A standardized scoring system for conflict of interest determination and mitigation for AASLD-sponsored continuing medical education events.

Continuing medical education (CME) is essential to increase the knowledge, skills, and professional performance of health care providers. To keep the content of CME relevant and balanced, conflict of interest (COI) determination and mitigation is essential. While the Accreditation Council for Continuing Medical Education provides oversight and guidelines, each organization that sponsors CME programs has its own protocol for COI. To standardize and simplify the American Association for the Study of Liver Diseases' approach to COI, we propose a standardized COI disclosure scoring system for all CME programs to notify the audience of any conflicts and how such conflicts can be mitigated.

Increasing liver stiffness is associated with higher incidence of hepatocellular carcinoma in hepatitis C infection and non-alcoholic fatty liver disease-A population-based study.

BACKGROUND & AIMS: Both non-alcoholic fatty liver disease (NAFLD) and hepatitis C virus (HCV) infection commonly result in hepatic fibrosis and may lead to cirrhosis. This study aims to determine the incidence of HCC in patients with HCV or NAFLD complicated by advanced fibrosis, inferred from measurements of liver stiffness. METHODS: Using Veterans Affairs (VA) Informatics and Computing Infrastructure (VINCI), we identified a nationwide cohort of patients with an existing diagnosis of HCV or NAFLD with liver transient elastography (TE) testing from 2015 to 2019. HCC cases, along with a random sample of non-HCC patients, were identified and validated, leading to calculation of incidence rates for HCC after adjustment for confounders. RESULTS: 26,161 patients carried a diagnosis of HCV and 13,629 were diagnosed with NAFLD at the time of testing. In those with HCV, rates of HCC increased with liver stiffness with incidences of 0.28 (95% CI 0.24, 0.34), 0.93 (95% CI 0.72, 1.17), 1.28 (95% CI 0.89, 1.79), and 2.79 (95% CI 2.47, 3.14)/100,000 person years for TE score ranges <9.5 kPa, 9.5-12.5 kPa, 12.5-14.5 kPa and >14.5 kPa, respectively, after a median follow-up of 2.3 years. HCC incidence also increased with higher TE liver stiffness measures in NAFLD after a median follow-up of 1.1 years. CONCLUSION: In this retrospective cohort, the incidence of HCC in HCV and NAFLD increases with higher TE liver stiffness measures, confirming that advanced fibrosis portends risk in viral and non-viral fibrotic liver diseases. Additional comparative studies are needed to determine the optimal cut point of TE liver stiffness to inform HCC screening guidelines and approaches.

Post-Liver Transplant Lymphoproliferative Disorder Presenting as Biliary Stricture.

A 63-year-old man with nonalcoholic steatohepatitis cirrhosis who underwent orthotopic liver transplant presented 1 year later with obstructive jaundice because of a biliary stricture. This anastomotic stricture was initially believed to be ischemic, but further investigation revealed malignant biliary obstruction because of encasement of the bile duct by a mass arising from liver segment VII, later determined to be post-transplant lymphoproliferative disorder with widespread metastasis. After reduction of immunosuppression and systemic chemotherapy, he experienced complete remission. This case illustrates the need to consider post-transplantation lymphoproliferative disorder-related biliary stricture in any postorthotopic liver transplantation transplant patient presenting with obstructive jaundice.

Drug-Induced Liver Injury from Statins.

The hydroxymethyglutaryl-coenzyme A reductase inhibitors (statins) are a commonly prescribed class of medication for the treatment of hyperlipidemia and coronary artery disease. This class of medication has several proven benefits, including reduction of mortality related to coronary artery disease. A major consideration when prescribing these drugs are the potential for adverse effects, mainly myalgias, myopathy, and hepatotoxicity. In this article, we summarize current data on statin-associated hepatotoxicity and highlight that the risk of clinically significant idiosyncratic drug-induced liver injury is actually quite small. We also review preclinical data suggesting potential hepatoprotective effects of statin therapy.

A cybersecurity primer for translational research.

Virtually all health care organizations have had at least one data breach since 2012. Most of the largest data breaches and Health Care Information Privacy and Accountability Act fines could have been prevented by the simplest of strategies. Each researcher must clearly understand his or her responsibilities and liability.

The effect of tranexamic acid on artificial joint materials: a biomechanical study (the bioTRANX study).

