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• W1598774704 abstract "The past two decades have witnessed a tremendous therapeutic advance in viral hepatitis, spearheaded by antiviral agents, which has resulted in a surge in the number of candidates for starting therapy. Accordingly, recent studies have striven to determine the optimal criteria for selecting patients who can benefit from antiviral treatment, and to decide the optimal starting time of antiviral treatment. This rapid evolution of antiviral treatment in hepatology has inevitably prompted the clinical need for a simple non-invasive diagnosis of liver fibrosis. Liver biopsy (LB) has been the “gold standard” for assessing the severity of necroinflammatory activity and liver fibrosis, but even in expert hands, it is invasive and sometimes associated with rare but serious complications, including bleeding, pneumothorax, and procedure-related death.1 In addition to sampling error, both intraobserver and interobserver variability can occur in histological interpretation.2 Despite these pitfalls, LB remains the gold standard due to the absence of better alternatives. Recently, however, many physicians have acknowledged that LB is an imperfect standard and have sought non-invasive serologic fibrosis markers and formulae using demographic and serologic biochemical variables to replace LB. Physicians' reluctance to perform LB due to potential complications and increasing patient refusal to undergo LB are other reasons for establishing reliable non-invasive serologic fibrosis markers and formulae. Before 2000, serologic fibrosis markers and formulae were in their infancy.3 More recently, the increasing need for more accurate prediction of liver fibrosis, however, has encouraged a flurry of publications on new non-invasive serologic fibrosis markers and formulae, such as the serum hyaluronic acid level, aspartate aminotransferase (AST)-to-alanine aminotransferase (ALT) ratio, AST-to-platelet ratio index, age–spleen–platelet ratio index, Forn's test, FibroTest (BioPredictive, Paris, France), FIBROSpect (Prometheus Laboratories, San Diego, CA, USA), HepaScore (Quest Diagnostics, San Juan Capistrano, CA, USA), European Liver Fibrosis Panel score, and the Hui index.4-8 Recently, transient elastography (TE) using FibroScan (EchoSens, Paris, France) was introduced as a promising non-invasive device for assessing liver fibrosis, and it has shown considerable accuracy for predicting cirrhosis in patients with chronic viral hepatitis.9-11 For a better prediction of liver fibrosis, some studies suggested the combined use of TE, serologic fibrosis markers, and demographic and serologic biochemical variables.12-14 In the current issue of the Journal of Gastroenterology and Hepatology, Lee et al.13 proposed a new fibrosis prediction formula, called the HALF index, which incorporated serum haptoglobin, apolipoprotein A1, α-2 macroglobulin, and TE as constituent variables. The superiority of the HALF index was proved by internal validation. The authors demonstrated that the area under the receiver–operator characteristic curve (AUROC) of the HALF index for predicting significant fibrosis (≥F2) was 0.915 (95% confidence interval: 0.868–0.949), which was significantly higher than the AUROC of TE alone (AUROC: 0.877; 95% confidence interval: 0.825–0.918; P = 0.010). However, as the confidence intervals of the HALF index and TE overlap, the statistical significance is questionable. Thus, the clinical applicability of the HALF index needs an independent external validation with a large sample size. In general, most non-invasive serologic fibrosis markers, formulae, and TE or TE-based prediction models are better at predicting liver cirrhosis than “significant fibrosis.” Interestingly, the AUROC of the HALF index for predicting significant fibrosis was higher than that for predicting liver cirrhosis (0.915 vs 0.892) in the study of Lee et al.,13 albeit minimally, whereas the AUROC of TE remained similar (0.877 vs 0.878). In a further analysis, the study population was stratified into two groups according to their serum ALT levels (high- and low-ALT groups) to check the influence of necroinflammation on the HALF index, which includes TE as a constituent factor. Importantly, the HALF index was not influenced by a high ALT, whereas the performance of TE increased significantly in the low ALT group, compatible with other reported findings. Conclusively, all these data indicate that the HALF index can predict significant fibrosis accurately, possibly better than TE, free of the influence of a high ALT in causing unreliable estimations of liver fibrosis. Therefore, if the HALF model can be validated sufficiently, it would be a useful tool for detecting significant fibrosis in patients with chronic viral hepatitis and for deciding when to start antiviral treatment. When we interpret the results of cross-sectional studies on non-invasive fibrosis prediction models, several issues should be considered. First, although most studies that assessed the performance of non-invasive fibrosis prediction models, including the study by Lee et al.,13 have used histological fibrosis grade as the standard for comparison, we should be aware of an important question regarding the discrepancy between the interpretation of LB and non-invasive fibrosis prediction models. The histological grading system generally concentrates on the architectural