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4. Heterogeneity of outcome measures in depression trials and the relevance of the content of outcome measures to patients: a systematic review

Author

Veal, Christopher, primary, Tomlinson, Anneka, additional, Cipriani, Andrea, additional, Bulteau, Samuel, additional, Henry, Chantal, additional, Müh, Chlöé, additional, Touboul, Suzanne, additional, De Waal, Nikki, additional, Levy-Soussan, Hana, additional, Furukawa, Toshi A, additional, Fried, Eiko I, additional, Tran, Viet-Thi, additional, and Chevance, Astrid, additional

Published
2024
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5. Research response to coronavirus disease 2019 needed better coordination and collaboration: a living mapping of registered trials

Author

Alawadhi, Solaf, Amer-Yahia, Sihem, Ávila, Camila, Bafeta, Aïda, Baudry, Julia, Bollig, Claudia, Bonnet, Hillary, Boutron, Isabelle, Bouet, Marinette, Cabanac, Guillaume, Chaimani, Anna, Chavalarias, David, Chen, Yaolong, Chevance, Astrid, Cohen-Boulakia, Sarah, Coquery, Emmanuel, Conil, Francoise, Davidson, Mauricia, De Nale, Laura, Devane, Declan, Diard, Elise, Doreau, Bastien, Evrenoglou, Theodoros, Fabri, Alice, Feron, Gilles, Ferrand, Gabriel, Fezeu, Leopold, Fouet, Mathilde, El Chall, Lina Ghosn, Graña, Carolina, Grasselli, Giacomo, Grolleau, François, Hacid, Mohand-Said, Haddy, Loubna, Hansen, Camilla, Hohlfeld, Ameer, Hróbjartsson, Asbjørn, Julia, Chantal, Mavridis, Dimitris, Meerpohl, Joerg J., Meyer, Brice, Naidoo, Nivantha, Thu, Van Nguyen, Oikonomidi, Theodora, Pienaar, Elizabeth, Quirke, Fiona, Rada, Gabriel, Ravaud, Philippe, Ripoll, Pierre, Riveros, Carolina, Rivière, Philippe, Sauvant, Marie, Schmucker, Christine, Toumani, Farouk, Tovey, David, Vuillemot, Romain, Xia, Jun, Yu, Xuan, Zoletic, Emina, Zweigenbaum, Pierre, Nguyen, Van Thu, and Barnier, Julien

Published
2021
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9. Subsyndromal and syndromal depressive symptoms among older adults with schizophrenia spectrum disorder: Prevalence and associated factors in a multicenter study

Author

Hoertel, Nicolas, Jaffré, Claire, Pascal de Raykeer, Rachel, McMahon, Kibby, Barrière, Sarah, Blumenstock, Yvonne, Portefaix, Christophe, Raucher-Chéné, Delphine, Béra-Potelle, Céline, Cuervo-Lombard, Christine, Chevance, Astrid, Guerin-Langlois, Christophe, Lemogne, Cédric, Airagnes, Guillaume, Peyre, Hugo, Kaladjian, Arthur, and Limosin, Frédéric

Published
2019
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15. Outcome domains that matter to people with chronic musculoskeletal pain, informal caregivers, and healthcare professionals: An international online survey

Author

Johansen, Simon Kristoffer, Møller, Lars B., McCracken, Lance, Chevance, Astrid, Hoegh, Morten, Lee, Rebecca, Kogi, Mette Ø., Djurtoft, Chris, Lyng, Kristian, Kamper, Steven, Goff, Anthony, Joletta Belton, and Prof. Michael Skovdal Rathleff

Subjects
People living with chronic pain, Chronic musculoskeletal pain, Caregivers, Healthcare professionals, Medicine and Health Sciences, Core outcome set, Outcome domain, Qualitative content analysis, Survey
Abstract

We will conduct an online international survey using large-scale qualitative content analyses of open-text answers. This current study aims to provide a comprehensive list of outcome domains that are important to people with chronic musculoskeletal pain, informal caregivers, and healthcare professionals.

Published
2023
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17. Chapitres 10, 11 et 13 de l'ouvrage 'Être étudiant avant et pendant la crise sanitaire'

Author

Facon-Barillot, Quentin, Morvan, Yannick, Chevance, Astrid, Vansimaeys, Camille, Romo, Lucia, and Frajerman, Ariel

Abstract

Vous trouverez tous les éléments décrits dans les trois chapitres de l'ouvrage "Être étudiant avant et pendant la crise sanitaire" de la Documentation Française dans ce répertoire, ainsi que le code R utilisée pour les générer. Vous pouvez retrouver l'ouvrage sur : https://www.vie-publique.fr/catalogue/288355-etre-etudiant-avant-et-pendant-la-crise-sanitaire

Published
2023
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18. How to select patient-important outcome for trials : a protocol for a systematic review of methods to elicit individual preferences and aggregating them into a collective preference

Author

Ribeiro Alexandre, Macé Antonin, Lang Jerome, Viappiani Paolo, Laslier Jean-François, Tran Viet-Thi, and Chevance Astrid

Subjects
collective preference, health preference research, individual preference, randomized controlled trials, core outcome set, outcomes, aggregation methods, patient preference
Abstract

A protocol for a systematic review

Published
2023
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23. How to measure mental pain? A systematic review to identify all measurement instruments of mental pain and a comparison of their measurement properties

Author

Charvet Camille, Boutron Isabelle, Morvan Yannick, Le Berre Catherine, Gaillard Raphaël, Chevance Astrid, and Fried Eiko

Subjects
systematic review, psychometric, mental pain, psychology, mental health, psychiatry, suicide
Abstract

This is the protocolof a systematic review to identify all measurement instruments of mental pain and a compare their measurement properties

Published
2021
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24. Research response to coronavirus disease 2019 needed better coordination and collaboration: a living mapping of registered trials

