FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study

doi:10.1016/S2468-1253(19)30383-8

科研成果详情

题名	FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study
作者	Newsome, Philip N 1,2,4; Sasso, Magali 5; Deeks, Jonathan J 1,3; Paredes, Angelo 7,8; Boursier, Jérôme 9,10; Chan, Wah-Kheong 11; Yilmaz, Yusuf 12,13; Czernichow, Sébastien 14; Zheng, Ming-Hua15,16; Wong, Vincent Wai-Sun 17; Allison, Michael 18; Tsochatzis, Emmanuel 19; Anstee, Quentin M 20,21; Sheridan, David A 22; Eddowes, Peter J 23; Guha, Indra N 23; Cobbold, Jeremy F 24; Paradis, Valérie 25; Bedossa, Pierre 21,26; Miette, Véronique 5; Fournier-Poizat, Céline 6; Sandrin, Laurent 5; Harrison, Stephen A 27
发表日期	2020-04
发表期刊	LANCET GASTROENTEROLOGY & HEPATOLOGY 影响因子和分区
语种	英语
原始文献类型	Article
其他关键词	FATTY LIVER-DISEASE ; TRANSIENT ELASTOGRAPHY ; MORTALITY ; OUTCOMES ; SYSTEM ; STAGE ; NAFLD ; RISK
摘要	Background The burden of non-alcoholic fatty liver disease (NAFLD) is increasing globally, and a major priority is to identify patients with non-alcoholic steatohepatitis (NASH) who are at greater risk of progression to cirrhosis, and who will be candidates for clinical trials and emerging new pharmacotherapies. We aimed to develop a score to identify patients with NASH, elevated NAFLD activity score (NAS >= 4), and advanced fibrosis (stage 2 or higher [F >= 2]). Methods This prospective study included a derivation cohort before validation in multiple international cohorts. The derivation cohort was a cross-sectional, multicentre study of patients aged 18 years or older, scheduled to have a liver biopsy for suspicion of NAFLD at seven tertiary care liver centres in England. This was a prespecified secondary outcome of a study for which the primary endpoints have already been reported. Liver stiffness measurement (LSM) by vibration-controlled transient elastography and controlled attenuation parameter (CAP) measured by FibroScan device were combined with aspartate aminotransferase (AST), alanine aminotransferase (All), or AST:ALT ratio. To identify those patients with NASH, an elevated NAS, and significant fibrosis, the best fitting multivariable logistic regression model was identified and internally validated using boot-strapping. Score calibration and discrimination performance were determined in both the derivation dataset in England, and seven independent international (France, USA, China, Malaysia, Turkey) histologically confirmed cohorts of patients with NAFLD (external validation cohorts). This study is registered with ClinicalTrials.gov , number NCT01985009. Findings Between March 20,2014, and Jan 17,2017,350 patients with suspected NAFLD attending liver clinics in England were prospectively enrolled in the derivation cohort. The most predictive model combined LSM, CAP, and AST, and was designated FAST (FibroScan-AST). Performance was satisfactory in the derivation dataset (C-statistic 0.80, 95% CI 0.76-0.85) and was well calibrated. In external validation cohorts, calibration of the score was satisfactory and discrimination was good across the full range of validation cohorts (C-statistic range 0.74-0 .95,0.85; 95% CI 0.83-0.87 in the pooled external validation patients' cohort; n=1026). Cutoff was 0.35 for sensitivity of 0.90 or greater and 0.67 for specificity of 0.90 or greater in the derivation cohort, leading to a positive predictive value (PPV) of 0.83 (84/101) and a negative predictive value (NPV) of 0.85 (93/110). In the external validation cohorts, PPV ranged from 0.33 to 0.81 and NPV from 0.73 to 1.0. Interpretation The FAST score provides an efficient way to non-invasively identify patients at risk of progressive NASH for clinical trials or treatments when they become available, and thereby reduce unnecessary liver biopsy in patients unlikely to have significant disease. Copyright (C) 2020 The Author(s). Published by Elsevier Ltd.
资助项目	Echosens; UK National Institute for Health ResearchNational Institute for Health Research (NIHR); UK National Institute of Health Research (NIHR) from the Biomedical Research Centre (BRC); NIHR Birmingham BRC; NIHR Newcastle BRC; IHR Nottingham BRC; NIHR Oxford BRC
出版者	ELSEVIER INC
