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Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder

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Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder. / Meister, Ramona; von Wolff, Alessa; Mohr, Hannes; Nestoriuc, Yvonne; Härter, Martin; Hölzel, Lars; Kriston, Levente.

In: J CLIN EPIDEMIOL, Vol. 71, 2016, p. 97-108.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Meister, R, von Wolff, A, Mohr, H, Nestoriuc, Y, Härter, M, Hölzel, L & Kriston, L 2016, 'Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder', J CLIN EPIDEMIOL, vol. 71, pp. 97-108. https://doi.org/10.1016/j.jclinepi.2015.10.007

APA

Meister, R., von Wolff, A., Mohr, H., Nestoriuc, Y., Härter, M., Hölzel, L., & Kriston, L. (2016). Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder. J CLIN EPIDEMIOL, 71, 97-108. https://doi.org/10.1016/j.jclinepi.2015.10.007

Vancouver

Meister R, von Wolff A, Mohr H, Nestoriuc Y, Härter M, Hölzel L et al. Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder. J CLIN EPIDEMIOL. 2016;71:97-108. https://doi.org/10.1016/j.jclinepi.2015.10.007

Bibtex

@article{557b3ab81a5e427991055112cabfda1e,
title = "Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder",
abstract = "OBJECTIVE: To investigate adverse event (AE) reporting practices in a systematic review of randomized controlled trials for persistent depressive disorder (PDD).STUDY DESIGN AND SETTING: 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, mixed) and publication year (before and after the publication of the 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.",
author = "Ramona Meister and {von Wolff}, Alessa and Hannes Mohr and Yvonne Nestoriuc and Martin H{\"a}rter and Lars H{\"o}lzel and Levente Kriston",
note = "Copyright {\textcopyright} 2015 Elsevier Inc. All rights reserved.",
year = "2016",
doi = "10.1016/j.jclinepi.2015.10.007",
language = "English",
volume = "71",
pages = "97--108",
journal = "J CLIN EPIDEMIOL",
issn = "0895-4356",
publisher = "Elsevier USA",

}

RIS

TY - JOUR

T1 - Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder

AU - Meister, Ramona

AU - von Wolff, Alessa

AU - Mohr, Hannes

AU - Nestoriuc, Yvonne

AU - Härter, Martin

AU - Hölzel, Lars

AU - Kriston, Levente

N1 - Copyright © 2015 Elsevier Inc. All rights reserved.

PY - 2016

Y1 - 2016

N2 - OBJECTIVE: To investigate adverse event (AE) reporting practices in a systematic review of randomized controlled trials for persistent depressive disorder (PDD).STUDY DESIGN AND SETTING: 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, mixed) and publication year (before and after the publication of the 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.

AB - OBJECTIVE: To investigate adverse event (AE) reporting practices in a systematic review of randomized controlled trials for persistent depressive disorder (PDD).STUDY DESIGN AND SETTING: 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, mixed) and publication year (before and after the publication of the 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.

U2 - 10.1016/j.jclinepi.2015.10.007

DO - 10.1016/j.jclinepi.2015.10.007

M3 - SCORING: Journal article

C2 - 26482955

VL - 71

SP - 97

EP - 108

JO - J CLIN EPIDEMIOL

JF - J CLIN EPIDEMIOL

SN - 0895-4356

ER -