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1. Published registered reports are rare, limited to one journal group, and inadequate for randomized controlled trials in the clinical field

Author: Norah Anthony, Antoine Tisseaux, Florian Naudet, Centre d'Investigation Clinique de La Réunion - INSERM (CIC 1410), Université de La Réunion (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de La Réunion (CHU La Réunion), CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: transparency, Epidemiology, Randomized controlled trials, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, protocol, outcomes switching, registered report, reproducibility
Abstract: ObjectiveRegistered reports relate to a new publication of a peer-review of the protocol before the start of the study, followed by an in-principle acceptance by the journal before the study starts. We aimed to describe randomized controlled trials (RCTs) in the clinical field published as registered reports.Study design and settingThis cross-sectional study (registration:https://osf.io/zf53p/) included registered report results for RCTs, identified on PubMed/Medline and on a list compiled by the Center for Open Science. It explored the proportion of reports that received in-principle acceptance (and/or published a protocol before inclusion of the first patient) and changes in the primary outcome.ResultsA total of 93 RCT publications identified as registered reports were included. All but one were published in the same journal group. The date of the in-principle acceptance was never documented. For most of these reports (79/93, 84.9 %) a protocol was published after the date of inclusion of the first patient. A change in the primary outcome was noted in 40/93 (44%) of these publications. Three out of the 40 (33%) mentioned this change.ConclusionsRandomized controlled trials in the clinical field identified as registered reports were rare, they originated from a single journal group and did not comply with the basic features of this format.Protocol registrationhttps://osf.io/zf53p/What is new ?The registered report format for clinical randomized controlled (RCTs) trials is still marginal and few journals make use of it.The clinical RCTs identified as registered reports were from a single journal group and did not necessarily comply with the basic features of this format, and common biases may thus persist.To improve research trustworthiness, more efforts need to be made by Journal publishers, trial funders, etc. for the implementation of this format for clinical RCTs.
Published: 2023
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2. Marketing pitches of ’magic mushrooms’ and ’psychedelics’ mask that psychotomimetics use exposes those vulnerable to serious adverse effects

Author: Alain Braillon, Florian Naudet, Independent Researcher, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Pharmacology, Psychiatry and Mental health, [SDV]Life Sciences [q-bio], Pharmacology (medical)
Abstract: International audience
Published: 2023
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3. Implementing clinical trial data sharing requires training a new generation of biomedical researchers

Author: Ulrich Mansmann, Clara Locher, Fabian Prasser, Tracey Weissgerber, Ulrich Sax, Martin Posch, Evelyne Decullier, Ioana A. Cristea, Thomas P. A. Debray, Leonhard Held, David Moher, John P. A. Ioannidis, Joseph S. Ross, Christian Ohmann, Florian Naudet, Ludwig-Maximilians-Universität München (LMU), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Medizinische Universität Wien = Medical University of Vienna, Hospices Civils de Lyon (HCL), Università degli Studi di Padova = University of Padua (Unipd), Universiteit Utrecht, Universität Zürich [Zürich] = University of Zurich (UZH), University of Ottawa [Ottawa], Stanford University, Yale School of Medicine [New Haven, Connecticut] (YSM), European Clinical Research Infrastructures Network [Dusseldorf] (ECRIN), Institut Universitaire de France (IUF), Ministère de l'Education nationale, de l’Enseignement supérieur et de la Recherche (M.E.N.E.S.R.), CHU Pontchaillou [Rennes], and Yale University
Subjects: Clinical trials, training, data sharing, [SDV]Life Sciences [q-bio], open science, General Medicine, individual patient data, General Biochemistry, Genetics and Molecular Biology
Abstract: International audience; Data sharing enhances the value of medical research and builds trust in clinical trials, but more biomedical researchers need to be trained in these approaches, which include meta-research, data science and ethical, legal and social issues.
Published: 2023
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4. Ten (not so) simple rules for clinical trial data-sharing

Author: Claude Pellen, Anne Le Louarn, Gilliosa Spurrier-Bernard, Evelyne Decullier, Jean-Marie Chrétien, Eric Rosenthal, Gérard Le Goff, David Moher, John P. A. Ioannidis, Florian Naudet, Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Hospices Civils de Lyon (HCL), Université de Lyon, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Agence Nationale de Recherches sur le Sida et les Hépatites Virales (ANRS), Ottawa Hospital Research Institute [Ottawa] (OHRI), Stanford University, Institut Universitaire de France (IUF), Ministère de l'Education nationale, de l’Enseignement supérieur et de la Recherche (M.E.N.E.S.R.), and Ministry of Higher Education, Research and Innovation
Subjects: Cellular and Molecular Neuroscience, Computational Theory and Mathematics, Ecology, Modeling and Simulation, [SDV]Life Sciences [q-bio], Genetics, Molecular Biology, Ecology, Evolution, Behavior and Systematics
Abstract: Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way. We propose 10 rules for researchers wishing to share their data. These rules cover the majority of elements to be considered in order to start the commendable process of clinical trial data-sharing: Rule 1: Abide by local legal and regulatory data protection requirements Rule 2: Anticipate the possibility of clinical trial data-sharing before obtaining funding Rule 3: Declare your intent to share data in the registration step Rule 4: Involve research participants Rule 5: Determine the method of data access Rule 6: Remember there are several other elements to share Rule 7: Do not proceed alone Rule 8: Deploy optimal data management to ensure that the data shared is useful Rule 9: Minimize risks Rule 10: Strive for excellence.
Published: 2023
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5. rTMS and depression: A correspondence you should take the time to read

Author: Ali Amad, Florian Naudet, Thomas Fovet, Lille Neurosciences & Cognition - U 1172 (LilNCog), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), King‘s College London, Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Institut Universitaire de France (IUF), and Ministère de l'Education nationale, de l’Enseignement supérieur et de la Recherche (M.E.N.E.S.R.)
Subjects: medical literature, Psychiatry and Mental health, Clinical Psychology, dorsolateral prefrontal cortex, Letter, practice guideline, [SDV]Life Sciences [q-bio], depression, functional connectivity, repetitive transcranial magnetic stimulation, human, major depression, writing
Abstract: International audience; [No abstract available]
Published: 2023
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6. Project Rebuild the Evidence Base (REB): a method to interpret randomised clinical trials and their meta-analysis to present solid benefit-risk assessments to patients

Author: Rémy, Boussageon, Clara, Blanchard, Elodie, Charuel, Thibault, Menini, Bruno, Pereira, Florian, Naudet, Behrouz, Kassai, François, Gueyffier, Michel, Cucherat, Hélène, Vaillant-Roussel, Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Collège National des Généralistes Enseignants (CNGE), Université de Poitiers, AutomédiCation aCcompagnement Pluriprofessionnel PatienT (ACCePPT), Université Clermont Auvergne (UCA), Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand, Centre d'Investigation Clinique [Rennes] (CIC), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Evidence-based medicine, Meta-analysis, Patient safety, Communication, Pharmacology (medical), Health-policy, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience; Evidence-based medicine is the cornerstone of shared-decision making in healthcare today. The public deserves clear, transparent and trust-worthy information on drug efficacy. Yet today, many drugs are prescribed and used without solid evidence of efficacy. Clinical trials and randomized clinical trials (RCTs) are the best method to evaluate drug efficacy and side effects. In a shared medical decision-making approach, general practitioners need drug assessment to be based on patient-important outcomes. The aim of project Rebuild the Evidence Base (REB) is to bridge the gap between the data needed in clinical practice and the data available from clinical research. The drugs will be assessed on clinical patient important outcomes and for a population. Using the Cochrane tools, we propose to analyse for each population and outcome : 1) a meta-analysis based on RCTs with a low risk of bias overall ; 2) an evaluate of results of confirmatory RCTs; 3) a statistical analysis of heterrogeneity between RCTs, and 4) an analysis of publication bias. Depending on the results of these analyses, the evidence will be categorised in 4 different levels: firm evidence, evidence (to be confirmed), signal or absence of evidence. Project REB proposes a method for reading and interpreting randomized clinical trials and their meta-analysis to produce quality data for general practitioners to focus on benefit-risk assessment in the interest of patients. If this data does not exist, it could enable clinical research to better its aim.
Published: 2022
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7. A Mirror-Image Trial or Smoke and Mirrors? Phase 3b Study on Digital Aripiprazole

Author: Florian Naudet, André Gillibert, Barbara Mintzes, Alain Braillon, Lisa Cosgrove, Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], CHU Rouen, Normandie Université (NU), The University of Sydney, University of British Columbia (UBC), University of Massachusetts [Boston] (UMass Boston), and University of Massachusetts System (UMASS)
Subjects: Psychiatry and Mental health, [SDV]Life Sciences [q-bio]
Abstract: International audience
Published: 2022
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8. The underutilization of medications for alcohol use disorders is a sensible choice

Author: Alain Braillon, Florian Naudet, CHU Amiens-Picardie, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), None, and Jonchère, Laurent
Subjects: [SDV] Life Sciences [q-bio], Alcoholism, EBM, [SDV]Life Sciences [q-bio], Internal Medicine, Humans, Off-label use, Harm-benefit ratio
Abstract: International audience
Published: 2022
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9. Alcohol-related liver disease treatment and EBM

Author: Alain Braillon, Florian Naudet, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Jonchère, Laurent
Subjects: [SDV] Life Sciences [q-bio], Hepatology, [SDV]Life Sciences [q-bio]
Abstract: International audience
Published: 2022
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10. Data Sharing and Reanalyses Among Randomized Clinical Trials Published in Surgical Journals Before and After Adoption of a Data Availability and Reproducibility Policy

Author: Damien, Bergeat, Nicolas, Lombard, Anis, Gasmi, Bastien, Le Floch, Florian, Naudet, Nutrition, Métabolismes et Cancer (NuMeCan), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Dr Naudet’s work on reproducibility is part of the ReiTheR project (Reproducibility in Therapeutic Research). This project is funded by the French National Research Agency (ANR-17-CE-36-0010-01)., ANR-17-CE36-0010,ReiTheR,Reproductibilité de la recherche thérapeutique(2017), Jonchère, Laurent, and Reproductibilité de la recherche thérapeutique - - ReiTheR2017 - ANR-17-CE36-0010 - AAPG2017 - VALID
Subjects: [SDV] Life Sciences [q-bio], Policy, Information Dissemination, [SDV]Life Sciences [q-bio], Humans, Reproducibility of Results, Periodicals as Topic, Randomized Controlled Trials as Topic
Abstract: International audience; IMPORTANCE: Clinical trial data sharing holds promise for maximizing the value of clinical research. The International Committee of Medical Journal Editors (ICMJE) adopted a policy promoting data sharing in July 2018. OBJECTIVE: To evaluate the association of the ICMJE data sharing policy with data availability and reproducibility of main conclusions among leading surgical journals. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study, conducted in October 2021, examined randomized clinical trials (RCTs) in 10 leading surgical journals before and after the implementation of the ICMJE data sharing policy in July 2018. EXPOSURE: Implementation of the ICMJE data sharing policy. MAIN OUTCOMES AND MEASURES: To demonstrate a pre-post increase in data availability from 5% to 25% (α = .05; β = 0.1), 65 RCTs published before and 65 RCTs published after the policy was issued were included, and their data were requested. The primary outcome was data availability (ie, the receipt of sufficient data to enable reanalysis of the primary outcome). When data sharing was available, the primary outcomes reported in the journal articles were reanalyzed to explore reproducibility. The reproducibility features of these studies were detailed. RESULTS: Data were available for 2 of 65 RCTs (3.1%) published before the ICMJE policy and for 2 of 65 RCTs (3.1%) published after the policy was issued (odds ratio, 1.00; 95% CI, 0.07-14.19; P > .99). A data sharing statement was observed in 11 of 65 RCTs (16.9%) published after the policy vs none before the policy (risk ratio, 2.20; 95% CI, 1.81-2.68; P = .001). Data obtained for reanalysis (n = 4) were not from RCTs published with a data sharing statement. Of the 4 RCTs with available data, all of them had primary outcomes that were fully reproduced. However, discrepancies or inaccuracies that were not associated with study conclusions were identified in 3 RCTs. These concerned the number of patients included in 1 RCT, the management of missing values in another RCT, and discrepant timing for the principal outcome declared in the study registration and reported in the third RCT. CONCLUSIONS AND RELEVANCE: This cross-sectional study suggests that data sharing practices are rare in surgical journals despite the ICMJE policy and that most RCTs published in these journals lack transparency. The results of these studies may not be reproducible by external researchers.
Published: 2022
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11. Antidepressants are not safe during pregnancy and in women of child-bearing age

Author: Alain Braillon, Susan Bewley, Aubrey Blumsohn, Florian Naudet, Jean‐Louis Montastruc, Joel R. Lexchin, Chercheur indépendant, King‘s College London, University of Sheffield [Sheffield], CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), York University [Toronto], Jonchère, Laurent, Centre Hospitalier Universitaire [Rennes], and CHU Toulouse [Toulouse]
Subjects: Pharmacology, drug safety, serotonin reuptake inhibitors, [SDV]Life Sciences [q-bio], Antidepressive Agents, 3. Good health, Pregnancy Complications, [SDV] Life Sciences [q-bio], 03 medical and health sciences, 0302 clinical medicine, Pregnancy, 030225 pediatrics, Humans, Female, Pharmacology (medical), developmental disorders, 030212 general & internal medicine, teratogenicity, Selective Serotonin Reuptake Inhibitors, ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2022
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12. Tolerability of duloxetine in elderly and in non-elderly adults: a protocol of a systematic review and individual participant data meta-analysis of randomized placebo-controlled trials

