title: Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review.
abstract: Assessment of treatment safety is 1 of the primary goals of clinical trials. Organizations and working groups have created reporting guidelines for adverse events (AEs). Previous research examining AE reporting for pharmacologic clinical trials of analgesics in major pain journals found many reporting inadequacies, suggesting that analgesic trials are not adhering to existing AE reporting guidelines. The present systematic review documented AE reporting in 3 main pain journals for nonpharmacologic, noninterventional (NP/NI) trials examining pain treatments. To broaden our pool of nonpharmacologic trials, we also included trials examining acupuncture, leech therapy, and noninvasive stimulation techniques (eg, transcutaneous electrical nerve stimulation). We documented AE reporting at 2 levels of specificity using coding manuals based on the Consolidated Standards of Reporting Trials (CONSORT) harms reporting standards and Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) AE reporting checklist. We identified a number of inadequacies in AE reporting across the 3 journals. For example, using the ACTTION coding manual, we found that less than one-half of the trials reported specific AE assessment methods; approximately one-third of the trials reported withdrawals due to AEs for each study arm; and about one-fourth of the trials reported all specific AEs. We also examined differences in AE reporting across several trial characteristics, finding that AE reporting was generally more detailed in trials with patients versus those using healthy volunteers undergoing experimentally evoked pain. These results suggest that investigators conducting and reporting NP/NI clinical trials are not adequately describing the assessment and occurrence of AEs.
authors.affiliation: School of Professional Psychology, Pacific University, Hillsboro, OR, USA. Electronic address: matthewh@pacificu.edu.
authors.forename: Matthew
authors.initials: M
authors.lastname: Hunsinger
authors.affiliation: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Smith
authors.affiliation: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Rothstein
authors.affiliation: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: McKeown
authors.affiliation: Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Parkhurst
authors.affiliation: United States Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Sharon
authors.initials: S
authors.lastname: Hertz
authors.affiliation: Analgesic Solutions, Natick, MA, and Tufts University, Boston, MA, USA.
authors.forename: Nathaniel P
authors.initials: NP
authors.lastname: Katz
authors.affiliation: United States Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Allison H
authors.initials: AH
authors.lastname: Lin
authors.affiliation: Department of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.affiliation: United States Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Bob A
authors.initials: BA
authors.lastname: Rappaport
authors.affiliation: Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.affiliation: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000700:Analgesics / Q000009:adverse effects*; D000529:Complementary Therapies / Q000009:adverse effects*; D006801:Humans; D010146:Pain / Q000188:drug therapy*; D059408:Pain Management / Q000009:adverse effects*; D017410:Practice Guidelines as Topic
chemical_list: D000700:Analgesics
keywords: Adverse events; Complementary and alternative medical treatments; Harms reporting; Safety reporting