Duggan, C., Parry, G., McMurran, M. et al. (2 more authors) (2014) The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials. Trials, 15. 335. ISSN 1745-6215
Abstract
Background:
There is a concern in the literature that harm from interventions is insufficiently documented in clinical trials in general, and in those assessing psychological treatments in particular. A recent decision by a trial steering committee to stop recruitment into a randomized controlled trial (RCT) of a psychological intervention for personality disorder led to an investigation of the recording of harm in trials funded by the National Institute for Health Research (NIHR).
Methods:
The protocols and final reports of all 82 NIHR trials funded between 1995 and 2013 were examined for the reporting of adverse events. These were subdivided by category of intervention.
Results:
None of the psychological intervention trials mentioned the occurrence of an adverse event in their final report. Trials of drug treatments were more likely to mention adverse events in their protocols compared with those using psychological treatments. When adverse events were mentioned, the protocols of psychological interventions relied heavily on severe adverse events guidelines from the National Research Ethics Service (NRES), which were developed for drug rather than psychological interventions and so may not be appropriate for the latter.
Conclusions:
This survey supported the belief that the reporting of adverse events in psychological treatments is weak and the criteria used may not be appropriate. Recommendations are made as to how current practice might be improved.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2014 Duggan et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
Keywords: | Harm; Adverse events; Psychological interventions; Clinical trials |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 01 Dec 2015 16:45 |
Last Modified: | 01 Dec 2015 16:45 |
Published Version: | http://dx.doi.org/10.1186/1745-6215-15-335 |
Status: | Published |
Publisher: | BioMed Central |
Refereed: | Yes |
Identification Number: | 10.1186/1745-6215-15-335 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:91044 |