Author: Jean-Charles, Roy, Chloé, Rousseau, Alexis, Jutel, Florian, Naudet, Gabriel, Robert, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), None, and Jonchère, Laurent
Subjects: Adult, Psychiatry, [SDV]Life Sciences [q-bio], Middle Aged, Duloxetine hydrochloride, Antidepressive Agents, humanities, [SDV] Life Sciences [q-bio], Meta-analysis, Treatment Outcome, Meta-Analysis as Topic, Quality of Life, Humans, Drug safety, Geriatric, Aged, Randomized Controlled Trials as Topic, Systematic Reviews as Topic
Abstract: International audience; BACKGROUND: Duloxetine is an antidepressant that benefits from a wide range of approval in the elderly population, while its safety for use compared to non-elderly is not clearly assessed. This protocol outlines a systematic review and individual participant data meta-analysis comparing the tolerability of duloxetine between elderly and non-elderly. METHODS: Searches will be conducted in PubMed, ClinicalTrials.gov , Clinicaltrialsregister.eu, data sharing platforms, FDA drug approval packages, European public assessment reports and withdrawn applications from the EMA website. The review will be performed on studies available in electronic databases from their date of inception to the 31 March 2022. Only randomized controlled clinical trials, comparing duloxetine to placebo, will be included in this meta-analysis. The studies will be selected if they comprise both elderly and non-elderly adults, in conditions of use of duloxetine approved by the European Medical Agency (EMA) and the Food and Drug Administration (FDA). The primary outcome will be the rate ratio of serious adverse events under duloxetine compared to placebo, between participants at least 65 years old and non-elderly. Second, the number of any adverse events, clinical efficacy and quality of life will be compared between elderly and non-elderly under both interventions. The quality of evidence in the tolerability of duloxetine will be assessed using the GRADE system. A one or two-stage individual participant data random effect meta-analysis will be conducted depending on the availability of the data. DISCUSSION: This meta-analysis will investigate the tolerability safety of duloxetine in the elderly population across all conditions approved by European and American regulatory authorities. The results from this meta-analysis are intended to help prescribers to provide better care for the elderly population. SYSTEMATIC REVIEW REGISTRATION: The protocol has been registered at the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD42019130488 ).
Published: 2022
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13. Medical journal requirements for clinical trial data sharing: Ripe for improvement

Author: Ioana A. Cristea, Ulrich Mansmann, Maximilian Siebert, Christian Ohmann, Jeanne Fabiola Gaba, Claude Pellen, Valentin Danchev, John P. A. Ioannidis, David Moher, Florian Naudet, Joshua D. Wallach, Cathrine Axfors, Centre d'Investigation Clinique [Rennes] (CIC), 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), CHU Pontchaillou [Rennes], Uppsala University, Stanford University, University of Pavia, Ludwig-Maximilians-Universität München (LMU), European Clinical Research Infrastructures Network [Dusseldorf] (ECRIN), Yale School of Public Health (YSPH), Ottawa Hospital Research Institute [Ottawa] (OHRI), FN received funding from the French National Research Agency for the ReiTheR (Reproducibility in Therapeutic Research) project, that this article was part of. Project Number: ANR-17-CE36-0010. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript., ANR-17-CE36-0010,ReiTheR,Reproductibilité de la recherche thérapeutique(2017), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Università degli Studi di Pavia = University of Pavia (UNIPV), Jonchère, Laurent, and Reproductibilité de la recherche thérapeutique - - ReiTheR2017 - ANR-17-CE36-0010 - AAPG2017 - VALID
Subjects: Biomedical Research, Medical Journals, [SDV]Life Sciences [q-bio], Publication Ethics, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Medicine and Health Sciences, 030212 general & internal medicine, Research Integrity, Clinical Trials as Topic, Policy Forum, Public Health, Global Health, Social Medicine and Epidemiology, General Medicine, Research Assessment, Reproducibility, 3. Good health, [SDV] Life Sciences [q-bio], Policy, Publication ethics, Medicine, Science policy, Periodicals as Topic, medicine.medical_specialty, Drug Research and Development, Science Policy, MEDLINE, Research and Analysis Methods, 03 medical and health sciences, Stakeholder Participation, medicine, Humans, Clinical Trials, Medical physics, Medical journal, Scientific Publishing, Pharmacology, Health Care Policy, Information Dissemination, business.industry, Randomized Controlled Trials, Health Care, Clinical trial, Data sharing, Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi, Clinical Medicine, Scientific publishing, business, Medical Humanities, 030217 neurology & neurosurgery
Abstract: Summary points: Efficient sharing and reuse of data from clinical trials are critical in advancing medical knowledge and developing improved treatments. We believe that the International Committee of Medical Journal Editors (ICMJE) clinical trial data sharing policy is currently inadequate. Although data sharing plans help increase transparency, they do not ensure that data are shared, and they are often inadequately implemented. We believe that the ICMJE should adapt a stronger policy on data sharing that is enforced rigorously in all ICMJE members and affiliated journals. The policy should include a strong evaluation component to ensure that all clinical trial data are shared, their value maximized, and data producers incentivized.
Published: 2021
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14. Characteristics of available studies and dissemination of research using major clinical data sharing platforms

Author: Joseph S. Ross, Harlan M. Krumholz, Joshua D. Wallach, Enrique Vazquez, Florian Naudet, Cary P. Gross, Henri Gouraud, Yale-NUS College, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), 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), Yale School of Public Health (YSPH), Yale University School of Medicine, 2020 Yale College Dean's Fellowship, 2020 Grace Hopper Richter Fellowship, National Institute on Alcohol Abuse and Alcoholism of the National Institutes of HealthUnited States Department of Health and Human ServicesNational Institutes of Health (NIH) - USANIH National Institute on Alcohol Abuse and Alcoholism (NIAAA) [K01AA028258], Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Yale School of Medicine [New Haven, Connecticut] (YSM)
Subjects: Pharmacology, transparency, Information Dissemination, business.industry, data sharing, [SDV]Life Sciences [q-bio], Internet privacy, General Medicine, 030204 cardiovascular system & hematology, Transparency (behavior), Research Personnel, Article, 3. Good health, Data sharing, 03 medical and health sciences, 0302 clinical medicine, Documentation, Clinical trials, Humans, 030212 general & internal medicine, Business
Abstract: Background/Aims: Over the past decade, numerous data sharing platforms have been launched, providing access to de-identified individual patient-level data and supporting documentation. We evaluated the characteristics of prominent clinical data sharing platforms, including types of studies listed as available for request, data requests received, and rates of dissemination of research findings from data requests. Methods: We reviewed publicly available information listed on the websites of six prominent clinical data sharing platforms: Biological Specimen and Data Repository Information Coordinating Center, ClinicalStudyDataRequest.com , Project Data Sphere, Supporting Open Access to Researchers–Bristol Myers Squibb, Vivli, and the Yale Open Data Access Project. We recorded key platform characteristics, including listed studies and available supporting documentation, information on the number and status of data requests, and rates of dissemination of research findings from data requests (i.e. publications in a peer-reviewed journals, preprints, conference abstracts, or results reported on the platform’s website). Results: The number of clinical studies listed as available for request varied among five data sharing platforms: Biological Specimen and Data Repository Information Coordinating Center (n = 219), ClinicalStudyDataRequest.com (n = 2,897), Project Data Sphere (n = 154), Vivli (n = 5426), and the Yale Open Data Access Project (n = 395); Supporting Open Access to Researchers did not provide a list of Bristol Myers Squibb studies available for request. Individual patient-level data were nearly always reported as being available for request, as opposed to only Clinical Study Reports (Biological Specimen and Data Repository Information Coordinating Center = 211/219 (96.3%); ClinicalStudyDataRequest.com = 2884/2897 (99.6%); Project Data Sphere = 154/154 (100.0%); and the Yale Open Data Access Project = 355/395 (89.9%)); Vivli did not provide downloadable study metadata. Of 1201 data requests listed on ClinicalStudyDataRequest.com , Supporting Open Access to Researchers–Bristol Myers Squibb, Vivli, and the Yale Open Data Access Project platforms, 586 requests (48.8%) were approved (i.e. data access granted). The majority were for secondary analyses and/or developing/validating methods ( ClinicalStudyDataRequest.com = 262/313 (83.7%); Supporting Open Access to Researchers–Bristol Myers Squibb = 22/30 (73.3%); Vivli = 63/84 (75.0%); the Yale Open Data Access Project = 111/159 (69.8%)); four were for re-analyses or corroborations of previous research findings ( ClinicalStudyDataRequest.com = 3/313 (1.0%) and the Yale Open Data Access Project = 1/159 (0.6%)). Ninety-five (16.1%) approved data requests had results disseminated via peer-reviewed publications ( ClinicalStudyDataRequest.com = 61/313 (19.5%); Supporting Open Access to Researchers–Bristol Myers Squibb = 3/30 (10.0%); Vivli = 4/84 (4.8%); the Yale Open Data Access Project = 27/159 (17.0%)). Forty-two (6.8%) additional requests reported results through preprints, conference abstracts, or on the platform’s website ( ClinicalStudyDataRequest.com = 12/313 (3.8%); Supporting Open Access to Researchers–Bristol Myers Squibb = 3/30 (10.0%); Vivli = 2/84 (2.4%); Yale Open Data Access Project = 25/159 (15.7%)). Conclusion: Across six prominent clinical data sharing platforms, information on studies and request metrics varied in availability and format. Most data requests focused on secondary analyses and approximately one-quarter of all approved requests publicly disseminated their results. To further promote the use of shared clinical data, platforms should increase transparency, consistently clarify the availability of the listed studies and supporting documentation, and ensure that research findings from data requests are disseminated.
Published: 2021
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15. An open science pathway for drug marketing authorization-Registered drug approval

Author: Ioana A. Cristea, Erick H. Turner, Rémy Boussageon, Maximilian Siebert, Florian Naudet, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Università degli Studi di Pavia = University of Pavia (UNIPV), Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), Oregon Health and Science University [Portland] (OHSU), Health Research Alliance, PLOS, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Università degli Studi di Pavia
Subjects: Drug marketing, Open science, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), [SDV]Life Sciences [q-bio], education, Authorization, General Medicine, 030204 cardiovascular system & hematology, medicine.disease, Clinical trial, 03 medical and health sciences, 0302 clinical medicine, medicine, Drug approval, Medicine, 030212 general & internal medicine, Medical emergency, business, health care economics and organizations
Abstract: International audience; Florian Naudet and co-authors propose a pathway involving registered criteria for evaluation and approval of new drugs.
Published: 2021
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16. How the new European data protection regulation affects clinical research and recommendations?

Author: Sophie Sénéchal-Cohen, Aurélie Guérin, Pierre-Henri Bertoye, Ariane Galaup, Valérie Plattner, Fabrice Ruiz, Michel Rubio, Jacques Demotes-Mainard, Dominique Deplanque, Claude Dubray, Frédérique Lesaulnier, Catherine Cornu, Mireille Violleau, Luc Duchossoy, Anne Vidal, Mihaela Matei, Jean-Marie Chrétien, Cécile Fouret, Valérie Edel, Tabassome Simon, Serge Bureau, Florian Naudet, Anne Viola, Romain Boidin, Cécile Delval, European Clinical Research Infrastructures Network [Paris] (ECRIN), Ecrin, Centre d'Investigation Clinique [Bron] (CIC1407), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Groupement Hospitalier Est [Bron], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Pfizer, participants of Giens XXXIV Round Table 'Clinical research': Pierre-Henri Bertoye 4 , Romain Boidin 5 , Serge Bureau 6 , Jean-Marie Chrétien 7 , Cécile Delval 8 , Dominique Deplanque 9 , Claude Dubray 10 , Luc Duchossoy 11 , Valérie Edel 12 , Cécile Fouret 13 , Ariane Galaup 14 , Frédérique Lesaulnier 15 , Mihaela Matei 1 , Florian Naudet 16 , Valérie Plattner 17 , Michel Rubio 18 , Fabrice Ruiz 19 , Sophie Sénéchal-Cohen 20 , Tabassome Simon 21 , Anne Vidal 22 , Anne Viola 23 , Mireille Violleau 24, European Clinical Research Infrastructures Network [Dusseldorf] (ECRIN), Ministère des Solidarités et de la Santé [Paris, France], UNICANCER, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), 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 Clermont-Ferrand, Sanofi Aventis R&D [Chilly-Mazarin], Medtronic SNT, Medtronic, Les entreprises du Médicament (LEEM), Comité d'éthique de l'Inserm = The Inserm Ethics Committee (CEI - IEC), Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Hospices Civils de Lyon (HCL), ClinSearch [Malakoff, France], AstraZeneca, CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Commission nationale de l'informatique des libertés (Cnil), CNIL, Laboratoire Roche [Boulogne-Billancourt], The Inserm Ethics Committee (IEC), and CCSD, Accord Elsevier
Subjects: Biomedical Research, Databases, Factual, International Cooperation, [SDV]Life Sciences [q-bio], Big data, Harmonization, 030226 pharmacology & pharmacy, Public interest, Clinical research, 03 medical and health sciences, 0302 clinical medicine, Regulatory texts, Data Protection Act 1998, Humans, Pharmacology (medical), Computer Security, Data protection, business.industry, Information Dissemination, Public relations, Transparency (behavior), 3. Good health, Data sharing, Europe, [SDV] Life Sciences [q-bio], Data access, General Data Protection Regulation, France, business, French data protection authority
Abstract: International audience; Clinical research on human subjects or their data is confronted with conflicting requirements with, on one hand, the principle of open science (transparency and data sharing), the possibilities offered by big data and the reuse of healthcare or research data, and on the other, changes to the regulatory and legislative framework, including the general data protection regulation (GDPR). A roundtable was organized in Giens, France in October 2018 to identify problem areas, the need for clarification and streamlining, and to make recommendations to promote clinical research while ensuring a high level of patient protection. After details were given about these developments, the roundtable participants were able to propose recommendations, primarily (1) to clarify: what is considered anonymized data, and what is "public interest" within the meaning of the GDPR; (2) for the French data protection authority (CNIL) to continue preparing reference methodologies to simplify the approval system; (3) to promote the secondary use of data by making it easier to inform patients and obtain broad patient consent, by specifying the circumstances under which their withdrawal and opposition rights apply, so as to limit the risk of bias; (4) to facilitate access to data warehouses by providing technological and methodological aids. The roundtable also recommends increasing discussions between authorities in Europe on research topics, encouraging French authorities to contribute to the preparation of codes of conduct and setting up a voluntary harmonization procedure to coordinate the opinions of data protection authorities, while ensuring that key documents are available in English.
Published: 2019
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17. Reconceptualising treatment-resistant depression as difficult-to-treat depression

