Concordance in a World without a Gold Standard: A New Non-Invasive Methodology for Improving Accuracy of Fibrosis Markers

• DOI: 10.1371/journal.pone.0003857
• Publication Date: 2008-12-03T22:57:39Z
• Authors: Thierry Poynard; Patrick Ingiliz; Laure Elkrief; Mona Munteanu; Pascal Lebray; Rachel Morra; Djamila Messous; Francoise Imbert ...; Dominique Roulot; Yves Benhamou; Dominique Thabut; Vlad Ratziu
• Keywords: Concordance; Gold standard (test)

Assessing liver fibrosis is traditionally performed by biopsy, an imperfect gold standard. Non-invasive techniques, stiffness measurements (LSM) and biomarkers [FibroTest(R) (FT)], are widely used in countries where they available. The aim was to identify factors associated with LSM accuracy using FT as a non-invasive endpoint vice versa. proof of concept taken the manufacturers recommendations for excluding patients at high risk false negative/positive. hypothesis that concordance between FT, would be improved high-risk patients. Thereafter, impact potential variability assessed same methods. Liver biopsy independent endpoints were validate results. Applying manufacturers' 2,004 increased strength (P<0.00001). Among 1,338 satisfying recommendations, methodology identified significant operator effect (P = 0.001) following (all P<0.01), related LSM: male gender, older age, NAFLD cause disease. Biopsy confirmed 391 these This study has validated estimates identification precautions use.