• Mark R Williams, Andrew McKeown, Zachary Pressman, Matthew Hunsinger, Kendrick Lee, Paul Coplan, Ian Gilron, Nathaniel P Katz, Michael P McDermott, Srinivasa N Raja, Bob A Rappaport, Michael C Rowbotham, Dennis C Turk, Robert H Dworkin, and Shannon M Smith.
• Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York.
• J Pain. 2016 Nov 1; 17 (11): 1137-1149.

AbstractThorough 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.Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

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