Adverse event assessment,analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations |
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| Authors: | Shannon M. Smith Anthony T. Wang Nathaniel P. Katz Michael P. McDermott Laurie B. Burke Paul Coplan Ian Gilron Sharon H. Hertz Allison H. Lin Bob A. Rappaport Michael C. Rowbotham Cristina Sampaio Michael Sweeney Dennis C. Turk Robert H. Dworkin |
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| Affiliation: | 1. Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA;2. School of Medicine, Case Western Reserve University, Cleveland, OH, USA;3. Analgesic Solutions, Natick, MA, USA;4. Tufts University, Boston, MA, USA;5. Departments of Biostatistics and Computational Biology and Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA;6. United States Food and Drug Administration, Silver Spring, MD, USA;g Purdue Pharma, LP, Stamford, CT, USA;h University of Pennsylvania, Philadelphia, PA, USA;i Queen’s University, Kingston, ON, Canada;j California Pacific Medical Center Research Institute, San Francisco, CA, USA;k CHDI, New York, NY, USA;l Depomed, Menlo Park, CA, USA;m Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA;n Departments of Anesthesiology and Neurology and Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA |
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| Abstract: | The development of valid and informative treatment risk–benefit profiles requires consistent and thorough information about adverse event (AE) assessment and participants’ AEs during randomized controlled trials (RCTs). Despite a 2004 extension of the Consolidated Standards of Reporting Trials (CONSORT) statement recommending the specific AE information that investigators should report, there is little evidence that analgesic RCTs adequately adhere to these recommendations. This systematic review builds on prior recommendations by describing a comprehensive checklist for AE reporting developed to capture clinically important AE information. Using this checklist, we coded AE assessment methods and reporting in all 80 double-blind RCTs of noninvasive pharmacologic treatments published in the European Journal of Pain, Journal of Pain, and PAIN® from 2006 to 2011. Across all trials, reports of AEs were frequently incomplete, inconsistent across trials, and, in some cases, missing. For example, >40% of trials failed to report any information on serious adverse events. Trials of participants with acute or chronic pain conditions and industry-sponsored trials typically provided more and better-quality AE data than trials involving pain-free volunteers or trials that were not industry sponsored. The results of this review suggest that improved AE reporting is needed in analgesic RCTs. We developed an ACTTION (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks) AE reporting checklist that is intended to assist investigators in thoroughly and consistently capturing and reporting these critically important data in publications. |
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| Keywords: | Adverse events Clinical trials Analgesic medications Systematic review CONSORT |
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