Simple clinical variables predict liver histology in hepatitis C: Prospective validation of a clinical prediction model

• Published in: Scandinavian journal of gastroenterology 2005-11, Vol.40 (11), p.1365-1371
• Main Authors: Romagnuolo, Joseph, Andrews, Christopher N., Bain, Vincent G., Bonacini, Maurizio, Cotler, Scott J., Ma, Mang, Sherman, Morris
• Format: Article
• Language: English
• Subjects: Adult; Aged; Alanine Transaminase - blood; Biological and medical sciences; Biopsy, Needle; Confidence Intervals; Disease Progression; Epidemiology; Female; fibrosis; Follow-Up Studies; Gastroenterology. Liver. Pancreas. Abdomen; hepatitis C; Hepatitis C, Chronic - pathology; Hepatitis C, Chronic - physiopathology; Human viral diseases; Humans; Immunohistochemistry; Infectious diseases; liver biopsy; Liver Cirrhosis - pathology; Liver Cirrhosis - physiopathology; Liver Function Tests; Male; Medical sciences; Middle Aged; multicenter; physical examination; Physical Examination - methods; Predictive Value of Tests; prospective; Prospective Studies; Risk Assessment; ROC Curve; Sensitivity and Specificity; Severity of Illness Index; validation study; Viral diseases; Viral hepatitis
• ISSN: 0036-5521; 1502-7708
• DOI: 10.1080/00365520500287400

Objective. A recent single-center multivariate analysis of hepatitis C (HCV) patients showed that having any two criteria: 1) ferritin ≥200 µg/l and 2)spider nevi and/or albumin ≤35 g/l predicted grade 2 or greater histological inflammation; the presence of any two of the following criteria: spider nevi, platelets ≤150×109/l, palpable splenomegaly and/or albumin ≤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. Material and 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