success was 64.5%. The early rebleeding and day-30 mortality rates were 35.4% and 21.3%, respectively. Rebleeding was significantly less common with than without Glubran®2 (OR, 0.47; 95% CI, 0.22–0.99; p = .047) and significantly more common with coils used alone (OR, 20.4; 95% CI, 10.13–50.14; p = .024). The only other factor independently associated with early rebleeding was having two or more comorbidities (OR, 20.14; 95% CI, 10.01–40.52; p = .047). Day-30 mortality was similar in the two treatment groups. A lower initial hemoglobin level was significantly associated with higher day-30 mortality (OR, 10.38; 95% CI, 10.10–10.74; p = .006). Fluoroscopy time was significantly shorter with Glubran®2 (20.8 ± 11.5 min vs. 35.5 ± 23.4 min, p = .002). Both groups (Glubran®2 vs. other agents) had similar rates of overall complications (10.7% vs. 9.1%, respectively, p = .786). Glubran®2 NBCA-MS as the primary agent allowed for faster and better clinical success compared to other embolic agents when used for TAE to safely stop refractory peptic ulcer bleeding. • Choice of embolic agent for arterial embolization of refractory peptic ulcer bleeding is still debated. We compared our experience with N-butyl cyanoacrylate (NBCA) glue vs. other embolic agents. • The use of Glubran®2 NBCA glue in the endovascular management of refractory peptic ulcer bleeding was significantly faster and more effective, and at least as safe compared to other embolic agents. • NBCA glue offers several advantages compared to other embolic agents and provides rapid hemostasis when used for arterial embolization to treat refractory peptic ulcer bleeding. It should be the first-line therapy.
Published: 2020

48. Perceptions of beneficiaries and health professionals regarding a conditional cash transfer program to improve pregnancy follow-up: a qualitative analysis of the NAITRE randomized controlled study

Author: AURELIE GODARD MARCEAU, Nicolas Meunier-Beillard, Philippe Deruelle, Mathieu Morin, Claude Virtos, Astrid Echman-Lacroix, Elodie Debras, Laurent Laforet, and Marc Bardou
Abstract: Background: Economic incentives have been used in several countries to improve pregnancy follow-up, to encourage families to bring their infants to see a doctor, and to promote school attendance. However, these conditional cash transfer programs (CCTs) are often subject to criticism. The NAITRE study, which is currently underway in France, assesses the use of CCT to promote prenatal care in women with low socioeconomic backgrounds and has also been the focus of such criticism. The objective of the qualitative study was to analyse how the CCT is perceived by the women and health professionals involved in the project. These data are essential for in-depth understanding of the elements that could encourage or deter a generalization of the process. Methods: A multicentre, cross-sectional, qualitative study was conducted among 26 women included in the NAITRE trial and 8 health professionals (physicians and midwives). All data were collected through semi-structured individual interviews and transcribed in their entirety. A thematic content analysis was then used to generate the results. Results: In the interviews, the women expressed surprise regarding the offer of a cash incentive. However, they did not perceive the CCT negatively, but saw it rather as a significant source of aid for women with limited financial resources. Some even expressed feeling as though they were supported far beyond the financial support. The health professionals were much less positive. Still, though they all stressed the ethical considerations related to the premise of the trial, they recognized the need for such an evaluation. Conclusions: In a country where access to health care is facilitated by a nationalized health insurance system, the use of a CCT to improve medical follow-up during pregnancy raises ethical questions for the health professionals involved. However, an analysis of the interviews conducted with the women who received compensation showed that they did not feel stigmatized. While the women generally reported that the CCT money allowed them to better prepare for the birth, none indicated that they changed their behaviour relative to medical follow-up during the pregnancy.
Published: 2020

49. Bleeding, Upper Gastrointestinal; Clinical Management

Author: Nicolas Chapelle and Marc Bardou
Published: 2020

50. Compassionate use of everolimus for refractory epilepsy in a patient with MTOR mosaic mutation

Author: Christel Thauvin-Robinet, Véronique Darmency, Jean-Baptiste Rivière, Arthur Sorlin, Pierre Vabres, Marc Bardou, Frédéric Huet, Nawale Hadouiri, Alexis Arzimanoglou, Laurent Guibaud, Maxime Luu, Laurence Faivre, Virginie Carmignac, CCSD, Accord Elsevier, Centre de génétique - Centre de référence des maladies rares, anomalies du développement et syndromes malformatifs (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Hôpital d'Enfants [CHU Dijon], Hôpital du Bocage, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Equipe GAD (LNC - U1231), Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, FHU TRANSLAD (CHU de Dijon), Centre d'Investigation Clinique 1432 (Dijon) - Module Plurithématique : Périnatalité Cancérologie Handicap et Ophtalmologie (CIC-P803), Université de Bourgogne (UB)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), and CHU Dijon
Subjects: 0301 basic medicine, Oncology, Compassionate Use Trials, medicine.medical_specialty, [SDV]Life Sciences [q-bio], 030105 genetics & heredity, Muscle hypertrophy, Craniofacial Abnormalities, 03 medical and health sciences, Internal medicine, Genetics, medicine, Humans, Everolimus, Child, Mechanistic target of rapamycin, Protein Kinase Inhibitors, Genetics (clinical), PI3K/AKT/mTOR pathway, Hypopigmentation, biology, business.industry, Mosaicism, TOR Serine-Threonine Kinases, Neuropsychology, General Medicine, Cortical dysplasia, medicine.disease, 3. Good health, Clinical trial, Malformations of Cortical Development, [SDV] Life Sciences [q-bio], 030104 developmental biology, Phenotype, Gain of Function Mutation, biology.protein, Female, Epilepsies, Partial, medicine.symptom, business, medicine.drug
Abstract: The MTOR gene encodes the mechanistic target of rapamycin (mTOR), which is a core component of the PI3K-AKT-mTOR signaling pathway. Postzygotic MTOR variants result in various mosaic phenotypes, referred to in OMIM as Smith-Kinsgmore syndrome or focal cortical dysplasia. We report here the case of a patient, with an MTOR mosaic gain-of-function variant (p.Glu2419Lys) in the DNA of 41% skin cells, who received compassionate off-label treatment with everolimus for refractory epilepsy. This 12-year-old-girl presented with psychomotor regression, intractable seizures, hypopigmentation along Blaschko's lines (hypomelanosis of Ito), asymmetric regional body overgrowth, and ocular anomalies, as well as left cerebral hemispheric hypertrophy with some focal underlying migration disorders. In response to the patient's increasingly frequent epileptic seizures, everolimus was initiated (after approval from the hospital ethics committee) at 5 mg/day and progressively increased to 12.5 mg/day. After 5 months of close monitoring (including neuropsychological and electroencephalographic assessment), no decrease in seizure frequency was observed. Though the physiopathological rationale was good, no significant clinical response was noticed under everolimus treatment. A clinical trial would be needed to draw conclusions, but, because the phenotype is extremely rare, it would certainly need to be conducted on an international scale.
Published: 2020

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