出版地	SAN DIEGO
ISSN	2468-1253
EISSN	2468-1253
卷号	5 期号:4 页码:362-373
DOI	10.1016/S2468-1253(19)30383-8
页数	12
WOS类目	Gastroenterology & Hepatology
WOS研究方向	Gastroenterology & Hepatology
WOS记录号	WOS:000519950400020
收录类别	SCIE ; PUBMED ; SCOPUS
URL	查看原文
PubMed ID	32027858
PMC记录号	PMC7066580
SCOPUSEID	2-s2.0-85079794619
ESI高被引论文	2020-09 ; 2020-11 ; 2021-01 ; 2021-03 ; 2021-05 ; 2021-07 ; 2021-11 ; 2022-01 ; 2022-03 ; 2022-07 ; 2022-09 ; 2022-11 ; 2023-01 ; 2023-03 ; 2023-05 ; 2023-07 ; 2023-09 ; 2023-11 ; 2024-01 ; 2024-03 ; 2024-05 ; 2024-07 ; 2024-09 ; 2024-11
自科自定义期刊分类	T2(B)类
通讯作者地址	[Newsome, Philip N]NIHR Birmingham Biomedical Research Centre and Centre for Liver and Gastrointestinal Research,University of Birmingham,Birmingham,B15 2TT,United Kingdom
Scopus学科分类	Hepatology;Gastroenterology
TOP期刊	TOP期刊
引用统计	被引频次：191[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/20864
专题	附属第一医院第一临床医学院（信息与工程学院）、附属第一医院
通讯作者	Newsome, Philip N
作者单位	1.National Institute for Health Research Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham,Birmingham,United Kingdom; 2.Centre for Liver and Gastrointestinal Research,Institute of Immunology and Immunotherapy,University of Birmingham,Birmingham,United Kingdom; 3.Test Evaluation Research Group,Institute of Applied Health Research,University of Birmingham,Birmingham,United Kingdom; 4.Liver Unit,University Hospitals Birmingham NHS Foundation Trust,Birmingham,United Kingdom; 5.R&D Department,Echosens,Paris,France; 6.Medical Affairs Department,Echosens,Paris,France; 7.Brooke Army Medical Center,Fort Sam Houston,United States; 8.Uniformed Services University of the Health Sciences,Bethesda,United States; 9.Department of Hepato-Gastroenterology,Angers University Hospital,Angers,France; 10.HIFIH Laboratory UPRES EA3859,Angers University,Angers,SFR4208,France; 11.Gastroenterology and Hepatology Unit,Gastrointestinal Endoscopy Unit,Department of Medicine,Faculty of Medicine,University of Malaya,Kuala Lumpur,Malaysia; 12.Liver Research Unit,Institute of Gastroenterology,Marmara University,Istanbul,Turkey; 13.Department of Gastroenterology,School of Medicine,Marmara University,Istanbul,Turkey; 14.Department of Nutrition,Hôpital Européen Georges-Pompidou (APHP),University of Paris,Paris,France; 15.NAFLD Research Center,Department of Hepatology,the First Affiliated Hospital of Wenzhou Medical University,Wenzhou,China; 16.Institute of Hepatology,Wenzhou Medical University,Wenzhou,China; 17.Department of Medicine and Therapeutics,The Chinese University of Hong Kong,Hong Kong,Hong Kong; 18.Department of Medicine,Cambridge Biomedical Research Centre,Cambridge University Hospitals NHS Foundation Trust,Cambridge,United Kingdom; 19.UCL Institute for Liver and Digestive Health,Royal Free Hospital and UCL,London,United Kingdom; 20.Institute of Cellular Medicine–Faculty of Medical Sciences,Newcastle University,Newcastle upon Tyne,United Kingdom; 21.Newcastle NIHR Biomedical Research Centre,Newcastle upon Tyne Hospitals NHS Trust,Newcastle upon Tyne,United Kingdom; 22.Institute of Translational and Stratified Medicine,University of Plymouth,Plymouth,United Kingdom; 23.NIHR Nottingham Biomedical Research Centre,Nottingham University Hospitals NHS Trust and the University of Nottingham,Nottingham,United Kingdom; 24.NIHR Oxford Biomedical Research Centre and Oxford Liver Unit,Oxford University Hospitals NHS Foundation Trust,John Radcliffe Hospital,Oxford,United Kingdom; 25.Pathology Department,Hôpital Beaujon,APHP,Clichy,France; 26.Liverpat,Paris,France; 27.Radcliffe Department of Medicine,University of Oxford,Oxford,United Kingdom
推荐引用方式 GB/T 7714	Newsome, Philip N,Sasso, Magali,Deeks, Jonathan J,et al. FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study[J]. LANCET GASTROENTEROLOGY & HEPATOLOGY,2020,5(4):362-373.
APA	Newsome, Philip N., Sasso, Magali., Deeks, Jonathan J., Paredes, Angelo., Boursier, Jérôme., ... & Harrison, Stephen A. (2020). FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study. LANCET GASTROENTEROLOGY & HEPATOLOGY, 5(4), 362-373.
MLA	Newsome, Philip N,et al."FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study".LANCET GASTROENTEROLOGY & HEPATOLOGY 5.4(2020):362-373.