Inadequate Dietary Education and Poor Adherence to a High Protein, Low Sodium Diet in Cirrhosis: Mixed Methods Approach.

BACKGROUND: Malnutrition in cirrhosis is associated with poor outcomes, leading to guidelines for a high protein, low sodium diet; however, there is no guidance regarding the implementation of diet education in clinical practice. METHODS: A mixed methods study enrolled 21 patients with cirrhosis and their caregivers. Semi-structured interviews on barriers and facilitators of dietary education and adherence were conducted. Demographic and clinical data were obtained, along with quantitative measures of dietary adherence, including 24-h food recall and spot urine sodium. Combined deductive and inductive coding was used to identify qualitative themes, along with a quantitative assessment of interviews. Quantitative data was reported using descriptive statistics with frequencies, mean and confidence intervals. RESULTS: Participants were mostly male (16/21) with a mean age 57.8 years (SE 2.8) and MELD-Na 9 (SE 1.2). 4 themes emerged: 1. More than 50% of participants and caregivers endorsed no or inadequate diet education 2. They reported mostly negative experiences with dietary adherence with largest impact on social life 3. Facilitators of adherence included the presence of household support and fear of complications of cirrhosis 4. Overwhelmingly desired non-generic handouts and information. Dietary adherence was poor with only one participant meeting protein and sodium requirements based on food recall. Four participants who adhered to < 2000 mg sodium had inadequate daily caloric intake. CONCLUSIONS: Dietary education is inadequate, and adherence to dietary recommendations is poor in patients with cirrhosis. Future studies should use these barriers and facilitators for intervention development.

Changes in Pancreas Volume in Living Donor Liver Transplant Recipients.

BACKGROUND: Metabolic factors have a significant role in the morbidity and mortality associated with chronic liver disease. The pancreas has a central role in metabolism and metabolic risk factors but has been largely ignored in liver transplantation. Small pancreas volume has been demonstrated in pathologic conditions such as type 1 and 2 diabetes. METHODS: This study assessed abdominal imaging before and after liver transplantation to determine if liver transplantation induces changes in pancreas volume in living donor liver transplant recipients. Our secondary outcome is to correlate pancreas volume with demographic, clinical, and outcome data. We conducted a retrospective study of pancreas volume in patients enrolled in the adult-to-adult living donor liver transplantation cohort study. Pancreas volume was manually calculated from 413 MRI or computed tomography images and correlated with imaging and clinical data. RESULTS: Pancreas volume declined by an average of 24% (87.8 ±â€…25.2 mL to 66.8 ±â€…20.4 mL, P < 0.0001), regardless of liver disease etiology. Pancreas volume correlated with portal blood flow, spleen volume, and liver enzyme levels. We found a correlation between smaller pancreas volume pretransplant and longer intensive care unit (ICU) stay across all patients (P < 0.05). Individuals with an ICU stay of <2 d had a larger average pancreas volume pretransplant than those with an ICU stay of 2 d or longer (91.2 mL versus 82.2 mL, P < 0.05). CONCLUSIONS: Pancreas volume is dynamic in liver transplant recipients and may reflect altered metabolism and risk of posttransplantation complications.

Patient-reported symptoms and interest in symptom monitoring in HCC treated with locoregional therapies: A qualitative study.

