Dataset Information

The Enhanced Liver Fibrosis test is associated with liver-related outcomes in postmenopausal women with risk factors for liver disease.

ABSTRACT:

Background

Chronic liver disease (CLD) is usually asymptomatic but earlier detection is critical to permit life-saving interventions for those at risk due to high alcohol consumption and increased body mass index (BMI). The aim of this study was to estimate the association between the Enhanced Liver Fibrosis (ELF) test and liver-related events (LRE) and its performance in predicting LRE in postmenopausal women with risk factors in a nested case-control study within the United Kingdom Trial of Ovarian Cancer Screening (UKCTOCS).

Methods

In a cohort of 95,126 we performed a case-control study measuring ELF in blinded samples from 173 participants with self-reported high alcohol use and / or BMI ?25?kg/m² comprising all 58 cases who developed LRE and 115 controls matched for age, alcohol and BMI who did not develop LRE during median follow-up of 8.5?years.

Results

Using Cox regression at an ELF threshold of 10.51 hazard ratios (HR) for LRE were 4.88 (95% confidence interval (CI) 2.37-10.03) (unadjusted model) and 4.62 (95% CI 2.12-10.08) (adjusted for deprivation and self-reported hypertension, heart disease, hypercholesterolaemia and diabetes). At a threshold of 9.8 HR for LRE were 2.21 (95% CI 1.22-3.97) (unadjusted model) and 2.18 (95% CI 1.19-4.01) (adjusted). ELF was evaluated as a time dependent variable by generating time-dependent Cox models; HRs at an ELF threshold of 10.51 were 1.94 (95% CI 1.10-3.39) (unadjusted) and 2.05 (95% CI 1.16-3.64) (adjusted) and at a threshold of 9.8 HRs were 1.85 (95% CI 1.09-3.15) (unadjusted) and 1.80 (95% CI 1.04-3.13) (adjusted). Area under the receiver operating characteristic curve for recruitment ELF predicting LRE was 0.58 (95% CI 0.49-0.68), and for second subsequent ELF 0.61 (95% CI 0.52-0.71).

Conclusion

This study demonstrates the association between ELF and CLD in postmenopausal women with risk factors for liver disease, creating the opportunity to intervene to reduce liver-related mortality and morbidity. Although larger studies are required, these results demonstrate the potential of ELF as a prognostic tool in health checks in primary care.

Trial registration

This study is nested in UKCTOCS. UKCTOCS is registered as an International Standard Randomised Controlled Trial, number ISRCTN22488978. Registered 06/04/2000.

SUBMITTER: Trembling PM

PROVIDER: S-EPMC7158048 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The Enhanced Liver Fibrosis test is associated with liver-related outcomes in postmenopausal women with risk factors for liver disease.

Trembling Paul M PM Apostolidou Sophia S Gentry-Maharaj Aleksandra A Parkes Julie J Ryan Andy A Tanwar Sudeep S Burnell Matthew M Harris Scott S Menon Usha U Rosenberg William M WM

BMC gastroenterology 20200415 1

<h4>Background</h4>Chronic liver disease (CLD) is usually asymptomatic but earlier detection is critical to permit life-saving interventions for those at risk due to high alcohol consumption and increased body mass index (BMI). The aim of this study was to estimate the association between the Enhanced Liver Fibrosis (ELF) test and liver-related events (LRE) and its performance in predicting LRE in postmenopausal women with risk factors in a nested case-control study within the United Kingdom Tri ...[more]