BACKGROUND: Tranexamic acid (TXA) has been successfully used to reduce bleeding in joint replacement. Recently local TXA has been advocated to reduce blood loss in total knee or hip replacement; however, this raised concerns about potential adverse effects of TXA upon the artificial joint replacement. MATERIALS AND METHODS: In this biomechanical study we compared the effects of TXA and saline upon the following biomechanical properties of artificial joint materials-(1) tensile properties (ultimate strength, stiffness and Young's modulus), (2) the wear rate using a multi-directional pin-on-plate machine, and (3) the surface topography of pins and plates before and after wear rate testing. RESULTS: There were no significant differences in tensile strength, wear rates or surface topography of either ultra-high-molecular-weight polyethylene pins or cobalt chromium molybdenum metal plates between specimens soaked in TXA and specimens soaked in saline. CONCLUSION: Biomechanical testing shows that there are no biomechanical adverse affects on the properties of common artificial joint materials from using topical TXA. LEVEL OF EVIDENCE: V.

Prevention of hepatitis B recurrence in liver transplant patients using oral antiviral therapy without long-term hepatitis B immunoglobulin.

BACKGROUND: Small studies have suggested that nucleos(t)ide analogue therapy (NAT) with reduced hepatitis B immunoglobulin (HBIG) duration may be efficacious in preventing post-liver transplantation (LT) HBV recurrence. OBJECTIVES: This larger study evaluates the use of NAT with short term (< 6 mo) or no HBIG for prevention of post-LT HBV recurrence. PATIENTS AND METHODS: All HBV patients undergoing LT at a university transplant center between 2002 and 2007 were identified retrospectively. Patient demographics, medication regimen, and adverse events were noted. The primary endpoint was HBV recurrence and secondary endpoints were graft and patient survival. RESULTS: 28 study patients were identified. Of these 28 patients, 4 (14%) received no HBIG, 6 (22%) received only inpatient HBIG, and 18 (64%) received inpatient HBIG and outpatient HBIG. 16 of the 28 patients (57%) received combination NAT and 12 patients (43%) received single NAT. At a median time of 15.5 months (range 9-24 months) post-LT, 4 of the 28 patients (14%) had recurrent HBV. Of those patients with recurrent HBV, 3 received both inpatient and outpatient HBIG and 1 received no HBIG. All cases of HBV recurrence were associated with noncompliance. CONCLUSIONS: NAT with short-term or no HBIG was efficacious and safe in preventing post-LT HBV. All compliant patients were HBV-free, including 9 patients who received no HBIG or only inpatient HBIG. Additional studies using NAT without HBIG appear justified.

Legal ramifications for physicians of patients who drive with hepatic encephalopathy.

BACKGROUND & AIMS: Hepatic encephalopathy, a spectrum of neuropsychiatric abnormalities that can occur in patients with liver dysfunction, negatively affects driving performance, but no study has examined legal ramifications. We studied state requirements for reporting hepatic encephalopathy and investigated whether lawsuits have been completed against physicians or patients for motor vehicle accidents that were related to hepatic encephalopathy. METHODS: We contacted motor vehicle departments from all 50 states and examined motor vehicle codes and legal databases to search for hepatic encephalopathy-related lawsuits. RESULTS: Definitions of a medically impaired driver varied considerably. No state specifically mentioned hepatic encephalopathy or patients with advanced liver disease. Only 6 (12%) of the states had mandatory reporting laws for drivers who have medical impairment, and 25 of the remaining 44 states (57%) provided legal immunity to physicians for reporting such patients. The legal databases did not contain any cases against physicians for failure to warn against driving or diagnose hepatic encephalopathy that resulted in an accident. There were no lawsuits identified against an encephalopathic patient for causing a motor vehicle accident. CONCLUSIONS: Only 6 states require physicians to report drivers with medical impairments. Hepatic encephalopathy is not specifically addressed in any state vehicle code. There are no completed lawsuits against physicians or patients for motor vehicle accidents associated with driving impairment from hepatic encephalopathy. In the absence of definitive laws, the onus of responsibility for identifying potentially hazardous drivers might still lie with the physician; physicians should carefully evaluate patients for driving abilities.

Evaluation and management of hepatitis B in pregnancy: a survey of current practices.

