title: Adverse Event Reporting in Clinical Trials of Intravenous and Invasive Pain Treatments: An ACTTION Systematic Review.
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.
  
  
  
  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.
authors: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York.
authors: Mark R
authors: MR
authors: Williams
authors: School of Public Health, City University of New York-Hunter College, New York, New York.
authors: Andrew
authors: A
authors: McKeown
authors: St. Louis University School of Medicine, St. Louis, Missouri.
authors: Zachary
authors: Z
authors: Pressman
authors: School of Professional Psychology, Pacific University, Hillsboro, Oregon.
authors: Matthew
authors: M
authors: Hunsinger
authors: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York.
authors: Kendrick
authors: K
authors: Lee
authors: Purdue Pharma, LP, Stamford, Connecticut; Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
authors: Paul
authors: P
authors: Coplan
authors: Departments of Anesthesiology and Perioperative Medicine and Biomedical and Molecular Sciences, Queen's University, Kingston, Ontario, Canada.
authors: Ian
authors: I
authors: Gilron
authors: Analgesic Solutions, Natick, Massachusetts; Department of Anesthesiology and Perioperative Medicine, Tufts University, Boston, Massachusetts.
authors: Nathaniel P
authors: NP
authors: Katz
authors: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York.
authors: Michael P
authors: MP
authors: McDermott
authors: Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors: Srinivasa N
authors: SN
authors: Raja
authors: Analgesic Concepts, Arlington, Virginia.
authors: Bob A
authors: BA
authors: Rappaport
authors: 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.
authors: Michael C
authors: MC
authors: Rowbotham
authors: Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington.
authors: Dennis C
authors: DC
authors: Turk
authors: Center for Human Experimental Therapeutics, and Departments of Anesthesiology, Neurology, and Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, New York.
authors: Robert H
authors: RH
authors: Dworkin
authors: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York. Electronic address: shannon1_smith@urmc.rochester.edu.
authors: Shannon M
authors: SM
authors: Smith
mesh_terms: D061605:Administration, Intravenous; D000700:Analgesics / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D016206:Databases, Bibliographic / Q000706:statistics & numerical data; D006801:Humans; D010146:Pain / Q000188:drug therapy*
chemical_list: D000700:Analgesics
keywords: Adverse event; clinical trial; intravenous; invasive; pain; reporting