Author

Nguyen, Van Thu, Rivière, Philippe, Ripoll, Pierre, Barnier, Julien, Vuillemot, Romain, Ferrand, Gabriel, Cohen-Boulakia, Sarah, Ravaud, Philippe, Boutron, Isabelle, Alawadhi, Solaf, Amer-Yahia, Sihem, Ávila, Camila, Bafeta, Aïda, Baudry, Julia, Bollig, Claudia, Bonnet, Hillary, Bouet, Marinette, Cabanac, Guillaume, Chaimani, Anna, Chavalarias, David, Chen, Yaolong, Chevance, Astrid, Coquery, Emmanuel, Conil, Francoise, Davidson, Mauricia, De Nale, Laura, Devane, Declan, Diard, Elise, Doreau, Bastien, Evrenoglou, Theodoros, Fabri, Alice, Feron, Gilles, Fezeu, Leopold, Fouet, Mathilde, El Chall, Lina Ghosn, Graña, Carolina, Grasselli, Giacomo, Grolleau, François, Hacid, Mohand-Said, Haddy, Loubna, Hansen, Camilla, Hohlfeld, Ameer, Hróbjartsson, Asbjørn, Julia, Chantal, Mavridis, Dimitris, Meerpohl, Joerg J., Meyer, Brice, Naidoo, Nivantha, Thu, Van Nguyen, Oikonomidi, Theodora, Pienaar, Elizabeth, Quirke, Fiona, Rada, Gabriel, Riveros, Carolina, Sauvant, Marie, Schmucker, Christine, Toumani, Farouk, Tovey, David, Xia, Jun, Yu, Xuan, Zoletic, Emina, and Zweigenbaum, Pierre

Subjects
Epidemiology
Abstract

Objectives: Researchers worldwide are actively engaging in research activities to search for preventive and therapeutic interventions against coronavirus disease 2019 (COVID-19). Our aim was to describe the planning of randomized controlled trials (RCTs) in terms of timing related to the course of the COVID-19 epidemic and research question evaluated. Study Design and Setting: We performed a living mapping of RCTs registered in the WHO International Clinical Trials Registry Platform. We systematically search the platform every week for all RCTs evaluating preventive interventions and treatments for COVID-19 and created a publicly available interactive mapping tool at https://covid-nma.com to visualize all trials registered. Results: By August 12, 2020, 1,568 trials for COVID-19 were registered worldwide. Overall, the median ([Q1–Q3]; range) delay between the first case recorded in each country and the first RCT registered was 47 days ([33–67]; 15–163). For the 9 countries with the highest number of trials registered, most trials were registered after the peak of the epidemic (from 100% trials in Italy to 38% in the United States). Most trials evaluated treatments (1,333 trials; 85%); only 223 (14%) evaluated preventive strategies and 12 postacute period intervention. A total of 254 trials were planned to assess different regimens of hydroxychloroquine with an expected sample size of 110,883 patients. Conclusion: This living mapping analysis showed that COVID-19 trials have relatively small sample size with certain redundancy in research questions. Most trials were registered when the first peak of the pandemic has passed.

Published
2021
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29. Impact des facteurs de risque psychosociaux liés au travail sur la santé mentale : étude transversale sur la population active française

Author

Daouda, Oumou S., Chevance, Astrid, Saporta, Gilbert, Gaillard, Raphaël, Hocine, Mounia, Laboratoire Modélisation, épidémiologie et surveillance des risques sanitaires (MESuRS), 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), Equipe 5 : METHODS - Méthodes de l’évaluation thérapeutique des maladies chroniques (CRESS - U1153), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CEDRIC. Méthodes statistiques de data-mining et apprentissage (CEDRIC - MSDMA), Centre d'études et de recherche en informatique et communications (CEDRIC), Ecole Nationale Supérieure d'Informatique pour l'Industrie et l'Entreprise (ENSIIE)-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)-Ecole Nationale Supérieure d'Informatique pour l'Industrie et l'Entreprise (ENSIIE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), Centre Hospitalier Sainte Anne [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hocine, Mounia N., and Ecole Nationale Supérieure d'Informatique pour l'Industrie et l'Entreprise (ENSIIE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Ecole Nationale Supérieure d'Informatique pour l'Industrie et l'Entreprise (ENSIIE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)

Subjects
santé mentale, régression logistique, [STAT.ME] Statistics [stat]/Methodology [stat.ME], [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, facteurs de risques psychosociaux, employés français, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, [STAT.ME]Statistics [stat]/Methodology [stat.ME]
Abstract

International audience; Introduction Au cours des dernières décennies, le monde du travail a connu de profond changement (organisation du travail, charge de travail. La précarisation croissante des emplois ou encore l’augmentation actuelle des pressions au travail ne sont pas sans conséquences sur l’aggravation des problèmes de santé mentale au travail. Ces troubles mentaux peuvent être la source d'une productivité limitée, des congés maladie souvent longs et multiples, des retraites anticipées, de dépression ou même de suicides. Cependant, les facteurs de risques psychosociaux (FRPS) liés aux troubles mentaux sont mal connus chez les employés. Comprendre les facteurs qui contribuent à une altération de la santé mentale peut aider à élaborer des stratégies de prévention et d’intervention efficaces afin de lutter contre ces troubles sur le lieu de travail. L’objectif de cette étude est d’identifier les facteurs environnementaux et organisationnels ayant un impact sur la santé mentale des employés.Méthodes Le présent travail est basé sur une étude transversale réalisée en mars 2018 sur un échantillon de 3200 actifs représentatifs de la population active française. Le niveau de santé mentale est mesuré avec le questionnaire GHQ-28. Quarante-quatre FRPS liés à l'environnement et à l'organisation du lieu de travail ont été documentés. Cinquante facteurs individuels liés aux caractéristiques sociodémographiques, à l'hygiène de vie et aux conditions médicales ont également été recueillies. Une régression logistique sur les 44 FRPS a été effectué afin d'identifier ceux ayant un impact important sur la santé mentale. La régression est ajustée sur le sexe, l'âge, la durée du travail par semaine, le travail en week-end, le travail de nuit, le travail en heures décalées, la durée du trajet professionnel, les antécédents de chômage et de maladies chroniques. Résultats L’échantillon de l’étude est constitué de 49% de femmes, avec un âge moyen de 41,4 ans (écart-type de 11.1 ans). En se basant sur la littérature et sur la distribution du score GHQ-28 de l'échantillon, nous avons choisi un seuil de 24 pour identifier les cas psychiatriques potentiels. Plus d’une personne active sur cinq (22.2%, Intervalle de Confiance [IC95%] 20.6-24.0) souffre de détresse conduisant à un trouble mental au moment de l'étude. Les résultats ont montré la difficulté de concilier vie privée et vie professionnelle comme étant le facteur le plus associé aux troubles mentaux (OR = 1.97, IC95% 1.52-2.54, Exposition [E] 15%). Ensuite, le manque de support entre collègues (OR = 1.63, IC95% 1.29-2.06, E = 28%) et les exigences émotionnelles au travail (OR = 1.43, IC95% 1.13-1.79, E = 42%) sont également associés à une mauvaise santé mentale. Être effrayé dans l'exercice de son travail, craindre pour son avenir professionnel, ne pas être satisfait de la communication et des échanges au travail et faire un travail nécessitant de longues périodes de concentration intenses sont aussi des facteurs associés aux troubles mentaux. Conclusion Cette étude propose un premier regard sur les troubles de santé mentale des salariés français et confirme l'urgence de s’emparer de la question de la santé mentale sur le lieu de travail. Étant donné que corrélation n'implique pas causalité, une analyse de causalité devrait également être effectuée afin de déterminer les facteurs sur lesquels agir en priorité pour d'améliorer la santé mentale des employés.