Author: Lisa Cosgrove, Allen F. Shaughnessy, Florian Naudet, Göran Högberg, Ioana A. Cristea, University of Massachusetts [Boston] (UMass Boston), University of Massachusetts System (UMASS), Centre Hospitalier Universitaire [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Tufts University School of Medicine [Boston], Università degli Studi di Pavia = University of Pavia (UNIPV), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and University of Pavia
Subjects: medicine.medical_specialty, business.industry, [SDV]Life Sciences [q-bio], MEDLINE, medicine.disease, 03 medical and health sciences, Psychiatry and Mental health, Depressive Disorder, Treatment-Resistant, 0302 clinical medicine, Terminology as Topic, Medicine, Humans, 030212 general & internal medicine, business, Psychiatry, Treatment-resistant depression, 030217 neurology & neurosurgery, Biological Psychiatry, Depression (differential diagnoses), ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2021
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18. Research transparency promotion by surgical journals publishing randomised controlled trials: a survey

Author: Damien Bergeat, Karim Boudjema, Florian Naudet, Nicolas Lombard, Laurent Sulpice, A. Gasmi, CHU Pontchaillou [Rennes], Nutrition, Métabolismes et Cancer (NuMeCan), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), ANR-17-CE36-0010,ReiTheR,Reproductibilité de la recherche thérapeutique(2017), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: medicine.medical_specialty, media_common.quotation_subject, [SDV]Life Sciences [q-bio], education, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Primary outcome, Promotion (rank), Randomized controlled trial, law, Surveys and Questionnaires, CONSORT statement, Humans, Medicine, 030212 general & internal medicine, Randomized Controlled Trials as Topic, media_common, Publishing, Randomised controlled trial, lcsh:R5-920, Impact factor, Information Dissemination, business.industry, Research, Consolidated Standards of Reporting Trials, Transparency (behavior), humanities, 3. Good health, Clinical trial, Family medicine, Data sharing, Periodicals as Topic, business, lcsh:Medicine (General), Conflict of interest
Abstract: Objective: To describe surgical journals’ position statements on data-sharing policies (primary objective) and to describe key features of their research transparency promotion.Methods: Only “SURGICAL” journals with an impact factor higher than 2 (Web of Science) were eligible for the study. They were included, if there were explicit instructions for clinical trial publication in the official instructions for authors, (OIA) and or if they had published randomized controlled trial (RCT) between 1st January 2016 and 31st December 2018. The primary outcome was the existence of a data-sharing policy included in the instructions for authors. Data sharing policies were grouped into 3 categories, inclusion of data sharing policy mandatory, optional or not available. Details on research transparency promotion were also collected, namely the existence of a “prospective registration of clinical trials requirement policy”; a conflict of interests (COIs) disclosure requirement and a specific reference to reporting guidelines, such as CONSORT for RCT. Results: Among the 87 surgical journals identified, 82 were included in the study: 67 (82%) had explicit instructions for RCT and the remaining 15 (18%) had published at least one RCT. The median impact factor was 2.98 [IQR=2.48-3.77] and in 2016 and 2017, the journals published a median of 11.5 RCT [IQR=5-20.75]. The OIA of four journals (5%) stated that the inclusion of a data sharing statement was mandatory, optional in 45% (n=37), and not included in 50% (n=41).No association was found between journal characteristics and the existence of data-sharing policies (mandatory or optional). A “prospective registration of clinical trials requirement” was associated with International Committee of Medical Journal Editors (ICMJE) allusion or affiliation and higher impact factors. Journals with specific RCT instructions in their OIA and journals referenced on the ICMJE website more frequently mandated the use of CONSORT guidelines. Conclusion: Research transparency promotion is still limited in surgical journals. Standardisation of journal requirements according to ICMJE guidelines could be a first step forward for research transparency promotion in surgery.
Published: 2020
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19. Restoring the Bacloville trial: efficacy and harms

Author: Ioana A. Cristea, Alain Braillon, Florian Naudet, Joel Lexchin, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Amiens-Picardie, Università degli Studi di Pavia = University of Pavia (UNIPV), York University [Toronto], Jonchère, Laurent, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Università degli Studi di Pavia
Subjects: medicine.medical_specialty, bias, [SDV]Life Sciences [q-bio], MEDLINE, baclofen, Medicine (miscellaneous), 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Medicine, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, business.industry, ethics, [SDV] Life Sciences [q-bio], Psychiatry and Mental health, Baclofen, chemistry, Alcohol, conflict of interests, randomized controlled trial, Physical therapy, business
Abstract: International audience
Published: 2020
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20. Preserving equipoise and performing randomized trials for COVID-19 social distancing interventions

Author: John P. A. Ioannidis, Ioana A. Cristea, Florian Naudet, Università degli Studi di Pavia = University of Pavia (UNIPV), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Meta-Research Innovation Center at Stanford (METRICS), Stanford School of Medicine [Stanford], Stanford Medicine, Stanford University-Stanford University-Stanford Medicine, Stanford University-Stanford University, METRICS is supported by a grant from the Laura andJohn Arnold Foundation. The work of JPAI is supported by an unrestrictedgift from Sue and Bob O’Donnell., Jonchère, Laurent, Università degli Studi di Pavia, Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Research design, Epidemiology, [SDV]Life Sciences [q-bio], Pneumonia, Viral, Applied psychology, Randomisation, randomised-controlled trials, research design and methods, statistics, Psychological intervention, 030204 cardiovascular system & hematology, Special Article, Betacoronavirus, 03 medical and health sciences, 0302 clinical medicine, Credibility, Design choice, Humans, 030212 general & internal medicine, Pandemics, Randomized Controlled Trials as Topic, Therapeutic Equipoise, SARS-CoV-2, Social distance, Public Health, Environmental and Occupational Health, COVID-19, 3. Good health, Coronavirus, [SDV] Life Sciences [q-bio], Intervention (law), Psychiatry and Mental health, Psychological Distance, Research Design, Social Conditions, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Observational study, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Coronavirus Infections, Psychology
Abstract: In the coronavirus disease 2019 (COVID-19) pandemic, a large number of non-pharmaceutical measures that pertain to the wider group of social distancing interventions (e.g. public gathering bans, closures of schools, workplaces and all but essential business, mandatory stay-at-home policies, travel restrictions, border closures and others) have been deployed. Their urgent deployment was defended with modelling and observational data of spurious credibility. There is major debate on whether these measures are effective and there is also uncertainty about the magnitude of the harms that these measures might induce. Given that there is equipoise for how, when and if specific social distancing interventions for COVID-19 should be applied and removed/modified during reopening, we argue that informative randomised-controlled trials are needed. Only a few such randomised trials have already been conducted, but the ones done to-date demonstrate that a randomised trials agenda is feasible. We discuss here issues of study design choice, selection of comparators (intervention and controls), choice of outcomes and additional considerations for the conduct of such trials. We also discuss and refute common counter-arguments against the conduct of such trials.
Published: 2020
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21. Pharmacotherapies for Alcohol Use Disorder: Over Both Sides of the Atlantic Ocean

Author: Florian Naudet, Alain Braillon, CHU Amiens-Picardie, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Jonchère, Laurent
Subjects: medicine.medical_specialty, drug safety, Letter, evidence based medicine, [SDV]Life Sciences [q-bio], MEDLINE, baclofen, Alcohol use disorder, drug repositioning, Off-label use, 03 medical and health sciences, 0302 clinical medicine, acamprosate, drug approval, medicine, Humans, 030212 general & internal medicine, human, Psychiatry, Atlantic Ocean, ComputingMilieux_MISCELLANEOUS, alcoholism, business.industry, drug marketing, Off-Label Use, General Medicine, medicine.disease, mortality, [SDV] Life Sciences [q-bio], business, naltrexone, 030217 neurology & neurosurgery
Abstract: International audience; [No abstract available]
Published: 2020
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22. Nalmefene in alcohol-dependent patients with a high drinking risk a limited efficacy in reducing alcohol consumption

Author: Alain Braillon, Florian Naudet, Clément Palpacuer, Fondation Ophtalmologique Adolphe de Rothschild [Paris], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: business.industry, General Neuroscience, alcohol dependence, [SDV]Life Sciences [q-bio], Alcohol, General Medicine, 3. Good health, 03 medical and health sciences, Psychiatry and Mental health, chemistry.chemical_compound, 0302 clinical medicine, Neurology, chemistry, nalmefene, Environmental health, medicine, 030212 general & internal medicine, Neurology (clinical), harm reduction, business, Alcohol consumption, 030217 neurology & neurosurgery, Nalmefene, ComputingMilieux_MISCELLANEOUS, medicine.drug
Abstract: International audience
Published: 2020
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23. Letter to the editor: Covid-19 and Vit-D: Disease mortality negatively correlates with sunlight exposure

Author: André Gillibert, Clara Locher, Alain Braillon, Florian Naudet, Jonchère, Laurent, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], CHU Amiens-Picardie, CHU Rouen, Normandie Université (NU), Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: 2019-20 coronavirus outbreak, Letter to the editor, genetic structures, Coronavirus disease 2019 (COVID-19), Epidemiology, Health, Toxicology and Mutagenesis, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Pneumonia, Viral, education, 030231 tropical medicine, Geography, Planning and Development, Scientific integrity, Article, Betacoronavirus, 03 medical and health sciences, 0302 clinical medicine, Bias, Humans, Medicine, [SDV.EE.SANT] Life Sciences [q-bio]/Ecology, environment/Health, 030212 general & internal medicine, Vitamin D, Pandemics, ComputingMilieux_MISCELLANEOUS, Sunlight, [SDV.EE.SANT]Life Sciences [q-bio]/Ecology, environment/Health, SARS-CoV-2, business.industry, Disease mortality, COVID-19, humanities, Reproducibility, Infectious Diseases, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Immunology, Vitamine D, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Coronavirus Infections, business
Abstract: The manuscript “Covid-19 And Vit-D: Disease Mortality Negatively Correlates with Sunlight Exposure” held our attention as we found fatal shortcomings that invalidates the analyses and conclusions.
Published: 2020
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24. Baclofen and Alcohol Use Disorders Breakthrough or Great White Elephant?

Author: Alain Braillon, Ioana A. Cristea, Florian Naudet, Joel Lexchin, CHU Amiens-Picardie, Centre d'Investigation Clinique [Rennes] (CIC), 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), CHU Pontchaillou [Rennes], Babes-Bolyai University [Cluj-Napoca] (UBB), York University [Toronto], and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: medicine.medical_specialty, History, Baclofen, [SDV]Life Sciences [q-bio], Alcohol, Alcohol use disorder, History, 21st Century, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Alcoholism, Drug Approval, France, GABA-B Receptor Agonists, Humans, Medicine, 030212 general & internal medicine, Psychiatry, ComputingMilieux_MISCELLANEOUS, business.industry, General Medicine, medicine.disease, 21st Century, chemistry, White elephant, business, 030217 neurology & neurosurgery
Abstract: International audience
Published: 2020
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25. Approval of esketamine for treatment-resistant depression - Authors' reply

Author: Ioana A. Cristea, Florian Naudet, Jonchère, Laurent, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Università degli Studi di Pavia = University of Pavia (UNIPV), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and University of Pavia
Subjects: medicine.medical_specialty, business.industry, [SDV]Life Sciences [q-bio], MEDLINE, medicine.disease, 030227 psychiatry, [SDV] Life Sciences [q-bio], 03 medical and health sciences, Psychiatry and Mental health, Esketamine, 0302 clinical medicine, Internal medicine, medicine, Ketamine, 030212 general & internal medicine, business, Treatment-resistant depression, Treatment resistant, Biological Psychiatry, Depression (differential diagnoses), ComputingMilieux_MISCELLANEOUS, medicine.drug
Abstract: International audience
Published: 2020
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26. Reply to the Letter to the Editor 'Mixing Apples and Oranges in Assessing Outcomes of Repetitive Transcranial Stimulation Meta-Analyses'

Author: Chloé Rousseau, Ali Amad, Renaud Jardri, John P. A. Ioannidis, Florian Naudet, Yann Larochelle, Sciences Cognitives et Sciences Affectives (SCALab) - UMR 9193 (SCALab), Université de Lille-Centre National de la Recherche Scientifique (CNRS), Centre d'Investigation Clinique [Rennes] (CIC), 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), Stanford University [Stanford], Laboratoire Sciences Cognitives et Sciences Affectives - UMR 9193 (SCALab), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Stanford University
Subjects: medicine.medical_specialty, Letter to the editor, business.industry, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Stimulation, General Medicine, Transcranial Magnetic Stimulation, Transcranial magnetic stimulation, 03 medical and health sciences, Psychiatry and Mental health, Clinical Psychology, 0302 clinical medicine, Physical medicine and rehabilitation, medicine, 030212 general & internal medicine, business, 030217 neurology & neurosurgery, Applied Psychology, Mixing (physics), ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2020
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27. The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days

