Summary Background Pembrolizumab immunotherapy has been associated with hepatotoxicity in 1%‐10% of oncology patients treated in clinical trials. Aim To describe the incidence, phenotypes and outcomes of liver injury in a large cohort of solid organ tumour patients receiving pembrolizumab Methods Liver injury was defined by serum alanine aminotransferase, alkaline phosphatase, and/or total bilirubin levels exceeding threshold values. The likelihood of drug‐induced liver injury was adjudicated by expert opinion. Results Seventy (14.3%) of the 491 pembrolizumab‐treated patients developed liver injury at a median of 62 days (6‐478) and 71.4% had a cholestatic injury profile at onset. The median age, gender and tumour types of liver injury patients were similar to those without, but hepatic metastases (53% vs 21%, P < 0.01) and prior systemic and liver‐directed therapy (71% vs 53%, P < 0.01) were more commonly observed in liver injury patients. During follow‐up, liver injury patients were less likely to experience tumour remission (10% vs 40.4%) and had higher mortality (67.1% vs 33.7%). Only 20 (28.6%) liver injury cases were adjudicated as probable drug‐induced hepatotoxicity; these patients were significantly more likely to present with an hepatocellular/mixed injury pattern (65% vs 12%), to receive corticosteroids (55% vs 12%) and had lower mortality (45% vs 76%) during follow‐up. Conclusions Oncology patients treated with pembrolizumab who develop liver injury experience poorer outcomes during follow‐up. The low incidence of confirmed drug hepatotoxicity highlights the need for thorough medical evaluation before initiating corticosteroids to optimise patient care.

Type 2 diabetes mellitus is known to affect adults in racial and ethnic minority groups disproportionately. When diabetes mellitus–related symptoms lead to the need for skilled care in the community-dwelling Medicare population, physicians can order the Medicare home health care (HHC) benefit, and Medicare-certified home health agencies can deliver it. Little is known about the extent to which racial and ethnic disparities exist in types and patterns of HHC services delivered to Medicare beneficiaries with diabetes mellitus when they are approved for the Medicare HHC benefit. This was examined by comparing racial and ethnic groups in terms of measures of HHC service use in a nationally representative sample of Medicare HHC beneficiaries with a primary diagnosis of type 2 diabetes mellitus. Uniform clinical data from the Outcome and Assessment Information Set were linked with Medicare HHC claims for beneficiaries who received a complete episode of HHC in 2002. In the study sample (n = 9,838), 62% of participants self-identified as white, 22% African American, 12% Hispanic, and 3% Asian. Nearly all (99%) participants in all racial and ethnic groups received skilled nursing services. Controlling for numerous sociodemographic and health-related covariates and geographic region of the country, African-American participants received fewer nurse visits per week and fewer visits per week from all clinical disciplines combined than whites (both P<.001), and Hispanic participants were less likely than whites to receive physical therapy (adjusted odds ratio (AOR) = 0.640, 95% confidence interval (CI) = 0.543–0.754, P<.001) or home health aide (AOR = 0.716, 95% CI = 0.582–0.880, P<.002) services. Lower use of skilled nursing and rehabilitation services by African Americans and of rehabilitation services by Hispanics warrant further clinical and research attention.

Background and ObjectivesHepatitis C virus (HCV) testing rates among U.S. birth-cohort patients have been studied extensively, limited data exists to differentiate birth-cohort screening from risk- or liver disease-based testing. This study aims to identify factors associated with HCV antibody (HCV-Ab) testing in a group of insured birth cohort patients, to determine true birth cohort testing rates, and to determine whether an electronic medical record (EMR)-driven Best Practice Alert (BPA) would improve birth cohort testing rates.MethodsAll birth-cohort outpatients between 2010 and 2015 were identified. HCV-Ab test results, clinical, and demographic variables were extracted from the EMR, and factors associated with testing were analyzed by logistic regression. True birth-cohort HCV screening rates were determined by detailed chart review for all outpatient visits during one calendar month. An automated Best Practice Alert was used to identify unscreened patients at the point of care, and to prompt HCV testing. Screening rates before and after system-wide implementation of the BPA were compared.ResultsThe historic HCV-Ab testing rate was 11.2% (11,976/106,753). Younger age, female gender, and African American, Asian, or Hispanic ethnicity, and medical comorbidities such as chronic hemodialysis, HIV infection, and rheumatologic and psychiatric comorbidities were associated with higher testing rates. However, during the one-month sampling period, true age cohort-based testing was performed in only 69/10,089 patients (0.68%). Following the system-wide implementation of the HCV BPA, testing rates increased from 0.68% to 10.76% (P<0.0001).ConclusionsWe documented low HCV-Ab testing rates in our baby boomers population. HCV testing was typically performed in the presence of known risk factors or established liver disease. The implementation of an EMR-based HCV BPA resulted in a marked increase in testing rates. Our study highlights current HCV screening gaps, and the utility of the EMR to improve screening rates and population health.

Introduction-Idiosyncratic drug-induced liver injury (DILI) is an important cause of liver injury that is difficult to diagnose and identify in the electronic medical record (EMR).Objective-Our objective was to develop a computerized algorithm that can reliably identify DILI cases from the EMR. Methods-The EMR was searched for all encounters with an International Classification of Diseases, Tenth Revision (ICD-10) T code for drug toxicity and a K-71 code for toxic liver injury between 1 October 2015 and 30 September 2018. Clinically significant liver injury was defined using predetermined laboratory values. An expert opinion causality score (1-3 = probable DILI, 4/5 = non-DILI), Roussel Uclaf Causality Assessment Method (RUCAM) score, and severity score was assigned to each case.Results-Among the 1,211,787 encounters searched, 517 had both an ICD-10 T code and a K-71 code, with 257 patients meeting the laboratory criteria. After excluding 75 cases of acetaminophen hepatotoxicity, the final study sample included 182 cases of potential DILI, with antineoplastics and antibiotics being the most frequently implicated agents. Causality assessment identified probable DILI in 121 patients (66.5%), whereas 61 (33.5%) had an alternative cause of liver injury. Although age, sex, race, and suspect drugs were similar, the probable DILI cases were more likely to present with a hepatocellular injury profile and have more severe liver injury than the non-DILI cases (p < 0.05).

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