BACKGROUND: Optimal management of hepatitis B (HBV) during pregnancy is unclear. Safety and efficacy data of antiviral therapy are limited. We assessed the practice patterns of hepatologists, gastroenterologists, and other physicians for evaluating and managing pregnant patients with HBV as well as the variation of these practice patterns by primary specialty and practice description. METHODS: An 18-question electronic survey was sent to physicians with a special interest in liver disease addressing the evaluation and management of HBV during pregnancy. RESULTS: A total of 226 physicians responded, of whom 68.5% characterized their primary specialty as hepatology, 26.5% as gastroenterology, and 4.9% as other; 62.4% were academic-based physicians, and 37.6% were community-based physicians. The average years in practice were 13.3. Initiation of antiviral therapy during pregnancy was supported by 51.8% of respondents. Of those against therapy initiation, 60.4% cited a lack of clear recommendations, 32.1% cited safety concerns, and 7.5% cited a lack of efficacy. For patients on antivirals who desired to become pregnant, 74.8% of respondents would continue antiviral therapy. The most common antiviral used in pregnancy was lamivudine (72.1%). HBV vaccination and HBV immunoglobulin for infants born to mothers with HBV were recommended by 98.7% of respondents; 57.5% would also recommend breastfeeding. If antivirals were being used, only 30.5% of respondents would still recommend breastfeeding. More hepatologists were "very comfortable" (P=.032) managing these patients compared to nonhepatologists. CONCLUSIONS: There is significant heterogeneity in the management of pregnant patients with HBV regardless of primary specialty or practice description. This variability likely reflects a lack of data and specific guidelines. Further research and more specific guidelines are needed.

Fatal lactic acidosis associated with the use of combination oral medications to treat reactivation of hepatitis B.

Oral nucleos(t)ide analogs for the treatment of hepatitis B virus (HBV) infection are well tolerated with minimal side effects. These agents do carry a Food and Drug Administration "black box" warning about the development of fatal lactic acidosis on the basis of data from the human immunodeficiency virus literature. However, no previously published cases of this lethal side effect have been reported in patients undergoing HBV treatment using the current Food and Drug Administration-approved HBV medications. We report a case of HBV reactivation after chemotherapy for leukemia, and the development of fatal lactic acidosis attributed to the use of combination oral HBV medications.

Use of specialty care versus standard retail pharmacies for treatment of hepatitis C.

BACKGROUND: Treatment for hepatitis C virus (HCV) is associated with significant adverse events. Improved adherence increases the probability of achieving sustained virologic response (SVR). Despite a lack of supporting literature, the use of specialty care pharmacies has increased in recent years in an attempt to improve HCV treatment outcomes. OBJECTIVE: To compare specialty care versus standard retail pharmacies in HCV treatment outcomes, utilization of office resources, and the use of supplemental medications. METHODS: A retrospective chart review was performed at a single academic institution for adults with HCV infection treated between 2001 and 2006. SVR was the primary endpoint. Secondary endpoints included therapy completion rates, HCV treatment dose reductions, additional phone calls and clinic visits, and the use of supplemental medications. RESULTS: One hundred ninety-seven patients were identified (102 standard and 95 specialty care pharmacy). There were no differences in baseline demographics between the groups, except for a higher proportion of African Americans using specialty care pharmacies. Overall SVR was 103/197 (52%). SVR was 57/102 (56%) in the standard pharmacy group and 46/95 (48%) in the specialty care pharmacy group. There were no statistically significant differences with regard to SVR (even after accounting for differences in ethnicity), the use of supplemental medications, additional clinic phone calls and visits required, and the reasons for HCV therapy discontinuation. There was a statistically significantly higher incidence of HCV medication dose reductions in the standard retail pharmacy group (45% vs 28%; p = 0.016). CONCLUSIONS: The use of specialty care pharmacies for the treatment of HCV was not associated with higher SVR rates. Patients using specialty care pharmacies had a lower incidence of interferon and/or ribavirin dose reductions, but there was no difference between the groups in therapy completion rates, use of additional office resources, or use of supplemental medications.

Biliary cast syndrome following liver transplantation: Predictive factors and clinical outcomes.