PMID: 32293289

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Project description:ImportanceThe most important surrogate for increased risk of adverse clinical outcomes among patients with nonalcoholic fatty liver disease (NAFLD) is the patient's stage of liver fibrosis. There is a significant barrier to risk-stratifying patients in clinical practice owing to the need for liver biopsy.ObjectiveTo determine the performance of the enhanced liver fibrosis (ELF) test as a noninvasive test for assessment of liver fibrosis among patients with NAFLD.Design, setting, and participantsThis retrospective cross-sectional study was conducted among patients recruited from a large, community-based hospital system's outpatient liver clinic from 2001 to 2020. Patients with NAFLD defined as steatosis greater than 5% without evidence of other liver disease or excessive alcohol use were included. Data were analyzed from August 2020 through February 2021.InterventionEnhanced liver fibrosis score was calculated.Main outcomes and measuresAdvanced fibrosis was identified by liver biopsy or transient elastography.ResultsAmong 829 patients with NAFLD, the mean (SD) age was 53.1 (14.0) years, there were 363 (43.8%) men, 294 patients (35.5%) had type 2 diabetes, and the mean (SD) fibrosis-4 (fib-4) score was 1.34 (0.97). There were 463 patients with liver biopsy, among whom 113 individuals (24.4%) had bridging fibrosis or cirrhosis; among 462 patients with transient elastography data, 79 individuals (17.1%) had liver stiffness results of 9.6 kPa or more (ie, advanced fibrosis). Patients with advanced fibrosis had statistically significantly increased mean (SD) ELF scores compared with patients without advanced fibrosis as determined by biopsy (10.1 [1.3] vs 8.6 [1.0]; P < .001) or transient elastography (10.0 [1.1] vs 9.0 [0.8]; P < .001). Among all patients with NAFLD, the area under the receiver operating characteristic curve (AUROC) for ELF in identifying patients with advanced fibrosis was 0.81 (95% CI, 0.77-0.85) for patients diagnosed by biopsy and 0.79 (95% CI, 0.75-0.82) for those diagnosed by transient elastography. Performance of the ELF score was similar among patients with NAFLD who were aged 65 years or older (AUROC, 0.74; 95% CI, 0.58-0.87) or had type 2 diabetes (AUROC, 0.78; 95% CI, 0.71-0.84). The combination of an ELF score of 7.2 or greater with a fib-4 score of 0.74 or greater was associated with a negative predictive value of 95.1% (95% CI, 91.8%-98.4%) and a sensitivity of 92.5% (95% CI, 87.4%-97.5%), which can reliably rule out advanced fibrosis. An ELF score of 9.8 or greater with a fib-4 score of 2.9 or greater was associated with a positive predictive value of 95.0% (95% CI, 85.5%-100%) and a specificity of 99.7% (95% CI, 99.1%-100%), which can be used to rule in advanced fibrosis.Conclusions and relevanceThese findings suggest that the ELF test performs well in identifying patients with NAFLD who are at increased risk of advanced fibrosis and that this test combined with fib-4 score may be reliably used in clinical practice to assess the presence or absence of advanced fibrosis among patients with NAFLD.

Project description:Postmenopausal women are at a higher risk of stress urinary incontinence (SUI). In a previous trial, electroacupuncture (EA) was shown to be an effective treatment for women with SUI. Here we present a secondary analysis to investigate the specific factors associated with response to acupuncture therapy among postmenopausal women with SUI.We conducted secondary analysis of data from a multicenter randomized controlled trial. This trial included a baseline period of 1 week and a treatment period of 6 weeks with electroacupuncture (EA) or sham electroacupuncture (SA). The patients were randomly assigned to 2 groups (EA group or SA group). Participants who showed a decrease in urine leakage by at least 50% from baseline level, as measured by 1-hour pad at week 6, were defined as responders. Baseline characteristics associated with response to acupuncture therapy (e.g., demographic, comorbidities, and lifestyle-related factors) were identified by logistic regression analysis and the interactions between treatment assignment and baseline characteristics assessed.This analysis included a total of 349 postmenopausal women, of whom 137 (39.3%) were classified as responders. Response rate in the EA group was significantly higher than that in the SA group (60.9% vs 18.9%, respectively; P < .001). On multivariable logistic regression analysis, only "mean number of urine pads used before treatment" remained a significant predictor of response to therapy (EA or SA). Greater weekly mean number of urine pads used before treatment showed a correlation with non-response to therapy, as the likelihood of clinical response reduced by 5.26% with increase in the weekly mean number of urine pads used (odds ratio 0.947, 95% confidence interval 0.902-0.993; P = .020). The interaction terms were not statistically significant.Postmenopausal women with SUI who used fewer number of pads per week before treatment were more likely to respond to therapy. This study provides valuable insights for pretreatment selection of women with SUI. Specific factors related to the therapeutic effects of acupuncture were not identified and need to be explored in future studies.Trial registration: Clinical Trials.gov: NCT01784172.

Dataset Information

The Enhanced Liver Fibrosis test is associated with liver-related outcomes in postmenopausal women with risk factors for liver disease.

Background

Methods

Results

Conclusion

Trial registration

Publications

The Enhanced Liver Fibrosis test is associated with liver-related outcomes in postmenopausal women with risk factors for liver disease.

Similar Datasets

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