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1. A multisociety Delphi consensus statement on new fatty liver disease nomenclature

Author

Rinella, Mary E, Lazarus, Jeffrey V, Ratziu, Vlad, Francque, Sven M, Sanyal, Arun J, Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal F, Anstee, Quentin M, Arab, Juan Pablo, Arrese, Marco, Bataller, Ramon, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher D, Narro, Graciela E Castro, Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna R, Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia D, Harrison, Stephen A, Kim, Seung Up, Koot, Bart G, Korenjak, Marko, Kowdley, Kris V, Lacaille, Florence, Loomba, Rohit, Mitchell-Thain, Robert, Morgan, Timothy R, Powell, Elisabeth E, Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram Prasad, Sookoian, Silvia C, Spearman, C Wendy, Tiniakos, Dina, Valenti, Luca, Vos, Miriam B, Wong, Vincent Wai-Sun, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, Newsome, Philip N, and group, NAFLD Nomenclature consensus

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Liver Disease, Digestive Diseases, Clinical Research, Hepatitis, Chronic Liver Disease and Cirrhosis, Substance Misuse, Oral and gastrointestinal, Good Health and Well Being, Female, Male, Humans, Non-alcoholic Fatty Liver Disease, Delphi Technique, Ethanol, Consensus, Hepatomegaly, NAFLD Nomenclature consensus group, ALD, Delphi, MASH, MASLD, Met-ALD, NAFLD, alcohol, metabolic, nomenclature, stigma, Public Health and Health Services, Gastroenterology & Hepatology, Clinical sciences
Abstract

The principal limitations of the terms NAFLD and NASH are the reliance on exclusionary confounder terms and the use of potentially stigmatising language. This study set out to determine if content experts and patient advocates were in favour of a change in nomenclature and/or definition. A modified Delphi process was led by three large pan-national liver associations. The consensus was defined a priori as a supermajority (67%) vote. An independent committee of experts external to the nomenclature process made the final recommendation on the acronym and its diagnostic criteria. A total of 236 panellists from 56 countries participated in 4 online surveys and 2 hybrid meetings. Response rates across the 4 survey rounds were 87%, 83%, 83%, and 78%, respectively. Seventy-four percent of respondents felt that the current nomenclature was sufficiently flawed to consider a name change. The terms "nonalcoholic" and "fatty" were felt to be stigmatising by 61% and 66% of respondents, respectively. Steatotic liver disease was chosen as an overarching term to encompass the various aetiologies of steatosis. The term steatohepatitis was felt to be an important pathophysiological concept that should be retained. The name chosen to replace NAFLD was metabolic dysfunction-associated steatotic liver disease (MASLD). There was consensus to change the definition to include the presence of at least 1 of 5 cardiometabolic risk factors. Those with no metabolic parameters and no known cause were deemed to have cryptogenic steatotic liver disease. A new category, outside pure metabolic dysfunction-associated steatotic liver disease, termed metabolic and alcohol related/associated liver disease (MetALD), was selected to describe those with metabolic dysfunction-associated steatotic liver disease, who consume greater amounts of alcohol per week (140-350 g/wk and 210-420 g/wk for females and males, respectively). The new nomenclature and diagnostic criteria are widely supported and non-stigmatising, and can improve awareness and patient identification.

Published
2023

3. A multisociety Delphi consensus statement on new fatty liver disease nomenclature

Author

Rinella, Mary E., Lazarus, Jeffrey V., Ratziu, Vlad, Francque, Sven M., Sanyal, Arun J., Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal F., Anstee, Quentin M., Arab, Juan Pablo, Arrese, Marco, Bataller, Ramon, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher D., Narro, Graciela E. Castro, Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna R., Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia D., Harrison, Stephen A., Kim, Seung Up, Koot, Bart G., Korenjak, Marko, Kowdley, Kris V., Lacaille, Florence, Loomba, Rohit, Mitchell-Thain, Robert, Morgan, Timothy R., Powell, Elisabeth E., Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram Prasad, Sookoian, Silvia C., Spearman, C. Wendy, Tiniakos, Dina, Valenti, Luca, Vos, Miriam B., Wong, Vincent Wai-Sun, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, and Newsome, Philip N.

Published
2024
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4. Validation of Serum Test for Advanced Liver Fibrosis in Patients With Nonalcoholic Steatohepatitis

Author

Loomba, Rohit, Jain, Anjali, Diehl, Anna Mae, Guy, Cynthia D, Portenier, Dana, Sudan, Ranjan, Singh, Seema, Faulkner, Claire, Richards, Lisa, Hester, Kelly D, Okada, Lauren, Li, Xiao-Jun, Mimms, Larry, and Abdelmalek, Manal F

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Hepatitis, Chronic Liver Disease and Cirrhosis, Digestive Diseases, Liver Disease, Detection, screening and diagnosis, 4.1 Discovery and preclinical testing of markers and technologies, Good Health and Well Being, Adult, Algorithms, Area Under Curve, Biopsy, Female, Humans, Hyaluronic Acid, Liver Cirrhosis, Male, Middle Aged, Non-alcoholic Fatty Liver Disease, ROC Curve, Reproducibility of Results, Retrospective Studies, Severity of Illness Index, Tissue Inhibitor of Metalloproteinase-1, alpha-Macroglobulins, Patient Stratification, NPV, Steatohepatitis, NASH, Gastroenterology & Hepatology, Clinical sciences
Abstract

Background & aimsWe analyzed markers of fibrosis in serum samples from patients with nonalcoholic fatty liver disease (NAFLD), assessed by liver biopsy. We used serum levels of markers to develop an algorithm to discriminate patients with advanced fibrosis from those with mild or moderate fibrosis and validated its performance in 2 independent cohorts of patients with NAFLD.MethodsWe performed a retrospective analysis of serum samples from 396 patients with NAFLD and different stages of fibrosis (F0-F4), collected from 2007 through 2017 on the day of liver biopsy (training cohort 1). We measured serum concentrations of alpha-2 macroglobulin (A2M), hyaluronic acid (HA), and TIMP metallopeptidase inhibitor 1 (TIMP1), and used measurements to develop an algorithm that could discriminate patients with NAFLD with advanced fibrosis (F3-F4; 24.1% of cohort) from those with mild or moderate fibrosis (F0-F2; 79.5% of cohort). We validated the algorithm using serum samples collected from a separate 396 patients from the same time period and location (validation cohort 1), as well as 244 patients with NAFLD evaluated at a separate location, from 2011 through 2017, within a median of 11 days of liver biopsy (cohort 2).ResultsThe algorithm identified patients with advanced fibrosis vs mild or moderate fibrosis in training cohort 1 with an area under the receiver operating characteristic (AUROC) curve of 0.867 (95% CI, 0.827-0.907), 84.8% sensitivity (95% CI, 75.5%-91.0%), and 72.3% specificity (95% CI, 66.9%-77.3%), at a cutoff score of 17. The AUROC for the combined validation cohorts 1 and 2 (n=640) was 0.856 (95% CI, 0.820-0.892), identifying patients with 79.7% sensitivity (95% CI, 71.9%-86.2%) and 75.7% specificity (95% CI, 71.8%-79.4%) at the predetermined cutoff score of 17. The algorithm had negative predictive values that ranged from 92.5% to 94.7% in the validation cohorts; it correctly classified 90.0% of F0 samples, 75.0% of F1 samples, 77.4% of F3 samples, and 94.4% of F4 samples.ConclusionWe developed an algorithm that identifies patients with advanced fibrosis from those with mild to moderate fibrosis in patients with NAFLD with an AUROC value of approximately 0.86, based on levels of serum biomarkers. We validated the findings in 2 separate sets of patients with biopsy-proven NAFLD. The algorithm can be used non-invasively to determine risk of advanced fibrosis in patients with NAFLD.