Published
2019

30. Validation d'un outil de classification de la recherche à destination des internes de médecine générale d'aprés la loi 'Jardé'

Author

Jouannin, Adeline, Andres, Emilie, de Fallois, Manon, Chevance, Astrid, Donnadieu, Stephane, Reymann, Jean-Michel, Pelé, Fabienne, Apel, Katharina, Pinot, Juliette, Brutus, Laurent, Mamzer-Bruneel, Marie-France, 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)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Université d'Angers (UA), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-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)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Université de Rennes (UR), Université de Nantes (UN), École pratique des hautes études (EPHE), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UNIV-RENNES), and École pratique des hautes études (EPHE)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)

Subjects
primary health care, general practice, biomedical research, [SDV]Life Sciences [q-bio], theses, law, ethics
Abstract

National audience; Objectif. Valider un outil de classification des protocoles de recherche en deux catégories : recherche impliquant la personne humaine (RIPH) ou non (non-RIPH) d’après la réglementation en vigueur depuis avril 2018, pour les thèses des internes de médecine générale (IMG). Distinguer parmi les non-RIPH celles qui relèvent de l’avis d’un comité d’éthique.Méthode. Classement indépendant des fiches de thèses par deux IMG à l’aide de l’arbre décisionnel construit à partir des textes réglementaires. Le classement était comparé au classement d’experts. Les classements divergents étaient débattus entre experts lors de réunions de délibération avec un objectif de consensus. À chaque optimisation de l’arbre décisionnel, le classement des fiches de thèses était intégralement repris par les deux IMG. En parallèle, les non-RIPH qui nécessitaient l’avis d’un comité d’éthique de la recherche hors CPP étaient identifiées.Résultats. 254 fiches de thèses ont été classées. La classification des experts retrouvait une prévalence de RIPH à 9 %. Le doute persistait pour deux fiches, deux autres étaient inclassables. Les réunions de délibération ont permis deux modifications de l’arbre décisionnel. La classification finale des IMG retrouvait une prévalence de RIPH à 11 %.Les indices informationnels de l’outil final retrouvaient une sensibilité à 1, une spécificité à 0,98, une VPP à 0,82, une VPN à 1. La moitié des fiches non-RIPH, bien que ne relevant pas d’un CPP, soulevaient des problématiques éthiques au regard des textes fondateurs internationaux nécessitant l’aval d’un comité d’éthique en vue d’une publication.Conclusion. Il n’existait pas d’outil validé pour classer les projets de recherche comme relevant ou non de la loi Jardé. L’arbre décisionnel proposé présente une validité intrinsèque satisfaisante. Bien que 91 % des projets soient classés non-RIPH, la moitié relevait de l’avis du comité d’éthique au regard des principes internationaux de l’éthiquede la recherche.

Published
2019

33. Side effect profile and comparative tolerability of 21 antidepressants in the acute treatment of major depression in adults: protocol for a network meta-analysis

Author

Tomlinson, Anneka, primary, Efthimiou, Orestis, additional, Boaden, Katharine, additional, New, Emma, additional, Mather, Sarah, additional, Salanti, Georgia, additional, Imai, Hissei, additional, Ogawa, Yusuke, additional, Tajika, Aran, additional, Kishimoto, Sanae, additional, Kikuchi, Sino, additional, Chevance, Astrid, additional, Furukawa, Toshi A, additional, and Cipriani, Andrea, additional

Published
2019
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36. Latent class analysis of the feared situations of social anxiety disorder: A population-based study.

Author

Peyre, Hugo, Hoertel, Nicolas, Rivollier, Fabrice, Landman, Benjamin, McMahon, Kibby, Chevance, Astrid, Lemogne, Cédric, Delorme, Richard, Blanco, Carlos, and Limosin, Frédéric

Subjects
DISEASE prevalence, MENTAL illness, SOCIAL anxiety, PATIENTS, DIAGNOSIS, THERAPEUTICS, PSYCHIATRIC epidemiology, MENTAL health, QUALITY of life, ANXIETY, FEAR, COMORBIDITY, SOCIOECONOMIC factors
Abstract

Background: Little is known about differences in mental health comorbidity and quality of life in individuals with social anxiety disorder (SAD) according to the number and the types of feared situations.Methods: Using a US nationally representative sample, the National Epidemiologic Survey on Alcohol and Related Conditions, we performed latent class analysis to compare the prevalence rates of mental disorders and quality of life measures across classes defined by the number and the types of feared social situations among individuals with SAD.Results: Among the 2,448 participants with a lifetime diagnosis of SAD, we identified three classes of individuals who feared most social situations but differed in the number of feared social situations (generalized severe [N = 378], generalized moderate [N = 1,049] and generalized low [N = 443]) and a class of subjects who feared only performance situations [N = 578]. The magnitude of associations between each class and a wide range of mental disorders and quality of life measures were consistent with a continuum model, supporting that the deleterious effects of SAD on mental health may increase with the number of social situations feared. However, we found that individuals with the "performance only" specifier may constitute an exception to this model because these participants had significantly better mental health than other participants with SAD.Conclusions: Our findings give additional support to the recent changes made in the DSM-5, including the introduction of the "performance only" specifier and the removal of the "generalized" specifier to promote the dimensional approach of the number of social fears. [ABSTRACT FROM AUTHOR]

