Diagnosis and management of chronic hepatitis B: A patient-friendly summary of the 2018 American Association for the Study of Liver Diseases practice guidance.

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Practical Approach to Starting a Telemedicine Program: Lessons From the Real World.

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Patient-reported outcomes in HCC: A scoping review by the Practice Metrics Committee of the American Association for the Study of Liver Diseases.

BACKGROUND AND AIMS: HCC is a leading cause of mortality in patients with advanced liver disease and is associated with significant morbidity. Despite multiple available curative and palliative treatments, there is a lack of systematic evaluation of patient-reported outcomes (PROs) in HCC. APPROACH AND RESULTS: The American Association for the Study of Liver Diseases Practice Metrics Committee conducted a scoping review of PROs in HCC from 1990 to 2021 to (1) synthesize the evidence on PROs in HCC and (2) provide recommendations on incorporating PROs into clinical practice and quality improvement efforts. A total of 63 studies met inclusion criteria investigating factors associated with PROs, the relationship between PROs and survival, and associations between HCC therapy and PROs. Studies recruited heterogeneous populations, and most were cross-sectional. Poor PROs were associated with worse prognosis after adjusting for clinical factors and with more advanced disease stage, although some studies showed better PROs in patients with HCC compared to those with cirrhosis. Locoregional and systemic therapies were generally associated with a high symptom burden; however, some studies showed lower symptom burden for transarterial radiotherapy and radiation therapy. Qualitative studies identified additional symptoms not routinely assessed with structured questionnaires. Gaps in the literature include lack of integration of PROs into clinical care to guide HCC treatment decisions, unknown impact of HCC on caregivers, and the effect of palliative or supportive care quality of life and health outcomes. CONCLUSION: Evidence supports assessment of PROs in HCC; however, clinical implementation and the impact of PRO measurement on quality of care and longitudinal outcomes need future investigation.

Quality measures in HCC care by the Practice Metrics Committee of the American Association for the Study of Liver Diseases.

The burden of HCC is substantial. To address gaps in HCC care, the American Association for the Study of Liver Diseases (AASLD) Practice Metrics Committee (PMC) aimed to develop a standard set of process-based measures and patient-reported outcomes (PROs) along the HCC care continuum. We identified candidate process and outcomes measures for HCC care based on structured literature review. A 13-member panel with content expertise across the HCC care continuum evaluated candidate measures on importance and performance gap using a modified Delphi approach (two rounds of rating) to define the final set of measures. Candidate PROs based on a structured scoping review were ranked by 74 patients with HCC across 7 diverse institutions. Out of 135 measures, 29 measures made the final set. These covered surveillance (6 measures), diagnosis (6 measures), staging (2 measures), treatment (10 measures), and outcomes (5 measures). Examples included the use of ultrasound (± alpha-fetoprotein [AFP]) every 6 months, need for surveillance in high-risk populations, diagnostic testing for patients with a new AFP elevation, multidisciplinary liver tumor board (MLTB) review of Liver Imaging-Reporting and Data System 4 lesions, standard evaluation at diagnosis, treatment recommendations based on Barcelona Clinic Liver Cancer staging, MLTB discussion of treatment options, appropriate referral for evaluation of liver transplantation candidacy, and role of palliative therapy. PROs include those related to pain, anxiety, fear of treatment, and uncertainty about the best individual treatment and the future. The AASLD PMC has developed a set of explicit quality measures in HCC care to help bridge the gap between guideline recommendations and measurable processes and outcomes. Measurement and subsequent implementation of these metrics could be a central step in the improvement of patient care and outcomes in this high-risk population.

Asian American/Pacific Islander and Hispanic Ethnic Enclaves, Neighborhood Socioeconomic Status, and Hepatocellular Carcinoma Incidence in California: An Update.