Published
2019

5. Aldafermin in patients with non-alcoholic steatohepatitis (ALPINE 2/3): a randomised, double-blind, placebo-controlled, phase 2b trial

Author

Harrison, Stephen A, Abdelmalek, Manal F, Neff, Guy, Gunn, Nadege, Guy, Cynthia D, Alkhouri, Naim, Bashir, Mustafa R, Freilich, Bradley, Kohli, Anita, Khazanchi, Arun, Sheikh, Muhammad Y, Leibowitz, Mark, Rinella, Mary E, Siddiqui, Mohammad S, Kipnes, Mark, Moussa, Sam E, Younes, Ziad H, Bansal, Meena, Baum, Seth J, Borg, Brian, Ruane, Peter J, Thuluvath, Paul J, Gottwald, Mildred, Khan, Mujib, Chen, Charles, Melchor-Khan, Liza, Chang, William, DePaoli, Alex M, Ling, Lei, and Lieu, Hsiao D

Published
2022
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6. FRI-208 qBallooning: AI-based ballooned hepatocyte detection and quantification by second harmonic generation/two photon excitation microscopy

Author

Kleiner, David E., primary, Clouston, Andrew D., additional, Goodman, Zachary, additional, Guy, Cynthia D., additional, Brunt, Elizabeth M., additional, Lackner, Carolin, additional, Tiniakos, Dina G., additional, Wee, Aileen, additional, Yeh, Matthew, additional, Leow, Wei Qiang, additional, Chng, Elaine, additional, Ren, Yayun, additional, Goh, George Boon Bee, additional, Powell, Elizabeth E., additional, Rinella, Mary E., additional, Sanyal, Arun J, additional, Neuschwander-Tetri, Brent A., additional, Younossi, Zobair, additional, Charlton, Michael, additional, Ratziu, Vlad, additional, Harrison, Stephen A., additional, Tai, Dean, additional, and Anstee, Quentin M., additional

Published
2024
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8. Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis

Author

Harrison, Stephen A., Neff, Guy, Guy, Cynthia D., Bashir, Mustafa R., Paredes, Angelo H., Frias, Juan P., Younes, Ziad, Trotter, James F., Gunn, Nadege T., Moussa, Sam E., Kohli, Anita, Nelson, Kristin, Gottwald, Mildred, Chang, William C.G., Yan, Andrew Z., DePaoli, Alex M., Ling, Lei, and Lieu, Hsiao D.

Published
2021
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9. MASLD in people with HIV exhibits higher fibrosis stage despite lower disease activity than in matched controls.

Author

Allende, Daniela S., Cummings, Oscar, Sternberg, Alice L., Behling, Cynthia A., Carpenter, Danielle, Gill, Ryan M., Guy, Cynthia D., Yeh, Matthew M., Gawrieh, Samer, Sterling, Richard K., Naggie, Susanna, Loomba, Rohit, Price, Jennifer C., McLaughlin, Mary, Hadigan, Colleen, Crandall, Holly, Belt, Patricia, Wilson, Laura, Chalasani, Naga P., and Kleiner, David E.

Subjects
TYPE 2 diabetes, BODY mass index, LIVER biopsy, RACE, HIV-positive persons
Abstract

Summary: Background: Metabolic dysfunction‐associated steatotic liver disease (MASLD) is common in people with HIV (PWH). The morphological spectrum of MASLD compared to matched controls and of the correlation between the NAFLD activity score (NAS) and fibrosis stage in PWH remains unknown. Methods: Overall, 107 liver biopsies from PWH with MASLD (MASLD‐PWH) were matched to 107 biopsies from individuals with MASLD and without HIV (MASLD controls) on age at biopsy, race/ethnicity, sex, type 2 diabetes, body mass index (BMI) and alanine aminotransferase (ALT) level. Biopsies were scored using NAS. Results: Compared to MASLD‐controls, MASLD‐PWH had lower steatosis grade (OR: 0.65, 95% CI: (0.47–0.90), p = 0.01), lower lobular inflammation grade (OR: 0.55, 95% CI: (0.34–0.89), p = 0.02), less portal inflammation (OR: 0.42, 95% CI: (0.25–0.72), p = 0.002) and less ballooned hepatocytes (OR: 0.60, 95% CI: (0.41–0.88), p = 0.01). Thus, NAS was lower in MASLD‐PWH (OR: 0.69, 95% CI: (0.56–0.85), p < 0.001) than in MASLD controls. There was a trend towards lower prevalence of steatohepatitis in MASLD‐PWH (OR: 0.84, 95% CI: (0.68–1.03), p = 0.09). A multivariate analysis demonstrated that MASLD‐PWH cases had significantly less steatosis (OR: 0.66, p = 0.03), portal inflammation (OR: 0.34, p = 0.001) and ballooned hepatocytes (OR: 0.55, p = 0.01), yet higher stage fibrosis (OR: 1.42, p = 0.03) compared to MASLD controls. Conclusion: The NAS and histological drivers of fibrosis (e.g. inflammation and hepatocyte ballooning) are less pronounced in MASLD‐PWH, and yet fibrosis stage was generally higher when compared to matched controls with MASLD without HIV. This suggests HIV‐specific factors beyond hepatic necroinflammation may contribute to fibrosis progression in MASLD‐PWH. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Patient Sex, Reproductive Status, and Synthetic Hormone Use Associate With Histologic Severity of Nonalcoholic Steatohepatitis

Author

Yang, Ju Dong, Abdelmalek, Manal F, Guy, Cynthia D, Gill, Ryan M, Lavine, Joel E, Yates, Katherine, Klair, Jagpal, Terrault, Norah A, Clark, Jeanne M, Unalp-Arida, Aynur, Diehl, Anna Mae, Suzuki, Ayako, Dasarathy, Srinivasan, Dasarathy, Jaividhya, Hawkins, Carol, McCullough, Arthur J, Pagadala, Mangesh, Pai, Rish, Sargent, Ruth, Bashir, Mustafa, Buie, Stephanie, Guy, Cynthia, Kigongo, Christopher, Pan, Yi-Ping, Piercy, Dawn, Chalasani, Naga, Cummings, Oscar W, Gawrieh, Samer, Ghabril, Marwan, Marri, Smitha, Ragozzino, Linda, Sandrasegaran, Kumar, Vuppalanchi, Raj, King, Debra, Osmack, Pat, Siegner, Joan, Stewart, Susan, Neuschwander-Tetri, Brent A, Torretta, Susan, Ang, Brandon, Behling, Cynthia, Bhatt, Archana, Loomba, Rohit, Middleton, Michael, Patton, Heather, Sirlin, Claude, Aouizerat, Bradley, Bass, Nathan M, Brandman, Danielle, Ferrell, Linda D, Gill, Ryan, Hameed, Bilal, Ramos, Claudia, Terrault, Norah, Ungermann, Ashley, Atla, Pradeep, Croft, Brandon, Garcia, Rebekah, Garcia, Sonia, Sheikh, Muhammad, Singh, Mandeep, Boyett, Sherry, Carucci, Laura, Contos, Melissa J, Kraft, Kenneth, Luketic, Velimir AC, Puri, Puneet, Sanyal, Arun J, Schlosser, Jolene, Siddiqui, Mohhamad S, Wolford, Ben, Ackermann, Sarah, Cooney, Shannon, Coy, David, Gelinas, Katie, Kowdley, Kris V, Lee, Maximillian, Pierce, Tracey, Mooney, Jody, Nelson, James E, Shaw, Cheryl, Siddique, Asma, Wang, Chia, Brunt, Elizabeth M, Fowler, Kathryn, Kleiner, David E, Grave, Gilman D, Doo, Edward C, Hoofnagle, Jay H, Robuck, Patricia R, Sherker, Averell, Belt, Patricia, Donithan, Michele, Hallinan, Erin, and Isaacson, Milana

