Accuracy of Noninvasive Diagnostic Tests for the Detection of Significant and Advanced Fibrosis Stages in Nonalcoholic Fatty Liver Disease: A Systematic Literature Review of the US Studies

Gosalia, Dhaval N.; Ratziu, Vlad; Stanicic, Filip; Vukicevic, D; Zah, Vladimir; Gunn, Nadege; Halegoua-DeMarzio, Dina; Tran, Tram

doi:10.3390/diagnostics12112608

Cited by 4 publications

(5 citation statements)

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“…The accuracy analysis showed that both threshold values for liver fibrosis assessment (manufacturer and ROC-derived) are characterized by high NPV values (91-98%), but lower PPV values, which was also observed by others [44,45]. We also found that the PPV values were higher for ROC-derived cut-offs and that using these threshold values gives fewer false positive results.…”

Section: Discussionsupporting

confidence: 82%

“…Additionally, we noted that the highest concordance rates (FIB-4/TE vs. FIB-4/LFRI) were shown for results indicating a low ALF risk, which may suggest that the second-level non-invasive tests, such as TE or LFRI, are more consistent in the low-risk assessment for excluding ALF, even in patients with MAFLD. On the contrary, the concordance rates in the intermediate- and high-risk categories were lower, which indirectly supports the recommendation that ALF risk in these groups should be verified by liver biopsy [ 9 , 45 , 46 ]. It should be mentioned that TE may have some limitations and may overestimate the risk of ALF, especially in obese individuals.…”

Section: Discussionsupporting

confidence: 71%

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Performance Evaluation of a Novel Non-Invasive Test for the Detection of Advanced Liver Fibrosis in Metabolic Dysfunction-Associated Fatty Liver Disease

Stefanska,

Bergmann,

Suwała

et al. 2024

Metabolites

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Metabolic dysfunction-associated fatty liver disease (MAFLD) may progress to advanced liver fibrosis (ALF). We evaluated the diagnostic accuracy of a novel Liver Fibrosis Risk Index (LFRI) in MAFLD subjects using transient elastography (TE) as the reference method for liver fibrosis measurement and then the diagnostic performance of a new two-step non-invasive algorithm for the detection of ALF risk in MAFLD, using Fibrosis-4 (FIB-4) followed by LFRI and comparing it to the reference algorithm based on FIB-4 and TE. We conducted a prospective study on 104 MAFLD European adult subjects. All consenting subjects underwent TE and measurements of FIB-4 and LFRI. For FIB-4 and TE, validated cut-offs were used. An ROC analysis showed that LFRI diagnosed severe fibrosis with moderate accuracy in MAFLD subjects with a negative predictive value above 90%. Using the new algorithm with LFRI thresholds recommended by the manufacturer, the number of subjects classified into ALF risk groups (low, intermediate, or high) differed significantly when compared with the reference algorithm (p = 0.001), with moderate agreement between them (weighted kappa (95% CI) = 0.59 (0.41–0.77)). To improve the performance of the LFRI-based algorithm, we modified cut-off points based on ROC curves obtained by dividing the study population according to the reference algorithm and observed no difference between algorithms (p = 0.054) in categorizing ALF risk, with a slight increase in the total agreement (weighted kappa (95% CI) = 0.63 (0.44–0.82)). Our findings suggest that using the novel LFRI as a second-line test may represent a potential alternative for liver fibrosis risk stratification in MAFLD patients; however, modified cut-offs are needed to optimize its performance.

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Section: Discussionsupporting

confidence: 82%

Section: Discussionsupporting

confidence: 71%

Performance Evaluation of a Novel Non-Invasive Test for the Detection of Advanced Liver Fibrosis in Metabolic Dysfunction-Associated Fatty Liver Disease

Stefanska,

Bergmann,

Suwała

et al. 2024

Metabolites

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“…These findings highlight the limitations of solely focusing on advanced fibrosis while broadening the scope of CVD risk assessments in MASLD. While FIB-4 < 1.3 and NFS < -1.455 demonstrate good performance in excluding advanced fibrosis [116,117] , aligning with the primary goal of current guidelines for fibrosis assessment in the MASLD population, they exhibit relatively poor performance in ruling out significant fibrosis [117][118][119] . This presents a notable challenge, with special reference to patients classified as low-risk, who represent up to 80% of individuals with MASLD [120] .…”

Section: New Evidence: Emphasis On Liver-related Parameters and Oppor...mentioning

confidence: 82%

Perspective article: determinants and assessment of cardiovascular risk in steatotic liver disease owing to metabolic dysfunction-addressing the challenge

