title: Adherence to CONSORT harms-reporting recommendations in publications of recent analgesic clinical trials: an ACTTION systematic review.
abstract: Recommendations for harms (ie, adverse events) reporting in randomized clinical trial publications were presented in a 2004 extension of the Consolidated Standards of Reporting Trials (CONSORT) statement. Our objectives were to assess harms reporting in 3 major pain journals (European Journal of Pain, Journal of Pain, and PAIN®) to determine whether harms reporting improved following publication of the 2004 CONSORT recommendations, and to examine study factors associated with adequacy of harms reporting. A total of 101 randomized, double-blind, noninvasive pharmacologic trials were identified in the 2000-2003 (epoch 1) and 2008-2011 (epoch 2) issues of these journals. Out of 10 reporting recommendations, the mean number fulfilled was 6.08 (SD2.65). Although more harms recommendations were fulfilled in epoch 2 (m(2)=6.49, SD2.66) than in epoch 1 (m(1)=5.39, SD2.52; P=0.04), only the recommendation to report harms per arm was satisfied by >90% of trials in epoch 2, whereas <60% reported withdrawals due to harms. Several trial characteristics (study design, participant type, pain type, frequency of treatment administration, treatment administration method, sponsor, and number of randomized participants) were significantly associated with harms reporting. However, when trial characteristics and epoch were entered into a multiple regression analysis, only trials studying pain patients, those using oral treatments, and industry-sponsored trials were associated with better harms reporting. Despite some improvement in harms reporting, greater improvement is needed to provide informative, consistent reporting of adverse events and safety in analgesic clinical trials.
authors.affiliation: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA Queen's University, Kingston, ON, Canada Analgesic Solutions, Natick, MA, USA Tufts University, Boston, MA, USA United States Food and Drug Administration, Bethesda, MA, USA Departments of Biostatistics and Computational Biology and Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA California Pacific Medical Center Research Institute, San Francisco, CA, USA CHDI, New York, NY, USA Departments of Anesthesiology and Neurology and Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Smith
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Chang
authors.forename: Anthony
authors.initials: A
authors.lastname: Pereira
authors.forename: Nirupa
authors.initials: N
authors.lastname: Shah
authors.forename: Ian
authors.initials: I
authors.lastname: Gilron
authors.forename: Nathaniel P
authors.initials: NP
authors.lastname: Katz
authors.forename: Allison H
authors.initials: AH
authors.lastname: Lin
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
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: 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*; D015897:Comorbidity; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D010146:Pain / Q000188:drug therapy* / Q000453:epidemiology*; D010506:Periodicals as Topic / Q000592:standards; D017410:Practice Guidelines as Topic; D015995:Prevalence; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data
chemical_list: D000700:Analgesics