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Randomized Controlled Trial
Inter-reader agreement of magnetic resonance imaging proton density fat fraction and its longitudinal change in a clinical trial of adults with nonalcoholic steatohepatitis.
- Jonathan C Hooker, Gavin Hamilton, Charlie C Park, Steven Liao, Tanya Wolfson, DehkordySoudabeh FazeliSFLiver Imaging Group, Department of Radiology, University of California, San Diego, 9500 Gilman Drive, San Diego, CA, 92093-0888, USA., Cheng William Hong, Adrija Mamidipalli, Anthony Gamst, Rohit Loomba, and Claude B Sirlin.
- Liver Imaging Group, Department of Radiology, University of California, San Diego, 9500 Gilman Drive, San Diego, CA, 92093-0888, USA.
- Abdom Radiol (NY). 2019 Feb 1; 44 (2): 482-492.
PurposeTo determine the inter-reader agreement of magnetic resonance imaging proton density fat fraction (PDFF) and its longitudinal change in a clinical trial of adults with nonalcoholic steatohepatitis (NASH).Study TypeWe performed a secondary analysis of a placebo-controlled randomized clinical trial of a bile acid sequestrant in 45 adults with NASH. A six-echo spoiled gradient-recalled-echo magnitude-based fat quantification technique was performed at 3 T. Three independent readers measured MRI-PDFF by placing one primary and two additional regions of interest (ROIs) in each segment at both time points. Cross-sectional agreement between the three readers was evaluated using intra-class correlation coefficients (ICCs) and coefficients of variation (CV). Additionally, we used Bland-Altman analyses to examine pairwise agreement between the three readers at baseline, end of treatment (EOT), and for longitudinal change.ResultsUsing all ROIs by all readers, mean PDFF at baseline, at EOT, and mean change in PDFF was 16.1%, 16.0%, and 0.07%, respectively. The 27-ROI PDFF measurements had 0.998 ICC and 1.8% CV at baseline, 0.998 ICC and 1.8% CV at EOT, and 0.997 ICC for longitudinal change. The 9-ROI PDFF measurements had corresponding values of 0.997 and 2.6%, 0.996 and 2.4%, and 0.994. Using 27 ROIs, the magnitude of the bias between readers for whole-liver PDFF measurement ranged from 0.03% to 0.06% points at baseline, 0.01% to 0.07% points at EOT, and 0.01% to 0.02% points for longitudinal change.ConclusionInter-reader agreement for measuring whole-liver PDFF and its longitudinal change is high. 9-ROI measurements have only slightly lower agreement than 27-ROI measurements.
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