Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder.
OBJECTIVE
To investigate adverse event (AE) reporting practices in a systematic review of randomized controlled trials for persistent depressive disorder (PDD).


METHODS
A 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.


RESULTS
Sixty 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).


CONCLUSIONS
There is a strong need to improve the current practice of assessing, analyzing, and reporting AEs, especially for psychotherapeutic studies.
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany. Electronic address: r.meister@uke.de.
Ramona
R
Meister
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
Alessa
A
von Wolff
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
Hannes
H
Mohr
Clinical Psychology and Psychotherapy, Institute of Psychology, University of Hamburg, Von-Melle-Park 5, 20146 Hamburg, Germany.
Yvonne
Y
Nestoriuc
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
Martin
M
Härter
Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Hauptstrasse 5, 79104 Freiburg, Germany.
Lars
L
Hölzel
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
Levente
L
Kriston
D000928:Antidepressive Agents / Q000009:adverse effects*; D002908:Chronic Disease; D003866:Depressive Disorder / Q000188:drug therapy / Q000628:therapy*; D006801:Humans; D011613:Psychotherapy / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012107:Research Design; D058028:Research Report
D000928:Antidepressive Agents
Adverse events; Chronic depression; Evidence-based medicine; Harms; Persistent depressive disorder; Pharmacotherapy; Psychotherapy; Randomized controlled trials; Side effects; Systematic review