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The overall value of hepatocellular carcinoma screening is defined by the balance of benefits and harms. Studies have only reported physical harms with none describing financial harms. We conducted a multicenter pragmatic randomized clinical trial of hepatocellular carcinoma screening outreach among 2872 patients with cirrhosis from March 2018 to April 2021. Patients with positive or indeterminate results and matched patients with negative results completed surveys at baseline and at follow-up measuring financial harms via Cancer Self-Administered Questionnaire and financial burden via Comprehensive Score for Financial Toxicity Functional Assessment of Chronic Illness Therapy. Univariable and multivariable longitudinal regression analyses were performed to compare changes in financial harms across groups: true positive, true negative, false positive, and indeterminate. Semistructured interviews were conducted in a subset of patients, sampled by center and test result. Of 311 patients who completed at least 1 follow-up survey (75% response rate), 37 had true positive, 133 true negative, 64 false positive, and 77 indeterminate results. Financial harms increased in true positive and false positive patients with no significant changes noted among those with true negative or indeterminate results. At follow-up, 21.8% of patients reported moderate-severe financial burden, which was not significantly associated with test results. Semistructured interviews revealed variation in the frequency and severity of financial harms based on test results, with increased harm in those with false positive results. Financial harms of hepatocellular carcinoma screening vary by test result and can pose a barrier that must be considered when determining the optimal screening program. [ABSTRACT FROM AUTHOR]

The available risk stratification indices for hepatocellular cancer (HCC) have limited applicability. We developed and externally validated an HCC risk stratification index in U.S. cohorts of patients with cirrhosis. We used data from 2 prospective U.S. cohorts to develop the risk index. Patients with cirrhosis were enrolled from 8 centers and followed until development of HCC, death, or December 31, 2021. We identified an optimal set of predictors with the highest discriminatory ability (C-index) for HCC. The predictors were refit using competing risk regression and its predictive performance was evaluated using the area under the receiver-operating characteristic curve (AUROC). External validation was performed in a cohort of 21,550 patients with cirrhosis seen in the U.S Veterans Affairs system between 2018 and 2019 with follow-up through 2021. We developed the model in 2431 patients (mean age 60 years, 31% women, 24% cured hepatitis C, 16% alcoholic liver disease, and 29% nonalcoholic fatty liver disease). The selected model had a C-index of 0.77 (95% confidence interval [CI], 0.73–0.81), and the predictors were age, sex, smoking, alcohol use, body mass index, etiology, α-fetoprotein, albumin, alanine aminotransferase, and platelet levels. The AUROCs were 0.75 (95% CI, 0.65–0.85) at 1 year and 0.77 (95% CI, 0.71–0.83) at 2 years, and the model was well calibrated. In the external validation cohort, the AUROC at 2 years was 0.70 with excellent calibration. The risk index, including objective and routinely available risk factors, can differentiate patients with cirrhosis who will develop HCC and help guide discussions regarding HCC surveillance and prevention. Future studies are needed for additional external validation and refinement of risk stratification. [ABSTRACT FROM AUTHOR]

The comparative effectiveness of tenofovir (TDF) vs entecavir (ETV) in reducing the risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B virus (HBV) remains unclear. Data from a retrospective Korean cohort study published by Choi et al1 initially suggested a lower-than-expected incidence of HCC in patients on long-term TDF. However, additional studies from Korea did not show a statistically significant difference in HCC incidence rate between TDF and ETV groups,2,3 and subsequent studies reported mixed results ranging from no association or a slight advantage for TDF.4 Most of these studies examined Asian patients from Korea, Taiwan, and China. [ABSTRACT FROM AUTHOR]