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Liver Disease, Digestive Diseases, Hepatitis, Estrogen, Chronic Liver Disease and Cirrhosis, Contraception/Reproduction, Aging, 4.1 Discovery and preclinical testing of markers and technologies, 6.1 Pharmaceuticals, Good Health and Well Being, Adolescent, Adult, Aged, Cross-Sectional Studies, Female, Histocytochemistry, Hormones, Humans, Male, Menopause, Middle Aged, Non-alcoholic Fatty Liver Disease, Reproduction, Risk Factors, Sex Factors, United States, Young Adult, Gender Differences, Fibrosis, Risk Factor Analysis., Nonalcoholic Steatohepatitis Clinical Research Network, Risk Factor Analysis, Gastroenterology & Hepatology, Clinical sciences
Abstract

Background & aimsSex and sex hormones can affect responses of patients with nonalcoholic fatty liver disease (NAFLD) to metabolic stress and development of hepatocyte injury and inflammation.MethodsWe collected data from 3 large U.S. studies of patients with NAFLD (between October 2004 and June 2013) to assess the association between histologic severity and sex, menopause status, synthetic hormone use, and menstrual abnormalities in 1112 patients with a histologic diagnosis of NAFLD. We performed logistic or ordinal logistic regression models, adjusting for covariates relevant to an increase of hepatic metabolic stress.ResultsPremenopausal women were at an increased risk of lobular inflammation, hepatocyte ballooning, and Mallory-Denk bodies than men and also at an increased risk of lobular inflammation and Mallory-Denk bodies than postmenopausal women (P < .01). Use of oral contraceptives was associated with an increased risk of lobular inflammation and Mallory-Denk bodies in premenopausal women, whereas hormone replacement therapy was associated with an increased risk of lobular inflammation in postmenopausal women (P < .05).ConclusionsBeing a premenopausal woman or a female user of synthetic hormones is associated with increased histologic severity of hepatocyte injury and inflammation among patients with NAFLD at given levels of hepatic metabolic stress.

Published
2017

14. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis

Author

Harrison, Stephen A, Bedossa, Pierre, Guy, Cynthia D, Schattenberg, Jörn M, Loomba, Rohit, Taub, Rebecca, Labriola, Dominic, Moussa, Sam E, Neff, Guy W, Rinella, Mary E, Anstee, Quentin M, Abdelmalek, Manal F, Younossi, Zobair, Baum, Seth J, Francque, Sven, Charlton, Michael R, Newsome, Philip N, Lanthier, Nicola, Schiefke, Ingolf, Mangia, Alessandra, Pericàs, Juan M, Patil, Rashmee, Sanyal, Arun J, Noureddin, Mazen, Bansal, Meena B, Alkhouri, Naim, Castera, Laurent, Rudraraju, Madhavi, Ratziu, Vlad, Miele, Luca, MAESTRO-NASH, Investigators, Miele, Luca (ORCID:0000-0003-3464-0068), Harrison, Stephen A, Bedossa, Pierre, Guy, Cynthia D, Schattenberg, Jörn M, Loomba, Rohit, Taub, Rebecca, Labriola, Dominic, Moussa, Sam E, Neff, Guy W, Rinella, Mary E, Anstee, Quentin M, Abdelmalek, Manal F, Younossi, Zobair, Baum, Seth J, Francque, Sven, Charlton, Michael R, Newsome, Philip N, Lanthier, Nicola, Schiefke, Ingolf, Mangia, Alessandra, Pericàs, Juan M, Patil, Rashmee, Sanyal, Arun J, Noureddin, Mazen, Bansal, Meena B, Alkhouri, Naim, Castera, Laurent, Rudraraju, Madhavi, Ratziu, Vlad, Miele, Luca, MAESTRO-NASH, Investigators, and Miele, Luca (ORCID:0000-0003-3464-0068)

Abstract

BACKGROUND Nonalcoholic steatohepatitis (NASH) is a progressive liver disease with no approved treatment. Resmetirom is an oral, liver-directed, thyroid hormone receptor beta-selective agonist in development for the treatment of NASH with liver fibrosis. METHODS We are conducting an ongoing phase 3 trial involving adults with biopsy-confirmed NASH and a fibrosis stage of F1B, F2, or F3 (stages range from F0 [no fibrosis] to F4 [cirrhosis]). Patients were randomly assigned in a 1:1:1 ratio to receive once-daily resmetirom at a dose of 80 mg or 100 mg or placebo. The two primary end points at week 52 were NASH resolution (including a reduction in the nonalcoholic fatty liver disease [NAFLD] activity score by >= 2 points; scores range from 0 to 8, with higher scores indicating more severe disease) with no worsening of fibrosis, and an improvement (reduction) in fibrosis by at least one stage with no worsening of the NAFLD activity score. RESULTS Overall, 966 patients formed the primary analysis population (322 in the 80-mg resmetirom group, 323 in the 100-mg resmetirom group, and 321 in the placebo group). NASH resolution with no worsening of fibrosis was achieved in 25.9% of the patients in the 80-mg resmetirom group and 29.9% of those in the 100-mg resmetirom group, as compared with 9.7% of those in the placebo group (P<0.001 for both comparisons with placebo). Fibrosis improvement by at least one stage with no worsening of the NAFLD activity score was achieved in 24.2% of the patients in the 80-mg resmetirom group and 25.9% of those in the 100-mg resmetirom group, as compared with 14.2% of those in the placebo group (P<0.001 for both comparisons with placebo). The change in low-density lipoprotein cholesterol levels from baseline to week 24 was -13.6% in the 80-mg resmetirom group and -16.3% in the 100-mg resmetirom group, as compared with 0.1% in the placebo group (P<0.001 for both comparisons with placebo). Diarrhea and nausea were more frequent with r

Published
2024

16. Alterations in zonal distribution and plasma membrane localization of hepatocyte bile acid transporters in patients with NAFLD

Author

Murphy, William A., primary, Diehl, Anna Mae, additional, Loop, Matthew Shane, additional, Fu, Dong, additional, Guy, Cynthia D., additional, Abdelmalek, Manal F., additional, Karachaliou, Georgia Sofia, additional, Sjöstedt, Noora, additional, Neuhoff, Sibylle, additional, Honkakoski, Paavo, additional, and Brouwer, Kim L. R., additional

Published
2024
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17. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis

