title: Deficiencies in reporting of statistical methodology in recent randomized trials of nonpharmacologic pain treatments: ACTTION systematic review.
abstract: OBJECTIVE
  The goal of this study was to assess the quality of reporting of statistical methods in randomized clinical trials (RCTs), including identification of primary analyses, missing data accommodation, and multiplicity adjustment, in studies of nonpharmacologic, noninterventional pain treatments (e.g., physical therapy, cognitive behavioral therapy, acupuncture, and massage).
  
  
  METHODS
  Systematic review of 101 articles reporting RCTs of pain treatments that were published between January 2006 and June 2013 in the European Journal of Pain, the Journal of Pain, and Pain.
  
  
  METHODS
  Systematic review.
  
  
  RESULTS
  Sixty-two percent of studies identified a primary outcome variable, 46% identified a primary analysis, and of those with multiple primary analyses, only 21% adjusted for multiplicity. Slightly over half (55%) of studies reported using at least one method to accommodate missing data. Only four studies reported prespecifying at least one of these four study methods.
  
  
  CONCLUSIONS
  This review identified deficiencies in the reporting of primary analyses and methods to adjust for multiplicity and accommodate missing data in articles disseminating results of nonpharmacologic, noninterventional trials. Investigators should be encouraged to indicate whether their analyses were prespecified and to clearly and completely report statistical methods in clinical trial publications to maximize the interpretability of trial results.
authors.affiliation: Department of Biostatistics and Epidemiology, University of Pennsylvania, 423 Guardian Dr., Philadelphia, PA 19104, USA.
authors.forename: Jordan D
authors.initials: JD
authors.lastname: Dworkin
authors.affiliation: City University of New York-Hunter College, 695 Park Ave, New York City, NY 10065, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: McKeown
authors.affiliation: Department of Biostatistics and Epidemiology, University of Pennsylvania, 423 Guardian Dr., Philadelphia, PA 19104, USA.
authors.forename: John T
authors.initials: JT
authors.lastname: Farrar
authors.affiliation: Department of Anesthesiology, Queen's University, 99 University Ave, Kingston, Ontario K7L3N6, Canada.
authors.forename: Ian
authors.initials: I
authors.lastname: Gilron
authors.affiliation: School of Professional Psychology, Pacific University, 222 SE 8th Ave, Hillsboro, OR 97123, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Hunsinger
authors.affiliation: VA Connecticut Healthcare System, 950 Campbell Ave, West Haven, CT 06516, USA.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Kerns
authors.affiliation: Department of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Rd, Rochester, NY 14642, USA; Department of Neurology, University of Rochester School of Medicine and Dentistry, 601 Elmwood Ave, Rochester, NY 14642, USA.
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.affiliation: Arlington, VA, USA.
authors.forename: Bob A
authors.initials: BA
authors.lastname: Rappaport
authors.affiliation: Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific St, Seattle, WA 98195, USA.
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.affiliation: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, 601 Elmwood Ave, Rochester, NY 14642, USA.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
authors.affiliation: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, 601 Elmwood Ave, Rochester, NY 14642, USA. Electronic address: jennifer_gewandter@urmc.rochester.edu.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Gewandter
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D020380:Needs Assessment; D010146:Pain / Q000175:diagnosis*; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D016032:Randomized Controlled Trials as Topic; D058028:Research Report; D012720:Severity of Illness Index; D013223:Statistics as Topic / Q000379:methods*
keywords: Clinical trials; Missing data; Multiplicity; Nonpharmacologic trials; Prespecification; Reporting