title: Clinical diagnostic scale: a useful tool in the evaluation of suspected hepatotoxic adverse drug reactions.
abstract: OBJECTIVE
  Due to an absence of specific markers, the diagnosis of drug-induced hepatotoxicity is necessarily based on circumstantial evidence and is often inaccurate. We have evaluated the use of the clinical diagnostic scale (CDS) in the causality assessment of hepatotoxic adverse drug reaction (ADR) reports.
  
  
  METHODS
  135 hepatic adverse ADRs reported to the Committee on Safety of Medicines in North East England 1992-6 were evaluated. Initially, "International Consensus Criteria" were used to classify reactions as "drug-related", "drug-unrelated" and "indeterminate". Using the CDS, each ADR was then categorised as either definite drug hepatotoxicity (score >17), probable (14-17), possible (10-13), unlikely (6-9), or drug hepatotoxicity excluded (<6).
  
  
  RESULTS
  49 ADRs were considered drug-related, 65 unrelated and 21 indeterminate. Reports classified as drug-related by consensus criteria scored higher on the CDS, with a median score of 12, range: 8-15, than either the indeterminate (8; [3-12]) or drug-unrelated reports (5; [2-11]) (p<0.0001). A CDS score of >9, identified 88% of the cases classified as drug-related hepatotoxicity by consensus criteria and excluded 98% of those unrelated to the drugs.
  
  
  CONCLUSIONS
  CDS scoring correlates well with the international consensus classification and may be a useful tool in the routine evaluation of suspected hepatotoxic drug reactions.
authors.affiliation: Centre for Liver Research, University of Newcastle, Newcastle upon Tyne, UK.
authors.forename: G P
authors.initials: GP
authors.lastname: Aithal
authors.forename: M D
authors.initials: MD
authors.lastname: Rawlins
authors.forename: C P
authors.initials: CP
authors.lastname: Day
mesh_terms: D056486:Chemical and Drug Induced Liver Injury; D003937:Diagnosis, Differential; D006801:Humans; D008107:Liver Diseases / Q000175:diagnosis*; D012680:Sensitivity and Specificity