BACKGROUND: Using more recent cancer registry data, we analyzed disparities in hepatocellular carcinoma (HCC) incidence by ethnic enclave and neighborhood socioeconomic status (nSES) among Asian American/Pacific Islander (AAPI) and Hispanic populations in California. METHODS: Primary, invasive HCC cases were identified from the California Cancer Registry during 1988-1992, 1998-2002, and 2008-2012. Age-adjusted incidence rates (per 100,000 population), incidence rate ratios, and corresponding 95% confidence intervals were calculated for AAPI or Hispanic enclave, nSES, and the joint effects of ethnic enclave and nSES by time period (and the combination of the three periods), sex, and race/ethnicity. RESULTS: In the combined time period, HCC risk increased 25% for highest versus lowest quintile of AAPI enclave among AAPI males. HCC risk increased 22% and 56% for lowest versus highest quintile of nSES among AAPI females and males, respectively. In joint analysis, AAPI males living in low nSES areas irrespective of enclave status were at 17% to 43% increased HCC risk compared with AAPI males living in areas of nonenclave/high nSES. HCC risk increased by 22% for Hispanic females living in areas of low nSES irrespective of enclave status and by 19% for Hispanic males living in areas of nonenclave/low nSES compared with their counterparts living in areas of nonenclave/high nSES. CONCLUSIONS: We found significant variation in HCC incidence by ethnic enclave and nSES among AAPI and Hispanic populations in California by sex and time period. IMPACT: Future studies should explore how specific attributes of enclaves and nSES impact HCC risk for AAPI and Hispanic populations.

Disparities in Hepatocellular Carcinoma Incidence in California: An Update.

BACKGROUND: Given changes in hepatocellular carcinoma (HCC) incidence and the ethnodemographic landscape, we analyzed recent HCC incidence patterns and trends in California. METHODS: Using 47,992 primary, invasive HCC cases diagnosed from 1988 to 2014 from the California Cancer Registry, we calculated age-adjusted incidence rates (IR), annual percent change (APC), and 95% confidence intervals (CI) by sex, race/ethnicity, and nativity among Hispanics and Asian ethnic groups. RESULTS: Compared with non-Hispanic Whites (NHW), all other racial/ethnic groups had higher HCC incidence. Vietnamese had the highest IRs (males: 47.4, 95% CI, 45.3-49.5; females: 14.1, 95% CI, 13.0-15.3). Foreign-born Chinese, Japanese, Korean, and Vietnamese had higher incidence than U.S.-born. The reverse was observed for Hispanic males, whereas no differences by nativity were seen for Hispanic females. IRs increased most for NHWs. Among Asians, male and female Filipinos and Japanese males experienced rate increases, whereas male and female Koreans and Chinese males experienced rate decreases. U.S.-born male and female Hispanics and Japanese had higher APCs than foreign-born, as did Filipino males, whereas Chinese males had a reverse pattern. Annual increases in HCC incidence slowed down in recent years for U.S.-born Hispanic males and females and stabilized among male NHWs and non-Hispanic Blacks. For some Asian groups, early time periods exhibited increasing/stable APCs, whereas later time periods showed decreasing APCs. CONCLUSIONS: We found significant racial/ethnic and nativity differences in HCC IRs and trends. IMPACT: With changing trends, closer surveillance of HCC incidence by disaggregated race/ethnicity and nativity is warranted among Hispanics and Asians.

Direct-Acting Antiviral Therapy Not Associated With Recurrence of Hepatocellular Carcinoma in a Multicenter North American Cohort Study.

BACKGROUND & AIMS: There is controversy over the effects of direct-acting antiviral (DAA) therapies for hepatitis C virus (HCV) infection on hepatocellular carcinoma (HCC) recurrence and tumor aggressiveness. We compared HCC recurrence patterns between DAA-treated and untreated HCV-infected patients who had achieved a complete response to HCC treatment in a North American cohort. METHODS: We conducted a retrospective cohort study of patients with HCV-related HCC with a complete response to resection, local ablation, transarterial chemo- or radioembolization, or radiation therapy from January 2013 through December 2017 at 31 health systems throughout the United States and Canada. Cox regression was used to examine the association between DAA therapy and time to recurrence after a complete response, with DAA therapy analyzed as a time-varying exposure. We also estimated the association between DAA therapy and risk of early HCC recurrence (defined as 365 days after complete response). RESULTS: Of 793 patients with HCV-associated HCC, 304 (38.3%) received DAA therapy and 489 (61.7%) were untreated. HCC recurred in 128 DAA-treated patients (42.1%; early recurrence in 52 patients) and 288 untreated patients (58.9%; early recurrence in 227 patients). DAA therapy was not associated with HCC recurrence (hazard ratio 0.90, 95% confidence interval 0.70-1.16) or early HCC recurrence (hazard ratio 0.96, 95% confidence interval 0.70-1.34) after we adjusted for study site, age, sex, Child-Pugh score, α-fetoprotein level, tumor burden, and HCC treatment modality. In DAA-treated and untreated patients, most recurrences were within the Milan criteria (74.2% vs 78.8%; P = .23). A larger proportion of DAA-treated than untreated patients received potentially curative HCC therapy for recurrent HCC (32.0% vs 24.6%) and achieved a complete or partial response (45.3% vs 41.0%) but this did not achieve statistical significance. CONCLUSION: In a large cohort of North American patients with complete response to HCC treatment, DAA therapy was not associated with increased overall or early HCC recurrence. HCC recurrence patterns, including treatment response, were similar in DAA-treated and untreated patients.

