Nice Model of Anty et al for Nonalcoholic Fatty Liver Disease in Morbidly Obese Patients

Patient selection: morbidly obese referred for bariatric surgery

Endpoint: activity score >= 5 in the NASH classification of Kleiner et al

Parameters:

(1) serum ALT concentration (using a Roche assay with pyridoxal phosphate on a Hitachi Modular)

(2) serum cytokeratin 18 fragment concentration (by ELISA kit M30-Apoptosense)

(3) clinical evidence for the metabolic syndrome using the International Diabetes Foundation (IDF) criteria

X =

= (0.0378 * (serum ALT in IU/L)) + (0.002215 * (serum CK18 in IU/L)) + (1.825 if metabolic syndrome present) - 5.654

probability of endpoint =

= 1 / (1 + EXP((-1) * X))

The prevalence of the endpoint was 12%. The best cutoff value was 0.14 (presumably the probability value). This had a sensitivity of 84% and specificity of 86%. A value >= 0.14 had a positive predictive value of 0.44, while a value < 0.14 had a negative predictive evalue of 0.98.

Limitations:

• The normal reference ranges for the assays were not listed.