BACKGROUND: Patient-reported outcomes (PRO) measures relevant to domains most important to patients with HCC who received locoregional therapies are needed to advance patient-centered research. Furthermore, electronic PRO monitoring in clinical care has been shown to reduce hospitalizations and deaths in patients with other cancers. We conducted a qualitative study among patients with HCC who recently received locoregional therapies to (1) identify common and distressing posttreatment symptoms to prioritize PRO domain selection and (2) gauge interest in an electronic PRO symptom monitoring system. METHODS: We performed semi-structured telephone interviews among adult patients who received locoregional therapies (median of 26 days after treatment) for treatment-naïve HCC at a single tertiary care center. Interviews were conducted until thematic saturation was reached. Qualitative content analysis was conducted to identify emerging themes and sub-themes. RESULTS: Ten of 26 patients (38%) reported at least 1 symptom before treatment. In contrast, all participants (n = 26) with recently treated HCC reported at least 1 posttreatment physical symptom, with the most common being appetite loss (73%), fatigue (58%), abdominal pain (46%), and nausea (35%). Most participants (77%) stated they saw potential benefits in posttreatment ePRO symptom monitoring. CONCLUSIONS: Posttreatment symptoms after HCC locoregional therapies are common and often severe. These data can inform and prioritize PRO domain selection. Patients are interested in ePRO monitoring to monitor and proactively address posttreatment symptoms. Given the clinical benefits in patients with metastatic cancers, ePRO monitoring warrants investigation in patients with HCC.

Identifying barriers and facilitators along the hepatitis C care cascade to inform human-centered design of contextualized treatment protocols for vulnerable populations in Austin, Texas: a qualitative study.

BACKGROUND: Hepatitis C virus (HCV) is a leading cause of liver-related mortality and morbidity. Despite effective direct acting antivirals and a simplified treatment algorithm, limited access to HCV treatment in vulnerable populations, including people experiencing homelessness (PEH) and people who inject drugs (PWID), hinders global elimination. Adapting the evidence-based, simplified HCV treatment algorithm to the organizational and contextual realities of non-traditional clinic settings serving vulnerable populations can help overcome specific barriers to HCV care. The first phase of the Erase Hep C study aimed to identify barriers and facilitators specific to these vulnerable populations to design the site-specific, simplified treatment protocols. METHODS: Forty-two semi-structured qualitative interviews, guided by the Practical, Robust Implementation and Sustainability Model (PRISM) framework, were conducted with clinic staff, community-based organizations providing screening and linkage to care, and patients diagnosed with HCV, to identify contextual barriers and facilitators to treatment at a local community health center's Health Care for the Homeless program in Austin, Texas. Audio-recorded interviews were systematically analyzed using thematic analysis informed by the PRISM framework and design thinking, to anchor barriers and facilitators along the HCV care cascade. Findings were fed into human-centered design workshops to co-design, with clinic staff, site-specific, simplified HCV treatment protocols. RESULTS: The specific needs of PEH and PWID patient populations informed barriers and facilitators of HCV care. Barriers included tracking patients who miss critical appointments or labs, medication access and adherence, and patient HCV knowledge. Clinical teams leveraged existing facilitators and incorporated solutions to barriers into clinic workflows to improve care coordination and medication access. Actionable solutions included augmenting existing staff roles, employing HCV care navigation throughout the cascade, and standardizing medication adherence counseling. CONCLUSIONS: Clinic staff identified HCV care facilitators to leverage, and designed actionable solutions to address barriers, to incorporate into site-specific treatment protocols to improve patient HCV outcomes. Methods used to incorporate staff and patient experiential knowledge into the design of contextualized treatment protocols in non-traditional clinic settings could serve as a model for future implementation research. The next phase of the study is protocol implementation and patient enrollment into a single-arm trial to achieve HCV cure.

Development, implementation, and feasibility of site-specific hepatitis C virus treatment workflows for treating vulnerable, high-risk populations: protocol of the Erase Hep C study - a prospective single-arm intervention trial.