changes in the liver parenchyma due to fibrosis progression, whereas non-invasive fibrosis prediction models seem to be related to the total amount of fibrosis. Thus, it can introduce a different bias to compare them directly. Second, nearly all of the studies of the non-invasive prediction of liver fibrosis have been cross-sectional, and their performance is reported using the AUROC for significant fibrosis or cirrhosis, with corresponding cut-off liver stiffness values and diagnostic indices, including sensitivity, specificity, and positive and negative predictive values. However, further development of alternative non-invasive methods for predicting liver fibrosis will be restricted if physicians rely solely on the results of cross-sectional studies. Because LB itself is an imperfect gold standard, achieving an AUROC close to 1 in an analysis based on LB data is impossible, even when certain serologic fibrosis markers, formulae, and TE or TE-based models measure liver fibrosis perfectly. Thus, if one insists that a certain newly-identified non-invasive fibrosis prediction marker or model has an AUROC of 1 (perfect concordance with LB data), the imperfection of the model is proven paradoxically. That is, although many of the reported non-invasive fibrosis prediction models with an AUROC over about 0.9 might have already been perfect in predicting liver fibrosis, we who believe LB to be the gold standard, have failed to recognize this. Furthermore, comparing two tests with different AUROC, even in the same population, is difficult because the small differences in AUROC do not necessarily mean that one non-invasive model with a lower AUROC has an inferior performance to that of the other models with a high AUROC, due to the imperfection of LB as a gold standard. Who knows whether this small difference in the AUROCs is caused by the non-invasive models, LB, or both. Third, since the perfect gold standard has yet to be determined, the validation of non-invasive serologic fibrosis markers, formulae, and TE or TE-based models using cross-sectional studies is inevitably limited. Only longitudinal studies using unequivocal clinical end-points related to the progression of liver fibrosis, such as decompensation events, hepatocellular carcinoma development, or liver-related death, can confirm the clinical relevance of the newly-proposed fibrosis prediction models.15-18 Fourth, the standardization of measuring biochemical parameters, such as ALT or AST, which are often used as constituent variables in fibrosis prediction models, and independent external validation with a sufficient sample size, are needed. Furthermore, incorporation of data from primary and secondary hospitals (not only from tertiary hospitals) should be considered for an accurate and complete validation of the utility of such non-invasive approaches. Lastly, the cost issue should be kept in mind in real clinical practice. We can use any variables we want to obtain a higher AUROC by adding it to fibrosis prediction models that already exist, or using them to construct an ideal non-invasive fibrosis prediction model. However, the slight increment in AUROC does not necessarily mean an increase in the prediction of liver fibrosis, and this strategy is more expensive and requires more blood from patients. Therefore, although a combination of expensive specific serologic markers, such as serum haptoglobin, apolipoprotein A1, and α-2 macroglobulin, as in the study by Lee et al.,13 predicted liver fibrosis well, one must consider insufficient money and inapplicability in primary clinics before proposing the widespread use of the HALF index. Despite these issues, new publications on new non-invasive serologic fibrosis markers, formulae, and TE or TE-based prediction models continue to emerge, competing for a higher AUROC without sufficient external and longitudinal validation and cost-effectiveness analyses. Therefore, we are often at a loss when deciding whether we should adhere to the old fibrosis prediction models until validation is completed, or to adopt a new one with a higher AUROC, but without validation. When we return to the basics, all efforts to find better non-invasive serologic fibrosis markers, formulae, and TE or TE-based models have been made to help physicians decide when to treat candidates with antiviral agents. We believe that many currently-available non-invasive fibrosis models can already predict the outcome of antiviral treatment well, compared to LB, even if they have slightly different AUROC. Therefore, after cautiously selecting non-invasive fibrosis prediction models from the results of adequately-validated cross-sectional studies, randomized longitudinal studies are required to compare the outcome of antiviral treatment (sustained viral response in hepatitis C and seroconversion in hepatitis B) among patients who were initially randomized according to histological analysis and non-invasive surrogate models before ultimate confirmation of whether the non-invasive surrogate models can replace LB. This study was supported by a grant from the Good Health R&D Project from the Ministry of Health, Welfare and Family Affairs, Republic of Korea (No. A050021)." @default.
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• W1598774704 title "Non-invasive assessment of liver fibrosis: The gap between ideal and real" @default.
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