Published
2016
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37. Research response to coronavirus disease 2019 needed better coordination and collaboration: a living mapping of registered trials

Author

Nguyen, Van Thu, Rivière, Philippe, Ripoll, Pierre, Barnier, Julien, Vuillemot, Romain, Ferrand, Gabriel, Cohen-Boulakia, Sarah, Ravaud, Philippe, Boutron, Isabelle, Alawadhi, Solaf, Amer-Yahia, Sihem, Ávila, Camila, Bafeta, Aïda, Baudry, Julia, Bollig, Claudia, Bonnet, Hillary, Bouet, Marinette, Cabanac, Guillaume, Chaimani, Anna, Chavalarias, David, Chen, Yaolong, Chevance, Astrid, Coquery, Emmanuel, Conil, Francoise, Davidson, Mauricia, De Nale, Laura, Devane, Declan, Diard, Elise, Doreau, Bastien, Evrenoglou, Theodoros, Fabri, Alice, Feron, Gilles, Fezeu, Leopold, Fouet, Mathilde, El Chall, Lina Ghosn, Graña, Carolina, Grasselli, Giacomo, Grolleau, François, Hacid, Mohand-Said, Haddy, Loubna, Hansen, Camilla, Hohlfeld, Ameer, Hróbjartsson, Asbjørn, Julia, Chantal, Mavridis, Dimitris, Meerpohl, Joerg J., Meyer, Brice, Naidoo, Nivantha, Thu, Van Nguyen, Oikonomidi, Theodora, Pienaar, Elizabeth, Quirke, Fiona, Rada, Gabriel, Riveros, Carolina, Sauvant, Marie, Schmucker, Christine, Toumani, Farouk, Tovey, David, Xia, Jun, Yu, Xuan, Zoletic, Emina, Zweigenbaum, Pierre, Nguyen, Van Thu, Rivière, Philippe, Ripoll, Pierre, Barnier, Julien, Vuillemot, Romain, Ferrand, Gabriel, Cohen-Boulakia, Sarah, Ravaud, Philippe, Boutron, Isabelle, Alawadhi, Solaf, Amer-Yahia, Sihem, Ávila, Camila, Bafeta, Aïda, Baudry, Julia, Bollig, Claudia, Bonnet, Hillary, Bouet, Marinette, Cabanac, Guillaume, Chaimani, Anna, Chavalarias, David, Chen, Yaolong, Chevance, Astrid, Coquery, Emmanuel, Conil, Francoise, Davidson, Mauricia, De Nale, Laura, Devane, Declan, Diard, Elise, Doreau, Bastien, Evrenoglou, Theodoros, Fabri, Alice, Feron, Gilles, Fezeu, Leopold, Fouet, Mathilde, El Chall, Lina Ghosn, Graña, Carolina, Grasselli, Giacomo, Grolleau, François, Hacid, Mohand-Said, Haddy, Loubna, Hansen, Camilla, Hohlfeld, Ameer, Hróbjartsson, Asbjørn, Julia, Chantal, Mavridis, Dimitris, Meerpohl, Joerg J., Meyer, Brice, Naidoo, Nivantha, Thu, Van Nguyen, Oikonomidi, Theodora, Pienaar, Elizabeth, Quirke, Fiona, Rada, Gabriel, Riveros, Carolina, Sauvant, Marie, Schmucker, Christine, Toumani, Farouk, Tovey, David, Xia, Jun, Yu, Xuan, Zoletic, Emina, and Zweigenbaum, Pierre

Abstract

Objectives: Researchers worldwide are actively engaging in research activities to search for preventive and therapeutic interventions against coronavirus disease 2019 (COVID-19). Our aim was to describe the planning of randomized controlled trials (RCTs) in terms of timing related to the course of the COVID-19 epidemic and research question evaluated. Study Design and Setting: We performed a living mapping of RCTs registered in the WHO International Clinical Trials Registry Platform. We systematically search the platform every week for all RCTs evaluating preventive interventions and treatments for COVID-19 and created a publicly available interactive mapping tool at https://covid-nma.com to visualize all trials registered. Results: By August 12, 2020, 1,568 trials for COVID-19 were registered worldwide. Overall, the median ([Q1–Q3]; range) delay between the first case recorded in each country and the first RCT registered was 47 days ([33–67]; 15–163). For the 9 countries with the highest number of trials registered, most trials were registered after the peak of the epidemic (from 100% trials in Italy to 38% in the United States). Most trials evaluated treatments (1,333 trials; 85%); only 223 (14%) evaluated preventive strategies and 12 postacute period intervention. A total of 254 trials were planned to assess different regimens of hydroxychloroquine with an expected sample size of 110,883 patients. Conclusion: This living mapping analysis showed that COVID-19 trials have relatively small sample size with certain redundancy in research questions. Most trials were registered when the first peak of the pandemic has passed.

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38. Research response to coronavirus disease 2019 needed better coordination and collaboration: a living mapping of registered trials