Development of Quality Measures in Cirrhosis by the Practice Metrics Committee of the American Association for the Study of Liver Diseases.

Health care delivery is increasingly evaluated according to quality measures, yet such measures are underdeveloped for cirrhosis. The Practice Metrics Committee of the American Association for the Study of Liver Diseases was charged with developing explicit process-based and outcome-based measures for adults with cirrhosis. We identified candidate measures from comprehensive reviews of the literature and input from expert clinicians and patient focus groups. We conducted an 11-member expert clinician panel and used a modified Delphi method to systematically identify a set of quality measures in cirrhosis. Among 119 candidate measures, 46 were identified as important measures to define the quality of cirrhosis care, including 26 process measures, 7 clinical outcome measures, and 13 patient-reported outcome measures. The final process measures captured care processes for ascites (n = 5), varices/bleeding (n = 7), hepatic encephalopathy (n = 4), hepatocellular cancer (HCC) screening (n = 1), liver transplantation evaluation (n = 2), and other care (n = 7). Clinical outcome measures included survival, variceal bleeding and rebleeding, early-stage HCC, liver-related hospitalization, and rehospitalization within 7 and 30 days. Patient-reported outcome measures covered physical symptoms, physical function, mental health, general function, cognition, social life, and satisfaction with care. The final list of patient-reported outcomes was validated in 79 patients with cirrhosis from nine institutions in the United States. Conclusion: We developed an explicit set of evidence-based quality measures for adult patients with cirrhosis. These measures are a tool for providers and institutions to evaluate their care quality, drive quality improvement, and deliver high-value cirrhosis care. The quality measures are intended to be applicable in any clinical care setting in which care for patients with cirrhosis is provided.

Patient-reported outcomes in cirrhosis: A scoping review of the literature.

Patients with cirrhosis seek improvement in their symptoms, functioning, quality of life, and satisfaction with the care they receive. However, these patient-reported outcomes (PROs) are not routinely measured for clinical care, research, or quality improvement. The members of the American Association for the Study of Liver Diseases Practice Metrics Committee, charged with developing quality indicators for clinical practice, performed a scoping review of PROs in cirrhosis. The aim is to synthesize a comprehensive set of PROs for inclusion into a standard patient-centered outcome set. We searched Medline, Embase, the Cumulative Index to Nursing and Allied Health Literature, PsycINFO, and the Cochrane Trial Library since inception, with final searches run between April 20 and June 1, 2017. Studies were included if they reported the construction and/or validation of a PRO instrument for patients with cirrhosis or if they assessed the clinical (case-mix) variables determining responses to established PRO scales. Eleven studies were selected that yielded 259 items specific to patients with cirrhosis. After removing duplicates, 152 unique items were isolated. These items were consolidated into seven domains: physical symptoms, physical function, mental health, general function, cognition, social life, and satisfaction with care. The seven domains included 52 subdomains (e.g., physical domain, abdominal pain subdomain). Twelve variables were identified that independently modified established PRO scales. These included clinical factors (severity of liver disease and its complications, medication burden, and comorbidities), specific PROs (cramps, pruritis), and surrogate outcome measures (falls, hospitalization). CONCLUSION: This scoping review identified and categorized a large existing set of PRO concepts that matter to patients with cirrhosis; these outcomes may now be translated into usable measures both for the assessment of the quality of cirrhosis care in clinical practice and to perform research from the patient's perspective. (Hepatology 2018;67:2375-2383).

Optimizing the pre-referral workup for gastroenterology and hepatology specialty care: consensus using the Delphi method.