BACKGROUND: Hepatitis C virus (HCV) is the leading indication for liver transplantation and liver-related mortality. The development of direct-acting antivirals (DAA) and a simplified treatment algorithm with a > 97% cure rate should make global elimination of HCV an achievable goal. Yet, vulnerable populations with high rates of HCV still have limited access to treatment. By designing locally contextualized site-specific HCV treatment workflows, we aim to cure HCV in vulnerable, high-risk populations, including people experiencing homelessness (PEH) and people who inject drugs (PWID), in Austin, TX, USA. METHODS: Our implementation science study will utilize a qualitative and design thinking approach to characterize patient and systemic barriers and facilitators to HCV treatment in vulnerable, high-risk populations seeking care across seven diverse primary care clinics serving PEHs and PWIDs. Qualitative interviews guided by the Practical, Robust Implementation and Sustainability Model (PRISM) framework will identify barriers and facilitators by leveraging knowledge and experience from both clinic staff and patients. Data synthesized using thematic analysis and design thinking will feed into workshops with clinic stakeholders for idea generation to design site-specific HCV treatment workflows. Providers will be trained on the use of a simplified HCV treatment algorithm with DAAs and clinic staff on the new site-specific HCV treatment workflows. These workflows will be implemented by the seven diverse primary care clinics serving vulnerable, high-risk populations. Implementation and clinical outcomes will be measured using data collected through interviews with staff as well as through medical chart review. DISCUSSION: Our study provides a model of how to contextualize and implement site-specific HCV treatment workflows targeting vulnerable, high-risk populations in other geographic locations. This model can be adopted for future implementation research programs aiming to develop and implement site-specific treatment workflows for vulnerable, high-risk populations and in primary care clinical settings for other disease states beyond just HCV. TRIAL REGISTRATION: Registered on ClinicalTrials.gov on July, 14, 2022. Identifier: NCT05460130 .

Consider hospice in end-stage liver disease prognostic scale to open discussions regarding six-month mortality.

Background and Aim: Hospice is underutilized in the management of patients with end-stage liver disease and may improve the patient experience at the end of life. This study aims to create a novel prognostic scale to accurately predict 6-month mortality to more comprehensively facilitate hospice referral. Methods: Sociodemographic, clinical, and laboratory variables associated with mortality from the United Network for Organ Sharing database were tested in univariate analysis followed by multivariate analyses with four predictor groups: Demographics, Diagnoses, Complexities, and Laboratory studies to develop the hospice in end-stage liver disease prognostic scale (HELP) scale (70% sample, N = 13 516) followed with replication in a 30% (N = 5792) internal validation sample. Results: Only the predictor groups of Complexities and Laboratory studies met the c-statistic threshold of 0.70 for inclusion in the multivariate analyses. Backward elimination in the final logistic regression and validated weighted transformation procedure resulted in: HELP scale = (functional status × 11) + (ascites × 3) + (SBP × 3) + (HE × 4) + (dialysis × 5) + (TIPS × -3) + (albumin × -3) + (MELD-Na ≥ 21 × 20). HELP scale had a strong predictive value for six-month mortality with Area under the Receiver Operating Curve (AUROC) 0.816 and replicated in the validation sample. Conclusion: HELP scale is a novel prognostic score utilizing the strength of model of end-stage liver disease-sodium (MELD-Na), along with clinical factors, for a more nuanced assessment of six-month mortality. This scale can provide an individualized approach in opening discussions of hospice referral and may be better accepted by patients and providers given its contextualization of important clinical factors.

Delayed Diagnostic Paracentesis Is Associated with Increased Preventable Healthcare Utilization in Disadvantaged Patient Populations with Advanced Liver Disease and Elevated INR.

BACKGROUND: Patients hospitalized with cirrhosis, ascites, and elevated INR often experience delays in timely diagnostic paracentesis. AIMS: Identify whether delays in diagnostic paracentesis were associated with adverse outcomes in a hospital system serving a large disadvantaged population. METHODS: Retrospective cohort analysis of patients admitted from January 2017 to October 2019 with cirrhosis, ascites, and INR ≥ 1.5 across a multi-hospital health system in central Texas. We examined demographic and clinical characteristics of patients with diagnostic paracentesis (1) ≤ 24 h; (2) > 24 h; (3) therapeutic only or no paracentesis. We used logistic regression to examine differences in clinical outcomes controlling for confounders. RESULTS: 479 patients met inclusion criteria. 30.0% (N = 143) were Latino, 6.7% (N = 32) African American, and 67.8% (N = 325) under or uninsured. 54.1% of patients received a diagnostic paracentesis ≤ 24 h of admission and 21.1% did not receive a diagnostic paracentesis during the hospitalization. Undergoing diagnostic paracentesis > 24 h of admission was associated with a 2.3 day increase in length of stay (95% CI 0.8-3.8), and OR 1.7 for an Emergency Room visit within 30 days of discharge (95% CI 1.1-2.7) compared to receiving a diagnostic paracentesis ≤ 24 h. Patients receiving diagnostic paracentesis in radiology were more likely to have a delay in procedure OR 5.8 (95% CI 2.8-8.6). CONCLUSION: Delayed diagnostic paracentesis is associated with increased preventable healthcare utilization compared with timely diagnostic paracentesis. Health systems should support efforts to ensure timely diagnostic paracentesis for patients with advanced liver disease, including performance at the bedside.

