title: Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations.
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.
authors.affiliation: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. shannon1_smith@urmc.rochester.edu
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Smith
authors.forename: Anthony T
authors.initials: AT
authors.lastname: Wang
authors.forename: Nathaniel P
authors.initials: NP
authors.lastname: Katz
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.forename: Laurie B
authors.initials: LB
authors.lastname: Burke
authors.forename: Paul
authors.initials: P
authors.lastname: Coplan
authors.forename: Ian
authors.initials: I
authors.lastname: Gilron
authors.forename: Sharon H
authors.initials: SH
authors.lastname: Hertz
authors.forename: Allison H
authors.initials: AH
authors.lastname: Lin
authors.forename: Bob A
authors.initials: BA
authors.lastname: Rappaport
authors.forename: Michael C
authors.initials: MC
authors.lastname: Rowbotham
authors.forename: Cristina
authors.initials: C
authors.lastname: Sampaio
authors.forename: Michael
authors.initials: M
authors.lastname: Sweeney
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards* / Q000706:statistics & numerical data*; D000700:Analgesics / Q000627:therapeutic use*; D017723:Drug Utilization Review; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005060:Europe / Q000453:epidemiology; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D019221:Mandatory Reporting; D010146:Pain / Q000188:drug therapy* / Q000453:epidemiology; D017410:Practice Guidelines as Topic; D015995:Prevalence; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D016896:Treatment Outcome
chemical_list: D000700:Analgesics