Jamalinia,

Lonardo

2024

Metab Target Organ Damage

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Metabolic dysfunction-associated steatotic liver disease (MASLD) stands as an independent risk factor for cardiovascular disease (CVD), which is the leading cause of mortality among MASLD patients. The diverse spectrum of cardio-nephro-metabolic and vascular manifestations inherent in MASLD highlights the complex profile of CVD risk associated with this condition. However, current approaches to assessing CVD risk in MASLD lack specificity, predominantly relying on traditional markers. Although it is widely accepted that patients with advanced fibrosis are more prone to CVD risk, recent evidence suggests that this isolated focus may overlook the remarkable phenotypic variability of this CVD risk across the entire MASLD population. Emerging data indicate a progressive escalation of CVD risk in parallel with the severity of MASLD, highlighting the need for precise disease staging to inform accurate risk assessment. To address this challenge, we propose a novel sequential approach to CVD risk assessment in MASLD. While traditional CVD risk factors remain essential, incorporating liver-specific parameters enhances risk stratification and guides targeted interventions to mitigate the substantial burden of cardiovascular disease in this vulnerable population. This approach involves initial screening using FIB-4 and NAFLD fibrosis score, followed by assessment of liver fibrosis with imaging-based non-invasive techniques in individuals at intermediate-high risk for advanced fibrosis and liver fat quantification in low-risk individuals. Future prospective investigations should focus on the simultaneous use of liver biomarkers and imaging modalities to evaluate, in a sex-specific manner, the efficacy of the proposed approach and to determine optimal thresholds of liver fibrosis and steatosis for optimal CVD risk assessment.

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“…These tests and their algorithms should be tested prospectively for their ability to predict outcomes and be cost-effective. 6 Until then, we do agree with the major guidelines and continue to suggest the use of the FIB-4 score as the first line NIT for risk stratification.…”

mentioning

confidence: 76%

Letter: should we abandon FIB‐4 to characterise noninvasively patients with NAFLD? Authors' reply

Henry

Younossi

2023

Aliment Pharmacol Ther

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We thank Pugliese et al. for their thoughtful comments on our recent review article addressing the use of the FIB-4 score as the initial noninvasive test (NIT) to risk stratify patients with NAFLD in primary care or endocrinology practices. 1,2 Pugliese et al point out the potential for a significant number of false-negative results from the use of FIB-4, especially among those with multiple risk factors. As a result, they suggest that combination scores should be used such as the Agile 3 or 4 scores. 2 It is important to recognise that our algorithm is based on recent recommendations by both AACE and AASLD recommending FIB-4 as the first NIT. 3,4 Although this first-line test can miss some patients, it does have good negative predictive value and is very easy to use in clinical practice. We do agree that combinations of NITs, as suggested in our algorithm and those provided by recent guidelines, should optimise the predictive value of noninvasive tests.However, using the same comparative values is required when comparing outcomes. One such example of this is the study Pugliese et al. cite in their letter where researchers studied a large diverse population with many different aetiologies of liver disease. The researchers compared results obtained using the FIB-4 score against results from trans-elastography (TE) values of 8 kPa and 12 kPa. In our algorithm, if the TE values range between 8 and 12 kPa, this zone is considered indeterminate and another test such as the Enhanced Liver Fibrosis (ELF) test should be considered. 5 We fully agree with Pugliese et al. that it is critical to develop and validate additional easy and more accurate noninvasive tests. These tests and their algorithms should be tested prospectively for their ability to predict outcomes and be cost-effective. 6 Until then, we do agree with the major guidelines and continue to suggest the use of the FIB-4 score as the first line NIT for risk stratification.

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Accuracy of Noninvasive Diagnostic Tests for the Detection of Significant and Advanced Fibrosis Stages in Nonalcoholic Fatty Liver Disease: A Systematic Literature Review of the US Studies

Cited by 4 publications

References 58 publications

Performance Evaluation of a Novel Non-Invasive Test for the Detection of Advanced Liver Fibrosis in Metabolic Dysfunction-Associated Fatty Liver Disease

Performance Evaluation of a Novel Non-Invasive Test for the Detection of Advanced Liver Fibrosis in Metabolic Dysfunction-Associated Fatty Liver Disease

Perspective article: determinants and assessment of cardiovascular risk in steatotic liver disease owing to metabolic dysfunction-addressing the challenge

Letter: should we abandon FIB‐4 to characterise noninvasively patients with NAFLD? Authors' reply

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