MELD-Na Accurately Predicts 6-Month Mortality in Patients With Decompensated Cirrhosis: Potential Trigger for Hospice Referral.

GOAL: The goal of this study was to determine the accuracy of Model of End-stage Liver Disease-Sodium (MELD-Na) in predicting 6-month mortality for patients listed for liver transplantation on the United Network of Organ Sharing (UNOS) waitlist. BACKGROUND: End-stage liver disease patients underutilize hospice services despite significant morbidity and mortality associated with advanced liver disease. A well-known barrier to hospice referral is clinician uncertainty in identifying patients with an expected survival of <6 months, a requirement for a referral. METHODS: Retrospective cross-sectional analysis was performed from UNOS data spanning February 27, 2002, to September 30, 2019. Inclusion criteria of patients aged 18 years and above, diagnosis of cirrhosis, liver transplant eligible, and listed in the UNOS database. Exclusion criteria included fulminant hepatic failure, prior history of liver transplantation, diagnosis of hepatocellular carcinoma, receipt of liver transplant in <180 days, or removal from waiting list <180 days for a reason other than death. MEASUREMENT: Mortality by 180 days. RESULTS: Of the 93,157 patients that met inclusion criteria, MELD-Na was calculated for all patients with sodium, total bilirubin, international normalized ratio, and creatinine available (N=79,611). The c -statistic with 95% confidence interval for MELD-Na for the predicted 6-month mortality was 0.83 (0.827-0.835). Mean MELD-Na of 28.2 was associated with ≤50% 6-month survival. CONCLUSION: MELD-Na is an objective, quick measure that can aid providers in identifying patients with increased 6-month mortality in time-constrained settings, and a score of 28 can trigger the discussion for hospice as a means of improving value-based health care.

Gender Disparities in Authorship of Invited Manuscripts During the COVID-19 Pandemic.

Introduction: Women have historically been under-represented in medical literature, particularly prominent in authorship of invited commentaries. With the instantaneous change in work environment forcing Americans to adapt to working at home, many theorize that women will be more adversely affected due to traditional concepts of women being more responsible for the home in addition to work responsibilities. Objective: Understand how women contributed to coronavirus disease 2019 (COVID-19) literature early in the pandemic. Methods: Cross-sectional analysis of manuscripts published in three high-impact U.S. medical journals from February to May 2020 was performed. We used log-binomial regression to examine for an association between COVID-19 status and likelihood of having at least one female first author, and evaluated for effect modification according to whether the manuscript was invited. Results: Among 980 manuscripts, 313 (31.9%) listed at least one female first author, 203 were written on COVID-19 (20.7%), and 144 (14.7%) were invited. There was no association between COVID-19 status and having at least one female first author overall (adjusted risk ratio [RR] 0.93, 95% confidence interval [CI] 0.72-1.19). The relationship between COVID-19 status and first-author sex was 0.23 (95% CI 0.06-0.92) for invited manuscripts and 1.04 (95% CI 0.81-1.35) for noninvited manuscripts (p for interaction 0.02). Discussion: We demonstrate that women were not less likely to be first authors on COVID-19 manuscripts but were less likely to be first authors on invited COVID-19 manuscripts. Early career female researchers are the most vulnerable for inability to meet metrics for promotion, accounting for the continued under-representation of women in senior academic roles. COVID-19 has the potential to exacerbate this disparity.