Author

Nguyen, Van Thu, Rivière, Philippe, Ripoll, Pierre, Barnier, Julien, Vuillemot, Romain, Ferrand, Gabriel, Cohen-Boulakia, Sarah, Ravaud, Philippe, Boutron, Isabelle, Alawadhi, Solaf, Amer-Yahia, Sihem, Ávila, Camila, Bafeta, Aïda, Baudry, Julia, Bollig, Claudia, Bonnet, Hillary, Bouet, Marinette, Cabanac, Guillaume, Chaimani, Anna, Chavalarias, David, Chen, Yaolong, Chevance, Astrid, Coquery, Emmanuel, Conil, Francoise, Davidson, Mauricia, De Nale, Laura, Devane, Declan, Diard, Elise, Doreau, Bastien, Evrenoglou, Theodoros, Fabri, Alice, Feron, Gilles, Fezeu, Leopold, Fouet, Mathilde, El Chall, Lina Ghosn, Graña, Carolina, Grasselli, Giacomo, Grolleau, François, Hacid, Mohand-Said, Haddy, Loubna, Hansen, Camilla, Hohlfeld, Ameer, Hróbjartsson, Asbjørn, Julia, Chantal, Mavridis, Dimitris, Meerpohl, Joerg J., Meyer, Brice, Naidoo, Nivantha, Thu, Van Nguyen, Oikonomidi, Theodora, Pienaar, Elizabeth, Quirke, Fiona, Rada, Gabriel, Riveros, Carolina, Sauvant, Marie, Schmucker, Christine, Toumani, Farouk, Tovey, David, Xia, Jun, Yu, Xuan, Zoletic, Emina, Zweigenbaum, Pierre, Nguyen, Van Thu, Rivière, Philippe, Ripoll, Pierre, Barnier, Julien, Vuillemot, Romain, Ferrand, Gabriel, Cohen-Boulakia, Sarah, Ravaud, Philippe, Boutron, Isabelle, Alawadhi, Solaf, Amer-Yahia, Sihem, Ávila, Camila, Bafeta, Aïda, Baudry, Julia, Bollig, Claudia, Bonnet, Hillary, Bouet, Marinette, Cabanac, Guillaume, Chaimani, Anna, Chavalarias, David, Chen, Yaolong, Chevance, Astrid, Coquery, Emmanuel, Conil, Francoise, Davidson, Mauricia, De Nale, Laura, Devane, Declan, Diard, Elise, Doreau, Bastien, Evrenoglou, Theodoros, Fabri, Alice, Feron, Gilles, Fezeu, Leopold, Fouet, Mathilde, El Chall, Lina Ghosn, Graña, Carolina, Grasselli, Giacomo, Grolleau, François, Hacid, Mohand-Said, Haddy, Loubna, Hansen, Camilla, Hohlfeld, Ameer, Hróbjartsson, Asbjørn, Julia, Chantal, Mavridis, Dimitris, Meerpohl, Joerg J., Meyer, Brice, Naidoo, Nivantha, Thu, Van Nguyen, Oikonomidi, Theodora, Pienaar, Elizabeth, Quirke, Fiona, Rada, Gabriel, Riveros, Carolina, Sauvant, Marie, Schmucker, Christine, Toumani, Farouk, Tovey, David, Xia, Jun, Yu, Xuan, Zoletic, Emina, and Zweigenbaum, Pierre

Abstract

Objectives: Researchers worldwide are actively engaging in research activities to search for preventive and therapeutic interventions against coronavirus disease 2019 (COVID-19). Our aim was to describe the planning of randomized controlled trials (RCTs) in terms of timing related to the course of the COVID-19 epidemic and research question evaluated. Study Design and Setting: We performed a living mapping of RCTs registered in the WHO International Clinical Trials Registry Platform. We systematically search the platform every week for all RCTs evaluating preventive interventions and treatments for COVID-19 and created a publicly available interactive mapping tool at https://covid-nma.com to visualize all trials registered. Results: By August 12, 2020, 1,568 trials for COVID-19 were registered worldwide. Overall, the median ([Q1–Q3]; range) delay between the first case recorded in each country and the first RCT registered was 47 days ([33–67]; 15–163). For the 9 countries with the highest number of trials registered, most trials were registered after the peak of the epidemic (from 100% trials in Italy to 38% in the United States). Most trials evaluated treatments (1,333 trials; 85%); only 223 (14%) evaluated preventive strategies and 12 postacute period intervention. A total of 254 trials were planned to assess different regimens of hydroxychloroquine with an expected sample size of 110,883 patients. Conclusion: This living mapping analysis showed that COVID-19 trials have relatively small sample size with certain redundancy in research questions. Most trials were registered when the first peak of the pandemic has passed.

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39. Research response to coronavirus disease 2019 needed better coordination and collaboration: a living mapping of registered trials

Author

Nguyen, Van Thu, Rivière, Philippe, Ripoll, Pierre, Barnier, Julien, Vuillemot, Romain, Ferrand, Gabriel, Cohen-Boulakia, Sarah, Ravaud, Philippe, Boutron, Isabelle, Alawadhi, Solaf, Amer-Yahia, Sihem, Ávila, Camila, Bafeta, Aïda, Baudry, Julia, Bollig, Claudia, Bonnet, Hillary, Bouet, Marinette, Cabanac, Guillaume, Chaimani, Anna, Chavalarias, David, Chen, Yaolong, Chevance, Astrid, Coquery, Emmanuel, Conil, Francoise, Davidson, Mauricia, De Nale, Laura, Devane, Declan, Diard, Elise, Doreau, Bastien, Evrenoglou, Theodoros, Fabri, Alice, Feron, Gilles, Fezeu, Leopold, Fouet, Mathilde, El Chall, Lina Ghosn, Graña, Carolina, Grasselli, Giacomo, Grolleau, François, Hacid, Mohand-Said, Haddy, Loubna, Hansen, Camilla, Hohlfeld, Ameer, Hróbjartsson, Asbjørn, Julia, Chantal, Mavridis, Dimitris, Meerpohl, Joerg J., Meyer, Brice, Naidoo, Nivantha, Thu, Van Nguyen, Oikonomidi, Theodora, Pienaar, Elizabeth, Quirke, Fiona, Rada, Gabriel, Riveros, Carolina, Sauvant, Marie, Schmucker, Christine, Toumani, Farouk, Tovey, David, Xia, Jun, Yu, Xuan, Zoletic, Emina, Zweigenbaum, Pierre, Nguyen, Van Thu, Rivière, Philippe, Ripoll, Pierre, Barnier, Julien, Vuillemot, Romain, Ferrand, Gabriel, Cohen-Boulakia, Sarah, Ravaud, Philippe, Boutron, Isabelle, Alawadhi, Solaf, Amer-Yahia, Sihem, Ávila, Camila, Bafeta, Aïda, Baudry, Julia, Bollig, Claudia, Bonnet, Hillary, Bouet, Marinette, Cabanac, Guillaume, Chaimani, Anna, Chavalarias, David, Chen, Yaolong, Chevance, Astrid, Coquery, Emmanuel, Conil, Francoise, Davidson, Mauricia, De Nale, Laura, Devane, Declan, Diard, Elise, Doreau, Bastien, Evrenoglou, Theodoros, Fabri, Alice, Feron, Gilles, Fezeu, Leopold, Fouet, Mathilde, El Chall, Lina Ghosn, Graña, Carolina, Grasselli, Giacomo, Grolleau, François, Hacid, Mohand-Said, Haddy, Loubna, Hansen, Camilla, Hohlfeld, Ameer, Hróbjartsson, Asbjørn, Julia, Chantal, Mavridis, Dimitris, Meerpohl, Joerg J., Meyer, Brice, Naidoo, Nivantha, Thu, Van Nguyen, Oikonomidi, Theodora, Pienaar, Elizabeth, Quirke, Fiona, Rada, Gabriel, Riveros, Carolina, Sauvant, Marie, Schmucker, Christine, Toumani, Farouk, Tovey, David, Xia, Jun, Yu, Xuan, Zoletic, Emina, and Zweigenbaum, Pierre