RATIONALE, AIMS AND OBJECTIVES: Specialty care referrals have doubled in the last decade. Optimization of the pre-referral workup by a primary care doctor can lead to a more efficient first specialty visit with the patient. Guidance regarding pre-referral laboratory testing is a first step towards improving the specialty referral process. Our aim was to establish consensus regarding appropriate pre-referral workup for common gastrointestinal and liver conditions. METHODS: The Delphi method was used to establish local consensus for recommending certain laboratory tests prior to specialty referral for 13 clinical conditions. Seven conditions from The University of Michigan outpatient referral guidelines were used as a baseline. An expert panel of three PCPs and nine gastroenterologists from three academic hospitals participated in three iterative rounds of electronic surveys. Each panellist ranked each test using a 5-point Likert scale (strongly disagree to strongly agree). Local panellists could recommend additional tests for the initial diagnoses, and also recommended additional diagnoses needing guidelines: iron deficiency anaemia, abdominal pain, irritable bowel syndrome, fatty liver disease, liver mass and cirrhosis. Consensus was defined as ≥70% of experts scoring ≥4 (agree or strongly agree). RESULTS: Applying Delphi methodology to extrapolate externally developed referral guidelines for local implementation resulted in considerable modifications. For some conditions, many tests from the external group were eliminated by the local group (abdominal bloating; iron deficiency anaemia; irritable bowel syndrome). In contrast, for chronic diarrhoea, abnormal liver enzymes and viral hepatitis, all/most original tests were retained with additional tests added. For liver mass, fatty liver disease and cirrhosis, there was high concordance among the panel with few tests added or eliminated. CONCLUSIONS: Consideration of externally developed referral guidelines using a consensus-building process leads to significant local tailoring and adaption. Our next steps include implementation and dissemination of these guidelines and evaluating their impact on care efficiency in clinical practice.

High Rate of Hospital Admissions Among Patients with Cirrhosis Seeking Care in US Emergency Departments.

BACKGROUND AND AIMS: Emergency Departments (ED) can serve as a gateway to specialty care for patients with cirrhosis with limited care access. We described the rates and characteristics of patients with cirrhosis who access United States (US) EDs, and identified factors associated with subsequent hospitalization. METHODS: Using data from the National Hospital Ambulatory Medical Care Survey, cirrhosis-related ED from 2000 to 2009 were identified and compared to all other ED visits. RESULTS: From 2000 to 2009, there were an estimated 1,029,693 cirrhosis and 877 million non-cirrhosis visits. Compared to the general ED population, those with cirrhosis were more frequently male (58 vs. 44 %, p = 0.02), Hispanic (18.6 vs. 10.6 %, p < 0.05), seeking care in urban areas (91.6 vs. 73.4 %, p < 0.05) and had Medicaid/no insurance (43 vs. 35 %, p < 0.01). Patients with cirrhosis were more frequently triaged immediately or emergently (72.3 vs. 54.2 %, p < 0.01). The majority were admitted or transferred to another hospital (66.8 vs. 17.4 %, p < 0.01). Among patients with cirrhosis, patients with age ≥ 65 years were more likely to be admitted (adjusted OR 2.49, 95 % CI 1.08-5.73), and Medicaid/uninsured (adjusted OR 0.34; 95 % CI 0.17-0.67) were less likely to be admitted, after adjusting for patient demographics, hospital characteristics, and triage score. CONCLUSIONS: Patient with cirrhosis account for approximately 100,000 US ED visits annually. The higher admission rates among patients with cirrhosis indicate a high acuity of illness. Older age among those admitted may reflect poorer functional status. Finally, high visit but low admission rates among those with Medicaid/no insurance suggest a gap in specialty care.

When to repatriate? Clinicians' perspectives on the transfer of patient management from specialty to primary care.

BACKGROUND: Subspecialty ambulatory care visits have doubled in the past 10 years and nearly half of all visits are for follow-up care. Could some of this care be provided by primary care providers (PCPs)? OBJECTIVE: To determine how often PCPs and specialists agree that a mutual patient's condition could be managed exclusively by the PCP, and to understand PCPs' perspectives on factors that influence decisions about 'repatriation,' or the transfer of patient management to primary care. DESIGN: A mixed method approach including paired surveys of PCPs and specialists about the necessity for ongoing specialty care of mutual patients, and interviews with PCPs about care coordination practices and reasons for differing opinions with specialists. PARTICIPANTS: One hundred and eighty-nine PCPs and 59 physicians representing five medicine subspecialties completed paired surveys for 343 patients. Semi-structured interviews were conducted with 16 PCPs. MEASUREMENTS: For each patient, PCPs and specialists were asked, "Could this diagnosis be managed exclusively by the PCP?" RESULTS: Specialists and PCPs agreed that transfer to primary care was appropriate for 16% of patients, whereas 36% had specialists and PCPs who agreed that ongoing specialty care was appropriate. Specialists were half as likely as PCPs to identify patients as appropriate for transfer to primary care. PCPs identified several factors that influence the likelihood that patients will be transferred to primary care, including perceived patient preferences, limited access to physician appointments, excessive workload, inter-clinician communication norms, and differences in clinical judgment. We group these factors into two domains: 'push-back' and 'pull-back' to primary care. CONCLUSIONS: At a large academic medical center, approximately one in six patients receiving ongoing specialty care could potentially be managed exclusively by a PCP. PCPs identified several non-clinical factors to explain continuation of specialty care when patient transfer to PCP is clinically appropriate.

