PMID- 27522950 OWN - NLM STAT- MEDLINE DCOM- 20170919 LR - 20181202 IS - 1528-8447 (Electronic) IS - 1526-5900 (Linking) VI - 17 IP - 11 DP - 2016 Nov TI - Adverse Event Reporting in Clinical Trials of Intravenous and Invasive Pain Treatments: An ACTTION Systematic Review. PG - 1137-1149 LID - S1526-5900(16)30158-4 [pii] LID - 10.1016/j.jpain.2016.07.006 [doi] AB - 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. CI - Copyright A(c) 2016 American Pain Society. Published by Elsevier Inc. All rights reserved. FAU - Williams, Mark R AU - Williams MR AD - Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York. FAU - McKeown, Andrew AU - McKeown A AD - School of Public Health, City University of New York-Hunter College, New York, New York. FAU - Pressman, Zachary AU - Pressman Z AD - St. Louis University School of Medicine, St. Louis, Missouri. FAU - Hunsinger, Matthew AU - Hunsinger M AD - School of Professional Psychology, Pacific University, Hillsboro, Oregon. FAU - Lee, Kendrick AU - Lee K AD - Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York. FAU - Coplan, Paul AU - Coplan P AD - Purdue Pharma, LP, Stamford, Connecticut; Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania. FAU - Gilron, Ian AU - Gilron I AD - Departments of Anesthesiology and Perioperative Medicine and Biomedical and Molecular Sciences, Queen's University, Kingston, Ontario, Canada. FAU - Katz, Nathaniel P AU - Katz NP AD - Analgesic Solutions, Natick, Massachusetts; Department of Anesthesiology and Perioperative Medicine, Tufts University, Boston, Massachusetts. FAU - McDermott, Michael P AU - McDermott MP AD - Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York. FAU - Raja, Srinivasa N AU - Raja SN AD - Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland. FAU - Rappaport, Bob A AU - Rappaport BA AD - Analgesic Concepts, Arlington, Virginia. FAU - Rowbotham, Michael C AU - Rowbotham MC AD - California Pacific Medical Center Research Institute, San Francisco, California; Department of Anesthesia and Perioperative Care, University of California, San Francisco School of Medicine, San Francisco, California. FAU - Turk, Dennis C AU - Turk DC AD - Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington. FAU - Dworkin, Robert H AU - Dworkin RH AD - Center for Human Experimental Therapeutics, and Departments of Anesthesiology, Neurology, and Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York. FAU - Smith, Shannon M AU - Smith SM AD - Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York. Electronic address: shannon1_smith@urmc.rochester.edu. LA - eng GR - U01 FD005936/FD/FDA HHS/United States PT - Journal Article PT - Review PT - Systematic Review DEP - 20160812 PL - United States TA - J Pain JT - The journal of pain JID - 100898657 RN - 0 (Analgesics) SB - IM MH - Administration, Intravenous MH - Analgesics/*adverse effects MH - *Clinical Trials as Topic MH - Databases, Bibliographic/statistics & numerical data MH - Humans MH - Pain/*drug therapy OTO - NOTNLM OT - Adverse event OT - clinical trial OT - intravenous OT - invasive OT - pain OT - reporting EDAT- 2016/08/16 06:00 MHDA- 2017/09/20 06:00 CRDT- 2016/08/16 06:00 PHST- 2016/04/19 00:00 [received] PHST- 2016/06/27 00:00 [revised] PHST- 2016/07/25 00:00 [accepted] PHST- 2016/08/16 06:00 [pubmed] PHST- 2017/09/20 06:00 [medline] PHST- 2016/08/16 06:00 [entrez] AID - S1526-5900(16)30158-4 [pii] AID - 10.1016/j.jpain.2016.07.006 [doi] PST - ppublish SO - J Pain. 2016 Nov;17(11):1137-1149. doi: 10.1016/j.jpain.2016.07.006. Epub 2016 Aug 12.