Author: Perrine Janiaud, Cathrine Axfors, Janneke van't Hooft, Ramon Saccilotto, Arnav Agarwal, Christian Appenzeller-Herzog, Despina G. Contopoulos-Ioannidis, Valentin Danchev, Ulrich Dirnagl, Hannah Ewald, Gerald Gartlehner, Steven N. Goodman, Noah A. Haber, Angeliki Diotima Ioannidis, John P. A. Ioannidis, Mark P. Lythgoe, Wenyan Ma, Malcolm Macleod, Mario Malički, Joerg J. Meerpohl, Yan Min, David Moher, Blin Nagavci, Florian Naudet, Christiane Pauli-Magnus, Jack W. O'Sullivan, Nico Riedel, Jan A. Roth, Mandy Sauermann, Stefan Schandelmaier, Andreas M. Schmitt, Benjamin Speich, Paula R. Williamson, Lars G. Hemkens, HAL UR1, Admin, University of Basel (Unibas), Meta-Research Innovation Center at Stanford (METRICS), Stanford School of Medicine [Stanford], Stanford Medicine, Stanford University-Stanford University-Stanford Medicine, Stanford University-Stanford University, Stanford University, Uppsala University, Universiteit van Amsterdam (UvA), University of Toronto, Stanford University School of Medicine [CA, USA], Berlin Institute of Health (BIH), Danube University Krems, University of California [Los Angeles] (UCLA), University of California (UC), Imperial College London, University of Edinburgh, University of Freiburg [Freiburg], Ottawa Hospital Research Institute [Ottawa] (OHRI), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], University Hospital Basel [Basel], McMaster University [Hamilton, Ontario], University of Oxford, University of Liverpool, Laura and John Arnold Foundation, 31CA30_196190, Schweizerischer Nationalfonds zur F&#x00F6, rderung der Wissenschaftlichen Forschung, Obstetrics and Gynaecology, University of California, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and University of Oxford [Oxford]
Subjects: 0301 basic medicine, China, clinical research agenda, hydroxychloroquine, Pneumonia, Viral, 0601 Biochemistry and Cell Biology, General Biochemistry, Genetics and Molecular Biology, Betacoronavirus, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Humans, 1112 Oncology and Carcinogenesis, 030212 general & internal medicine, General Pharmacology, Toxicology and Pharmaceutics, Pandemics, [SDV.MHEP.ME] Life Sciences [q-bio]/Human health and pathology/Emerging diseases, Clinical Trials as Topic, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, General Immunology and Microbiology, SARS-CoV-2, covid 19, COVID-19, 1103 Clinical Sciences, Articles, General Medicine, 16. Peace & justice, 3. Good health, 030104 developmental biology, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Health Services Research, Coronavirus Infections, Research Article
Abstract: Background: Never before have clinical trials drawn as much public attention as those testing interventions for COVID-19. We aimed to describe the worldwide COVID-19 clinical research response and its evolution over the first 100 days of the pandemic. Methods: Descriptive analysis of planned, ongoing or completed trials by April 9, 2020 testing any intervention to treat or prevent COVID-19, systematically identified in trial registries, preprint servers, and literature databases. A survey was conducted of all trials to assess their recruitment status up to July 6, 2020. Results: Most of the 689 trials (overall target sample size 396,366) were small (median sample size 120; interquartile range [IQR] 60-300) but randomized (75.8%; n=522) and were often conducted in China (51.1%; n=352) or the USA (11%; n=76). 525 trials (76.2%) planned to include 155,571 hospitalized patients, and 25 (3.6%) planned to include 96,821 health-care workers. Treatments were evaluated in 607 trials (88.1%), frequently antivirals (n=144) or antimalarials (n=112); 78 trials (11.3%) focused on prevention, including 14 vaccine trials. No trial investigated social distancing. Interventions tested in 11 trials with >5,000 participants were also tested in 169 smaller trials (median sample size 273; IQR 90-700). Hydroxychloroquine alone was investigated in 110 trials. While 414 trials (60.0%) expected completion in 2020, only 35 trials (4.1%; 3,071 participants) were completed by July 6. Of 112 trials with detailed recruitment information, 55 had recruited Conclusions: The size and speed of the COVID-19 clinical trials agenda is unprecedented. However, most trials were small investigating a small fraction of treatment options. The feasibility of this research agenda is questionable, and many trials may end in futility, wasting research resources. Much better coordination is needed to respond to global health threats.
Published: 2020
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28. Clinical application of mesenchymal stem cells in periodontal regeneration A systematic review and meta-analysis

Author: Sylvie Jeanne, Florian Naudet, Marie Philippe, Solen Novello, Alexandre Debouche, Institut des Sciences Chimiques de Rennes (ISCR), Centre National de la Recherche Scientifique (CNRS)-Institut de Chimie du CNRS (INC)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Ecole Nationale Supérieure de Chimie de Rennes (ENSCR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA), CHU Pontchaillou [Rennes], Université de Rennes 1 - UFR d'Odontologie (UR1 Odontologie), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Centre d'Investigation Clinique [Rennes] (CIC), 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 (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Ecole Nationale Supérieure de Chimie de Rennes (ENSCR)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Université de Rennes - UFR d'Odontologie (UR Odontologie), Université de Rennes (UR), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: 0301 basic medicine, medicine.medical_specialty, [SDV]Life Sciences [q-bio], Alveolar Bone Loss, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, systematic review, law, Internal medicine, Regeneration in humans, Periodontal Attachment Loss, periodontal regeneration, medicine, Humans, Regeneration, Gingival recession, ComputingMilieux_MISCELLANEOUS, Randomized Controlled Trials as Topic, mesenchymal stem cells, business.industry, Regeneration (biology), Mesenchymal stem cell, Small sample, 030206 dentistry, 3. Good health, meta-analysis, 030104 developmental biology, Meta-analysis, tissue engineering, Guided Tissue Regeneration, Periodontal, Periodontics, Stem cell, medicine.symptom, business
Abstract: Objective To evaluate the potential efficacy of mesenchymal stem cells (MSCs) in periodontal regeneration in humans on the following main outcomes: clinical attachment level (CAL), probing depth (PD), and gingival recession (GR). Background The clinical application of stem cells in periodontal regeneration has begun in recent years, but clinical practices are not yet standardized and no recommendations are available at this time. Methods Electronic database searches and hand searches were conducted. All types of studies, case series, and case reports were qualitatively described. Double-blind randomized controlled trials (RCTs) evaluating MSCs in periodontal regeneration were included in a meta-analysis if they compared administration of MSCs vs application of stem cell-free therapy in the control group, in healthy patients with periodontal defects, with a minimum of three mo of follow-up. Results Fifteen reports were included in qualitative analysis, involving 123 patients and 158 periodontal defects. Only two small RCTs at high risk of bias, with a total of 59 patients and 70 periodontal defects, were included in the meta-analysis. A small but significant difference between test and control groups was found for CAL at three mo (-0.90 mm, 95% CI [-1.51; -0.29]), but not for PD and GR. Conclusion Low-quality evidence suggests that MSC-based therapy may have a small impact on periodontal regeneration. However, due to the monocentric character, the small sample size, and potential heterogeneity across the two included RCTs, these results must not be considered as definitive. High-quality RCTs are needed before any clinical use of MSCs in periodontal regeneration.
Published: 2020
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29. US Food and Drug Administration approval of esketamine and brexanolone

Author: Ioana A. Cristea, Florian Naudet, Universitatea Babeş-Bolyai [Cluj-Napoca], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Postpartum depression, medicine.medical_specialty, [SDV]Life Sciences [q-bio], MEDLINE, Pregnanolone, Food and drug administration, Depression, Postpartum, 03 medical and health sciences, Depressive Disorder, Treatment-Resistant, 0302 clinical medicine, Internal medicine, medicine, Humans, 030212 general & internal medicine, Biological Psychiatry, Depression (differential diagnoses), health care economics and organizations, business.industry, United States Food and Drug Administration, beta-Cyclodextrins, Drug administration, medicine.disease, Antidepressive Agents, United States, 3. Good health, 030227 psychiatry, Psychiatry and Mental health, Esketamine, Drug Combinations, Female, Ketamine, business, medicine.drug
Abstract: International audience; In March 2019, The USFood and Drug Administration (FDA) approved twonew antidepressants -esketamine for treatment-resistant depression (TRD)1and brexanolone for postpartum depression (PPD).
Published: 2019
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30. Increase value and reduce waste in research on psychological therapies

Author: Florian Naudet, Ioana A. Cristea, Universitatea Babeş-Bolyai [Cluj-Napoca], Centre d'Investigation Clinique [Rennes] (CIC), 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), Financial supportIoana A. Cristea was supported by a grant from the Romanian Ministery of Research and Innovation, CNCS – UEFISCDI (project number PN-III-P1-1.1-TE-2016-1054). The funder had no role in the design of the study, collection, analysis and interpretation of data, and the decision to approve publication.We would like to thank Dr. Tom E. Hardwicke for comments on an early draft of the manuscript., and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Research design, 050103 clinical psychology, Open science, Biomedical Research, [SDV]Life Sciences [q-bio], Psychological intervention, Experimental and Cognitive Psychology, Transparency, Publication bias, 03 medical and health sciences, meta-Research, 0302 clinical medicine, Bias, Humans, 0501 psychology and cognitive sciences, Data sharing, Psychological treatment, Psychotherapy, Reproducibility, Research waste, Risk of bias, 030304 developmental biology, 0303 health sciences, business.industry, 05 social sciences, Usability, Mental health, 3. Good health, Psychiatry and Mental health, Clinical Psychology, Risk analysis (engineering), Guideline Adherence, business, Psychology, 030217 neurology & neurosurgery, Psychopathology
Abstract: International audience; A seminal Lancet series focused on increasing value and reducing waste in biomedical research, providing a transferrable template to diagnose problems in research. Our goal was to document how some of these sources of waste apply to mental health and particularly psychological treatments research. We synthesize and critically evaluate empirical findings in relation to four major sources: i) defining research priorities; ii) research design, methods and analysis; iii) accessibility of research information; iv) accuracy and usability of research reports. We demonstrate that each source of waste considered is well-represented and amply documented within this field. We describe hype and insufficient consideration of what is known in defining research priorities, persistent risk of bias, particularly due to selective outcome reporting, for psychotherapy trials across mental disorders, intellectual and financial biases, direct and indirect evidence of publication bias, largely inexistent adoption of data sharing, issues of multiplicity and fragmentation of data and findings, and insufficient adoption of reporting guidelines.We expand on a few general solutions, including supporting meta-research, properly testing interventions to increase research quality, placing open science at the center of psychological treatment research and remaining vigilant particularly regarding the strains of research currently prioritized, such as experimental psychopathology.
Published: 2019
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31. The YOMEGA non-inferiority trial

Author: Damien Bergeat, Karim Boudjema, Laurent Sulpice, Florian Naudet, Bernard Meunier, CHU Pontchaillou [Rennes], Laboratoire Traitement du Signal et de l'Image (LTSI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Nutrition, Métabolismes et Cancer (NuMeCan), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Institut National de la Recherche Agronomique (INRA)-Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: 03 medical and health sciences, 0302 clinical medicine, business.industry, [SDV]Life Sciences [q-bio], Non inferiority trial, Medicine, 030212 general & internal medicine, General Medicine, 030204 cardiovascular system & hematology, business, ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2019
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32. Power behind the throne: A clinical trial simulation study evaluating the impact of controllable design factors on the power of antidepressant trials

Author: Raphaël Gaillard, Raphaël Porcher, Philippe Ravaud, Astrid Chevance, Florian Naudet, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), Stanford University, Centre d'Investigation Clinique [Rennes] (CIC), 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), Institut de psychiatrie et neurosciences (U894 / UMS 1266), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Columbia University [New York], IMD20131229282, Fondation pour la Recherche Médicale, Jonchère, Laurent, 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), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Stanford University [Stanford], and Centre de Psychiatrie et Neurosciences (U894)
Subjects: medicine.medical_specialty, [SDV]Life Sciences [q-bio], [SDV.MHEP.PSM] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, behavioral disciplines and activities, Source Population, 03 medical and health sciences, 0302 clinical medicine, Physical medicine and rehabilitation, Disease severity, Rating scale, mental disorders, Outcome Assessment, Health Care, medicine, Humans, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, Clinical Trials as Topic, Depressive Disorder, clinical trials, Models, Statistical, business.industry, Remission Induction, methodology, modeling, Original Articles, Reference drug, Antidepressive Agents, Clinical trial, [SDV] Life Sciences [q-bio], Psychiatry and Mental health, Sample size determination, Research Design, antidepressants, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, depression, Antidepressant, business, 030217 neurology & neurosurgery
Abstract: Objective To evaluate the impact of controllable design factors on the power of antidepressants trials. Methods Using clinical trial simulation (CTS), we analyzed the combined impact on the power of trials of controllable design factors (sample size, outcome metrics, and disease severity at inclusion) and uncontrollable parameters (heterogeneity of diseases labeled "depression" in the source population and selective effects of drugs on items of the Hamilton Depression Rating Scale [HDRS], the most used outcome measurement tool). We elaborated 3,840 scenarios calibrated with real data, particularly the publication bias-corrected effect size. Results For an effect size of 0.26, simulations revealed that in trials with ≤650 participants, power was less than 80%. Among the tested outcome metrics, the "remission" outcome provided more robustness for sample heterogeneity, whereas the continuous outcome "HDRS changes" provided more robustness when investigating drugs with a selective effect on the HDRS items. For the "remission" outcome, the power of trials increased with increasing HDRS threshold at inclusion but decreased with the outcomes "response" and "HDRS changes. Drugs with a selective effect on the HDRS items could not reach the same power as for the reference drug. Conclusion Our study allows for drawing recommendations to avoid underpowered trials of antidepressants.
Published: 2019
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33. Challenging the promotion of antidepressants for nonsevere depression