The effectiveness of hepatocellular carcinoma (HCC) surveillance is mitigated by underuse in clinical practice, highlighting a need for interventions. We evaluated the effectiveness of mailed HCC surveillance outreach to promote HCC surveillance in patients with cirrhosis. We conducted a multicenter pragmatic randomized clinical trial comparing mailed outreach for surveillance ultrasound (n = 1436) and usual care with visit-based surveillance (n = 1436) among patients with cirrhosis at 3 health systems (tertiary care referral center, safety net health system, and Veterans Affairs medical center) from April 2018 to December 2019. The primary outcome of this interim analysis was guideline concordant semiannual HCC surveillance over a 12-month period and a secondary outcome was proportion time covered by surveillance. All patients were included in intention-to-screen analyses. Compared with usual care, the outreach arm had significantly higher semiannual surveillance (35.1% vs 21.9%) and lower no-surveillance (29.8% vs 43.5%) (P <.001), resulting in significant increases in the proportion of time covered by surveillance (41.3% vs 31.0%; P <.001). The intervention increased HCC surveillance across most predefined subgroups; however, there were site-level differences in the intervention effect, with significant increases in semiannual surveillance at the Veterans Affairs and safety net health systems but not at the tertiary care referral center. Mailed outreach significantly increased semiannual HCC surveillance vs usual care in patients with cirrhosis, with a consistent intervention effect across most examined subgroups. Continued follow-up is ongoing to determine if these increases in surveillance translate into improved downstream outcomes includi.ng early HCC detection and curative treatment receipt. (ClinicalTrials.gov , Numbers: NCT02582918 and NCT03756051). [ABSTRACT FROM AUTHOR]

Depression and anxiety can have negative effects on patients and are important to treat. There have been few studies of their prevalence among patients with cirrhosis. We aimed to characterize the prevalence and risk factors for depression and anxiety in a large multi-center cohort of patients with cirrhosis. We conducted a telephone-based survey of patients with cirrhosis at 3 health systems in the United States (a tertiary-care referral center, a safety net system, and a Veterans hospital) from April through December 2018. Of 2871 patients approached, 1021 (35.6%) completed the survey. Depression and anxiety were assessed using the PHQ-9 (range 0–25) and STAI (range 20–80) instruments, with clinically significant values defined as PHQ-9 ≥15 and STAI ≥40. We performed multivariate logistic regression analysis to identify factors associated with significant depression and anxiety. The median PHQ-9 score was 7 (25th percentile–75th percentile, 3–12) and the median STAI score was 33 (25th percentile–75th percentile, 23–47); 15.6% of patients had moderately severe to severe depression and 42.6% of patients had high anxiety. In multivariable analyses, self-reported poor health (odds ratio [OR], 4.08; 95% CI, 1.79–9.28), being widowed (OR, 2.08; 95% CI, 1.07–4.05), fear of hepatocellular carcinoma (OR, 1.89; 95% CI, 1.04–3.42), higher household income (OR, 0.30; 95% CI, 0.10–0.95), and Hispanic ethnicity (OR, 0.57; 95% CI, 0.33–0.97) were associated with moderately severe to severe depression. Male sex (OR, 0.71; 95% CI, 0.51–0.98), self-reported poor health (OR, 2.73; 95% CI, 1.73–4.32), and fear of hepatocellular carcinoma (OR, 2.24; 95% CI, 1.33–3.78) were associated with high anxiety. Nearly 1 in 6 patients with cirrhosis have moderately severe to severe depression and nearly half have moderate–severe anxiety. Patients with cirrhosis should be evaluated for both of these disorders. [ABSTRACT FROM AUTHOR]