Author

Harrison, Stephen A., primary, Bedossa, Pierre, additional, Guy, Cynthia D., additional, Schattenberg, Jörn M., additional, Loomba, Rohit, additional, Taub, Rebecca, additional, Labriola, Dominic, additional, Moussa, Sam E., additional, Neff, Guy W., additional, Rinella, Mary E., additional, Anstee, Quentin M., additional, Abdelmalek, Manal F., additional, Younossi, Zobair, additional, Baum, Seth J., additional, Francque, Sven, additional, Charlton, Michael R., additional, Newsome, Philip N., additional, Lanthier, Nicolas, additional, Schiefke, Ingolf, additional, Mangia, Alessandra, additional, Pericàs, Juan M., additional, Patil, Rashmee, additional, Sanyal, Arun J., additional, Noureddin, Mazen, additional, Bansal, Meena B., additional, Alkhouri, Naim, additional, Castera, Laurent, additional, Rudraraju, Madhavi, additional, and Ratziu, Vlad, additional

Published
2024
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20. Patient Sex, Reproductive Status, and Synthetic Hormone Use Associate With Histologic Severity of Nonalcoholic Steatohepatitis

Author

Dasarathy, Srinivasan, Dasarathy, Jaividhya, Hawkins, Carol, McCullough, Arthur J., Pagadala, Mangesh, Pai, Rish, Sargent, Ruth, Abdelmalek, Manal F., Bashir, Mustafa, Buie, Stephanie, Diehl, Anna Mae, Guy, Cynthia, Kigongo, Christopher, Pan, Yi-Ping, Piercy, Dawn, Chalasani, Naga, Cummings, Oscar W., Gawrieh, Samer, Ghabril, Marwan, Marri, Smitha, Ragozzino, Linda, Sandrasegaran, Kumar, Vuppalanchi, Raj, King, Debra, Osmack, Pat, Siegner, Joan, Stewart, Susan, Neuschwander-Tetri, Brent A., Torretta, Susan, Ang, Brandon, Behling, Cynthia, Bhatt, Archana, Loomba, Rohit, Middleton, Michael, Patton, Heather, Sirlin, Claude, Aouizerat, Bradley, Bass, Nathan M., Brandman, Danielle, Ferrell, Linda D., Gill, Ryan, Hameed, Bilal, Ramos, Claudia, Terrault, Norah, Ungermann, Ashley, Atla, Pradeep, Croft, Brandon, Garcia, Rebekah, Garcia, Sonia, Sheikh, Muhammad, Singh, Mandeep, Boyett, Sherry, Carucci, Laura, Contos, Melissa J., Kraft, Kenneth, Luketic, Velimir A.C., Puri, Puneet, Sanyal, Arun J., Schlosser, Jolene, Siddiqui, Mohhamad S., Wolford, Ben, Ackermann, Sarah, Cooney, Shannon, Coy, David, Gelinas, Katie, Kowdley, Kris V., Lee, Maximillian, Pierce, Tracey, Mooney, Jody, Nelson, James E., Shaw, Cheryl, Siddique, Asma, Wang, Chia, Brunt, Elizabeth M., Fowler, Kathryn, Kleiner, David E., Grave, Gilman D., Doo, Edward C., Hoofnagle, Jay H., Robuck, Patricia R., Sherker, Averell, Belt, Patricia, Clark, Jeanne M., Donithan, Michele, Hallinan, Erin, Isaacson, Milana, May, Kevin P., Miriel, Laura, Sternberg, Alice, Tonascia, James, Ünalp-Arida, Aynur, Van Natta, Mark, Vaughn, Ivana, Wilson, Laura, Yates, Katherine, Yang, Ju Dong, Guy, Cynthia D., Gill, Ryan M., Lavine, Joel E., Klair, Jagpal, Terrault, Norah A., Unalp-Arida, Aynur, and Suzuki, Ayako

Published
2017
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21. A multi-society Delphi consensus statement on new fatty liver disease nomenclature

