Diagnostic accuracy of non-invasive tests for advanced fibrosis in patients with NAFLD: an individual patient data meta-analysis

Mozes, Ferenc Emil and Lee, Jenny A. and Selvaraj, Emmanuel Anandraj and Jayaswal, Arjun Narayan Ajmer and Trauner, Michael and Boursier, Jerome and Fournier, Celine and Staufer, Katharina and Stauber, Rudolf E. and Bugianesi, Elisabetta and Younes, Ramy and Gaia, Silvia and Lupsor-Platon, Monica and Petta, Salvatore and Shima, Toshihide and Okanoue, Takeshi and Mahadeva, Sanjiv and Chan, Wah Kheong and Eddowes, Peter J. and Hirschfield, Gideon M. and Newsome, Philip Noel and Wong, Vincent Wai-Sun and de Ledinghen, Victor and Fan, Jiangao and Shen, Feng and Cobbold, Jeremy F. and Sumida, Yoshio and Okajima, Akira and Schattenberg, Joern M. and Labenz, Christian and Kim, Won and Lee, Myoung Seok and Wiegand, Johannes and Karlas, Thomas and Yilmaz, Yusuf and Aithal, Guruprasad Padur and Palaniyappan, Naaventhan and Cassinotto, Christophe and Aggarwal, Sandeep and Garg, Harshit and Ooi, Geraldine J. and Nakajima, Atsushi and Yoneda, Masato and Ziol, Marianne and Barget, Nathalie and Geier, Andreas and Tuthill, Theresa and Brosnan, M. Julia and Anstee, Quentin Mark and Neubauer, Stefan and Harrison, Stephen A. and Bossuyt, Patrick M. and Pavlides, Michael and Investigators, LITMUS (2022) Diagnostic accuracy of non-invasive tests for advanced fibrosis in patients with NAFLD: an individual patient data meta-analysis. GUT, 71 (5). pp. 1006-1019. ISSN 0017-5749, DOI https://doi.org/10.1136/gutjnl-2021-324243.

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Objective Liver biopsy is still needed for fibrosis staging in many patients with non-alcoholic fatty liver disease. The aims of this study were to evaluate the individual diagnostic performance of liver stiffness measurement by vibration controlled transient elastography (LSM-VCTE), Fibrosis-4 Index (FIB-4) and NAFLD (non-alcoholic fatty liver disease) Fibrosis Score (NFS) and to derive diagnostic strategies that could reduce the need for liver biopsies. Design Individual patient data meta-analysis of studies evaluating LSM-VCTE against liver histology was conducted. FIB-4 and NFS were computed where possible. Sensitivity, specificity and area under the receiver operating curve (AUROC) were calculated. Biomarkers were assessed individually and in sequential combinations. Results Data were included from 37 primary studies (n=5735; 45% women; median age: 54 years; median body mass index: 30 kg/m(2); 33% had type 2 diabetes; 30% had advanced fibrosis). AUROCs of individual LSM-VCTE, FIB-4 and NFS for advanced fibrosis were 0.85, 0.76 and 0.73. Sequential combination of FIB-4 cut-offs (<1.3; >= 2.67) followed by LSM-VCTE cut-offs (<8.0; >= 10.0 kPa) to rule-in or rule-out advanced fibrosis had sensitivity and specificity (95% CI) of 66% (63-68) and 86% (84-87) with 33% needing a biopsy to establish a final diagnosis. FIB-4 cut-offs (<1.3; >= 3.48) followed by LSM cut-offs (<8.0; >= 20.0 kPa) to rule out advanced fibrosis or rule in cirrhosis had a sensitivity of 38% (37-39) and specificity of 90% (89-91) with 19% needing biopsy. Conclusion Sequential combinations of markers with a lower cut-off to rule-out advanced fibrosis and a higher cut-off to rule-in cirrhosis can reduce the need for liver biopsies.

Item Type: Article
Funders: Innovative Medicines Initiative 2 (IMI2) Joint Undertaking (Gran No. 777377), Horizon 2020, EFPIA
Uncontrolled Keywords: hepatic fibrosis; fatty liver; clinical decision making; biostatistics
Subjects: R Medicine
Divisions: Faculty of Medicine
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 09 Oct 2023 07:07
Last Modified: 09 Oct 2023 07:07
URI: http://eprints.um.edu.my/id/eprint/42456

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