More than 20% of patients with cirrhosis do not receive semi-annual hepatocellular carcinoma (HCC) surveillance as recommended. Few studies have evaluated the effects of patient-level factors on surveillance receipt. We administered a telephone survey to a large cohort of patients with cirrhosis from 3 health systems (a tertiary care referral center, a safety-net health system, and Veterans Affairs) to characterize patient knowledge, attitudes, and perceived barriers of HCC surveillance. Multinomial logistic regression was performed to identify factors associated with HCC surveillance receipt (semi-annual and annual vs none) during the 12-month period preceding survey administration. Of 2871 patients approached, 1020 (35.5%) completed the survey. Patients had high levels of concern about developing HCC and high levels of knowledge about HCC. However, patients had knowledge deficits, including believing surveillance was unnecessary when physical examination and laboratory results were normal. Nearly half of patients reported barriers to surveillance, including costs (28.9%), difficulty scheduling (24.1%), and transportation (17.8%). In the year before the survey, 745 patients (73.1%) received 1 or more surveillance examination; 281 received on-schedule, semi-annual surveillance and 464 received annual surveillance. Semi-annual HCC surveillance (vs none) was significantly associated with receipt of hepatology subspecialty care (odds ratio, 30.1; 95% CI, 17.5–51.8) and inversely associated with patient-reported barriers (odds ratio, 0.62; 95% CI, 0.41–0.94). Patterns of associations comparing annual vs no surveillance were similar although the magnitude of effects were reduced. Patient-reported barriers such as knowledge deficits, costs, difficulty scheduling, and transportation are significantly associated with less frequent receipt of HCC surveillance, indicating a need for patient-centered interventions, such as patient navigation. [ABSTRACT FROM AUTHOR]

Little is known about long-term outcomes of acute kidney injury (AKI) in patients with cirrhosis. Outcomes can vary with stage of AKI, chronic kidney disease, and trajectory of renal function. We collected data from the Department of Veterans Affairs and identified 6917 patients with cirrhosis who developed AKI during hospitalization at any of its 127 hospitals, from 2004 through 2014. We used latent class analysis of serial creatinine measurements during the index hospitalization to determine trajectories of renal function. Overall, 32% of patients died within 90 days of discharge from the hospital and 48% of patients died within 1 year. We identified 5 distinct in-hospital renal trajectories: mild AKI with full improvement (24.8% of patients died 90 within days), severe AKI with rapid improvement (24.7% of patients died within 90 days), moderate AKI with partial improvement (33.7% of patients died within 90 days), moderate to severe AKI with partial improvement (42.0% of patients died within 90 days), and severe AKI with minimal improvement (48.0% of patients died within 90 days). Trajectories were associated significantly with mortality within 90 days and 1 year of mortality. Patients with severe AKI with minimal improvement had the highest risk of death within 90 days (adjusted odds ratio, 3.08; 95% CI, 2.54–3.72) and within 1 year (adjusted odds ratio, 2.71; 95% CI, 2.25–3.27) compared with patients with mild AKI with full improvement. The highest 90-day postdischarge mortality (65.2%) was observed in patients with normal or near-normal prehospitalization renal function who developed severe AKI with minimal improvement during hospitalization. In an analysis of almost 7000 veterans with cirrhosis who were hospitalized for AKI, we found the pattern of renal trajectory to be associated with mortality after discharge. Renal trajectory patterns can be used to identify subgroups of patients with cirrhosis and AKI who should receive intensive postdischarge management. [ABSTRACT FROM AUTHOR]

Large administrative databases using International Classification of Diseases (ICD) codes are useful for epidemiologic, health services, and outcomes research.1,2 However, coding accuracy of disease conditions could be a limiting factor. Cirrhosis prevalence is increasing because of an aging hepatitis C cohort and an increase in nonalcoholic steatohepatitis.3 We previously examined the validity of ICD, 9th revision (ICD-9), codes for cirrhosis in US Department of Veterans Affairs (VA) administrative databases.4,5 This work has formed the basis for many clinical, epidemiologic, and health services research studies. However, with transition from the ICD-9 to ICD, 10th revision (ICD-10), coding system, it is important to determine the validity of these new cirrhosis codes in administrative databases. Although the greater number of codes in the ICD-10 system may be associated with greater specificity and coding accuracy than with the ICD-9 system, this hypothesis remains untested. [ABSTRACT FROM AUTHOR]