Author: Joel Lexchin, Aubrey Blumsohn, Alain Braillon, K. Fierlbeck, David B Menkes, L. M'sahli, Florian Naudet, J. H. Noble, CHU Amiens-Picardie, York University [Toronto], University at Buffalo [SUNY] (SUNY Buffalo), State University of New York (SUNY), University of Auckland [Auckland], Dalhousie University [Halifax], University of Sheffield [Sheffield], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Depressive Disorder, Major, medicine.medical_specialty, Depression, business.industry, media_common.quotation_subject, [SDV]Life Sciences [q-bio], MEDLINE, Antidepressive Agents, 03 medical and health sciences, Psychiatry and Mental health, 0302 clinical medicine, Promotion (rank), [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, medicine, Humans, 030212 general & internal medicine, Psychiatry, business, 030217 neurology & neurosurgery, Depression (differential diagnoses), ComputingMilieux_MISCELLANEOUS, media_common
Abstract: International audience
Published: 2019
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34. Efficacy of acetylleucine in vertigo and dizziness: a systematic review of randomised controlled trials

Author: Florian Naudet, Rémy Boussageon, Helene Vaillant Roussel, Nematollah Jaafari, Clara Blanchard, Denis Pouchain, Paul Vanderkam, Marie Christine Perault-Pochat, Département de Médecine Générale, Université de Poitiers (DMG), Université de Poitiers - Faculté de Médecine et de Pharmacie, Université de Poitiers-Université de Poitiers, Unité de Recherche Clinique [CH Henri Laborit, Poitiers], Centre Hospitalier Henri Laborit (CHL), Centre d'Investigation Clinique [Rennes] (CIC), 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), Département de Médecine Générale [CHRU Tours], Université Francois Rabelais [Tours]-Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), AutomédiCation aCcompagnement Pluriprofessionnel PatienT (ACCePPT), Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Departement Médecine Générale [Clermont-Ferrand] (UFR Médecine), Université d'Auvergne - Clermont-Ferrand I (UdA), Service de pharmacologie clinique et de sensibilisation [CHU Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupement de recherche en Psychiatrie (GDR Psychiatrie (3557)), Centre National de la Recherche Scientifique (CNRS), Evaluation et modélisation des effets thérapeutiques, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), VIGNAL, Alexine, Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Université Francois Rabelais [Tours]
Subjects: medicine.medical_specialty, [SDV.SP.MED] Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Treatment outcome, Pharmacology toxicology, MEDLINE, Placebo, 030226 pharmacology & pharmacy, Dizziness, MESH: Dizziness, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, law, Leucine, Vertigo, otorhinolaryngologic diseases, MESH: vertigo, Medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Medical prescription, Randomized Controlled Trials as Topic, Pharmacology, Randomised controlled trial, Acetylleucine, biology, business.industry, General Medicine, biology.organism_classification, 3. Good health, Physical therapy, MESH: Treatment outcome, MESH: Randomised controlled trial, business, MESH: Acetylleucine, medicine.drug
Abstract: International audience; PURPOSE:To assess the efficacy of acetylleucine to improve or stop an attack of vertigo and dizziness (vertigo/dizziness).METHODS:Systematic review by 2 independent reviewers. Consultation of the Medline, Cochrane and ClinicalTrials.gov databases until September 2018. Keywords used: Acetylleucine, Tanganil®, Acetyl-DL-leucine, Acetyl-leucine. Trial selection: randomised controlled trials (RCTs) comparing acetylleucine against placebo.RESULTS:Up until 2018, no RCTs have been published on the efficacy of acetylleucine in vertigo/dizziness.CONCLUSION:There is no solid evidence of the efficacy of acetylleucine in vertigo/dizziness. Given its frequent prescription and the cost generated for the French social security system, high-quality randomised trials should be carried out to assess its efficacy.
Published: 2019
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35. Excess Significance Bias in Repetitive Transcranial Magnetic Stimulation Literature for Neuropsychiatric Disorders

Author: Chloé Rousseau, Yann Larochelle, Renaud Jardri, Ali Amad, Florian Naudet, John P. A. Ioannidis, Sciences Cognitives et Sciences Affectives (SCALab) - UMR 9193 (SCALab), Université de Lille-Centre National de la Recherche Scientifique (CNRS), King‘s College London, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre d'Investigation Clinique [Rennes] (CIC), 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), Stanford University, Laboratoire Sciences Cognitives et Sciences Affectives - UMR 9193 (SCALab), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: medicine.medical_specialty, medicine.medical_treatment, Repetitive transcranial magnetic stimulation, [SDV]Life Sciences [q-bio], Audiology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Power calculations, Medicine, Humans, 030212 general & internal medicine, Clinical efficacy, Trial registration, Sensitivity analyses, Applied Psychology, ComputingMilieux_MISCELLANEOUS, business.industry, Mental Disorders, General Medicine, Transcranial Magnetic Stimulation, 030227 psychiatry, 3. Good health, Transcranial magnetic stimulation, Psychiatry and Mental health, Clinical Psychology, Meta-analysis, Treatment Outcome, Strictly standardized mean difference, Excess significance, Nervous System Diseases, business, 030217 neurology & neurosurgery
Abstract: Introduction: Repetitive transcranial magnetic stimulation (rTMS) has been widely tested and promoted for use in multiple neuropsychiatric conditions, but as for many other medical devices, some gaps may exist in the literature and the evidence base for the clinical efficacy of rTMS remains under debate. Objective: We aimed to test for an excess number of statistically significant results in the literature on the therapeutic efficacy of rTMS across a wide range of meta-analyses and to characterize the power of studies included in these meta-analyses. Methods: Based on power calculations, we computed the expected number of “positive” datasets for a medium effect size (standardized mean difference, SMD = 0.30) and compared it with the number of observed “positive” datasets. Sensitivity analyses considered small (SMD = 0.20), modest (SMD = 0.50), and large (SMD = 0.80) effect sizes. Results: A total of 14 meta-analyses with 228 datasets (110 for neurological disorders and 118 for psychiatric disorders) were assessed. For SMD = 0.3, the number of observed “positive” studies (n = 94) was larger than expected (n = 35). We found evidence for an excess of significant findings overall (p < 0.0001) and in 8/14 meta-analyses. Evidence for an excess of significant findings was also observed for SMD = 0.5 for neurological disorders. Of the 228 datasets, 0 (0%), 0 (0%), 3 (1%), and 53 (23%) had a power >0.80, respectively, for SMDs of 0.30, 0.20, 0.50, and 0.80. Conclusion: Most studies in the rTMS literature are underpowered. This results in fragmentation and waste of research efforts. The somewhat high frequency of “positive” results seems spurious and may reflect bias. Caution is warranted in accepting rTMS as an established treatment for neuropsychiatric conditions.
Published: 2019
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36. Open science practices in clinical psychology journals An audit study

Author: Cristea, Ioana, Florian, NAUDET, Nutu, Daria, Gentili, Claudio, Babes-Bolyai University [Cluj-Napoca] (UBB), University of L'Aquila [Italy] (UNIVAQ), Centre d'Investigation Clinique [Rennes] (CIC), 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), Ontario Ministry of Research, Innovation and Science, MRISPN-III-P1- 1.1-TE-2016 –1054Corporation for National and Community Service, CNCS, and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: 050103 clinical psychology, Journal, Best practice, [SDV]Life Sciences [q-bio], Psychology, Clinical, Information Dissemination, MEDLINE, 050801 communication & media studies, Guidelines as Topic, Disclosure, Audit, PsycINFO, Transparency, reporting guidelines, 0508 media and communications, 0502 economics and business, Humans, 0501 psychology and cognitive sciences, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries), Biological Psychiatry, ComputingMilieux_MISCELLANEOUS, Impact factor, Conflict of Interest, 05 social sciences, Transparency (behavior), Reproducibility, Data sharing, Psychiatry and Mental health, clinical psychology, Open science, Journal Impact Factor, Periodicals as Topic, Psychology, 050203 business & management, Editorial Policies, Clinical psychology
Abstract: We conducted an audit of 60 clinical psychology journals, covering the first 2 quartiles by impact factor on Web of Science. We evaluated editorial policies in 5 domains crucial to reproducibility and transparency (prospective registration, data sharing, preprints, endorsement of reporting guidelines and conflict of interest [COI] disclosure). We examined implementation in a randomly selected cross-sectional sample of 201 articles published in 2017 in the "best practice" journals, defined as having explicit supportive policies in 4 out of 5 domains. Our findings showed that 15 journals cited prospective registration, 40 data sharing, 15 explicitly permitted preprints, 28 endorsed reporting guidelines, and 52 had mandatory policies for COI disclosure. Except for COI disclosure, few policies were mandatory: registration in 15 journals, data sharing in 1, and reporting guidelines for randomized trials in 18 and for meta-analyses in 15. Seventeen journals were identified as "best practice." An analysis of recent articles showed extremely low compliance for prospective registration (3% articles) and data sharing (2%). One preprint could be identified. Reporting guidelines were endorsed in 19% of the articles, though for most articles this domain was rated as nonapplicable. Only half of the articles included a COI disclosure. Desired open science policies should become clear and mandatory, and their enforcement streamlined by reducing the multiplicity of guidelines and templates. (PsycINFO Database Record (c) 2019 APA, all rights reserved).
Published: 2019
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37. Urinary TIMP-2 and MMP-2 are significantly associated with poor bladder compliance in adult patients with spina bifida

Author: Zine-Eddine Khene, Anne Corlu, C. Richard, Jacques Kerdraon, Laurent Siproudhis, Xavier Gamé, Nelly Senal, M. Jezequel, Guillaume Bouguen, Charlène Brochard, Claude Bendavid, Florian Naudet, Quentin Alimi, B. Peyronnet, Andrea Manunta, Juliette Hascoet, Bruno Clément, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), 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), Nutrition, Métabolismes et Cancer (NuMeCan), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape, CHU Toulouse [Toulouse], Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Recherche Agronomique (INRA)-Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)
Subjects: Male, [SDV]Life Sciences [q-bio], 030232 urology & nephrology, Hydronephrosis, Urine, Kidney, chemistry.chemical_compound, 0302 clinical medicine, Nerve Growth Factor, Medicine, Prospective Studies, Spinal Dysraphism, ComputingMilieux_MISCELLANEOUS, Upper urinary tract, Urinary bladder, medicine.diagnostic_test, Area under the curve, Middle Aged, uroydnamics, spina bifida, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Matrix Metalloproteinase 2, Urodynamic testing, Female, urinary bladder, Adult, medicine.medical_specialty, Urology, Urinary system, neurogenic, compliance, Dinoprostone, Transforming Growth Factor beta1, Young Adult, 03 medical and health sciences, Humans, Urinary Bladder, Neurogenic, Tissue Inhibitor of Metalloproteinase-2, Creatinine, business.industry, Spina bifida, Brain-Derived Neurotrophic Factor, medicine.disease, Urodynamics, chemistry, Neurology (clinical), Atrophy, business, Biomarkers
Abstract: Aims To assess the predictive values of six urinary markers (nerve growth factor [NGF], brain-derived neurotrophic factor [BDNF], matrix metalloproteinase 2 [MMP-2], tissue inhibitor metalloproteinase 2 [TIMP-2], transformation growth factor β-1 [TGF-B1], and prostaglandin 2 [PGE2]) for adverse urodynamic features and for upper urinary tract damage in adult patients with spina bifida. Materials and methods A single-center prospective trial was conducted from March 2015 to March 2017 including all consecutive adult patients with spina bifida seen for urodynamic testing. The urine was collected and stored at -80°C. A urodynamic and an upper urinary tract were systematically performed. At the end of the inclusion period, urines were defrosted and urinary nerve growth factor, BDNF, TIMP-2, and TGF-B1 were assessed using validated ELISA kits. The urinary markers levels were adjusted on the urinary creatinine level. Urinary MMP-2 levels were assessed by zymography. Results Fourty patients were included. Only TIMP-2 and MMP-2 were significantly associated with poor bladder compliance (P = .043 and P = .039, respectively). TIMP-2 was also the only urinary marker significantly associated with upper urinary tract damage on imaging (OR = 19.81; P = .02). Of all urodynamic parameters, bladder compliance and maximum detrusor pressure were the only ones associated with upper urinary tract damage on imaging (P = .01 and P = .02), The diagnostic performances of urinary TIMP-2 for upper urinary tract damage were slightly superior to PdetMax and bladder compliance with an area under the curve of 0.72. Conclusion Urinary TIMP-2 and MMP-2 were significantly associated with poor bladder compliance and urinary TIMP-2 was significantly associated with upper urinary tract damage. These findings support a pathophysiological role of extracellular matrix remodeling in poor bladder compliance of adult patients with spina bifida.
Published: 2019
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38. The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project Rationale and design of the database and the collection of evidence available at approval of novel drugs