Biliary cast syndrome (BCS), the presence of biliary casts and debris causing biliary obstruction, occurs in 4%-18% of orthotopic liver transplant (OLT) recipients. Potential consequences include cholangitis and graft damage or loss. Limited data exist regarding the etiology and outcomes of BCS. The purpose of this study was to evaluate donor and recipient risk factors and determine the impact of BCS. A retrospective review of 355 OLT cases identified 9 BCS patients (2.5%) diagnosed by cholangiography. Twenty-six matched controls were also identified. The warm ischemic time was significantly longer in BCS patients. Other recipient and donor preoperative and intraoperative characteristics, including the donor risk index, revealed no significant differences. Overall patient survival showed a trend toward worse outcomes at 6, 12, and 18 months and end of follow-up in the BCS group. Overall graft survival was also worse in the BCS group at all time periods, with statistical significance demonstrated at 18 months and end of follow-up. The number of therapeutic biliary procedures and hospital readmissions was significantly higher in the BCS group. Twenty-two percent of the BCS patients required repeat OLT versus none of the control patients. In conclusion, BCS is an uncommon complication of OLT. Except for a longer warm ischemic time, recipient and donor factors did not predict the occurrence of BCS. BCS patients showed a significantly worse graft survival, as well as a trend toward worse patient survival. Given the negative impact of BCS on liver transplant outcomes, further studies appear justified.

The liver transplant recipient: what you need to know for long-term care.

In general, long-term treatment of hypertension, diabetes, and obesity after liver transplantation is similar to that for the general population. Measure bone density within the first year after transplantation. Treat osteoporosis with standard agents. Joint replacement surgery appears safe in this group of patients. Resume standard screening for malignancy 2 to 3 years after transplantation, and repeat at intervals similar to that used with the general population. Given the high risk of skin cancer, transplant recipients should wear sunblock (SPF >40) and have routine dermatologic examinations. Patients should wait at least 2 years before considering pregnancy and use barrier-type methods in this period. Vaccinate patients against hepatitis A and B, influenza, and pneumococcus. Avoid live vaccines.

Operative risk of total hip and knee arthroplasty in cirrhotic patients.

Limited data exist on the safety of primary total hip arthroplasty (THA) and total knee arthroplasty (TKA) in cirrhotic patients. We retrospectively reviewed outcomes of these procedures in cirrhotic patients and matched controls. Significant adverse outcomes occurred in 20.7% (6 of 29) of cirrhotic patients compared with 3.23% (3 of 93) of controls. No significant differences were seen between the groups for elective TKA or THA. However, 80% (4 of 5) of the cirrhotic patients undergoing emergent THA secondary to fracture had major complications, with a 60% (3 of 5) mortality rate. There was a trend toward worse overall outcome in cirrhotic patients with more advanced liver disease. In conclusion, primary THA or TKA can be safely performed electively in Child's A and B cirrhotic patients. However, emergent THA to repair fractures in cirrhotic patients is associated with significantly increased morbidity and mortality.

The downstream financial effect of hepatology.

As a more consultative but less procedurally oriented specialty, Hepatology has been considered a financial liability in some academic centers. However, no actual data exist on the relative contribution of a Hepatology practice. The purpose of this study was to evaluate the direct and indirect (i.e., downstream effect) charges generated by a Hepatology section in comparison with a Gastroenterology section. Using a computerized database, retrospective cohorts of new outpatient consultations and initial admissions seen by the Hepatology and Gastroenterology sections over a 3-month period were created. The cohorts were followed for 12 months. Charges generated directly to the section (direct charges) and to the hospital system (indirect charges) were calculated. Each cohort consisted of 179 patients. The Hepatology patients generated 5,851,463 dollars in overall charges for the hospital, compared with 2,273,339 dollars for the Gastroenterology cohort. Only 3.6% of the Hepatology charges were direct, compared with 15.9% of the Gastroenterology charges. For every 1 dollar billed by Hepatology, the hospital system generated an additional 26.95 dollars in charges (51.03 dollars for the orthotopic liver transplantation patients, and 14.26 dollars for the non-orthotopic liver transplantation patients). For every 1 dollar billed by Gastroenterology, the hospital system generated an additional 5.31 dollars in charges. Similar inpatient collection rates were seen between the two groups (27.7% for hepatology and 33.6% for gastroenterology). In conclusion, although Hepatology generates only a small amount of direct charges, it accounts for a very substantial amount of indirect or downstream billing for an academic medical center. This study validates the importance of a hospital's support for a Hepatology section, especially in a center performing orthotopic liver transplantation.

Current immunosuppression in liver transplantation.

Liver transplantation has emerged from an experimental therapy to a highly successful treatment for end-stage liver disease. The single most important factor in this progression has been the development of effective immunosuppressive regimens. This article will outline the various immunosuppressive agents used in liver transplantation.