Late presentation of colorectal cancer in a vulnerable population.

OBJECTIVES: We examined colorectal cancer (CRC) stage at presentation and mortality in a vulnerable population compared with nationally representative data. METHODS: CRC cases were identified from San Francisco General Hospital (SFGH) and the Surveillance Epidemiology and End Results (SEER) database. RESULTS: Fifty-five percent of the SFGH cohort presented with advanced disease, compared with 44% of the SEER cohort. Increased risk of advanced stage at presentation at SFGH compared with SEER was most evident among blacks and Asians. There was weak evidence for worse survival at SFGH compared with SEER overall. This varied by race with poorer survival at SFGH among whites and possibly blacks but some evidence for better survival among Asians. Among CRC patients at SFGH, Asians and Hispanics had better survival than whites and blacks. At SFGH, 44% had a diagnosis of CRC within 1 year of establishing care there. Of those who had established care at SFGH for at least 1 year, only 22% had exposure to CRC screening tests. CONCLUSIONS: These findings allow examination of CRC presentation by ethnicity in vulnerable populations and identify areas where access and utilization of CRC screening can be improved.

Physical, social, and psychological consequences of treatment for hepatitis C : a community-based evaluation of patient-reported outcomes.

BACKGROUND: Hepatitis C virus (HCV) antiviral therapy entails a long treatment course, as well as significant side effects that can lead to medication non-adherence and premature termination of treatment. Few large studies have comprehensively examined patient perspectives on the treatment experience, particularly the social and personal effects. OBJECTIVE: We sought to understand how a diverse group of patients' lives were affected during HCV treatment, and to obtain suggestions about how to better support patients during treatment. METHODS: On average, 13 months after therapy we interviewed by telephone a consecutive sample of 200 patients treated for hepatitis C with ribavirin and pegylated interferon in a comprehensive, integrated health plan in the years 2008-2010. Mixed (quantitative and qualitative) survey methods were used. RESULTS: The response rate was 68.9 %. Mean age at treatment was 51 years; 63.0 % were men; and Black, Hispanic, Asian, and White non-Hispanic racial/ethnic groups were similarly represented. Patients whose treatment was managed by nurses or clinical pharmacists (vs. physicians) were more likely to report their providers as being part of their support system (83.5 % vs. 58.9 %; p < 0.001). Most patients reported flu-like symptoms (93.5 %) and psychiatric problems (84.5 %), and 42.5 % reported side effects lasted up to 6 months after treatment. Black patients reported discontinuing treatment prematurely due to side effects more often than non-Blacks (29.4 % vs. 12.1 %; p < 0.001). Physical side effects (69.5 % of patients), psychiatric issues (43.5 %), and employment (27.4 %) were ranked among the three most difficult challenges. Patients desired help in anticipating and arranging work modifications during treatment. Most patients rated peer support, nutritional guidance, and weekly provider contact by telephone as potentially helpful resources for future patients undergoing HCV treatment. CONCLUSIONS: Patient perspectives can help formulate and refine HCV treatment support programs. Effective support programs for diverse populations are crucial as the complexities and costs of HCV treatment increase. The call for greater support from peers, providers, and employers demands new systems such as patient-centered care teams.

Radiofrequency ablation of recurrent hepatocellular carcinoma in a patient after liver transplantation: two-year follow-up.

Orthotopic liver transplantation is frequently performed for patients with end-stage liver disease complicated by the development of small hepatocellular carcinomas (HCCs). Since the adaptation of the Milan criteria, the rate of posttransplantation recurrence has significantly decreased to a rate of 10%-20%. In the setting of recurrence after transplantation, survival rates are poor, with a median of 9 months. Survival can be extended with use of definitive therapies, most often surgical. The present report describes a patient with recurrent intrahepatic HCC after liver transplantation who was treated with radiofrequency ablation and has survived 24 months with normalization of alpha-fetoprotein levels and no evidence of viable tumor on imaging.