Author

Mary E, R, Jeffrey V, L, Vlad, R, Sven M, F, Arun J, S, Fasiha, K, Diana, R, Manal F, A, Quentin M, A, Juan Pablo, A, Marco, A, Ramon, B, Ulrich, B, Jerome, B, Elisabetta, B, Christopher, B, Graciela E, C, Abhijit, C, Helena, C, Donna, C, Kenneth, C, Mohamed, E, Samuel, K, Wayne, E, Jiangao, F, Samer, G, Cynthia D, G, Stephen A, H, Seung Up, K, Bart, K, Marko, K, Kris, K, Florence, L, Rohit, L, Robert, M, Timothy R, M, Elisabeth, P, Michael, R, Manuel, R, Marcelo, S, Shivaram Prasad, S, Silvia C, S, C Wendy, S, Dina, T, Luca, V, Miriam B, V, Vincent, W, Stavra, X, Yusuf, Y, Zobair, Y, Ansley, H, Marcela, V, Newsome, NVeeral Ajmeral, P, Alazawi, W, Alkhatry, M, Alkhouri, N, Allen, A, Allison, M, Alswat, K, R Alvares-da-Silva, M, Alves-Bezerra, M, J Armstrong, M, Arufe, D, Aschner, P, Baffy, G, Bansal, M, Bedossa, P, Belfort, R, Berg, T, Berzigotti, A, Betel, M, Bianco, C, Brass, C, L Brosgart, C, Matthews Brunt, E, Buti, M, Caldwell, S, Carr, R, Casanovas, T, Castera, L, Caussy, C, Cerda, E, Chalasani, N, Kheong Chan, W, Charatcharoenwitthaya, P, Charlton, M, Cheung, A, Chiodi, D, Chung, R, Cohen, D, Corey, K, P Cotrim, H, Crespo, J, Dassanayake, A, Davidson, N, De Knegt, R, De Ledinghen, V, Demir, M, Diaz, S, Mae Diehl, A, Dimmig, B, Dirchwolf, M, Duseja, A, Dvorak, K, Ekstedt, M, El Wakil, R, Lucía Ferraz, M, Friedman, S, Fuchs, M, Gastaldelli, A, Geerts, A, Geier, A, Girala, M, Goh, G, Goossens, N, Graupera, I, Hagström, H, Henry, Z, Hunyady, B, Hutchison, A, Isaacs, S, Jornayvaz, F, Kemp, C, Kile, D, Kim, W, Kleiner, D, Kohli, R, Kugelmas, M, Lavine, J, Lazo, M, Leite, N, Lozano, A, Luukkonen, P, Macedo, P, Mansour, D, Mantzoros, C, Marchesini, G, Marciano, S, Martinez, K, Vladimirova Mateva, L, M Mato, J, Mccary, A, Miele, L, Mikolasevic, I, Miller, V, Moreno, R, Moylan, C, Nakajima, A, Charles Nault, J, Norris, S, Noureddin, M, P Oliveira, C, Ong, A, Padilla, M, Pais, R, Panduro, A, K Panigrahi, M, Papatheodoridis, G, Pelusi, S, Pérez, M, Perez Escobar, J, Perseghin, G, Pessoa, M, Petta, S, Pinzani, M, Platon Lupsor, M, Rabiee, A, Romeo, S, Rotman, Y, Rowe, I, Salupere, R, Satapathy, S, M Schattenberg, J, Schaufert, W, Schnabl, B, Seim, L, Serfaty, L, Shapiro, D, K Singal, A, Skladany, L, Stefan, N, Stine, J, Sundaram, S, Svegliati-Baroni, G, Szabo, G, Tacke, F, Tanwandee, T, Targher, G, Terrault, N, Tetri, B, Thiele, M, Tisthammer, B, Torre Delgadillo, A, Trauner, M, Tsochatzis, E, Van Kleef, L, Van Mil, S, Vanwagner, L, Antonio Velarde Ruiz Velasco, J, Vesterhus, M, Vilar-Gomez, E, Watt, K, Wattacheril, J, Wilkins, F, Willemse, J, Zekry, A, Zelber-Sagi, S, Rinella, Mary E, Lazarus, Jeffrey V, Ratziu, Vlad, Francque, Sven M, Sanyal, Arun J, Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal F, Anstee, Quentin M, Arab, Juan Pablo, Arrese, Marco, Bataller, Ramon, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher, Castro Narro, Graciela E, Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna, Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia D, Harrison, Stephen A, Kim, Seung Up, Koot, Bart, Korenjak, Marko, Kowdley, Kris, Lacaille, Florence, Loomba, Rohit, Mitchell-Thain, Robert, Morgan, Timothy R, Powell, Elisabeth, Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram Prasad, Sookoian, Silvia C, Spearman, C Wendy, Tiniakos, Dina, Valenti, Luca, Vos, Miriam B, Wai-Sun Wong, Vincent, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, Philip NVeeral Ajmeral, William Alazawi, Maryam Alkhatry, Naim Alkhouri, Alina Allen, Michael Allison, Khalid Alswat, Mario R Alvares-da-Silva, Michele Alves-Bezerra, Matthew J Armstrong, Diego Arufe, Pablo Aschner, Gyorgy Baffy, Meena Bansal, Pierre Bedossa, Renata Belfort, Thomas Berg, Annalisa Berzigotti, Michael Betel, Cristiana Bianco, Clifford Brass, Carol L Brosgart, Elizabeth Matthews Brunt, Maria Buti, Steve Caldwell, Rotonya Carr, Teresa Casanovas, Laurent Castera, Cyrielle Caussy, Eira Cerda, Naga Chalasani, Wah Kheong Chan, Phunchai Charatcharoenwitthaya, Michael Charlton, Amanda Cheung, Daniela Chiodi, Ray Chung, David Cohen, Kathleen Corey, Helma P Cotrim, Javier Crespo, Anuradha Dassanayake, Nicholas Davidson, Robert De Knegt, Victor De Ledinghen, Münevver Demir, Sebastian Diaz, Anna Mae Diehl, Bruce Dimmig, Melisa Dirchwolf, Ajay Duseja, Karel Dvorak, Mattias Ekstedt, Reda El Wakil, María Lucía Ferraz, Scott Friedman, Michael Fuchs, Amalia Gastaldelli, Anja Geerts, Andreas Geier, Marcos Girala, George Goh, Nicolas Goossens, Isabel Graupera, Hannes Hagström, Zachary Henry, Bela Hunyady, Alan Hutchison, Scott Isaacs, François Jornayvaz, Cynthia Kemp, Denise Kile, Won Kim, David Kleiner, Rohit Kohli, Marcelo Kugelmas, Joel Lavine, Mariana Lazo, Nathalie Leite, Adelina Lozano, Panu Luukkonen, Paula Macedo, Dina Mansour, Christos Mantzoros, Giulio Marchesini, Sebastián Marciano, Kim Martinez, Lyudmila Vladimirova Mateva, Jose M Mato, Alexis McCary, Luca Miele, Ivana Mikolasevic, Veronica Miller, Rosalba Moreno, Cynthia Moylan, Atsushi Nakajima, Jean Charles Nault, Suzanne Norris, Mazen Noureddin, C P Oliveira, Arlin Ong, Martín Padilla, Raluca Pais, Arturo Panduro, Manas K Panigrahi, George Papatheodoridis, Serena Pelusi, Marlene Pérez, Juanita Perez Escobar, Gianluca Perseghin, Mario Pessoa, Salvatore Petta, Massimo Pinzani, Monica Platon Lupsor, Atoosa Rabiee, Stefano Romeo, Yaron Rotman, Ian Rowe, Riina Salupere, Sanjaya Satapathy, Jörn M Schattenberg, Wendy Schaufert, Bernd Schnabl, Lynn Seim, Lawrence Serfaty, David Shapiro, Ashwani K Singal, Lubomir Skladany, Norbert Stefan, Jonathan Stine, Shikha Sundaram, Gianluca Svegliati-Baroni, Gyonzgi Szabo, Frank Tacke, Tawesak Tanwandee, Giovanni Targher, Norah Terrault, Brent Tetri, Maja Thiele, Baron Tisthammer, Aldo Torre Delgadillo, Michael Trauner, Emmanuel Tsochatzis, Laurens Van Kleef, Saskia Van Mil, Lisa VanWagner, Jose Antonio Velarde Ruiz Velasco, Mette Vesterhus, Eduardo Vilar-Gomez, Kymberly Watt, Julia Wattacheril, Fonda Wilkins, José Willemse, Amany Zekry, Shira Zelber-Sagi, Mary E, R, Jeffrey V, L, Vlad, R, Sven M, F, Arun J, S, Fasiha, K, Diana, R, Manal F, A, Quentin M, A, Juan Pablo, A, Marco, A, Ramon, B, Ulrich, B, Jerome, B, Elisabetta, B, Christopher, B, Graciela E, C, Abhijit, C, Helena, C, Donna, C, Kenneth, C, Mohamed, E, Samuel, K, Wayne, E, Jiangao, F, Samer, G, Cynthia D, G, Stephen A, H, Seung Up, K, Bart, K, Marko, K, Kris, K, Florence, L, Rohit, L, Robert, M, Timothy R, M, Elisabeth, P, Michael, R, Manuel, R, Marcelo, S, Shivaram Prasad, S, Silvia C, S, C Wendy, S, Dina, T, Luca, V, Miriam B, V, Vincent, W, Stavra, X, Yusuf, Y, Zobair, Y, Ansley, H, Marcela, V, Newsome, NVeeral Ajmeral, P, Alazawi, W, Alkhatry, M, Alkhouri, N, Allen, A, Allison, M, Alswat, K, R Alvares-da-Silva, M, Alves-Bezerra, M, J Armstrong, M, Arufe, D, Aschner, P, Baffy, G, Bansal, M, Bedossa, P, Belfort, R, Berg, T, Berzigotti, A, Betel, M, Bianco, C, Brass, C, L Brosgart, C, Matthews Brunt, E, Buti, M, Caldwell, S, Carr, R, Casanovas, T, Castera, L, Caussy, C, Cerda, E, Chalasani, N, Kheong Chan, W, Charatcharoenwitthaya, P, Charlton, M, Cheung, A, Chiodi, D, Chung, R, Cohen, D, Corey, K, P Cotrim, H, Crespo, J, Dassanayake, A, Davidson, N, De Knegt, R, De Ledinghen, V, Demir, M, Diaz, S, Mae Diehl, A, Dimmig, B, Dirchwolf, M, Duseja, A, Dvorak, K, Ekstedt, M, El Wakil, R, Lucía Ferraz, M, Friedman, S, Fuchs, M, Gastaldelli, A, Geerts, A, Geier, A, Girala, M, Goh, G, Goossens, N, Graupera, I, Hagström, H, Henry, Z, Hunyady, B, Hutchison, A, Isaacs, S, Jornayvaz, F, Kemp, C, Kile, D, Kim, W, Kleiner, D, Kohli, R, Kugelmas, M, Lavine, J, Lazo, M, Leite, N, Lozano, A, Luukkonen, P, Macedo, P, Mansour, D, Mantzoros, C, Marchesini, G, Marciano, S, Martinez, K, Vladimirova Mateva, L, M Mato, J, Mccary, A, Miele, L, Mikolasevic, I, Miller, V, Moreno, R, Moylan, C, Nakajima, A, Charles Nault, J, Norris, S, Noureddin, M, P Oliveira, C, Ong, A, Padilla, M, Pais, R, Panduro, A, K Panigrahi, M, Papatheodoridis, G, Pelusi, S, Pérez, M, Perez Escobar, J, Perseghin, G, Pessoa, M, Petta, S, Pinzani, M, Platon Lupsor, M, Rabiee, A, Romeo, S, Rotman, Y, Rowe, I, Salupere, R, Satapathy, S, M Schattenberg, J, Schaufert, W, Schnabl, B, Seim, L, Serfaty, L, Shapiro, D, K Singal, A, Skladany, L, Stefan, N, Stine, J, Sundaram, S, Svegliati-Baroni, G, Szabo, G, Tacke, F, Tanwandee, T, Targher, G, Terrault, N, Tetri, B, Thiele, M, Tisthammer, B, Torre Delgadillo, A, Trauner, M, Tsochatzis, E, Van Kleef, L, Van Mil, S, Vanwagner, L, Antonio Velarde Ruiz Velasco, J, Vesterhus, M, Vilar-Gomez, E, Watt, K, Wattacheril, J, Wilkins, F, Willemse, J, Zekry, A, Zelber-Sagi, S, Rinella, Mary E, Lazarus, Jeffrey V, Ratziu, Vlad, Francque, Sven M, Sanyal, Arun J, Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal F, Anstee, Quentin M, Arab, Juan Pablo, Arrese, Marco, Bataller, Ramon, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher, Castro Narro, Graciela E, Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna, Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia D, Harrison, Stephen A, Kim, Seung Up, Koot, Bart, Korenjak, Marko, Kowdley, Kris, Lacaille, Florence, Loomba, Rohit, Mitchell-Thain, Robert, Morgan, Timothy R, Powell, Elisabeth, Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram Prasad, Sookoian, Silvia C, Spearman, C Wendy, Tiniakos, Dina, Valenti, Luca, Vos, Miriam B, Wai-Sun Wong, Vincent, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, Philip NVeeral Ajmeral, William Alazawi, Maryam Alkhatry, Naim Alkhouri, Alina Allen, Michael Allison, Khalid Alswat, Mario R Alvares-da-Silva, Michele Alves-Bezerra, Matthew J Armstrong, Diego Arufe, Pablo Aschner, Gyorgy Baffy, Meena Bansal, Pierre Bedossa, Renata Belfort, Thomas Berg, Annalisa Berzigotti, Michael Betel, Cristiana Bianco, Clifford Brass, Carol L Brosgart, Elizabeth Matthews Brunt, Maria Buti, Steve Caldwell, Rotonya Carr, Teresa Casanovas, Laurent Castera, Cyrielle Caussy, Eira Cerda, Naga Chalasani, Wah Kheong Chan, Phunchai Charatcharoenwitthaya, Michael Charlton, Amanda Cheung, Daniela Chiodi, Ray Chung, David Cohen, Kathleen Corey, Helma P Cotrim, Javier Crespo, Anuradha Dassanayake, Nicholas Davidson, Robert De Knegt, Victor De Ledinghen, Münevver Demir, Sebastian Diaz, Anna Mae Diehl, Bruce Dimmig, Melisa Dirchwolf, Ajay Duseja, Karel Dvorak, Mattias Ekstedt, Reda El Wakil, María Lucía Ferraz, Scott Friedman, Michael Fuchs, Amalia Gastaldelli, Anja Geerts, Andreas Geier, Marcos Girala, George Goh, Nicolas Goossens, Isabel Graupera, Hannes Hagström, Zachary Henry, Bela Hunyady, Alan Hutchison, Scott Isaacs, François Jornayvaz, Cynthia Kemp, Denise Kile, Won Kim, David Kleiner, Rohit Kohli, Marcelo Kugelmas, Joel Lavine, Mariana Lazo, Nathalie Leite, Adelina Lozano, Panu Luukkonen, Paula Macedo, Dina Mansour, Christos Mantzoros, Giulio Marchesini, Sebastián Marciano, Kim Martinez, Lyudmila Vladimirova Mateva, Jose M Mato, Alexis McCary, Luca Miele, Ivana Mikolasevic, Veronica Miller, Rosalba Moreno, Cynthia Moylan, Atsushi Nakajima, Jean Charles Nault, Suzanne Norris, Mazen Noureddin, C P Oliveira, Arlin Ong, Martín Padilla, Raluca Pais, Arturo Panduro, Manas K Panigrahi, George Papatheodoridis, Serena Pelusi, Marlene Pérez, Juanita Perez Escobar, Gianluca Perseghin, Mario Pessoa, Salvatore Petta, Massimo Pinzani, Monica Platon Lupsor, Atoosa Rabiee, Stefano Romeo, Yaron Rotman, Ian Rowe, Riina Salupere, Sanjaya Satapathy, Jörn M Schattenberg, Wendy Schaufert, Bernd Schnabl, Lynn Seim, Lawrence Serfaty, David Shapiro, Ashwani K Singal, Lubomir Skladany, Norbert Stefan, Jonathan Stine, Shikha Sundaram, Gianluca Svegliati-Baroni, Gyonzgi Szabo, Frank Tacke, Tawesak Tanwandee, Giovanni Targher, Norah Terrault, Brent Tetri, Maja Thiele, Baron Tisthammer, Aldo Torre Delgadillo, Michael Trauner, Emmanuel Tsochatzis, Laurens Van Kleef, Saskia Van Mil, Lisa VanWagner, Jose Antonio Velarde Ruiz Velasco, Mette Vesterhus, Eduardo Vilar-Gomez, Kymberly Watt, Julia Wattacheril, Fonda Wilkins, José Willemse, Amany Zekry, and Shira Zelber-Sagi

