title: Reporting of adverse events and statistical details of efficacy estimates in randomized clinical trials of pain in temporomandibular disorders: Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks systematic review.
abstract: BACKGROUND
  Statistical methods and adverse events (that is, harms) data affect the accuracy of conclusions about the risk-to-benefit ratio of treatments for temporomandibular disorders (TMDs). The authors reviewed the quality of reporting in TMD clinical trials to highlight practices that are in need of improvement.
  
  
  METHODS
  The authors included articles published between 1969 and May 31, 2013, in which the investigators reported randomized clinical trials of TMD treatments with pain as a principal outcome variable. Investigators in trials of nonpharmacologic and noninvasive treatments were required to at least mask the participants and assessors; all others were required to be double masked.
  
  
  RESULTS
  Ninety articles qualified for this review: 39 published between 1971 and 2005 (older articles) and 51 published between 2006 and 2013 (newer articles). Specification of primary outcome analyses, methods to accommodate missing data, and adverse event collection methods and rates were generally poor. In some cases, there was apparent improvement from the older to the newer cohort; however, reporting of these methodological details remained inadequate even in the newer articles.
  
  
  CONCLUSIONS
  This review is designed to alert authors, reviewers, editors, and readers of TMD clinical trials to these issues and improve reporting quality in the future.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Gewandter
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Smith
authors.forename: Andrew
authors.initials: A
authors.lastname: McKeown
authors.forename: Kenessa
authors.initials: K
authors.lastname: Edwards
authors.forename: Aastha
authors.initials: A
authors.lastname: Narula
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Pawlowski
authors.forename: Daniel
authors.initials: D
authors.lastname: Rothstein
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Desjardins
authors.forename: Samuel F
authors.initials: SF
authors.lastname: Dworkin
authors.forename: Robert A
authors.initials: RA
authors.lastname: Gross
authors.forename: Richard
authors.initials: R
authors.lastname: Ohrbach
authors.forename: Bob A
authors.initials: BA
authors.lastname: Rappaport
authors.forename: Barry J
authors.initials: BJ
authors.lastname: Sessle
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
mesh_terms: D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use; D018771:Arthralgia / Q000209:etiology* / Q000628:therapy; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D018570:Risk Assessment; D013705:Temporomandibular Joint Disorders / Q000150:complications* / Q000628:therapy; D016896:Treatment Outcome
chemical_list: D000700:Analgesics
keywords: Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks; Temporomandibular disorder; clinical trials; harms reporting; missing data; multiplicity