TY - JOUR
T1 - ACR Ultrasound Liver Reporting and Data System
T2 - Multicenter Assessment of Clinical Performance at One Year
AU - Millet, John D.
AU - Kamaya, Aya
AU - Choi, Hailey H.
AU - Dahiya, Nirvikar
AU - Murphy, Paul M.
AU - Naveed, Mujtaba Z.
AU - O'Boyle, Mary
AU - Parra, Laura A.
AU - Perez, Marcelina G.
AU - Pirmoazen, Amir M.
AU - Rodgers, Shuchi K.
AU - Wasnik, Ashish P.
AU - Maturen, Katherine E.
N1 - Funding Information:
Dr Maturen receives royalties from Elsevier and Wolters-Kluwer and is a consultant for Allena Pharmaceuticals. Dr Kamaya receives royalties from Amirsys/Elsevier, has research agreements with Philips and Siemens, and is supported by National Institutes of Health grants R01 CA195443, R01 CA215520-01A1, and U01 CA210020-01A1. All other authors state that they have no conflict of interest related to the material discussed in this article.
Publisher Copyright:
© 2019 American College of Radiology
PY - 2019/12
Y1 - 2019/12
N2 - Purpose: The aim of this study was to evaluate the clinical performance of the ACR's Ultrasound Liver Reporting and Data System (US LI-RADS™) for detecting hepatocellular carcinoma (HCC) in patients at high risk for HCC. Methods: In this retrospective, multicenter study, 2,050 patients at high risk for HCC (1,078 men and 972 women; mean age, 57.7 years) at five sites in the United States had undergone screening liver ultrasound from January 2017 to February 2018, and US LI-RADS observation categories and visualization scores were assigned on a clinical basis. Ultrasound reports and patient records were retrospectively reviewed and follow-up imaging studies and/or pathologic reports recorded. Descriptive statistics were generated, and multivariate logistic regression analysis was used to analyze the relationship of clinical and reader-based predictors of limited visualization. Diagnostic performance data were calculated in the subset of patients with confirmatory testing. Results: The most common indications for HCC screening were cirrhosis (n = 1,054 [51.4%]), noncirrhotic hepatitis B virus infection (n = 555 [27.1%]), and noncirrhotic hepatitis C virus infection (n = 234 [11.4%]). US LI-RADS observation categories assigned were US-1 (negative) in 90.4% (n = 1,854), US-2 (subthreshold) in 4.6% (n = 95), and US-3 (positive) in 4.9% (n = 101). Visualization scores were A (no or minimal limitations) in 76.8% (n = 1,575), B (moderate limitations) in 18.9% (n = 388), and C (severe limitations) in 4.2% (n = 87). Confirmatory tests, including multiphase contrast-enhanced CT or MRI (n = 331) or histopathology (n = 18), were available for 349 patients (17.0%). The sensitivity of US LI-RADS in this subset of patients was 82.4%, specificity was 74.2%, positive predictive value was 35.3%, and negative predictive value was 96.1%. Conclusions: Approximately 90% of US LI-RADS screening examinations were negative, 5% subthreshold, and 5% positive. Visualization scores were diagnostically acceptable in the vast majority (>95%) of examinations. US LI-RADS emphasized sensitivity and negative predictive value, which are key characteristics of a screening test.
AB - Purpose: The aim of this study was to evaluate the clinical performance of the ACR's Ultrasound Liver Reporting and Data System (US LI-RADS™) for detecting hepatocellular carcinoma (HCC) in patients at high risk for HCC. Methods: In this retrospective, multicenter study, 2,050 patients at high risk for HCC (1,078 men and 972 women; mean age, 57.7 years) at five sites in the United States had undergone screening liver ultrasound from January 2017 to February 2018, and US LI-RADS observation categories and visualization scores were assigned on a clinical basis. Ultrasound reports and patient records were retrospectively reviewed and follow-up imaging studies and/or pathologic reports recorded. Descriptive statistics were generated, and multivariate logistic regression analysis was used to analyze the relationship of clinical and reader-based predictors of limited visualization. Diagnostic performance data were calculated in the subset of patients with confirmatory testing. Results: The most common indications for HCC screening were cirrhosis (n = 1,054 [51.4%]), noncirrhotic hepatitis B virus infection (n = 555 [27.1%]), and noncirrhotic hepatitis C virus infection (n = 234 [11.4%]). US LI-RADS observation categories assigned were US-1 (negative) in 90.4% (n = 1,854), US-2 (subthreshold) in 4.6% (n = 95), and US-3 (positive) in 4.9% (n = 101). Visualization scores were A (no or minimal limitations) in 76.8% (n = 1,575), B (moderate limitations) in 18.9% (n = 388), and C (severe limitations) in 4.2% (n = 87). Confirmatory tests, including multiphase contrast-enhanced CT or MRI (n = 331) or histopathology (n = 18), were available for 349 patients (17.0%). The sensitivity of US LI-RADS in this subset of patients was 82.4%, specificity was 74.2%, positive predictive value was 35.3%, and negative predictive value was 96.1%. Conclusions: Approximately 90% of US LI-RADS screening examinations were negative, 5% subthreshold, and 5% positive. Visualization scores were diagnostically acceptable in the vast majority (>95%) of examinations. US LI-RADS emphasized sensitivity and negative predictive value, which are key characteristics of a screening test.
KW - LI-RADS
KW - Ultrasound
KW - hepatocellular carcinoma
KW - screening
KW - surveillance
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U2 - 10.1016/j.jacr.2019.05.020
DO - 10.1016/j.jacr.2019.05.020
M3 - Article
C2 - 31173745
AN - SCOPUS:85068748476
SN - 1558-349X
VL - 16
SP - 1656
EP - 1662
JO - JACR Journal of the American College of Radiology
JF - JACR Journal of the American College of Radiology
IS - 12
ER -