Abstract

Objectives: Researchers worldwide are actively engaging in research activities to search for preventive and therapeutic interventions against coronavirus disease 2019 (COVID-19). Our aim was to describe the planning of randomized controlled trials (RCTs) in terms of timing related to the course of the COVID-19 epidemic and research question evaluated. Study Design and Setting: We performed a living mapping of RCTs registered in the WHO International Clinical Trials Registry Platform. We systematically search the platform every week for all RCTs evaluating preventive interventions and treatments for COVID-19 and created a publicly available interactive mapping tool at https://covid-nma.com to visualize all trials registered. Results: By August 12, 2020, 1,568 trials for COVID-19 were registered worldwide. Overall, the median ([Q1–Q3]; range) delay between the first case recorded in each country and the first RCT registered was 47 days ([33–67]; 15–163). For the 9 countries with the highest number of trials registered, most trials were registered after the peak of the epidemic (from 100% trials in Italy to 38% in the United States). Most trials evaluated treatments (1,333 trials; 85%); only 223 (14%) evaluated preventive strategies and 12 postacute period intervention. A total of 254 trials were planned to assess different regimens of hydroxychloroquine with an expected sample size of 110,883 patients. Conclusion: This living mapping analysis showed that COVID-19 trials have relatively small sample size with certain redundancy in research questions. Most trials were registered when the first peak of the pandemic has passed.

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40. Research response to coronavirus disease 2019 needed better coordination and collaboration: a living mapping of registered trials

Author

Nguyen, Van Thu, Rivière, Philippe, Ripoll, Pierre, Barnier, Julien, Vuillemot, Romain, Ferrand, Gabriel, Cohen-Boulakia, Sarah, Ravaud, Philippe, Boutron, Isabelle, Alawadhi, Solaf, Amer-Yahia, Sihem, Ávila, Camila, Bafeta, Aïda, Baudry, Julia, Bollig, Claudia, Bonnet, Hillary, Bouet, Marinette, Cabanac, Guillaume, Chaimani, Anna, Chavalarias, David, Chen, Yaolong, Chevance, Astrid, Coquery, Emmanuel, Conil, Francoise, Davidson, Mauricia, De Nale, Laura, Devane, Declan, Diard, Elise, Doreau, Bastien, Evrenoglou, Theodoros, Fabri, Alice, Feron, Gilles, Fezeu, Leopold, Fouet, Mathilde, El Chall, Lina Ghosn, Graña, Carolina, Grasselli, Giacomo, Grolleau, François, Hacid, Mohand-Said, Haddy, Loubna, Hansen, Camilla, Hohlfeld, Ameer, Hróbjartsson, Asbjørn, Julia, Chantal, Mavridis, Dimitris, Meerpohl, Joerg J., Meyer, Brice, Naidoo, Nivantha, Thu, Van Nguyen, Oikonomidi, Theodora, Pienaar, Elizabeth, Quirke, Fiona, Rada, Gabriel, Riveros, Carolina, Sauvant, Marie, Schmucker, Christine, Toumani, Farouk, Tovey, David, Xia, Jun, Yu, Xuan, Zoletic, Emina, Zweigenbaum, Pierre, Nguyen, Van Thu, Rivière, Philippe, Ripoll, Pierre, Barnier, Julien, Vuillemot, Romain, Ferrand, Gabriel, Cohen-Boulakia, Sarah, Ravaud, Philippe, Boutron, Isabelle, Alawadhi, Solaf, Amer-Yahia, Sihem, Ávila, Camila, Bafeta, Aïda, Baudry, Julia, Bollig, Claudia, Bonnet, Hillary, Bouet, Marinette, Cabanac, Guillaume, Chaimani, Anna, Chavalarias, David, Chen, Yaolong, Chevance, Astrid, Coquery, Emmanuel, Conil, Francoise, Davidson, Mauricia, De Nale, Laura, Devane, Declan, Diard, Elise, Doreau, Bastien, Evrenoglou, Theodoros, Fabri, Alice, Feron, Gilles, Fezeu, Leopold, Fouet, Mathilde, El Chall, Lina Ghosn, Graña, Carolina, Grasselli, Giacomo, Grolleau, François, Hacid, Mohand-Said, Haddy, Loubna, Hansen, Camilla, Hohlfeld, Ameer, Hróbjartsson, Asbjørn, Julia, Chantal, Mavridis, Dimitris, Meerpohl, Joerg J., Meyer, Brice, Naidoo, Nivantha, Thu, Van Nguyen, Oikonomidi, Theodora, Pienaar, Elizabeth, Quirke, Fiona, Rada, Gabriel, Riveros, Carolina, Sauvant, Marie, Schmucker, Christine, Toumani, Farouk, Tovey, David, Xia, Jun, Yu, Xuan, Zoletic, Emina, and Zweigenbaum, Pierre

Abstract

Objectives: Researchers worldwide are actively engaging in research activities to search for preventive and therapeutic interventions against coronavirus disease 2019 (COVID-19). Our aim was to describe the planning of randomized controlled trials (RCTs) in terms of timing related to the course of the COVID-19 epidemic and research question evaluated. Study Design and Setting: We performed a living mapping of RCTs registered in the WHO International Clinical Trials Registry Platform. We systematically search the platform every week for all RCTs evaluating preventive interventions and treatments for COVID-19 and created a publicly available interactive mapping tool at https://covid-nma.com to visualize all trials registered. Results: By August 12, 2020, 1,568 trials for COVID-19 were registered worldwide. Overall, the median ([Q1–Q3]; range) delay between the first case recorded in each country and the first RCT registered was 47 days ([33–67]; 15–163). For the 9 countries with the highest number of trials registered, most trials were registered after the peak of the epidemic (from 100% trials in Italy to 38% in the United States). Most trials evaluated treatments (1,333 trials; 85%); only 223 (14%) evaluated preventive strategies and 12 postacute period intervention. A total of 254 trials were planned to assess different regimens of hydroxychloroquine with an expected sample size of 110,883 patients. Conclusion: This living mapping analysis showed that COVID-19 trials have relatively small sample size with certain redundancy in research questions. Most trials were registered when the first peak of the pandemic has passed.

