title: The quality of safety reporting in trials is still suboptimal: survey of major general medical journals.
abstract: OBJECTIVE
  To evaluate whether the quality of reporting harms improved after the publication of the Extension of the Consolidated Standards of Reporting Trials (CONSORT) statement and predictors that influence the safety reporting in randomized controlled trials (RCTs)
  
  
  METHODS
  Systematic survey of published RCTs assessing drugs. In MEDLINE, we identified 228 RCTs published in Annals of Internal Medicine, British Medical Journal, Journal of American Medical Association, The Lancet, and The New England Journal of Medicine in 2003 and 2006.
  
  
  RESULTS
  The reporting of harms have improved over time both in quality and extent of space. However, the mean score as an overall measure of adequacy in reporting harms was 0.58 in 2003 and increased to 0.67 in 2006, indicating a moderate safety reporting. Safety was more adequate in trials with statistically significant results for efficacy, private funding, primary harms outcome, and anti-infective, antineoplasmatic, or immunosuppressive agents.
  
  
  CONCLUSIONS
  The use of the Extension of the CONSORT statement may be associated with improving the quality of safety reporting in RCTs, but there are still deficiencies that need to be corrected to use quantitative objective evidence for harms in performing meta-analyses and making therapeutic decisions.
authors.affiliation: Department of Hygiene and Epidemiology, School of Medicine, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece. haidich@med.auth.gr
authors.forename: Anna-Bettina
authors.initials: AB
authors.lastname: Haidich
authors.forename: Charis
authors.initials: C
authors.lastname: Birtsou
authors.forename: Theodore
authors.initials: T
authors.lastname: Dardavessis
authors.forename: Ilias
authors.initials: I
authors.lastname: Tirodimos
authors.forename: Malamatenia
authors.initials: M
authors.lastname: Arvanitidou
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions; D019983:Guideline Adherence; D006801:Humans; D011643:Publishing / Q000592:standards*; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000592:standards*