Author: Hannah Ewald, Juan Martin-Liberal, Aviv Ladanie, Lars G. Hemkens, Tiago V. Pereira, Arnav Agarwal, Benjamin Kasenda, Heiner C. Bucher, Francesco Sclafani, Thomas Schmid, Benjamin Speich, Florian Naudet, John P. A. Ioannidis, University of Basel (Unibas), Swiss Tropical and Public Health Institute [Basel], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Toronto, McMaster University [Hamilton, Ontario], Oswaldo Cruz German Hospital [São Paulo], Royal Marsden NHS Foundation Trust, Catalan Institute of Oncology (ICO), Vall d'Hebron Institute of Oncology [Barcelone] (VHIO), Vall d'Hebron University Hospital [Barcelona], St. Clara Hospital [Basel], Stanford University, KLS-3587-02-2015, Krebsliga Schweiz, Troccaz, Olivier, Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Comparative Effectiveness Research, Time Factors, Databases, Factual, Medicine (miscellaneous), computer.software_genre, 0302 clinical medicine, Clinical trials, Risk Factors, Neoplasms, Medicine, Pharmacology (medical), 030212 general & internal medicine, Drug Approval, Cancer, lcsh:R5-920, Database, Marketing authorization, Data Collection, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, Drug regulation, US Food and Drug Administration (FDA), 3. Good health, [SDV.SP] Life Sciences [q-bio]/Pharmaceutical sciences, Identification (information), Treatment Outcome, Data extraction, Research Design, Evidence synthesis, 030220 oncology & carcinogenesis, lcsh:Medicine (General), Approval package, Antineoplastic Agents, Risk Assessment, Food and drug administration, 03 medical and health sciences, Drugs and biologics, Humans, Biological Products, Data collection, business.industry, United States Food and Drug Administration, Drugs, Investigational, medicine.disease, United States, Clinical trial, Systematic review, business, Relevant information, computer
Abstract: Background The available evidence on the benefits and harms of novel drugs and therapeutic biologics at the time of approval is reported in publicly available documents provided by the US Food and Drug Administration (FDA). We aimed to create a comprehensive database providing the relevant information required to systematically analyze and assess this early evidence in meta-epidemiological research. Methods We designed a modular and flexible database of systematically collected data. We identified all novel cancer drugs and therapeutic biologics approved by the FDA between 2000 and 2016, recorded regulatory characteristics, acquired the corresponding FDA approval documents, identified all clinical trials reported therein, and extracted trial design characteristics and treatment effects. Herein, we describe the rationale and design of the data collection process, particularly the organization of the data capture, the identification and eligibility assessment of clinical trials, and the data extraction activities. Discussion We established a comprehensive database on the comparative effects of drugs and therapeutic biologics approved by the FDA over a time period of 17 years for the treatment of cancer (solid tumors and hematological malignancies). The database provides information on the clinical trial evidence available at the time of approval of novel cancer treatments. The modular nature and structure of the database and the data collection processes allow updates, expansions, and adaption for a continuous meta-epidemiological analysis of novel drugs. The database allows us to systematically evaluate benefits and harms of novel drugs and therapeutic biologics. It provides a useful basis for meta-epidemiological research on the comparative effects of innovative cancer treatments and continuous evaluations of regulatory developments.
Published: 2018
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39. Assessing scientists for hiring, promotion, and tenure

Author: Steven N. Goodman, Frank Miedema, John P. A. Ioannidis, Ioana A. Cristea, Florian Naudet, David Moher, Ottawa Hospital Research Institute [Ottawa] (OHRI), Stanford University, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Babes-Bolyai University [Cluj-Napoca] (UBB), University Medical Center [Utrecht], Jonchère, Laurent, Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Employee Incentive Plans, 0301 basic medicine, Science and Technology Workforce, Science Policy, Status quo, QH301-705.5, Best practice, media_common.quotation_subject, [SDV]Life Sciences [q-bio], Bibliometrics, Biology, Careers in Research, Research and Analysis Methods, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, Promotion (rank), Citation analysis, Humans, Biology (General), Scientific Publishing, media_common, Research Monitoring, General Immunology and Microbiology, Unintended consequences, business.industry, Research, General Neuroscience, Reproducibility of Results, Research Assessment, Public relations, Faculty, [SDV] Life Sciences [q-bio], Professions, Laboratory Personnel, 030104 developmental biology, Incentive, Research Design, Perspective, People and Places, Citation Analysis, Research Reporting Guidelines, Scientists, Population Groupings, Science policy, General Agricultural and Biological Sciences, business
Abstract: International audience; Assessment of researchers is necessary for decisions of hiring, promotion, and tenure. A burgeoning number of scientific leaders believe the current system of faculty incentives and rewards is misaligned with the needs of society and disconnected from the evidence about the causes of the reproducibility crisis and suboptimal quality of the scientific publication record. To address this issue, particularly for the clinical and life sciences, we convened a 22-member expert panel workshop in Washington, DC, in January 2017. Twenty-two academic leaders, funders, and scientists participated in the meeting. As background for the meeting, we completed a selective literature review of 22 key documents critiquing the current incentive system. From each document, we extracted how the authors perceived the problems of assessing science and scientists, the unintended consequences of maintaining the status quo for assessing scientists, and details of their proposed solutions. The resulting table was used as a seed for participant discussion. This resulted in six principles for assessing scientists and associated research and policy implications. We hope the content of this paper will serve as a basis for establishing best practices and redesigning the current approaches to assessing scientists by the many players involved in that process.
Published: 2018
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40. Specific and non-specific effects of psychotherapeutic interventions for depression: Results from a meta-analysis of 84 studies

Author: Clément Palpacuer, Bruno Falissard, Laurent Gallet, Dominique Drapier, Jean-Michel Reymann, Florian Naudet, Centre d'Investigation Clinique [Rennes] (CIC), 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), CHU Pontchaillou [Rennes], Centre Hospitalier Guillaume Régnier [Rennes], Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Service de Psychiatrie de l'adulte [Rennes], Centre Hospitalier Guillaume Régnier-Université européenne de Bretagne - European University of Brittany (UEB)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Service de Pharmacologie [Rennes], Santé mentale et santé publique (SMSP - U1178), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11), D-PSY-D-META, Rennes CHU, Centre d'Investigation Clinique [Rennes] ( CIC ), 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 ), Comportement et noyaux gris centraux [Rennes], Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Université européenne de Bretagne ( UEB ) -CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Université européenne de Bretagne ( UEB ) -Centre Hospitalier Guillaume Régnier, Service de Pharmacologie, 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 ), Institut des Neurosciences Cliniques de Rennes (INCR)-CHU Pontchaillou [Rennes]-Université européenne de Bretagne - European University of Brittany (UEB)-Université de Rennes 1 (UR1), Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR), and Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-Centre Hospitalier Guillaume Régnier
Subjects: Male, medicine.medical_specialty, [SDV]Life Sciences [q-bio], Poison control, Suicide prevention, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Intervention (counseling), [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, Injury prevention, Outcome Assessment, Health Care, medicine, Humans, 030212 general & internal medicine, Psychiatry, Biological Psychiatry, Depression (differential diagnoses), Randomized Controlled Trials as Topic, [ SDV ] Life Sciences [q-bio], Human factors and ergonomics, Databases, Bibliographic, 030227 psychiatry, 3. Good health, Psychotherapy, Psychiatry and Mental health, Meta-analysis, depression, Female, Psychology, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Clinical psychology
Abstract: International audience; There is a long-standing and very active debate regarding which psychotherapeutic intervention should be used in depressive disorders. However, the effects of psychotherapies may result majorly from non-specific factors rather than from specific factors related to the type of psychotherapeutic intervention. We performed a systematic review and meta-analysis on aggregated data to understand how the effects of different psychotherapies are impacted by non-specific factors. We included randomized controlled trials that assessed the efficacy of psychotherapeutic interventions in the treatment of adult depressive disorders. The primary outcome was the change in depression score from baseline to the latest follow-up visit (i.e. response). A meta-regression was performed to predict response according to the type of intervention and non-specific factors (e.g. number of treatment sessions, length of follow-up, therapeutic allegiance of the investigator). The main analysis included 214 study arms from 84 trials. The effects of psychotherapies compared to the waiting list control condition failed to remain significant after adjusting for non-specific factors. Response increased with the number of treatment sessions (β = 0.03, 95% CI [0.01; 0.04]) and the length of follow-up (β = 0.01, 95% CI [0.00; 0.02]). Response also improved in case of presumed therapeutic allegiances among investigators (β = 0.29, 95% CI [0.07; 0.52]). Response to psychotherapies seems to be closely related to non-specific effects. The development of a well-designed trial that controls for non-specific factors might help disentangle the effects of psychotherapies.
Published: 2017
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41. Manic switches induced by antidepressants: an umbrella review comparing randomized controlled trials and observational studies

Author: N. Allain, Jean-Marie Batail, Cyril Leven, François Montastruc, Bruno Falissard, J. S. Allain, Florian Naudet, Dominique Drapier, E. Polard, Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Centre Hospitalier Guillaume Régnier [Rennes], CHU Pontchaillou [Rennes], 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 en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Stanford University, This work was supported by a local grant from Rennes CHU (CORECT: COmité de la Recherche Clinique et Translationelle)., Jonchère, Laurent, Comportement et noyaux gris centraux [Rennes], Université de Rennes 1 (UR1) - Université européenne de Bretagne (UEB) - CHU Pontchaillou [Rennes] - Institut des Neurosciences Cliniques de Rennes (INCR), Université de Rennes 1 (UR1) - Hôpital Pontchaillou - Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Paul Brousse, Université Paris-Sud - Paris 11 (UP11) - Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Paul Brousse, Santé mentale et santé publique (SMSP), Université Paris-Sud - Paris 11 (UP11) - Université Paris Descartes - Paris 5 (UPD5) - Institut National de la Santé et de la Recherche Médicale (INSERM) - AP-HP Hôpital Necker - Enfants Malades [Paris], Université de Versailles Saint-Quentin-en-Yvelines (UVSQ) - Université Paris-Sud - Paris 11 (UP11) - Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Paul Brousse - Institut National de la Santé et de la Recherche Médicale (INSERM), Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps [Toulouse], Université Paul Sabatier - Toulouse 3 (UPS) - Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), and Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées
Subjects: Adult, Male, medicine.medical_specialty, Bipolar Disorder, affective disorders, [SDV]Life Sciences [q-bio], law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Meta-Analysis as Topic, law, Internal medicine, mental disorders, medicine, Prevalence, Humans, 030212 general & internal medicine, Bipolar disorder, Psychiatry, Major depressive episode, Child, ComputingMilieux_MISCELLANEOUS, Randomized Controlled Trials as Topic, Depressive Disorder, Major, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Middle Aged, medicine.disease, Antidepressive Agents, 3. Good health, 030227 psychiatry, [SDV] Life Sciences [q-bio], Psychiatry and Mental health, Observational Studies as Topic, Meta-analysis, Systematic review, Child, Preschool, depression, randomized controlled trial, Antidepressant, Regression Analysis, Observational study, Female, medicine.symptom, Psychology, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience; OBJECTIVE: We aimed to explore whether the prevalence of manic switch was underestimated in randomized controlled trials (RCTs) compared to observational studies (OSs). METHOD: Meta-analyses and simple and systematic reviews were identified by two reviewers in a blinded, standardized manner. All relevant references were extracted to include RCTs and OSs that provided data about manic switch prevalence after antidepressant treatment for a major depressive episode. The primary outcome was manic switch prevalence in the different arms of each study. A meta-regression was conducted to quantify the impact of certain variables on manic switch prevalence. RESULTS: A total of 57 papers (35 RCTs and 22 OSs) were included in the main analysis. RCTs underestimated the rate of manic switch [0.53 (0.32-0.87)]. Overestimated prevalence was related to imipraminics [1.85 (1.22-2.79)]; to serotonin-norepinephrine reuptake inhibitors [1.74 (1.06-2.86)]; and to other classes of drugs [1.58 (1.08-2.31)], compared to placebo treatment. The prevalence of manic switch was lower among adults than among children [0.2 (0.07-0.59)]; and higher [20.58 (8.41-50.31)] in case of bipolar disorder. CONCLUSION: Our results highlight an underestimation of the rates of manic switch under antidepressants in RCTs compared to the rates observed in observational studies.
Published: 2017
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42. The learning curve effect on embolization of cerebral dural arteriovenous fistula single-center experience in 48 consecutive patients

