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1. Improving study design for antidepressant effectiveness assessment

Author

Naudet, Florian, Millet, Bruno, Reymann, Jean-Michel, Falissard, Bruno, 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), 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, Centre Hospitalier Guillaume Régnier, Service de Pharmacologie [Rennes], CHU Pontchaillou [Rennes], This paper was supported by the Institut National de la Santé et de la Recherche Médicale (INSERM)., Le Corre, Morgane, 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 (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 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), Service de Pharmacologie, and 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)

Subjects
Depressive Disorder, Major, clinical trials, [SDV.SP.MED] Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Psychometrics, [ SDV.MHEP.PSM ] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, [ SDV.SP.MED ] Life Sciences [q-bio]/Pharmaceutical sciences/Medication, [SDV.MHEP.PSM] Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Reproducibility of Results, effectiveness, methodology, Original Articles, Personality Assessment, Antidepressive Agents, Observational Studies as Topic, Double-Blind Method, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Research Design, Surveys and Questionnaires, antidepressants, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Outcome Assessment, Health Care, depression, Humans, Randomized Controlled Trials as Topic
Abstract

Antidepressants effectiveness in major depressive disorder (MDD) is still questioned because the extrapolation of randomized controlled trial (RCT) results to “real life” settings is problematic. The application of the RCT paradigm in a disorder of this type, where global care plays a central role, raises questions regarding the internal and external validity of this type of study. Outcome measurement, attrition rates, the ability of the double‐blind design to control for expectations, placebo response, the representativeness of trial participants and publication bias are major methodological pitfalls. This review discusses these issues. It is illustrated using original data and proposes some alternatives for assessing antidepressant effectiveness via different approaches. Some are easy to implement, such as ecological measures, qualitative approaches, improvement of analytical strategy and improvement of blinding procedures. Some are sophisticated, involving temporary deception to deal with the confounding effect of expectations, and they raise ethical issues. Others resort to external validity, this being the case in observational studies. But all are necessary to explore antidepressant effectiveness. Copyright © 2013 John Wiley & Sons, Ltd.

Published
2013

2. 'Serving Two Masters' and the Chief Audit Executive's Communication: Experimental Evidence About Internal Auditors’ Judgments

Author

Florian Hoos, Anne d'Arcy, Natalia Kochetova-Kozloski, Haldemann, Antoine, Groupement de Recherche et d'Etudes en Gestion à HEC (GREGH), Ecole des Hautes Etudes Commerciales (HEC Paris)-Centre National de la Recherche Scientifique (CNRS), and HEC Paris Research Paper Series

Subjects
corporate governance, internal audit function, effectiveness, internal controls, Control environment, Engineering, media_common.quotation_subject, Applied psychology, Audit committee, Accounting, Chief audit executive, Joint audit, jel:M42, jel:M48, JEL: M - Business Administration and Business Economics • Marketing • Accounting • Personnel Economics/M.M4 - Accounting and Auditing/M.M4.M48 - Government Policy and Regulation, Set (psychology), media_common, business.industry, Corporate governance, Ambiguity, jel:G34, Internal audit, [SHS.GESTION]Humanities and Social Sciences/Business administration, JEL: M - Business Administration and Business Economics • Marketing • Accounting • Personnel Economics/M.M4 - Accounting and Auditing/M.M4.M42 - Auditing, business, [SHS.GESTION] Humanities and Social Sciences/Business administration
Abstract

The position of an internal audit function as a “servant of two masters” (i.e. management and the audit committee) may lead to a conflict of priorities. In this setting, the tone at the top set by the Chief Audit Executive (CAE) plays a critical role in balancing the potentially competing preferences of management and the audit committee. We examine whether the emphasis in the CAE’s communication with internal auditors influences their judgments. We also test whether such influence is more pronounced in an internal audit task where potential for justification created through task complexity and ambiguity is high, as compared to low. We test two hypotheses in a mixed experimental design with the communicated preferences of the CAE to subordinates (cost reduction vs. effectiveness of internal controls) as a between-subjects factor, and levels of opportunity for justification (low, medium, high) manipulated within subjects. Findings suggest that the emphasis in the CAE’s message can bias internal auditors’ judgments, and such influence is more pronounced when the opportunity for justification is high, resulting in the elimination of a significantly greater number of internal controls and the design of less effective processes.

Published
2013