Complementary and Alternative Medicine Use in United States Adults With Liver Disease.

GOALS: To describe the complementary and alternative medicine (CAM) use in US adults with liver disease. BACKGROUND: The prevalence and patterns of CAM use among US adults with liver disease have not been well characterized. The 2012 National Health Interview Survey is considered the most current and comprehensive source of information on CAM use in US adults. STUDY: Using the results of the 2012 National Health Interview Survey, the prevalence of CAM use, most common modalities used, reasons for CAM use, perceived benefits, perceived helpfulness and importance, and disclosure of CAM to health care providers were compared between adults with and without liver disease. RESULTS: Of the 647 adults with liver disease, 41% reported using CAM in the prior year, compared with 33% of adults without liver disease. The most common modality was herbs and supplements (23%), and 3% of respondents reported consumption of a potentially hepatotoxic substance in the previous 30 days. Only a small proportion of CAM therapies were used specifically for liver disease, with milk thistle being the most common. Among respondents with liver disease, CAM was used more commonly for anxiety or depression, fatigue, and substance use. The majority believed that these therapies improved health. Nearly one-third of therapies were not reported to health care providers, mostly due to failure of the provider to ask. CONCLUSIONS: CAM use, particularly herbs and supplements, is prevalent among US adults with liver disease. Many do not disclose their CAM use to their providers, despite some using potentially hepatotoxic substances.

Significant Morbidity and Mortality Among Hospitalized End-Stage Liver Disease Patients in Medicare.

CONTEXT: For end-stage liver disease (ESLD) patients, care focuses on managing the life-threatening complications of portal hypertension, causing high resource utilization. OBJECTIVES: To describe the end-of-life trajectory of hospitalized ESLD patients in Medicare. METHODS: Using a 5% random sample of Medicare fee-for-service beneficiaries, we performed a retrospective cohort study, identifying hospitalized ESLD and heart failure (HF) patients (2007-2011). Index hospitalization end points included mortality, discharge to hospice, and length of stay. Postdischarge end points included all-cause mortality, rehospitalization, hospice enrollment, and days alive and out of hospital (DAOH). Follow-up was at one and three years after index hospitalization discharge. A reference cohort of decompensated HF patients was used for baseline comparison. RESULTS: At one year, the ESLD cohort (n = 22,311) had 209 DAOH; decompensated HF (n = 85,397) had 252 DAOH. Among ESLD patients, inpatient mortality was 13.5%; all-cause mortality was 64.9%. For these outcomes, rates were higher in those with ESLD than HF. In the ESLD group, rehospitalization rate was 59.1% (slightly lower than the HF group), hospice enrollment rate was 36.1%, and there were higher than expected cancer rates. For hospice-enrolled patients, the median length of time spent in hospice was nine days. The HF cohort had lower hospice enrollment, but more days enrolled. CONCLUSION: The results of this study show that morbidity and mortality rates associated with end of life in ESLD are substantial. There is an acute need for alternative approaches to manage the care of ESLD patients.

Development of a lateral mobility task to identify individuals at risk for mobility disability and functional decline.

Lateral mobility is integral to many activities of daily living involving transfer from one position to another. The objective of this study was to develop and evaluate the validity and test-retest reliability of a lateral-mobility (LATMOB) task for older adults. Measurements of lateral mobility, balance, and strength and self-reported and performance-based physical functioning were obtained in 63 women and 77 men > or = 50 years of age. The LATMOB task was significantly correlated with age, knee-extensor strength, grip strength, functional reach, and one-leg-stance time. Test-retest reliability of the task was excellent. The LATMOB task was highly correlated with the car task. Balance was significantly correlated with time to get into and out of a car and performance on the LATMOB task. The LATMOB task was significantly correlated with the Short Physical Performance Battery score. The LATMOB task is valid and reliable, but additional work is needed to assess its sensitivity to change and predictive validity.