Abstract

The principal limitations of the terms NAFLD and NASH are the reliance on exclusionary confounder terms and the use of potentially stigmatising language. This study set out to determine if content experts and patient advocates were in favour of a change in nomenclature and/or definition. A modified Delphi process was led by three large pan-national liver associations. The consensus was defined a priori as a supermajority (67%) vote. An independent committee of experts external to the nomenclature process made the final recommendation on the acronym and its diagnostic criteria. A total of 236 panellists from 56 countries participated in 4 online surveys and 2 hybrid meetings. Response rates across the 4 survey rounds were 87%, 83%, 83%, and 78%, respectively. Seventy-four percent of respondents felt that the current nomenclature was sufficiently flawed to consider a name change. The terms “nonalcoholic” and “fatty” were felt to be stigmatising by 61% and 66% of respondents, respectively. Steatotic liver disease was chosen as an overarching term to encompass the various aetiologies of steatosis. The term steatohepatitis was felt to be an important pathophysiological concept that should be retained. The name chosen to replace NAFLD was metabolic dysfunction–associated steatotic liver disease (MASLD). There was consensus to change the definition to include the presence of at least 1 of 5 cardiometabolic risk factors. Those with no metabolic parameters and no known cause were deemed to have cryptogenic steatotic liver disease. A new category, outside pure metabolic dysfunction–associated steatotic liver disease, termed metabolic and alcohol related/associated liver disease (MetALD), was selected to describe those with metabolic dysfunction–associated steatotic liver disease, who consume greater amounts of alcohol per week (140–350 g/wk and 210–420 g/wk for females and males, respectively). The new nomenclature and diagnostic criteria are widely supported and non-stigmati

