Accuracy of the Enhanced Liver Fibrosis Test in Patients With Type 2 Diabetes Mellitus and Its Clinical Implications
The diagnostic performance of the Fibrosis-4 (FIB-4) index and nonalcoholic fatty liver disease (NAFLD) fibrosis score (NFS) is poor in patients with type 2 diabetes mellitus (T2DM). We determined the usefulness of the Enhanced Liver Fibrosis (ELF) test in patients with T2DM. A total of 1228 patient...
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| Veröffentlicht in: | Clinical gastroenterology and hepatology 2024-04, Vol.22 (4), p.789-797.e8 |
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| creator | Arai, Taeang Takahashi, Hirokazu Seko, Yuya Toyoda, Hidenori Hayashi, Hideki Yamaguchi, Kanji Iwaki, Michihiro Yoneda, Masato Shima, Toshihide Fujii, Hideki Morishita, Asahiro Kawata, Kazuhito Tomita, Kengo Kawanaka, Miwa Yoshida, Yuichi Ikegami, Tadashi Notsumata, Kazuo Oeda, Satoshi Atsukawa, Masanori Kamada, Yoshihiro Sumida, Yoshio Fukushima, Hideaki Miyoshi, Eiji Aishima, Shinichi Okanoue, Takeshi Itoh, Yoshito Nakajima, Atsushi |
| description | The diagnostic performance of the Fibrosis-4 (FIB-4) index and nonalcoholic fatty liver disease (NAFLD) fibrosis score (NFS) is poor in patients with type 2 diabetes mellitus (T2DM). We determined the usefulness of the Enhanced Liver Fibrosis (ELF) test in patients with T2DM.
A total of 1228 patients with biopsy-proven NAFLD were enrolled. The diagnostic performance of the ELF test for predicting advanced fibrosis in participants with or without T2DM was evaluated in comparison with the FIB-4 index and NFS.
Overall, the area under the curve of the ELF test for predicting advanced fibrosis was greater (0.828) than that of the FIB-4 index (0.727) and NFS (0.733). The diagnostic performance of the ELF test (area under the curve, 0.820) was also superior to that of the FIB-4 index (0.698) and NFS (0.700) in patients with T2DM. With the low cutoff values for each noninvasive test, the ELF test provided an acceptable false negative rate (cutoff value 9.8, 6.7%) in this population, unlike the FIB-4 index (1.30, 14.5%) and NFS (−1.455, 12.4%). After propensity score matching to avoid selection bias including age, sex, body mass index, and the prevalence of advanced fibrosis, the ELF test with a low cutoff value showed a high sensitivity (≥91.4%) and a high negative predictive value (≥96.8%), irrespective of the presence or absence of T2DM.
The high diagnostic performance of the ELF test for predicting advanced fibrosis in individuals with or without T2DM could address an unmet medical need for accurate assessment of liver fibrosis in patients with diabetes and NAFLD.
[Display omitted] |
| doi_str_mv | 10.1016/j.cgh.2023.11.022 |
| format | Article |
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A total of 1228 patients with biopsy-proven NAFLD were enrolled. The diagnostic performance of the ELF test for predicting advanced fibrosis in participants with or without T2DM was evaluated in comparison with the FIB-4 index and NFS.
Overall, the area under the curve of the ELF test for predicting advanced fibrosis was greater (0.828) than that of the FIB-4 index (0.727) and NFS (0.733). The diagnostic performance of the ELF test (area under the curve, 0.820) was also superior to that of the FIB-4 index (0.698) and NFS (0.700) in patients with T2DM. With the low cutoff values for each noninvasive test, the ELF test provided an acceptable false negative rate (cutoff value 9.8, 6.7%) in this population, unlike the FIB-4 index (1.30, 14.5%) and NFS (−1.455, 12.4%). After propensity score matching to avoid selection bias including age, sex, body mass index, and the prevalence of advanced fibrosis, the ELF test with a low cutoff value showed a high sensitivity (≥91.4%) and a high negative predictive value (≥96.8%), irrespective of the presence or absence of T2DM.
The high diagnostic performance of the ELF test for predicting advanced fibrosis in individuals with or without T2DM could address an unmet medical need for accurate assessment of liver fibrosis in patients with diabetes and NAFLD.
