To reach consensus on NAFLD nomenclature, evaluation process must be democratic
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I never would have thought the debate on nonalcoholic fatty liver disease nomenclature would be as contentious as it is.
It is important to go back historically and look at the evolution of NAFLD nomenclature. It started in 1980, when the term “nonalcoholic steatohepatitis” was coined by Professor Jurgen Ludwig. In 2002, we had the first AASLD single topic conference on NAFLD, during which alternate names were discussed. Subsequently, in 2020, a paper was published in Gastroenterology that proposed a name change to metabolic dysfunction-associated liver disease (MAFLD). This raised several crucial issues such as the importance of a ‘positive’ diagnosis, the avoidance of the stigma introduced by alcohol in the name and the association with other metabolic comorbidities. In addition to the name change, the MAFLD proposal changed the disease definition to allow more liberal alcohol use, which changes the natural history of the disease and may have important negative implications for drug and biomarker development. Unfortunately, MAFLD was propagated without a formal process to assess its limitations.
Based on concerns over the validity of the process, the impact on drug and biomarker development, the effect of alcohol and lack of clarity on metabolic dysfunction, the AASLD and EASL convened a large group of content experts and consensus methodology experts to achieve consensus on any new nomenclature. This rigorous Delphi consensus process that began 2 years ago, is comprised of multiple stakeholders (liver organizations, endocrine societies, patient advocacy groups) across North and South America, Europe, the Asia Pacific region, Middle East and North Africa to address all areas related to the nomenclature of NAFLD, where MAFLD was discussed and considered. The key questions addressed through the process include: What are the issues with current nomenclature? Can an alternate name alleviate those concerns? What is the importance of steatohepatitis in the disease definition? How should the role of alcohol be accounted for and how might the name change affect disease awareness, design endpoints and regulatory approvals? Can an alternate name deliver a better-defined subtype to reduce heterogeneity and incorporate future advances in medicine?
This Delphi process has included four anonymous survey rounds and two in-person meetings to deliberate and influence the subsequent set of questions and statements. The fourth round was recently completed, and results are anticipated soon. The results of the process thus far highlighted the stigma associated with the term ‘fatty’ as well and any future name will strive to avoid this. With respect to the definition, there has been clear consensus that due to the role alcohol plays in disease progression, a more liberal allowance of alcohol is not appropriate. More nuanced discussions are ongoing regarding any other changes to the current definition, bearing in mind that any change would not deter the tremendous ongoing progress in therapeutics and outcomes prediction.
At this juncture, it is critical that we come together as a field and unify behind what has been fair and rigorous multi-stakeholder, multi-society Delphi process led by expert methodologists. There may be no perfect name, but through this process will emerge the least imperfect name that can adapt as we learn more about the disease and its subtypes in the years to come.
We need a name change, but we cannot just publish a paper, come up with a name and expect everybody to adopt it. That does not work and has never worked in medicine. This is no different. It needs to be put through rigorous scientific process.
- Reference:
- Mohammed E, et al. Gastroenterology. 2020;doi:10.1053/j.gastro.2019.11.312.
- For more information:
- Stephen A. Harrison, MD, FAASLD, is a visiting professor of hepatology in the Radcliffe department of medicine at the University of Oxford, U.K.
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