Published
2023

22. A multi-society Delphi consensus statement on new fatty liver disease nomenclature

Author

Rinella, Mary E, Lazarus, Jeffrey V, Ratziu, Vlad, Francque, Sven M, Sanyal, Arun J, Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal F, Anstee, Quentin M, Arab, Juan Pablo, Arrese, Marco, Bataller, Ramon, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher, Castro Narro, Graciela E, Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna, Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia D, Harrison, Stephen A, Kim, Seung Up, Koot, Bart, Korenjak, Marko, Kowdley, Kri, Lacaille, Florence, Loomba, Rohit, Mitchell-Thain, Robert, Morgan, Timothy R, Powell, Elisabeth, Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram Prasad, Sookoian, Silvia C, Spearman, C Wendy, Tiniakos, Dina, Valenti, Luca, Vos, Miriam B, Wai-Sun Wong, Vincent, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, Newsome, Philip N, Miele, Luca, NAFLD Nomenclature consensus, Group, Miele, Luca (ORCID:0000-0003-3464-0068), Rinella, Mary E, Lazarus, Jeffrey V, Ratziu, Vlad, Francque, Sven M, Sanyal, Arun J, Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal F, Anstee, Quentin M, Arab, Juan Pablo, Arrese, Marco, Bataller, Ramon, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher, Castro Narro, Graciela E, Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna, Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia D, Harrison, Stephen A, Kim, Seung Up, Koot, Bart, Korenjak, Marko, Kowdley, Kri, Lacaille, Florence, Loomba, Rohit, Mitchell-Thain, Robert, Morgan, Timothy R, Powell, Elisabeth, Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram Prasad, Sookoian, Silvia C, Spearman, C Wendy, Tiniakos, Dina, Valenti, Luca, Vos, Miriam B, Wai-Sun Wong, Vincent, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, Newsome, Philip N, Miele, Luca, NAFLD Nomenclature consensus, Group, and Miele, Luca (ORCID:0000-0003-3464-0068)

Abstract

Unlabelled: The principal limitations of the terms nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) are the reliance on exclusionary confounder terms and the use of potentially stigmatising language. This study set out to determine if content experts and patient advocates were in favour of a change in nomenclature and/or definition. Methods: A modified Delphi process was led by three large pan-national liver associations. Consensus was defined a priori as a supermajority (67%) vote. An independent committee of experts external to the nomenclature process made the final recommendation on the acronym and its diagnostic criteria. Results: A total of 236 panellists from 56 countries participated in four online surveys and two hybrid meetings. Response rates across the 4 survey rounds were 87%, 83%, 83% and 78%, respectively. 74% of respondents felt that the current nomenclature was sufficiently flawed to consider a name change. The terms 'non-alcoholic' and 'fatty' were felt to be stigmatising by 61% and 66% of respondents, respectively. Steatotic liver disease (SLD) was chosen as an overarching term to encompass the various aetiologies of steatosis. The term steatohepatitis was felt to be an important pathophysiological concept that should be retained. The name chosen to replace NAFLD was metabolic dysfunction-associated steatotic liver disease (MASLD). There was consensus to change the definition to include the presence of at least one of five cardiometabolic risk factors. Those with no metabolic parameters and no known cause were deemed to have cryptogenic SLD. A new category, outside pure MASLD, termed MetALD was selected to describe those with MASLD who consume greater amounts of alcohol per week (140 to 350 g/week and 210 to 420 g/week for females and males respectively). Conclusions: The new nomenclature and diagnostic criteria are widely supported, non-stigmatising and can improve awareness and patient identification.

Published
2023

23. A multisociety Delphi consensus statement on new fatty liver disease nomenclature

Author

Rinella, Mary E., Lazarus, Jeffrey V., Ratziu, Vlad, Francque, Sven M., Sanyal, Arun J., Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal, Anstee, Quentin, Arab, Juan Pablo, Arrese, Marco, Bataller, Ramón, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher D., Castro Narro, Graciela E., Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna R., Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia D., Harrison, Stephen A., Kim, Seung Up, Koot, Bart G., Korenjak, Marko, Kowdley, Kris V., Lacaille, Florence, Loomba, Rohit, Mitchell-Thain, Robert, Morgan, Timothy R., Powell, Elisabeth E., Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram Prasad, Sookoian, Silvia C., Spearman, C. Wendy, Tiniakos, Dina, Valenti, Luca, Vos, Miriam B., Wong, Vincent Wai-Sun, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, Newsome, Philip N., on behalf of the NAFLD Nomenclature consensus group, Rinella, Mary E., Lazarus, Jeffrey V., Ratziu, Vlad, Francque, Sven M., Sanyal, Arun J., Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal, Anstee, Quentin, Arab, Juan Pablo, Arrese, Marco, Bataller, Ramón, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher D., Castro Narro, Graciela E., Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna R., Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia D., Harrison, Stephen A., Kim, Seung Up, Koot, Bart G., Korenjak, Marko, Kowdley, Kris V., Lacaille, Florence, Loomba, Rohit, Mitchell-Thain, Robert, Morgan, Timothy R., Powell, Elisabeth E., Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram Prasad, Sookoian, Silvia C., Spearman, C. Wendy, Tiniakos, Dina, Valenti, Luca, Vos, Miriam B., Wong, Vincent Wai-Sun, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, Newsome, Philip N., and on behalf of the NAFLD Nomenclature consensus group

Abstract

The principal limitations of the terms NAFLD and NASH are the reliance on exclusionary confounder terms and the use of potentially stigmatising language. This study set out to determine if content experts and patient advocates were in favor of a change in nomenclature and/or definition. A modified Delphi process was led by three large pan-national liver associations. The consensus was defined a priori as a supermajority (67%) vote. An independent committee of experts external to the nomenclature process made the final recommendation on the acronym and its diagnostic criteria. A total of 236 panelists from 56 countries participated in 4 online surveys and 2 hybrid meetings. Response rates across the 4 survey rounds were 87%, 83%, 83%, and 78%, respectively. Seventy-four percent of respondents felt that the current nomenclature was sufficiently flawed to consider a name change. The terms “nonalcoholic” and “fatty” were felt to be stigmatising by 61% and 66% of respondents, respectively. Steatotic liver disease was chosen as an overarching term to encompass the various aetiologies of steatosis. The term steatohepatitis was felt to be an important pathophysiological concept that should be retained. The name chosen to replace NAFLD was metabolic dysfunction–associated steatotic liver disease. There was consensus to change the definition to include the presence of at least 1 of 5 cardiometabolic risk factors. Those with no metabolic parameters and no known cause were deemed to have cryptogenic steatotic liver disease. A new category, outside pure metabolic dysfunction–associated steatotic liver disease, termed metabolic and alcohol related/associated liver disease (MetALD), was selected to describe those with metabolic dysfunction–associated steatotic liver disease, who consume greater amounts of alcohol per week (140–350 g/wk and 210–420 g/wk for females and males, respectively). The new nomenclature and diagnostic criteria are widely supported and nonstigmatising, and c