[Display omitted]</description><identifier>ISSN: 1542-3565</identifier><identifier>EISSN: 1542-7714</identifier><identifier>DOI: 10.1016/j.cgh.2023.11.022</identifier><identifier>PMID: 38048934</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Alanine Transaminase ; Aspartate Aminotransferases ; Biopsy ; Diabetes ; Diabetes Mellitus, Type 2 - complications ; ELF ; Fibrosis ; Humans ; Liver - pathology ; Liver Cirrhosis - pathology ; NAFLD ; Non-alcoholic Fatty Liver Disease - complications ; Non-alcoholic Fatty Liver Disease - diagnosis ; Non-alcoholic Fatty Liver Disease - epidemiology ; Noninvasive Tests ; Severity of Illness Index</subject><ispartof>Clinical gastroenterology and hepatology, 2024-04, Vol.22 (4), p.789-797.e8</ispartof><rights>2024 AGA Institute</rights><rights>Copyright © 2024 AGA Institute. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c353t-c7e0e54a2939f2b21240b829e9508ec5e39fba67b49195f4af4c2db8919a5fdd3</citedby><cites>FETCH-LOGICAL-c353t-c7e0e54a2939f2b21240b829e9508ec5e39fba67b49195f4af4c2db8919a5fdd3</cites><orcidid>0000-0003-1900-4389</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.cgh.2023.11.022$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38048934$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Arai, Taeang</creatorcontrib><creatorcontrib>Takahashi, Hirokazu</creatorcontrib><creatorcontrib>Seko, Yuya</creatorcontrib><creatorcontrib>Toyoda, Hidenori</creatorcontrib><creatorcontrib>Hayashi, Hideki</creatorcontrib><creatorcontrib>Yamaguchi, Kanji</creatorcontrib><creatorcontrib>Iwaki, Michihiro</creatorcontrib><creatorcontrib>Yoneda, Masato</creatorcontrib><creatorcontrib>Shima, Toshihide</creatorcontrib><creatorcontrib>Fujii, Hideki</creatorcontrib><creatorcontrib>Morishita, Asahiro</creatorcontrib><creatorcontrib>Kawata, Kazuhito</creatorcontrib><creatorcontrib>Tomita, Kengo</creatorcontrib><creatorcontrib>Kawanaka, Miwa</creatorcontrib><creatorcontrib>Yoshida, Yuichi</creatorcontrib><creatorcontrib>Ikegami, Tadashi</creatorcontrib><creatorcontrib>Notsumata, Kazuo</creatorcontrib><creatorcontrib>Oeda, Satoshi</creatorcontrib><creatorcontrib>Atsukawa, Masanori</creatorcontrib><creatorcontrib>Kamada, Yoshihiro</creatorcontrib><creatorcontrib>Sumida, Yoshio</creatorcontrib><creatorcontrib>Fukushima, Hideaki</creatorcontrib><creatorcontrib>Miyoshi, Eiji</creatorcontrib><creatorcontrib>Aishima, Shinichi</creatorcontrib><creatorcontrib>Okanoue, Takeshi</creatorcontrib><creatorcontrib>Itoh, Yoshito</creatorcontrib><creatorcontrib>Nakajima, Atsushi</creatorcontrib><creatorcontrib>Japan Study Group of Nonalcoholic Fatty Liver Disease (JSG-NAFLD)</creatorcontrib><title>Accuracy of the Enhanced Liver Fibrosis Test in Patients With Type 2 Diabetes Mellitus and Its Clinical Implications</title><title>Clinical gastroenterology and hepatology</title><addtitle>Clin Gastroenterol Hepatol</addtitle><description>The diagnostic performance of the Fibrosis-4 (FIB-4) index and nonalcoholic fatty liver disease (NAFLD) fibrosis score (NFS) is poor in patients with type 2 diabetes mellitus (T2DM). We determined the usefulness of the Enhanced Liver Fibrosis (ELF) test in patients with T2DM.
A total of 1228 patients with biopsy-proven NAFLD were enrolled. The diagnostic performance of the ELF test for predicting advanced fibrosis in participants with or without T2DM was evaluated in comparison with the FIB-4 index and NFS.
Overall, the area under the curve of the ELF test for predicting advanced fibrosis was greater (0.828) than that of the FIB-4 index (0.727) and NFS (0.733). The diagnostic performance of the ELF test (area under the curve, 0.820) was also superior to that of the FIB-4 index (0.698) and NFS (0.700) in patients with T2DM. With the low cutoff values for each noninvasive test, the ELF test provided an acceptable false negative rate (cutoff value 9.8, 6.7%) in this population, unlike the FIB-4 index (1.30, 14.5%) and NFS (−1.455, 12.4%). After propensity score matching to avoid selection bias including age, sex, body mass index, and the prevalence of advanced fibrosis, the ELF test with a low cutoff value showed a high sensitivity (≥91.4%) and a high negative predictive value (≥96.8%), irrespective of the presence or absence of T2DM.
The high diagnostic performance of the ELF test for predicting advanced fibrosis in individuals with or without T2DM could address an unmet medical need for accurate assessment of liver fibrosis in patients with diabetes and NAFLD.