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41. Research response to coronavirus disease 2019 needed better coordination and collaboration: a living mapping of registered trials

Author

Nguyen, Van Thu, Rivière, Philippe, Ripoll, Pierre, Barnier, Julien, Vuillemot, Romain, Ferrand, Gabriel, Cohen-Boulakia, Sarah, Ravaud, Philippe, Boutron, Isabelle, Alawadhi, Solaf, Amer-Yahia, Sihem, Ávila, Camila, Bafeta, Aïda, Baudry, Julia, Bollig, Claudia, Bonnet, Hillary, Bouet, Marinette, Cabanac, Guillaume, Chaimani, Anna, Chavalarias, David, Chen, Yaolong, Chevance, Astrid, Coquery, Emmanuel, Conil, Francoise, Davidson, Mauricia, De Nale, Laura, Devane, Declan, Diard, Elise, Doreau, Bastien, Evrenoglou, Theodoros, Fabri, Alice, Feron, Gilles, Fezeu, Leopold, Fouet, Mathilde, El Chall, Lina Ghosn, Graña, Carolina, Grasselli, Giacomo, Grolleau, François, Hacid, Mohand-Said, Haddy, Loubna, Hansen, Camilla, Hohlfeld, Ameer, Hróbjartsson, Asbjørn, Julia, Chantal, Mavridis, Dimitris, Meerpohl, Joerg J., Meyer, Brice, Naidoo, Nivantha, Thu, Van Nguyen, Oikonomidi, Theodora, Pienaar, Elizabeth, Quirke, Fiona, Rada, Gabriel, Riveros, Carolina, Sauvant, Marie, Schmucker, Christine, Toumani, Farouk, Tovey, David, Xia, Jun, Yu, Xuan, Zoletic, Emina, Zweigenbaum, Pierre, Nguyen, Van Thu, Rivière, Philippe, Ripoll, Pierre, Barnier, Julien, Vuillemot, Romain, Ferrand, Gabriel, Cohen-Boulakia, Sarah, Ravaud, Philippe, Boutron, Isabelle, Alawadhi, Solaf, Amer-Yahia, Sihem, Ávila, Camila, Bafeta, Aïda, Baudry, Julia, Bollig, Claudia, Bonnet, Hillary, Bouet, Marinette, Cabanac, Guillaume, Chaimani, Anna, Chavalarias, David, Chen, Yaolong, Chevance, Astrid, Coquery, Emmanuel, Conil, Francoise, Davidson, Mauricia, De Nale, Laura, Devane, Declan, Diard, Elise, Doreau, Bastien, Evrenoglou, Theodoros, Fabri, Alice, Feron, Gilles, Fezeu, Leopold, Fouet, Mathilde, El Chall, Lina Ghosn, Graña, Carolina, Grasselli, Giacomo, Grolleau, François, Hacid, Mohand-Said, Haddy, Loubna, Hansen, Camilla, Hohlfeld, Ameer, Hróbjartsson, Asbjørn, Julia, Chantal, Mavridis, Dimitris, Meerpohl, Joerg J., Meyer, Brice, Naidoo, Nivantha, Thu, Van Nguyen, Oikonomidi, Theodora, Pienaar, Elizabeth, Quirke, Fiona, Rada, Gabriel, Riveros, Carolina, Sauvant, Marie, Schmucker, Christine, Toumani, Farouk, Tovey, David, Xia, Jun, Yu, Xuan, Zoletic, Emina, and Zweigenbaum, Pierre

Abstract

Objectives: Researchers worldwide are actively engaging in research activities to search for preventive and therapeutic interventions against coronavirus disease 2019 (COVID-19). Our aim was to describe the planning of randomized controlled trials (RCTs) in terms of timing related to the course of the COVID-19 epidemic and research question evaluated. Study Design and Setting: We performed a living mapping of RCTs registered in the WHO International Clinical Trials Registry Platform. We systematically search the platform every week for all RCTs evaluating preventive interventions and treatments for COVID-19 and created a publicly available interactive mapping tool at https://covid-nma.com to visualize all trials registered. Results: By August 12, 2020, 1,568 trials for COVID-19 were registered worldwide. Overall, the median ([Q1–Q3]; range) delay between the first case recorded in each country and the first RCT registered was 47 days ([33–67]; 15–163). For the 9 countries with the highest number of trials registered, most trials were registered after the peak of the epidemic (from 100% trials in Italy to 38% in the United States). Most trials evaluated treatments (1,333 trials; 85%); only 223 (14%) evaluated preventive strategies and 12 postacute period intervention. A total of 254 trials were planned to assess different regimens of hydroxychloroquine with an expected sample size of 110,883 patients. Conclusion: This living mapping analysis showed that COVID-19 trials have relatively small sample size with certain redundancy in research questions. Most trials were registered when the first peak of the pandemic has passed.

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42. Important adverse events to be evaluated in antidepressant trials and meta-analyses in depression: a large international preference study including patients and healthcare professionals.

Author

Chevance A, Tomlinson A, Ravaud P, Touboul S, Henshall C, Tran VT, and Cipriani A

Subjects
Adult, Male, Female, Humans, Antidepressive Agents adverse effects, Anxiety, Delivery of Health Care, Depression drug therapy, Depressive Disorder drug therapy
Abstract

