title: Evaluation of the reproducibility of the Naranjo Adverse Drug Reaction Probability Scale score in published case reports.
abstract: OBJECTIVE
  To assess the reproducibility of Naranjo Adverse Drug Reaction Probability Scale (APS) scores in published case reports.
  
  
  METHODS
  Reliability analysis.
  
  
  RESULTS
  Randomly selected case reports using the APS were identified from the Web of Science database. The APS scores were blinded from the case reports, and scores were then independently calculated by four raters, using the APS. The percentage of exact agreement between raters' and the published APS scores was calculated for all case reports. Categorical scores were compared by using a weighted κ statistic. For numerical scores, descriptive statistics were computed by using raw and absolute difference scores. Twenty-four case reports were independently scored by four raters. Exact agreement between all raters' scores and the published APS scores was found in five (21%) of the 24 reports. Agreement between individual rater's scores and the published categorical score ranged from 42% to 79%. Weighted κ ranged from 0.12 to 0.61, corresponding to strengths of agreement between poor and good. Difference in scoring by raters resulted in 18% and 27% of case reports being reclassified into higher and lower than reported APS categories, respectively.
  
  
  CONCLUSIONS
  Exact agreement between raters' scores and the published APS score was infrequent. We recommend that authors of case reports include all pertinent details of the case and that journals ensure the robustness of the causality assessment during peer review.
authors.affiliation: Department of Pharmacy, Mount Sinai Hospital, Toronto, Ontario, Canada; Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Ruby
authors.initials: R
authors.lastname: Liang
authors.forename: Bjug
authors.initials: B
authors.lastname: Borgundvaag
authors.forename: Mark
authors.initials: M
authors.lastname: McIntyre
authors.forename: Crystal
authors.initials: C
authors.lastname: Thwaites
authors.forename: Kelsey
authors.initials: K
authors.lastname: Ragan
authors.forename: Andrew
authors.initials: A
authors.lastname: Wyllie
mesh_terms: D015984:Causality; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000503:physiopathology; D006801:Humans; D020407:Internet; D008499:Medical Records; D010506:Periodicals as Topic; D011338:Probability Theory; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000379:methods
keywords: Naranjo Adverse Drug Reaction Probability Scale; case reports; causality; reproducibility