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.1,2,3,5; Sasso, Magali6,7; Deeks, Jonathan J.1,2,4; Paredes, Angelo8,9; Boursier, Jerome10,11; Chan, Wah-Kheong12; Yilmaz, Yusuf13,14; Czernichow, Sebastien15; Zheng, Ming-Hua16,17; Wong, Vincent Wai-Sun18; Allison, Michael19; Tsochatzis, Emmanuel20,21; Anstee, Quentin M.22,23; Sheridan, David A.24; Eddowes, Peter J.25,26; Guha, Indra N.25,26; Cobbold, Jeremy F.27,28; Paradis, Valerie29; Bedossa, Pierre23,30; Miette, Veronique6,7; Fournier-Poizat, Celine30; Sandrin, Laurent6,7; Harrison, Stephen A.31
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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 |
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 |
发表日期 | 2020-04 |
URL | 查看原文 |
Pubmed记录号 | 32027858 |
PMC记录号 | PMC7066580 |
Scopus记录号 | 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 |
自科自定义期刊分类 | T2(B)类 |
引用统计 | |
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 |
通讯作者 | Newsome, Philip N. |
作者单位 | 1.Univ Hosp Birmingham NHS Fdn Trust, Natl Inst Hlth Res Biomed Res Ctr, Birmingham, W Midlands, England; 2.Univ Birmingham, Birmingham, W Midlands, England; 3.Univ Birmingham, Ctr Liver & Gastrointestinal Res, Inst Immunol & Immunotherapy, Birmingham, W Midlands, England; 4.Univ Birmingham, Test Evaluat Res Grp, Inst Appl Hlth Res, Birmingham, W Midlands, England; 5.Univ Hosp Birmingham NHS Fdn Trust, Liver Unit, Birmingham, W Midlands, England; 6.Echosens, R&D Dept, Paris, France; 7.Echosens, Med Affairs Dept, Paris, France; 8.Brooke Army Med Ctr, Ft Sam Houston, TX 78234 USA; 9.Uniformed Serv Univ Hlth Sci, Bethesda, MD 20814 USA; 10.Angers Univ Hosp, Dept Hepatogastroenterol, Angers, France; 11.Angers Univ, HIFIH Lab, UPRES EA3859, SFR4208, Angers, France; 12.Univ Malaya, Gastroenterol & Hepatol Unit, Gastrointestinal Endoscopy Unit, Dept Med,Fac Med, Kuala Lumpur, Malaysia; 13.Marmara Univ, Inst Gastroenterol, Liver Res Unit, Istanbul, Turkey; 14.Marmara Univ, Sch Med, Dept Gastroenterol, Istanbul, Turkey; 15.Univ Paris, Hop Europeen Georges Pompidou, AP HP, Dept Nutr, Paris, France; 16.Wenzhou Med Univ, NAFLD Res Ctr, Dept Hepatol, Affiliated Hosp 1, Wenzhou, Peoples R China; 17.Wenzhou Med Univ, Inst Hepatol, Wenzhou, Peoples R China; 18.Chinese Univ Hong Kong, Dept Med & Therapeut, Hong Kong, Peoples R China; 19.Cambridge Univ Hosp NHS Fdn Trust, Cambridge Biomed Res Ctr, Dept Med, Cambridge, England; 20.Royal Free Hosp, UCL Inst Liver & Digest Hlth, London, England; 21.UCL, London, England; 22.Newcastle Univ, Inst Cellular Med, Fac Med Sci, Newcastle Upon Tyne, Tyne & Wear, England; 23.Newcastle Upon Tyne Hosp NHS Trust, Newcastle NIHR Biomed Res Ctr, Newcastle Upon Tyne, Tyne & Wear, England; 24.Univ Plymouth, Inst Translat & Stratified Med, Plymouth, Devon, England; 25.Nottingham Univ Hosp NHS Trust, NIHR Nottingham Biomed Res Ctr, Nottingham, England; 26.Univ Nottingham, Nottingham, England; 27.Oxford Univ Hosp NHS Fdn Trust, John Radcliffe Hosp, NIHR Oxford Biomed Res Ctr, Oxford, England; 28.Oxford Univ Hosp NHS Fdn Trust, John Radcliffe Hosp, Oxford Liver Unit, Oxford, England; 29.Hop Beaujon, AP HP, Pathol Dept, Clichy, France; 30.Liverpat, Paris, France; 31.Univ Oxford, Radcliffe Dept Med, Oxford, England |
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, Jerome., ... & 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. |
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