title: Simple clinical variables predict liver histology in hepatitis C: prospective validation of a clinical prediction model.
abstract: OBJECTIVE
  A recent single-center multivariate analysis of hepatitis C (HCV) patients showed that having any two criteria: 1) ferritin > or =200 microg/l and 2) spider nevi and/or albumin < or = 35 g/l predicted grade 2 or greater histological inflammation; the presence of any two of the following criteria: spider nevi, platelets < or =150 x 109/l, palpable splenomegaly and/or albumin < or =35 g/l predicted stage 2 or greater histological fibrosis. Absence of predictors also predicted a lack of inflammation and fibrosis. Our aim was prospectively to validate this clinical prediction model using an independent multicenter sample.
  
  
  METHODS
  Eighty-one patients with previously untreated active chronic HCV underwent physical examination, laboratory investigation, and liver biopsy. Biopsies were read, in blinded fashion, by a single pathologist, using a modified Hytiroglou (1995) scale. The clinical scoring system was correlated with histology; likelihood ratios (LRs), Fisher's exact p-values, and receiver operating characteristics (ROCs) were calculated.
  
  
  RESULTS
  Data recording was complete in 77 and 38 patients regarding fibrotic stage and inflammatory grade, respectively. For fibrosis, 3/3 patients with any three criteria (LR 17, positive predictive value (PPV) 100%), 4/5 patients with any two criteria (LR 5.1), and 15/47 with no criteria (LR 0.6, negative predictive value (NPV) 68%) had stage 2 or greater fibrosis on biopsy (p=0.01). For inflammation, 5/5 patients with both criteria (LR 15, PPV 100%), and 8/19 patients with no criteria (LR 0.5, NPV 58%) had moderate-severe inflammation on liver biopsy (p=0.036). When missing variables were assumed to be normal, recalculated LRs were almost identical. An alanine aminotransferase (ALAT) level <60 U/l may increase the NPVs.
  
  
  CONCLUSIONS
  This independent multicenter data set has validated our published model which uses simple clinical variables accurately and significantly to predict hepatic fibrosis and inflammation in HCV patients.
authors.affiliation: Digestive Disease Center, University of South Carolina, 96 Jonathon Lucas Street, PO Box 250 327, Charleston, SC 29425, USA. romagnuo@musc.edu
authors.forename: Joseph
authors.initials: J
authors.lastname: Romagnuolo
authors.forename: Christopher N
authors.initials: CN
authors.lastname: Andrews
authors.forename: Vincent G
authors.initials: VG
authors.lastname: Bain
authors.forename: Maurizio
authors.initials: M
authors.lastname: Bonacini
authors.forename: Scott J
authors.initials: SJ
authors.lastname: Cotler
authors.forename: Mang
authors.initials: M
authors.lastname: Ma
authors.forename: Morris
authors.initials: M
authors.lastname: Sherman
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood*; D001707:Biopsy, Needle; D016001:Confidence Intervals; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D019698:Hepatitis C, Chronic / Q000473:pathology* / Q000503:physiopathology; D006801:Humans; D007150:Immunohistochemistry; D008103:Liver Cirrhosis / Q000473:pathology* / Q000503:physiopathology; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D010808:Physical Examination / Q000379:methods*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012372:ROC Curve; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index
chemical_list: D000410:Alanine Transaminase