Highlights
- •Only 5 of 10 Consolidated Standards of Reporting Trials harms recommendations were fulfilled on average.
- •Adverse event (AE) assessments, number of AEs, and denominators were well reported.
- •The specific AEs evaluated and withdrawals due to AEs were less well reported.
- •Little improvement in AE reporting occurred between 2000 to 2003 and 2008 to 2012.
- •8% of the reviewed articles failed to report any information on AEs.
Abstract
Thorough assessment and reporting of adverse events (AEs) facilitates a detailed understanding
of a treatment's risk–benefit profile. Although the Consolidated Standards of Reporting
Trials (CONSORT) 2004 statement provides recommendations regarding AE reporting, adherence
to these standards is often inadequate. We investigated AE reporting in clinical trials
of intravenous and invasive pain treatments published in 6 major anesthesiology and
pain journals between 2000 to 2003 and 2006 to 2012. We examined whether AE reporting
improved after publication of the 2004 CONSORT recommendations and also comprehensively
reviewed AE assessment using the Analgesic, Anesthetic, and Addiction Clinical Trial
Translations, Innovations, Opportunities, and Networks (ACTTION) AE reporting recommendations.
No improvement was found overall in CONSORT harms reporting scores from pre- to postpublication
of the CONSORT recommendations, with only 5 of 10 fulfilled on average. AE reporting
assessed using the ACTTION coding manual was generally inadequate, and 8% of articles
failed to report any AE information at all. Anesthesiology and pain journals were
similar in AE reporting quality, although industry-sponsored trials reported more
AE information than nonindustry sponsored trials. Improvement is needed in AE reporting
in analgesic clinical trials. The CONSORT checklist and ACTTION AE recommendations
can assist investigators and editors in improving clinical trial transparency and
quality.
Perspective
This systematic review of AE reporting in intravenous and invasive pain treatment
trials shows that little improvement has been made since the 2004 CONSORT harms reporting
guidelines. Better assessment and reporting of treatment AEs is necessary to understand
the full clinical effect of intravenous and invasive treatments.
Key words
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Article info
Publication history
Published online: August 11, 2016
Footnotes
Financial support for this project was provided by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration (FDA). ACTTION has received research contracts, grants, or other revenue from the FDA, multiple pharmaceutical and device companies, and other sources. The views expressed in this article are those of the authors, none of whom have financial conflicts of interest specifically related to the issues discussed in this article. No official endorsement by the FDA or the pharmaceutical and device companies that have provided unrestricted grants to support the activities of ACTTION should be inferred.
Supplementary data accompanying this article are available online at www.jpain.org and www.sciencedirect.com.
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© 2016 by the American Pain Society