Published
2023

24. Targeting senescent hepatocytes using the thrombomodulin-PAR1 inhibitor vorapaxar ameliorates NAFLD progression

Author

Maeso-Díaz, Raquel, primary, Du, Kuo, additional, Pan, Christopher, additional, Guy, Cynthia D., additional, Oh, Seh Hoon, additional, Chen, Tianyi, additional, Wang, Liuyang, additional, Ko, Dennis C., additional, Tang, Linda, additional, Dutta, Rajesh K., additional, Jun, Ji Hye, additional, Suzuki, Ayako, additional, Abdelmalek, Manal F., additional, Wang, Xiao-Fan, additional, and Diehl, Anna Mae, additional

Published
2023
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25. Data from Paracrine Hedgehog Signaling Drives Metabolic Changes in Hepatocellular Carcinoma

Author

Chan, Isaac S., primary, Guy, Cynthia D., primary, Chen, Yuping, primary, Lu, Jiuyi, primary, Swiderska-Syn, Marzena, primary, Michelotti, Gregory A., primary, Karaca, Gamze, primary, Xie, Guanhua, primary, Krüger, Leandi, primary, Syn, Wing-Kin, primary, Anderson, Blair R., primary, Pereira, Thiago A., primary, Choi, Steve S., primary, Baldwin, Albert S., primary, and Diehl, Anna Mae, primary

Published
2023
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26. Supplementary Methods , Figure Legends 1-5 from Paracrine Hedgehog Signaling Drives Metabolic Changes in Hepatocellular Carcinoma

Author

Chan, Isaac S., primary, Guy, Cynthia D., primary, Chen, Yuping, primary, Lu, Jiuyi, primary, Swiderska-Syn, Marzena, primary, Michelotti, Gregory A., primary, Karaca, Gamze, primary, Xie, Guanhua, primary, Krüger, Leandi, primary, Syn, Wing-Kin, primary, Anderson, Blair R., primary, Pereira, Thiago A., primary, Choi, Steve S., primary, Baldwin, Albert S., primary, and Diehl, Anna Mae, primary

Published
2023
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27. Supplementary Figures 1-5 from Paracrine Hedgehog Signaling Drives Metabolic Changes in Hepatocellular Carcinoma

Author

Chan, Isaac S., primary, Guy, Cynthia D., primary, Chen, Yuping, primary, Lu, Jiuyi, primary, Swiderska-Syn, Marzena, primary, Michelotti, Gregory A., primary, Karaca, Gamze, primary, Xie, Guanhua, primary, Krüger, Leandi, primary, Syn, Wing-Kin, primary, Anderson, Blair R., primary, Pereira, Thiago A., primary, Choi, Steve S., primary, Baldwin, Albert S., primary, and Diehl, Anna Mae, primary

Published
2023
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28. Supplementary Table 1 from Paracrine Hedgehog Signaling Drives Metabolic Changes in Hepatocellular Carcinoma

Author

Chan, Isaac S., primary, Guy, Cynthia D., primary, Chen, Yuping, primary, Lu, Jiuyi, primary, Swiderska-Syn, Marzena, primary, Michelotti, Gregory A., primary, Karaca, Gamze, primary, Xie, Guanhua, primary, Krüger, Leandi, primary, Syn, Wing-Kin, primary, Anderson, Blair R., primary, Pereira, Thiago A., primary, Choi, Steve S., primary, Baldwin, Albert S., primary, and Diehl, Anna Mae, primary

Published
2023
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38. Reply

Author

Yang, Ju Dong, Guy, Cynthia D., and Suzuki, Ayako

Published
2015
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41. The nonalcoholic steatohepatitis extended hepatocyte ballooning score: histologic classification and clinical significance.

Author

Gill, Ryan M., Allende, Daniela, Belt, Patricia H., Behling, Cynthia A., Cummings, Oscar W., Guy, Cynthia D., Carpenter, Daniela, Neuschwander-Tetri, Brent A., Sanyal, Arun J., Tonascia, James, Van Natta, Mark L., Wilson, Laura A., Yamada, Goro, Yeh, Matthew, and Kleiner, David E.

Subjects
NON-alcoholic fatty liver disease, FATTY liver, BODY mass index, MEDICAL research, METABOLIC syndrome, LIVER biopsy
Abstract

Background and Aims: The NAFLD activity score was developed to measure histologic changes in NAFLD during therapeutic trials. Hepatocyte ballooning (HB) is the most specific feature in steatohepatitis diagnosis, yet the impact of variations in HB has not been incorporated. Approach and Results: Liver biopsies from patients enrolled in the NASH Clinical Research Network with an initial diagnosis of NASH or NAFL (n =1688) were evaluated to distinguish classic hepatocyte ballooning (cHB) from smaller, nonclassic hepatocyte ballooning (nHB), and also to designate severe ballooning and assign an extended hepatocyte ballooning (eB) score [0 points, no ballooning (NB); 1 point, few or many nHB; 2 points, few cHB; 3 points, many cHB; 4 points, severe cHB] to the biopsy assessment. The eB score was reproducible among NASH CRN liver pathologists (weighted kappa 0.76) and was significantly associated with older age (mean 52.1 y, cHB; 48.5 y, nHB, p< 0.001), gender (72.3% female, cHB; 54.5% female, nHB, p < 0.001), diabetes (49.8% diabetes, cHB; 28.2% diabetes, nHB, p <0.001), metabolic syndrome (68.5% metabolic syndrome, nHB; 50.2% metabolic syndrome, NB, p <0.001), and body mass index [33.2, 34.2, 35 mean body mass index (kg/m2); NB, nHB, and cHB, respectively, p <0.05]. Finally, fibrosis stage, as a marker of disease severity, was significantly correlated with the eB score (p< 0.001). Conclusions: The eB score allows for a reproducible and more precise delineation of the range of ballooned hepatocyte morphology and corresponds with both clinical features of NASH and fibrosis stage. [ABSTRACT FROM AUTHOR]

Published
2023
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44. Signals from dying hepatocytes trigger growth of liver progenitors

Author

Jung, Youngmi, Witek, Rafal P., Syn, Wing-Kin, Choi, Steve S., Omenetti, Alessia, Premont, Richard, Guy, Cynthia D., and Diehl, Anna Mae

Subjects
Liver cells -- Physiological aspects, Liver cells -- Research, Cellular signal transduction -- Research, Apoptosis -- Research, Hedgehog proteins -- Physiological aspects, Hedgehog proteins -- Research, Health
Published
2010

49. Glycemic Control Predicts Severity of Hepatocyte Ballooning and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease

Author

Alexopoulos, Anastasia‐Stefania, primary, Crowley, Matthew J., additional, Wang, Ying, additional, Moylan, Cynthia A., additional, Guy, Cynthia D., additional, Henao, Ricardo, additional, Piercy, Dawn L., additional, Seymour, Keri A., additional, Sudan, Ranjan, additional, Portenier, Dana D., additional, Diehl, Anna Mae, additional, Coviello, Andrea D., additional, and Abdelmalek, Manal F., additional

Published
2021
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50. Point‐of‐Care Assessment of DCD Livers During Normothermic Machine Perfusion in a Nonhuman Primate Model

Author

Kesseli, Samuel J., primary, Gloria, Jared N., additional, Abraham, Nader, additional, Halpern, Samantha E., additional, Cywinska, Greta N., additional, Zhang, Min, additional, Moris, Dimitrios, additional, Schmitz, Robin, additional, Shaw, Brian I., additional, Fitch, Zachary W., additional, Song, Mingqing, additional, Guy, Cynthia D., additional, Hartwig, Mathew G, additional, Knechtle, Stuart, additional, and Barbas, Andrew S., additional

Published
2021
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