Author: Denis Trystram, Jean-Christophe Ferré, J.Y. Gauvrit, Hélène Raoult, Florian Naudet, D. Le Foll, Service de radiologie et imagerie médicale [Rennes] = Radiology [Rennes], CHU Pontchaillou [Rennes], Vision, Action et Gestion d'informations en Santé (VisAGeS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Inria Rennes – Bretagne Atlantique, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-SIGNAUX ET IMAGES NUMÉRIQUES, ROBOTIQUE (IRISA-D5), Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-IMT Atlantique (IMT Atlantique), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-IMT Atlantique (IMT Atlantique), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de neuroradiologie [Paris], Hôpital Sainte-Anne, SIGNAUX ET IMAGES NUMÉRIQUES, ROBOTIQUE (IRISA-D5), Université de Bretagne Sud (UBS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National de Recherche en Informatique et en Automatique (Inria)-École normale supérieure - Rennes (ENS Rennes)-Centre National de la Recherche Scientifique (CNRS)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-CentraleSupélec-IMT Atlantique Bretagne-Pays de la Loire (IMT Atlantique), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Université de Bretagne Sud (UBS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Inria Rennes – Bretagne Atlantique, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Male, medicine.medical_treatment, Middle meningeal artery, Single Center, 030218 nuclear medicine & medical imaging, 0302 clinical medicine, Dural arteriovenous fistulas, Outcome Assessment, Health Care, Embolization, 10. No inequality, ComputingMilieux_MISCELLANEOUS, Aged, 80 and over, education.field_of_study, Radiological and Ultrasound Technology, medicine.diagnostic_test, Middle Aged, Embolization, Therapeutic, 3. Good health, Treatment Outcome, Quartile, Female, Radiology, Cerebral Arterial Diseases, Cerebral angiography, Adult, medicine.medical_specialty, Population, Arteriovenous fistula, 03 medical and health sciences, Young Adult, medicine.artery, medicine, Humans, Radiology, Nuclear Medicine and imaging, education, Dural arteriovenous fistula, Learning curve, Aged, Retrospective Studies, Central Nervous System Vascular Malformations, business.industry, Angiography, Digital Subtraction, medicine.disease, Surgery, Cerebral Angiography, Neurology (clinical), business, 030217 neurology & neurosurgery, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: Summary Background Cerebral dural arteriovenous fistulas (DAVFs) are rare intracranial vascular lesions but can cause significant morbidity and mortality. Objectives To analyze the effect of the center's experience on DAVF embolization efficacy and safety. Methods From May 2008 to October 2014, 57 embolization procedures were attempted on 48 patients (37 men and 11 women; median age: 63.9 years) for DAVF in a single center. DAVF presented with cortical venous reflux in 44/48 cases (91.7%) and hemorrhagic manifestation in 21/48 cases (43.75%). Angiographic occlusion quality, whether complete or incomplete (efficacy), and neurological complications (safety) were recorded. The patient population was divided into four consecutive quartiles during the inclusion period to assess the progress profile. Efficacy and safety outcomes were compared with Fisher's test. Results A logistic regression was performed to explore a learning curve phenomenon, showing a significant association between the chronological rank in the cohort and embolization efficacy (P = 0.007). Significant differences were found between first and last quarter (P = 0.036). The endovascular technique involved an arterial injection of Onyx® in 36/48 cases (75%), administered via the middle meningeal artery in 25/36 cases (69.5%). The complete occlusion rate improved significantly from 33.3% for the first quartile of the population, to 75.0% for the 2nd and 3rd quartiles and 83.3% for the last quartile. Neurological complications were found in 7/48 patients (14.6%), the rate decreased by 41.7% to 16.7%, without statistically difference. Conclusion The efficacy and safety of DAVF embolization improved with the experience gained at the center, suggesting the existence of a learning curve.
Published: 2017
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43. A randomised cross-over study assessing the 'blue pyjama syndrome' in major depressive episode

Author: Gabriel Robert, Bruno Falissard, Maxence Rangé, Jacques Soulabaille, Jean-Marie Batail, Dominique Drapier, Florian Naudet, Stéphane Brousse, Hélèna Delmas, Département Universitaire de psychiatrie [Rennes], Centre Hospitalier Guillaume Régnier [Rennes], Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Santé mentale et santé publique (SMSP - U1178), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Meta-Research Innovation Center at Stanford (METRICS), Stanford School of Medicine [Stanford], Stanford Medicine, Stanford University-Stanford University-Stanford Medicine, Stanford University-Stanford University, no source, Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR), Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Comportement et noyaux gris centraux [Rennes], Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Université européenne de Bretagne ( UEB ) -CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), 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 d'Investigation Clinique [Rennes] ( CIC ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Meta-Research Innovation Center at Stanford [CA, USA] ( METRICS ), Stanford University School of Medicine [CA, USA], Naudet, Florian, and Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR)
Subjects: Male, medicine.medical_specialty, Science, [ SDV.MHEP.PSM ] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, [SDV.MHEP.PSM] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Article, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Disease severity, law, mental disorders, medicine, Humans, 030212 general & internal medicine, Prospective Studies, Prospective cohort study, Psychiatry, Major depressive episode, Observer Variation, Psychiatric Status Rating Scales, Depressive Disorder, Major, Multidisciplinary, Cross-Over Studies, business.industry, Reproducibility of Results, Middle Aged, Crossover study, Mood, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Psychiatric status rating scales, Medicine, Female, medicine.symptom, business, Observer variation, 030217 neurology & neurosurgery
Abstract: This paper introduces a “blue pyjama syndrome” (whereby wearing hospital pyjamas results in an exaggerated impression of severity). We performed a 5-day, prospective, randomized, cross-over study in a French mood disorder unit for inpatients. At Day 1 (D1) and Day 5 (D5), two 5-minute video interviews were recorded with patients in pyjamas or in day clothes (the sequence was randomly allocated). Psychiatrists unaware of the study objective assessed the videos and scored their clinical global impressions (CGI, with scores ranging from 1 to 7). Of 30 participants with major depressive episode selected for inclusion, 26 participants (69% women) provided useable data for an evaluation by 10 psychiatrists. Pyjamas significantly increased the psychiatrists’ CGI ratings of disease severity by 0·65 [0·27; 1·02] points. The psychiatrists’ global impressions also rated patients as significantly less severe at D5 in comparison with D1 by −0·66 [−1·03; −0·29] points. The “blue pyjama syndrome” is in the same order of magnitude as the difference observed after a week of hospitalisation. This potentially calls into question the reliability and validity of observer ratings of depression.
Published: 2017
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44. Is electroconvulsive therapy an evidence-based treatment for catatonia? A systematic review and meta-analysis

Author: Ali Amad, Arnaud Leroy, Florian Naudet, Andrew Francis, Pierre Thomas, Guillaume Vaiva, Sciences Cognitives et Sciences Affectives (SCALab) - UMR 9193 ( SCALab ), Université de Lille-Centre National de la Recherche Scientifique ( CNRS ), CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] ( CIC ), 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 ), Institute of psychiatry, Laboratoire Sciences Cognitives et Sciences Affectives - UMR 9193 (SCALab), Université de Lille-Centre National de la Recherche Scientifique (CNRS), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Sciences Cognitives et Sciences Affectives (SCALab) - UMR 9193 (SCALab), Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: medicine.medical_specialty, Evidence-based medicine, Catatonia, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Cochrane Library, law.invention, 03 medical and health sciences, 0302 clinical medicine, Electroconvulsive therapy, Randomized controlled trial, law, Outcome Assessment, Health Care, Humans, Medicine, Pharmacology (medical), Intensive care medicine, Psychiatry, Adverse effect, Biological Psychiatry, [ SDV ] Life Sciences [q-bio], business.industry, General Medicine, medicine.disease, 030227 psychiatry, 3. Good health, Psychiatry and Mental health, Meta-analysis, Observational study, business, 030217 neurology & neurosurgery, RCT
Abstract: International audience; We aimed to review and discuss the evidence-based arguments for the efficacy of electroconvulsive therapy (ECT) in the treatment of catatonia. Randomized controlled trials (RCTs) and observational studies focusing on the response to ECT in catatonia were selected in PubMed, the Cochrane Library, Embase, ClinicalTrials.gov and Current Controlled Trials through October 2016 and qualitatively described. Trials assessing pre-post differences using a catatonia or clinical improvement rating scale were pooled together using a random effect model. Secondary outcomes were adverse effects of anesthesia and seizure. 564 patients from 28 studies were included. RCTs were of low quality and were heterogeneous; therefore, it was not possible to combine their efficacy results. An improvement of catatonic symptoms after ECT treatment was evidenced in ten studies (SMD = -3.14, 95% CI [-3.95; -2.34]). The adverse effects that were reported in seven studies included mental confusion, memory loss, headache, or adverse effects associated with anesthesia. ECT protocols were heterogeneous. The literature consistently describes improvement in catatonic symptoms after ECT. However, the published studies fail to demonstrate efficacy and effectiveness. It is now crucial to design and perform a quality RCT to robustly validate the use of ECT in catatonia.Prospero registration information PROSPERO 2016 CRD42016041660.
Published: 2017
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45. Influence of subthalamic deep-brain stimulation on cognitive action control in incentive context

Author: Gabriel Robert, Claire Haegelen, Paul Sauleau, Thibaut Dondaine, Sophie Drapier, Jean-François Houvenaghel, Florian Naudet, Pierre Jannin, Soizic Argaud, Dominique Drapier, Joan Duprez, Marc Vérin, Service de Neurologie [Rennes] = Neurology [Rennes], CHU Pontchaillou [Rennes], Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de neurochirurgie [Rennes] = Neurosurgery [Rennes], Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), The study wasfunded by University of Rennes1, Equipe Medicis, Ltsi, Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Male, Deep brain stimulation, Cognitive Neuroscience, medicine.medical_treatment, Deep Brain Stimulation, Parkinson's disease, Simon Task, Experimental and Cognitive Psychology, Context (language use), Neuropsychological Tests, Impulsivity, Action selection, Severity of Illness Index, 050105 experimental psychology, 03 medical and health sciences, Behavioral Neuroscience, 0302 clinical medicine, Barratt Impulsiveness Scale, Cognition, Reward, medicine, Reaction Time, Humans, 0501 psychology and cognitive sciences, [SDV.NEU] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Aged, [SDV.IB] Life Sciences [q-bio]/Bioengineering, Motivation, subthalamic nucleus, Chi-Square Distribution, 05 social sciences, Parkinson Disease, Middle Aged, nervous system diseases, Subthalamic nucleus, Incentive, Treatment Outcome, surgical procedures, operative, nervous system, Cognitive control, Female, [SDV.IB]Life Sciences [q-bio]/Bioengineering, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], medicine.symptom, Psychology, therapeutics, 030217 neurology & neurosurgery, Cognitive psychology
Abstract: International audience; Subthalamic nucleus deep-brain stimulation (STN-DBS) is an effective treatment in Parkinson's disease (PD), but can have cognitive side effects, such as increasing the difficulty of producing appropriate responses when a habitual but inappropriate responses represent strong alternatives. STN-DBS also appears to modulate representations of incentives such as monetary rewards. Furthermore, conflict resolution can be modulated by incentive context. We therefore used a rewarded Simon Task to assess the influence of promised rewards on cognitive action control in 50 patients with PD, half of whom were being treated with STN-DBS. Results were analyzed according to the activation-suppression model. We showed that STN-DBS (i) favored the expression of motor impulsivity, as measured with the Barratt Impulsiveness Scale, (ii) facilitated the expression of incentive actions as observed with a greater increase in speed according to promised reward in patients with versus without DBS and (iii) may increase impulsive action selection in an incentive context. In addition, analysis of subgroups of implanted patients suggested that those who exhibited the most impulsive action selection had the least severe disease. This may indicate that patients with less marked disease are more at risk of developing impulsivity postoperatively. Finally, in these patients, incentive context increased the difficulty of resolving conflict situations. As a whole, the current study revealed that in patients with PD, STN-DBS affects the cognitive processes involved in conflict resolution, reward processing and the influence of promised rewards on conflict resolution.
Published: 2016
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46. Exploring 'psychic transparency' during pregnancy: a mixed-methods approach

Author: Jacques Dayan, Bruno Falissard, Asha Dindoyal, Florian Naudet, Sylvie Tordjman, Ouriel Rosenblum, Cécile Oriol, Patrice Poulain, CHU Pontchaillou [Rennes], Laboratoire Psychologie de la Perception (LPP - UMR 8242), Université Paris Descartes - Paris 5 (UPD5)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Guillaume Régnier [Rennes], Neuropsychologie cognitive et neuroanatomie fonctionnelles de la mémoire humaine, Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-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), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Paul Brousse, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse, 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), Troubles du comportement alimentaire de l'adolescent (UMR_S 669), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11), Centre d'Investigation Clinique [Rennes] (CIC), 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), Institut National de la Santé et de la Recherche Médicale, PHUPEA, Laboratoire Psychologie de la Perception ( LPP - UMR 8242 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Centre National de la Recherche Scientifique ( CNRS ), Université de Caen Normandie ( UNICAEN ), Normandie Université ( NU ) -Normandie Université ( NU ) -École pratique des hautes études ( EPHE ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Centre de Recherches Psychanalyse, Médecine et Société ( CRPMS EA 3522 ), Université Paris Diderot - Paris 7 ( UPD7 ), Troubles du comportement alimentaire de l'adolescent ( UMR_S 669 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris-Sud - Paris 11 ( UP11 ), Equipe OUTRE-MER (IPSOM) ( U1178 Inserm ), 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 ) -Université Paris-Sud - Paris 11 ( UP11 ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Service de Psychiatrie de l'adulte [Rennes], Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Université européenne de Bretagne ( UEB ) -Centre Hospitalier Guillaume Régnier, Comportement et noyaux gris centraux [Rennes], Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Université européenne de Bretagne ( UEB ) -CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Centre d'Investigation Clinique [Rennes] ( CIC ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Paris-Sud - Paris 11 ( UP11 ) -Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Paul Brousse, Université Paris-Sud - Paris 11 ( UP11 ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Normandie Université (NU)-Normandie Université (NU)-École Pratique des Hautes Études (EPHE), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), École pratique des hautes études (EPHE)-Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherches Psychanalyse, Médecine et Société (CRPMS), Université Paris Diderot - Paris 7 (UPD7), Equipe OUTRE-MER (IPSOM) (U1178 Inserm), Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-Centre Hospitalier Guillaume Régnier, Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Institut des Neurosciences Cliniques de Rennes (INCR)-CHU Pontchaillou [Rennes]-Université européenne de Bretagne - European University of Brittany (UEB)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), and Jonchère, Laurent
Subjects: Adult, medicine.medical_specialty, Mixed methods, [ SDV.MHEP.PSM ] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, [SDV.MHEP.PSM] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Reproductive medicine, Poison control, [SHS.PSY]Humanities and Social Sciences/Psychology, [ SCCO.PSYC ] Cognitive science/Psychology, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Suicide prevention, Occupational safety and health, Psychic, 03 medical and health sciences, [ SHS.PSY ] Humanities and Social Sciences/Psychology, 0302 clinical medicine, Pregnancy, Injury prevention, Obstetrics and Gynaecology, medicine, Humans, Women, Psychiatry, Qualitative Research, Psychic transparency, Medicine(all), [ SDV ] Life Sciences [q-bio], Obstetrics and Gynecology, Human factors and ergonomics, General Medicine, 16. Peace & justice, medicine.disease, Psychoanalytic Interpretation, humanities, 030227 psychiatry, Dreams, Psychodynamic, [SDV.MHEP.GEO] Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Parity, Reproductive Medicine, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, [SCCO.PSYC]Cognitive science/Psychology, Female, France, Psychology, 030217 neurology & neurosurgery, Clinical psychology, Research Article
Abstract: International audience; Background: Psychic transparency is described as a psychic crisis occurring during pregnancy. The objective was to test if it was clinically detectable. Methods: Seven primiparous and seven nulliparous subjects were recorded during 5 min of spontaneous speech about their dreams. 25 raters from five groups (psychoanalysts, psychiatrists, general practitioners, pregnant women and medical students) listened to the audiotapes. They were asked to rate the probability of the women being pregnant or not. Their ability to discriminate the primiparous women was tested. The probability of being identified correctly or not was calculated for each woman. A qualitative analysis of the speech samples was performed. Results: No group of rater was able to correctly classify pregnant and non-pregnant women. However, the raters' choices were not completely random. The wish to be pregnant or to have a baby could be linked to a primiparous classification whereas job priorities could be linked to a nulliparous classification. Conclusions: It was not possible to detect Psychic transparency in this study. The wish for a child might be easier to identify. In addition, the raters' choices seemed to be connected to social representations of motherhood. © 2016 The Author(s).
Published: 2016
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47. Intracavernous Injections in Spinal Cord Injured Men With Erectile Dysfunction, a Systematic Review and Meta-Analysis

