• Ramona Meister, Alessa von Wolff, Hannes Mohr, Yvonne Nestoriuc, Martin Härter, Lars Hölzel, and Levente Kriston.
• Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany. Electronic address: r.meister@uke.de.
• J Clin Epidemiol. 2016 Mar 1; 71: 97-108.

ObjectivesTo investigate adverse event (AE) reporting practices in a systematic review of randomized controlled trials for persistent depressive disorder (PDD).Study Design And SettingA systematic electronic database search was conducted up to October 2014 to identify randomized controlled trials investigating pharmacologic, psychotherapeutic, and combined treatments for PDD in adults. We calculated the number and percentage of studies that reported predefined AE information. All calculations were carried out including all studies and stratified for study type (pharmacologic, psychotherapeutic, and mixed) and publication year [before and after the publication of the Consolidated Standards of Reporting Trials (CONSORT) extension for harms in 2004], respectively.ResultsSixty studies, reported in 126 publications, were included. Across all studies, reporting of AE information was insufficient. Substantial differences between studies that investigated different treatments emerged. Most pharmacologic studies (39/42) and mixed studies (7/9) reported any AE information, although the amount of information varied and the reported methods to assess and analyze AEs were heterogeneous. We found no substantial change in reporting practices after the publication of the CONSORT extension. Psychotherapeutic studies, although almost entirely published after the CONSORT extension, largely neglected reporting of any AE information (1/9).ConclusionsThere is a strong need to improve the current practice of assessing, analyzing, and reporting AEs, especially for psychotherapeutic studies.Copyright © 2016 Elsevier Inc. All rights reserved.

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