Background: Non-serious adverse events (NSAEs) should be captured and reported because they can have a significant negative impact on patients and treatment adherence. However, the reporting of NSAEs in randomised controlled trials (RCTs) is limited., Objective: To identify the most important NSAEs of antidepressants for patients and clinicians, to be evaluated in RCTs and meta-analyses., Methods: We conducted online international surveys in English, German and French, including (1) adults prescribed an antidepressant for a depressive episode and (2) healthcare professionals (HCPs) prescribing antidepressants. Participants ranked the 30 most frequent NSAEs reported in the scientific literature. We fitted logit models for sets of ranked items and calculated for each AE the probability to be ranked higher than the least important AE. We also identified additional patient-important AEs not included in the ranking task via open-ended questions., Findings: We included 1631 patients from 44 different countries (1290 (79.1%) women, mean age 39.4 (SD 13), 289 (37.1%) with severe depression (PHQ-9 score ≥20)) and 281 HCPs (224 (79.7%) psychiatrists). The most important NSAEs for patients were insomnia (95.9%, 95% CI 95.2% to 96.5%), anxiety (95.2%, 95% CI 94.3% to 95.9%) and fatigue (94.6%, 95% CI 93.6% to 95.4%). The most important NSAEs for HCPs were sexual dysfunction (99.2%, 95% CI 98.5% to 99.6%), weight gain (98.9%, 95% CI 97.7% to 99.4%) and erectile problems (98.8%, 95% CI 97.7% to 99.4%). Participants reported 66 additional NSAEs, including emotional numbing (8.6%), trouble with concentration (7.6%) and irritability (6%)., Conclusions: These most important NSAEs should be systematically reported in antidepressant trials., Clinical Implications: The most important NSAEs should contribute to the core outcome set for harms in depression., Competing Interests: Competing interests: ACh, PR, CH, V-TT and ST declare no conflict of interests. ACi received research and consultancy fees from Italian Network for Paediatric Trials (INCiPiT), CARIPLO Foundation and Angelini Pharma outside this work. AT received consultancy fees from INCiPiT and Angelini Pharma outside this work., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Published
2022
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43. How to measure mental pain: a systematic review assessing measures of mental pain.

Author

Charvet C, Boutron I, Morvan Y, Le Berre C, Touboul S, Gaillard R, Fried E, and Chevance A

Subjects
Humans, Psychometrics, Self Report, Pain diagnosis, Mental Disorders diagnosis, Mental Disorders therapy, Suicide
Abstract

Question: Although mental pain is present in many mental disorders and is a predictor of suicide, it is rarely investigated in research or treated in care. A valid tool to measure it is a necessary first step towards better understanding, predicting and ultimately relieving this pain., Study Selection and Analysis: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we performed a systematic review to identify all published standardised measures of mental pain. We used qualitative content analysis to evaluate the similarity of each measure, quantified via Jaccard Index scores ranging from no similarity (0) to full similarity (1). Finally, using the Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, we evaluated each measure's development (assessing 35 features), its content validity (31 features) and if the latter was rated at least adequate, its other psychometric properties., Findings: We identified 10 self-reported scales of mental pain in 2658 screened studies relying on diverse definitions of this construct. The highest average similarity coefficient for any given measure was 0.24, indicative of weak similarity (individual pairwise coefficients from 0 to 0.5). Little to no information was provided regarding the development and the content validity of all 10 scales. Therefore, their development and content validity were rated 'inadequate' or 'doubtful'., Conclusions and Clinical Implications: There is not enough evidence of validity to recommend using one measure over others in research or clinical practice. Heterogeneous use of disparate measures across studies limits comparison and combination of their results in meta-analyses. Development by all stakeholders (especially patients) of a consensual patient-reported measure for mental pain is needed., Prospero Registration Number: CRD42021242679., Competing Interests: Competing interests: CC, IB, CLB, YM, EF, ST and AC report no conflict of interest. RG has received compensation as a member of the scientific advisory board of Janssen, Lundbeck, Roche, SOBI, Takeda. He has served as consultant and/or speaker for AstraZeneca, Boehringer-Ingelheim, Pierre Fabre, Lilly, Lundbeck, LVMH, MAPREG, Novartis, Otsuka, Pileje, SANOFI, Servier and received compensation, and he has received research support from Servier. Co-founder and stock shareholder: Regstem., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2022
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45. Side effect profile and comparative tolerability of 21 antidepressants in the acute treatment of major depression in adults: protocol for a network meta-analysis.

Author

Tomlinson A, Efthimiou O, Boaden K, New E, Mather S, Salanti G, Imai H, Ogawa Y, Tajika A, Kishimoto S, Kikuchi S, Chevance A, Furukawa TA, and Cipriani A

Subjects
Acute Disease, Adult, Clinical Protocols, Humans, Antidepressive Agents adverse effects, Depressive Disorder, Major drug therapy, Drug-Related Side Effects and Adverse Reactions diagnosis, Drug-Related Side Effects and Adverse Reactions epidemiology, Network Meta-Analysis, Randomized Controlled Trials as Topic
Abstract

Introduction: We have recently compared all second-generation as well as selected first-generation antidepressants in terms of efficacy and acceptability in the acute treatment of major depression. Here we present a protocol for a network meta-analysis aimed at extending these results, updating the evidence base and comparing all second-generation as well as selected first-generation antidepressants in terms of specific adverse events and tolerability in the acute treatment of major depression in adults., Methods and Analysis: We will include all double-blind randomised controlled trials comparing one active drug with another or with placebo in the acute treatment major depression in adults. We will compare the following active agents: agomelatine, amitriptyline, bupropion, citalopram, clomipramine, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, nefazodone, paroxetine, reboxetine, sertraline, trazodone, venlafaxine, vilazodone and vortioxetine. The main outcomes will include the total number of patients experiencing specific adverse events; experiencing serious adverse events; and experiencing at least one adverse event. Published and unpublished studies will be retrieved through relevant database searches, trial registries and websites; reference selection and data extraction will be completed by at least two independent reviewers. For each outcome we will undertake a network meta-analysis to synthesise all evidence. We will use local and global methods to evaluate consistency. We will perform all analyses in R. We will assess the quality of evidence contributing to network estimates with the Confidence in Network Meta-Analysis web application., Discussion: This work will provide an in- depth analysis and an insight into the specific adverse events of individual antidepressants., Ethics and Dissemination: This review does not require ethical approval., Prospero Registration Number: CRD42019128141., Competing Interests: Competing interests: SK reports grants from the Mental Health Okamoto Memorial Foundation, Pfizer Health Research Foundation and KDDI Foundation outside the submitted work. IH reports lecture fees from Mitsubishi-Tanabe and Yoshitomi. TAF reports personal fees from Meiji, Mitsubishi-Tanabe, MSD and Pfizer and a grant from Mitsubishi-Tanabe, outside the submitted work; TAF has a pending patent 2018-177688. All other authors report no conflict of interest, (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2019
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