Author: Isabelle Bonan, Clément Chéhensse, M. Damphousse, Lucie Chochina, François Giuliano, Florian Naudet, Andrea Manunta, CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), 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), Service d'urologie [Rennes] = Urology [Rennes], Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Vision, Action et Gestion d'informations en Santé (VisAGeS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Inria Rennes – Bretagne Atlantique, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-SIGNAUX ET IMAGES NUMÉRIQUES, ROBOTIQUE (IRISA-D5), Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), CentraleSupélec-Télécom Bretagne-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de Recherche en Informatique et en Automatique (Inria)-École normale supérieure - Rennes (ENS Rennes)-Université de Bretagne Sud (UBS)-Centre National de la Recherche Scientifique (CNRS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-CentraleSupélec-Télécom Bretagne-Université de Rennes 1 (UR1), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École normale supérieure - Rennes (ENS Rennes)-Université de Bretagne Sud (UBS)-Centre National de la Recherche Scientifique (CNRS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA), Laboratoire Mouvement Sport Santé (M2S), École normale supérieure - Cachan (ENS Cachan)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université de Rennes 2 (UR2), Université de Rennes (UNIV-RENNES)-Université de Brest (UBO)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Handicap neuromusculaire : Physiopathologie, Biothérapie et Pharmacologies appliquées (END-ICAP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS), École normale supérieure - Cachan (ENS Cachan)-Université de Rennes (UR)-Université de Brest (UBO)-Université de Rennes 2 (UR2)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), and Jonchère, Laurent
Subjects: Male, 030506 rehabilitation, Urology, Endocrinology, Diabetes and Metabolism, Vasodilator Agents, Population, 030232 urology & nephrology, Intracavernous injection, Quadriplegia, law.invention, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Randomized controlled trial, Erectile Dysfunction, law, Papaverine, Medicine, Humans, Orthopedics and Sports Medicine, Prospective Studies, Alprostadil, education, Spinal cord injury, Spinal Cord Injuries, Retrospective Studies, Paraplegia, education.field_of_study, business.industry, Penile Erection, Rehabilitation, Obstetrics and Gynecology, medicine.disease, 3. Good health, Psychiatry and Mental health, Erectile dysfunction, Reproductive Medicine, Moxisylyte, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Anesthesia, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, 0305 other medical science, business, Sexual function, 030217 neurology & neurosurgery, medicine.drug
Abstract: International audience; Introduction: Despite improvements in the care of patients after spinal cord injury (SCI), permanent impairment of locomotion, sensation, and autonomic function remains a major hurdle. After the acute stage of injury, recovering sexual function is a high priority.Aim: To review the efficacy of intracavernous injections (ICIs) in men with SCI and to identify prognostic factors affecting the efficacy of ICIs in this population.Methods: Systematic review of the literature was conducted using the PubMed-Medline, Embase, EBSCO, Web of Science, and Cochrane Library databases. The literature search was restricted to articles published in English, French, and Spanish up to November 2014 using the key words alprostadil, papaverine, moxisylite, alpha-blocking agent, phentolamine, intracavernous injection, spinal cord injuries, paraplegia, quadriplegia, and erectile dysfunction. Studies involving patients with SCI and erectile dysfunction treated with ICIs of alprostadil, papaverine, and α-blocking agents, including retrospective and prospective cohorts, population studies, and randomized controlled trials, were included.Main Outcome Measure:Overall response rate to ICI for erectile dysfunction in patients with SCI.Results: Of 283 studies identified, 23 involved 713 patients with SCI. ICIs resulted in successful erections in 88% of patients (n = 713, 95% CI = 83%–92%). Erections were obtained in 93% of patients (n = 101, 95% CI = 83%–99%) with the combination of papaverine and phentolamine, in 91% (n = 274, 95% CI = 78%–97%) with papaverine alone, and in 80% (n = 119, 95% CI = 64%–90%) with alprostadil. Type of injected drug, doses, level of injury (complete or incomplete), extent of injury, age, time since injury, and persistence or transience of erections were evaluated, but statistical analysis could not identify specific factors predictive of a response to ICI.Conclusion: ICIs are an effective treatment of erectile dysfunction in men with SCI. No predictive factor for efficacy could be identified. Studies comparing the response to ICI in upper vs lower motor neuron lesions could improve our understanding of ICI failure.
Published: 2016
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48. Controlled Attenuation Parameter and Liver Stiffness Measurements for Steatosis Assessment in the Liver Transplant of Brain Dead Donors

Author: Florian Naudet, Paul Carrier, Eric Bellissant, François Labrousse, Claire Mancia, Nicolas Pichon, Véronique Loustaud-Ratti, 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), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), CHU Limoges, Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR), Troubles du comportement alimentaire de l'adolescent (UMR_S 669), Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes], Homéostasie Cellulaire et Pathologies (HCP), Université de Limoges (UNILIM)-CHU Limoges-Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503), Service d'Hématologie biologique [CHU Limoges], Université de Limoges (UNILIM), Centre d'Investigation Clinique de Limoges (CIC1435), CHU Limoges-Institut National de la Santé et de la Recherche Médicale (INSERM), 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)-CHU Limoges, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), 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 ), Université de Limoges ( UNILIM ) -Université de Limoges ( UNILIM ), Comportement et noyaux gris centraux [Rennes], Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Université européenne de Bretagne ( UEB ) -CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Troubles du comportement alimentaire de l'adolescent ( UMR_S 669 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris-Sud - Paris 11 ( UP11 ), Centre d'Investigation Clinique [Rennes] ( CIC ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Service de Pharmacologie, Homéostasie Cellulaire et Pathologies ( HCP ), Université de Limoges ( UNILIM ) -CHU Limoges-Génomique, Environnement, Immunité, Santé, Thérapeutique ( GEIST FR CNRS 3503 ), Université de Limoges ( UNILIM ), Centre d'Investigation Clinique de Limoges ( CIC1435 ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -CHU Limoges, Institut des Neurosciences Cliniques de Rennes (INCR)-CHU Pontchaillou [Rennes]-Université européenne de Bretagne - European University of Brittany (UEB)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), and Université de Limoges (UNILIM)-Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503)-CHU Limoges
Subjects: Adult, Liver Cirrhosis, Male, Brain Death, medicine.medical_specialty, Biopsy, [SDV]Life Sciences [q-bio], Urology, 030230 surgery, Severity of Illness Index, Decision Support Techniques, Donor Selection, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Predictive Value of Tests, medicine, Humans, Prospective Studies, Aged, Transplantation, medicine.diagnostic_test, Receiver operating characteristic, [ SDV ] Life Sciences [q-bio], Donor selection, business.industry, Middle Aged, medicine.disease, Tissue Donors, Confidence interval, Liver Transplantation, Surgery, Fatty Liver, Liver, ROC Curve, Area Under Curve, Predictive value of tests, Liver biopsy, Elasticity Imaging Techniques, Female, 030211 gastroenterology & hepatology, France, Steatosis, business
Abstract: International audience; Background - One of the main selection criteria of the quality of a liver graft is the degree of steatosis, which will determine the success of the transplantation. The aim of this study was to evaluate the ability of FibroScan and its related methods Controlled Attenuation Parameter and Liver Stiffness to assess objectively steatosis and fibrosis in livers from brain-dead donors to be potentially used for transplantation. Methods - Over a period of 10 months, 23 consecutive brain dead donors screened for liver procurement underwent a FibroScan and a liver biopsy. Results - The different predictive models of liver retrievability using liver biopsy as the gold standard have led to the following area under receiver operating characteristic curve: 76.6% (95% confidence intervals [95% CIs], 48.2%-100%) when based solely on controlled attenuation parameter, 75.0% (95% CIs, 34.3%-100%) when based solely on liver stiffness, and 96.7% (95% CIs, 88.7%-100%) when based on combined indices. Conclusions - Our study suggests that a preoperative selection of brain-dead donors based on a combination of both Controlled Attenuation Parameter and Liver Stiffness obtained with FibroScan could result in a good preoperative prediction of the histological status and degree of steatosis of a potential liver graft.
Published: 2015
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49. Preoperative brain metabolism and quality of life after subthalamic nucleus stimulation in Parkinson's disease

Author: Florence Le Jeune, Pierre Jannin, Marc Vérin, Claire Haegelen, Sophie Drapier, Paul Sauleau, Jean-François Houvenaghel, Florian Naudet, Nathalie Le Clanche, Sophie Langner-Lemercier, CHU Pontchaillou [Rennes], Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de neurochirurgie [Rennes] = Neurosurgery [Rennes], Service de Neurologie [Rennes] = Neurology [Rennes], Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Male, medicine.medical_specialty, Parkinson's disease, Neurology, Deep Brain Stimulation, Context (language use), Quality of life, Subthalamic Nucleus, Internal medicine, Humans, Medicine, ComputingMilieux_MISCELLANEOUS, Aged, Neuroradiology, business.industry, [SCCO.NEUR]Cognitive science/Neuroscience, Neuropsychology, Parkinson Disease, Middle Aged, medicine.disease, nervous system diseases, 3. Good health, Surgery, Patient Outcome Assessment, surgical procedures, operative, nervous system, Dyskinesia, Positron-Emission Tomography, Preoperative Period, Quality of Life, Cardiology, Biomarker (medicine), Female, Neurology (clinical), medicine.symptom, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: Subthalamic nucleus deep brain stimulation (STN-DBS) has been proven to improve health-related quality of life (HRQoL) in patients with Parkinson’s disease (PD) presenting medically refractory motor complications and dyskinesia. However, some patients fail to benefit from STN-DBS despite rigorous preoperative selection. We postulated that they have a particular, clinically ineloquent, brain metabolism before surgery. We divided 40 stimulated PD patients into two groups (responders vs. nonresponders) depending on whether they reported or not a clinically significant improvement in their quality of life 1 year after surgery. We retrospectively compared their preoperative brain metabolism on the basis of 18F-fluorodeoxyglucose positron emission tomography (18F-FDG PET) scans. We also analyzed their neuropsychological and psychiatric profiles before and after surgery. All 40 patients met the STN-DBS selection criteria, but only 50 % of them had significantly improved 1 year after surgery. Preoperative PET scans showed that metabolism was higher in the left insula, both inferior frontal gyri and left precentral gyrus in nonresponders than in responders. Clinically, postoperative motor scores were similar in both groups, but a worsening of the depression score was observed among nonresponders. PET imaging revealed that nonresponders were characterized by distinctive brain functioning pre-surgery, in regions involved in associative and limbic circuits, as a result of PD-related degeneration. STN-DBS may have interfered with this already abnormal circuitry, leading to the occurrence of complex nonmotor symptoms reducing quality of life. Preoperative brain metabolism could be a useful biomarker for anticipating STN-DBS efficacy in terms of HRQoL in the context of advanced PD.
Published: 2015
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50. Cardiovascular risk and androgen deprivation therapy for prostate cancer: systematic review and meta-analysis of randomised controlled trials and observational studies (METADTCR)

Author: S. Vincendeau, Lucie-Marie Scailteux, Quentin Alimi, Emmanuel Oger, Florian Naudet, Centre d'Investigation Clinique [Rennes] (CIC), 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), Troubles du comportement alimentaire de l'adolescent (UMR_S 669), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11), CIC-IT Rennes, Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes], Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Pharmacologie, Centre d'Investigation Clinique [Rennes] ( CIC ), 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 ), Troubles du comportement alimentaire de l'adolescent ( UMR_S 669 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris-Sud - Paris 11 ( UP11 ), and Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale ( INSERM )
Subjects: Pharmacology, Oncology, medicine.medical_specialty, [ SDV ] Life Sciences [q-bio], business.industry, [SDV]Life Sciences [q-bio], 02 engineering and technology, 030204 cardiovascular system & hematology, medicine.disease, 3. Good health, Andrology, Androgen deprivation therapy, 03 medical and health sciences, Prostate cancer, 020210 optoelectronics & photonics, 0302 clinical medicine, Internal medicine, Meta-analysis, 0202 electrical engineering, electronic engineering, information engineering, medicine, Pharmacology (medical), Observational study, business, ComputingMilieux_MISCELLANEOUS
Abstract: International audience; no abstract
Published: 2015
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