[Display omitted]</description><subject>Alanine Transaminase</subject><subject>Aspartate Aminotransferases</subject><subject>Biopsy</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - complications</subject><subject>ELF</subject><subject>Fibrosis</subject><subject>Humans</subject><subject>Liver - pathology</subject><subject>Liver Cirrhosis - pathology</subject><subject>NAFLD</subject><subject>Non-alcoholic Fatty Liver Disease - complications</subject><subject>Non-alcoholic Fatty Liver Disease - diagnosis</subject><subject>Non-alcoholic Fatty Liver Disease - epidemiology</subject><subject>Noninvasive Tests</subject><subject>Severity of Illness Index</subject><issn>1542-3565</issn><issn>1542-7714</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kD1PwzAURS0E4qPwA1iQR5YGfzaxmFApUKkIhiJGy3FeqKs0KbZTqf8eVy2MTH62zrvyPQhdU5JRQkd3y8x-LTJGGM8ozQhjR-icSsGGeU7F8WHmciTP0EUIS0KYEio_RWe8IKJQXJyj-GBt743d4q7GcQF40i5Ma6HCM7cBj59c6bvgAp5DiNi1-N1EB20M-NPFBZ5v14AZfnSmhAgBv0LTuNgHbNoKTxM1blzrrGnwdLVu0hBd14ZLdFKbJsDV4Rygj6fJfPwynL09T8cPs6HlksehzYGAFIYprmpWMsoEKQumQElSgJWQnkszykuhqJK1MLWwrCqLdDOyrio-QLf73LXvvvtUQK9csOmLpoWuD5oVquBUJFkJpXvUprrBQ63X3q2M32pK9E62XuokW-9ka0p1kp12bg7xfbmC6m_j124C7vcApJIbB14Hm-Qlu86Djbrq3D_xP0-gj30</recordid><startdate>202404</startdate><enddate>202404</enddate><creator>Arai, Taeang</creator><creator>Takahashi, Hirokazu</creator><creator>Seko, Yuya</creator><creator>Toyoda, Hidenori</creator><creator>Hayashi, Hideki</creator><creator>Yamaguchi, Kanji</creator><creator>Iwaki, Michihiro</creator><creator>Yoneda, Masato</creator><creator>Shima, Toshihide</creator><creator>Fujii, Hideki</creator><creator>Morishita, Asahiro</creator><creator>Kawata, Kazuhito</creator><creator>Tomita, Kengo</creator><creator>Kawanaka, Miwa</creator><creator>Yoshida, Yuichi</creator><creator>Ikegami, Tadashi</creator><creator>Notsumata, Kazuo</creator><creator>Oeda, Satoshi</creator><creator>Atsukawa, Masanori</creator><creator>Kamada, Yoshihiro</creator><creator>Sumida, Yoshio</creator><creator>Fukushima, Hideaki</creator><creator>Miyoshi, Eiji</creator><creator>Aishima, Shinichi</creator><creator>Okanoue, Takeshi</creator><creator>Itoh, Yoshito</creator><creator>Nakajima, Atsushi</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1900-4389</orcidid></search><sort><creationdate>202404</creationdate><title>Accuracy of the Enhanced Liver Fibrosis Test in Patients With Type 2 Diabetes Mellitus and Its Clinical Implications</title><author>Arai, Taeang ; 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We determined the usefulness of the Enhanced Liver Fibrosis (ELF) test in patients with T2DM.
A total of 1228 patients with biopsy-proven NAFLD were enrolled. The diagnostic performance of the ELF test for predicting advanced fibrosis in participants with or without T2DM was evaluated in comparison with the FIB-4 index and NFS.
Overall, the area under the curve of the ELF test for predicting advanced fibrosis was greater (0.828) than that of the FIB-4 index (0.727) and NFS (0.733). The diagnostic performance of the ELF test (area under the curve, 0.820) was also superior to that of the FIB-4 index (0.698) and NFS (0.700) in patients with T2DM. With the low cutoff values for each noninvasive test, the ELF test provided an acceptable false negative rate (cutoff value 9.8, 6.7%) in this population, unlike the FIB-4 index (1.30, 14.5%) and NFS (−1.455, 12.4%). After propensity score matching to avoid selection bias including age, sex, body mass index, and the prevalence of advanced fibrosis, the ELF test with a low cutoff value showed a high sensitivity (≥91.4%) and a high negative predictive value (≥96.8%), irrespective of the presence or absence of T2DM.
The high diagnostic performance of the ELF test for predicting advanced fibrosis in individuals with or without T2DM could address an unmet medical need for accurate assessment of liver fibrosis in patients with diabetes and NAFLD.
[Display omitted]</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>38048934</pmid><doi>10.1016/j.cgh.2023.11.022</doi><orcidid>https://orcid.org/0000-0003-1900-4389</orcidid></addata></record> |
| fulltext | fulltext |
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| ispartof | Clinical gastroenterology and hepatology, 2024-04, Vol.22 (4), p.789-797.e8 |
| issn | 1542-3565 1542-7714 |
| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Alanine Transaminase Aspartate Aminotransferases Biopsy Diabetes Diabetes Mellitus, Type 2 - complications ELF Fibrosis Humans Liver - pathology Liver Cirrhosis - pathology NAFLD Non-alcoholic Fatty Liver Disease - complications Non-alcoholic Fatty Liver Disease - diagnosis Non-alcoholic Fatty Liver Disease - epidemiology Noninvasive Tests Severity of Illness Index |
| title | Accuracy of the Enhanced Liver Fibrosis Test in Patients With Type 2 Diabetes Mellitus and Its Clinical Implications |
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