Performance of non-invasive tests and histology for the prediction of clinical outcomes in patients with non-alcoholic fatty liver disease: an individual participant data meta-analysis
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Mózes, Ferenc | Lee, Jenny | Vali, Yasaman | Alzoubi, Osama | Staufer, Katharina | Trauner, Michael | Paternostro, Rafael | Stauber, Rudolf E. | Holleboom, Adriaan, G | van Dijk, Anne-Marieke | Mak, Anne Linde | Boursier, Jérôme | de Saint Loup, Marc | Shima, Toshihide | Bugianesi, Elisabetta | Gaia, Silvia | Armandi, Angelo | Shalimar, S. | Lupșor-Platon, Monica | Wai-Sun Wong, Vincent | Li, Guanlin | Wong, Grace Lai-Hung | Cobbold, Jeremy | Karlas, Thomas | Wiegand, Johannes | Sebastiani, Giada | Tsochatzis, Emmanuel | Liguori, Antonio | Yoneda, Masato | Nakajima, Atsushi | Hagström, Hannes | Akbari, Camilla | Hirooka, Masashi | Chan, Wah-Kheong | Mahadeva, Sanjiv | Rajaram, Ruveena | Zheng, Ming-Hua | George, Jacob | Eslam, Mohammed | Petta, Salvatore | Pennisi, Grazia | Viganò, Mauro | Ridolfo, Sofia | Aithal, Guruprasad Padur | Palaniyappan, Naaventhan | Lee, Dae Ho | Ekstedt, Mattias | Nasr, Patrik | Cassinotto, Christophe | de Ledinghen, Victor | Berzigotti, Annalisa | Mendoza, Yuly | Noureddin, Mazen | Truong, Emily | Fournier-Poizat, Céline | Geier, Andreas | Martic, Miljen | Tuthill, Theresa | Anstee, Quentin, M | Harrison, Stephen, A | Bossuyt, Patrick | Pavlides, Michael | Daly, Ann | Govaere, Olivier | Cockell, Simon | Tiniakos, Dina | Bedossa, Pierre | Burt, Alastair | Oakley, Fiona | Cordell, Heather | Day, Christopher | Wonders, Kristy | Missier, Paolo | Mcteer, Matthew | Vale, Luke | Oluboyede, Yemi | Breckons, Matt | Zafarmand, Hadi | Nieuwdorp, Max | Verheij, Joanne | Ratziu, Vlad | Clément, Karine | Patino-Navarrete, Rafael | Pais, Raluca | Paradis, Valerie | Schuppan, Detlef | Schattenberg, Jörn | Surabattula, Rambabu | Myneni, Sudha | Straub, Beate | Vidal-Puig, Toni | Vacca, Michele | Rodrigues-Cuenca, Sergio | Allison, Mike | Kamzolas, Ioannis | Petsalaki, Evangelia | Campbell, Mark | Lelliott, Chris | Davies, Susan | Orešič, Matej | Hyötyläinen, Tuulia | Mcglinchey, Aiden | Mato, Jose | Millet, Óscar | Dufour, Jean-François | Masoodi, Mojgan | Neubauer, Stefan | Akhtar, Salma | Olodo-Atitebi, Seliat | Banerjee, Rajarshi | Kelly, Matt | Shumbayawonda, Elizabeth | Dennis, Andrea | Andersson, Anneli | Wigley, Ioan | Romero-Gómez, Manuel | Gómez-González, Emilio | Ampuero, Javier | Castell, Javier | Gallego-Durán, Rocío | Fernández, Isabel | Montero-Vallejo, Rocío | Karsdal, Morten | Rasmussen, Daniel Guldager Kring | Leeming, Diana Julie | Sinisi, Antonia | Musa, Kishwar | Sandt, Estelle | Tonini, Manuela | Rosso, Chiara | Marra, Fabio | Gastaldelli, Amalia | Svegliati, Gianluca | Francque, Sven | Vonghia, Luisa | Driessen, Ann | Kechagias, Stergios | Yki-Järvinen, Hannele | Porthan, Kimmo | Arola, Johanna | van Mil, Saskia | Papatheodoridis, George | Cortez-Pinto, Helena | Rodrigues, Cecilia | Valenti, Luca | Pelusi, Serena | Miele, Luca | Trautwein, Christian | Reißing, Johanna | Francis, Susan | Bradley, Christopher | Hockings, Paul | Schneider, Moritz | Newsome, Philip | Hübscher, Stefan | Wenn, David | Rosenquist, Christian | Trylesinski, Aldo | Mayo, Rebeca | Alonso, Cristina | Duffin, Kevin | Perfield, James | Chen, Yu | Yunis, Carla | Harrington, Magdalena Alicia | Miller, Melissa | Chen, Yan | Mcleod, Euan James | Ross, Trenton | Bernardo, Barbara | Schölch, Corinna | Ertle, Judith | Younes, Ramy | Oldenburger, Anouk | Coxson, Harvey | Ostroff, Rachel | Alexander, Leigh | Biegel, Hannah | Kjær, Mette Skalshøi | Harder, Lea Mørch | Davidsen, Peter | Ellegaard, Jens | Balp, Maria-Magdalena | Brass, Clifford | Jennings, Lori | Löffler, Jürgen | Applegate, Douglas | Shankar, Sudha | Torstenson, Richard | Lindén, Daniel | Llorca, Anne | Kalutkiewicz, Michael | Pepin, Kay | Ehman, Richard | Horan, Gerald | Ho, Gideon | Tai, Dean | Chng, Elaine | Patterson, Scott | Billin, Andrew | Doward, Lynda | Twiss, James | Thakker, Paresh | Derdak, Zoltan | Landgren, Henrik | Lackner, Carolin | Gouw, Annette | Hytiroglou, Prodromos
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CCSD ; Elsevier -
International audience.
Background: Histologically assessed liver fibrosis stage has prognostic significance in patients with non-alcoholic fatty liver disease (NAFLD) and is accepted as a surrogate endpoint in clinical trials for non-cirrhotic NAFLD. Our aim was to compare the prognostic performance of non-invasive tests with liver histology in patients with NAFLD.Methods: This was an individual participant data meta-analysis of the prognostic performance of histologically assessed fibrosis stage (F0–4), liver stiffness measured by vibration-controlled transient elastography (LSM-VCTE), fibrosis-4 index (FIB-4), and NAFLD fibrosis score (NFS) in patients with NAFLD. The literature was searched for a previously published systematic review on the diagnostic accuracy of imaging and simple non-invasive tests and updated to Jan 12, 2022 for this study. Studies were identified through PubMed/MEDLINE, EMBASE, and CENTRAL, and authors were contacted for individual participant data, including outcome data, with a minimum of 12 months of follow-up. The primary outcome was a composite endpoint of all-cause mortality, hepatocellular carcinoma, liver transplantation, or cirrhosis complications (ie, ascites, variceal bleeding, hepatic encephalopathy, or progression to a MELD score ≥15). We calculated aggregated survival curves for trichotomised groups and compared them using stratified log-rank tests (histology: F0–2 vs F3 vs F4; LSM: <10 vs 10 to <20 vs ≥20 kPa; FIB-4: <1·3 vs 1·3 to ≤2·67 vs >2·67; NFS: <–1·455 vs –1·455 to ≤0·676 vs >0·676), calculated areas under the time-dependent receiver operating characteristic curves (tAUC), and performed Cox proportional-hazards regression to adjust for confounding. This study was registered with PROSPERO, CRD42022312226.Findings: Of 65 eligible studies, we included data on 2518 patients with biopsy-proven NAFLD from 25 studies (1126 [44·7%] were female, median age was 54 years [IQR 44–63), and 1161 [46·1%] had type 2 diabetes). After a median follow-up of 57 months [IQR 33–91], the composite endpoint was observed in 145 (5·8%) patients. Stratified log-rank tests showed significant differences between the trichotomised patient groups (p<0·0001 for all comparisons). The tAUC at 5 years were 0·72 (95% CI 0·62–0·81) for histology, 0·76 (0·70–0·83) for LSM-VCTE, 0·74 (0·64–0·82) for FIB-4, and 0·70 (0·63–0·80) for NFS. All index tests were significant predictors of the primary outcome after adjustment for confounders in the Cox regression. Interpretation: Simple non-invasive tests performed as well as histologically assessed fibrosis in predicting clinical outcomes in patients with NAFLD and could be considered as alternatives to liver biopsy in some cases.
