Diagnostic accuracy of non-invasive tests for advanced fibrosis in patients with NAFLD: an individual patient data meta-analysis.
Mózes Ferenc Emil, Lee Jenny A, Selvaraj Emmanuel Anandraj, Jayaswal Arjun Narayan Ajmer, Trauner Michael, Boursier Jerome, Fournier Céline, Staufer Katharina, Stauber Rudolf E, Bugianesi Elisabetta, Younes Ramy, Gaia Silvia, Lupșor-Platon Monica, Petta Salvatore, Shima Toshihide, Okanoue Takeshi, Mahadeva Sanjiv, Chan Wah-Kheong, Eddowes Peter J, Hirschfield Gideon M, Newsome Philip Noel, Wong Vincent Wai-Sun, de Ledinghen Victor, Fan Jiangao, Shen Feng, Cobbold Jeremy F, Sumida Yoshio, Okajima Akira, Schattenberg Jörn M, Labenz Christian, Kim Won, Lee Myoung Seok, Wiegand Johannes, Karlas Thomas, Yılmaz Yusuf, Aithal Guruprasad Padur, Palaniyappan Naaventhan, Cassinotto Christophe, Aggarwal Sandeep, Garg Harshit, Ooi Geraldine J, Nakajima Atsushi, Yoneda Masato, Ziol Marianne, Barget Nathalie, Geier Andreas, Tuthill Theresa, Brosnan M Julia, Anstee Quentin Mark, Neubauer Stefan, Harrison Stephen A, Bossuyt Patrick M, Pavlides Michael, LITMUS Investigators
Gut · 2022 · PMID 34001645 · 인용 520
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/m2; 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.