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Background: Non‐alcoholic steatohepatitis has emerged as a leading cause of cirrhosis, and obesity‐associated comorbidities, including renal disease, have increased in prevalence. Obesity predisposes the kidney to hyperfiltration injury, potentially impairing acute kidney injury recovery. Identification of patients at risk for renal dysfunction is impeded by poor performance of renal function estimating equations among cirrhotics. To better understand obesity among cirrhotics and renal disease progression, we examined likelihood of kidney transplantation (KT) waitlisting after liver transplant alone (LTA) by obesity class. Methods: 68 607 LTA recipients were identified in SRTR (2005–2018). Fine and Gray competing risks models were used to analyze likelihood of KT waitlisting. Results: 27.4% of recipients were obese (BMI ≥ 30 kg/m2) and were 10% more likely to require KT waitlisting (aHR: 1.10, 95%CI: 1.01–1.20). Risk was highest among recipients with Classes II and III obesity (BMI: ≥35 kg/m2) (aHR: 1.37, 95%CI: 1.17–1.56). Moreover, recipients with Classes II and III obesity were 57% more likely to require KT waitlisting within one year post‐LTA (aHR: 1.57, 95%CI: 1.18–2.10) compared to non‐obese recipients. Discussion: These findings suggest obesity was a risk factor for renal recovery failure and/or renal disease progression post‐LTA and may confound identification of renal dysfunction and/or prediction of renal recovery among cirrhotics. [ABSTRACT FROM AUTHOR]

There has been an increase in hepatitis B (HBV) detection during pregnancy in the United States and an emphasis on measures to decrease mother‐to‐child transmission of HBV. We performed a multicentre retrospective study (2015–2018) evaluating care among all women with HBV during pregnancy. We determined rates and predictors of adherence to key maternal care measures including: (1) referral to HBV specialty care, (2) assessment of HBV DNA, and (3) initiation of antiviral therapy, and (4) rates of HBIG and HBV vaccine completion in infants. We evaluated two interventions to improve HBV care: (1) clinical decision support with best practice alert and (2) co‐location of HBV care in obstetrics department. We identified 372 women with HBV during pregnancy. Patients had a median age of 33 (IQR 29, 36), were mostly of Asian (49%) or Black (36%) race, HBeAg‐negative (83%) with HBV DNA ≤2000 IU/mL (65%) and maximum ALT ≤25 (66%). Regarding care measures, 62% were referred to an HBV specialist, 85% had HBV DNA checked during pregnancy and 68% with HBV DNA ≥200,000 were initiated on antiviral therapy. Co‐located obstetric‐liver diseases clinics appeared to improve adherence to maternal care measures. All infants received HBIG and the first HBV vaccine dose, 106 (81%) received the second, 94 (74%) received the 3rd dose, but fewer at the recommended time intervals. We identified clear gaps in adherence to HBV care measures for both mothers and infants. Co‐location of HBV care in the obstetrics department shows promise in improving adherence to maternal care measures. [ABSTRACT FROM AUTHOR]

Summary: Cirrhosis is associated with hormonal dysregulation, as evidenced by secondary amenorrhoea in reproductive‐aged women, and feminization of cirrhotic men. Whether hormone levels vary by severity of cirrhosis in women is not known. If identified, such changes may have important clinical relevance, particularly, as low sex hormone binding globulin (SHBG) and follicle stimulating hormone (FSH) are known to promote metabolic and cardiovascular disease in women. In a cohort of post‐menopausal women with chronic hepatitis C virus (HCV) infection, we compared comprehensive sex hormone levels by presence of cirrhosis, as well as across Child‐Turcotte‐Pugh (CTP) class. Results: There were n = 18 cirrhotic and n = 21 noncirrhotic women with a median age of 57 years (interquartile range [IQR] 53‐62). Compared to noncirrhotics, cirrhotic women had higher oestradiol (11.0 vs 6.0 pg/mL, P = 0.05) and oestrone levels (32.0 vs 8.0 ng/mL, P < 0.001), and lower sex hormone binding globulin (SHBG) (69.2 vs 155.6 nmol/L, P = 0.001), and FSH levels (4.9 vs 89.6 mIU/mL, P < 0.001). Among cirrhotic women, there was a progressive decline in FSH and SHBG and concurrent rise in oestrone levels from CTP class A to C (test of trend, P values ≤0.02). Cirrhosis is associated with lower FSH and SHBG levels in cirrhotic compared to noncirrhotic women with HCV infection. In cirrhotic women, these levels demonstrate steady decline by disease severity. Given known associations of low SHBG and FSH with cardio‐metabolic disease, the clinical implications of hormonal changes by cirrhosis severity in HCV‐infected women warrants investigation. [ABSTRACT FROM AUTHOR]

Abstract: Background & Aims: There is limited knowledge about hepatitis B virus (HBV) flare among pregnant women. We evaluated the incidence, determinants and outcomes of HBV flare in a multicultural cohort of pregnant HBV‐infected women in the United States. Methods: We performed a retrospective cohort study of pregnant hepatitis B surface antigen‐positive women cared for at hospital‐based clinics of 4 medical centres in Southeastern Pennsylvania from 2006 to 2015. The main outcome was incident HBV flare (alanine aminotransferase [ALT] ≥2 times upper limit of normal) during pregnancy or within 6 months after delivery. Among patients with flare, we determined development of jaundice (total bilirubin ≥2.5 mg/dL) and hepatic decompensation. Multivariable logistic regression was used to estimate odds ratios (ORs) of HBV flare for risk factors of interest, including timing of flare (during pregnancy versus post‐delivery), nulliparity, younger age, HBV e antigen (HBeAg) status, and lack of anti‐HBV therapy. Results: Among 310 pregnant predominantly African HBV‐infected women with 388 pregnancies, the incidence of HBV flare was 14% (95% CI, 10‐18%) during pregnancy and 16% (95% CI, 11‐24%) post‐delivery. Jaundice developed in 12% and hepatic decompensation in 2%. Positive HBeAg was associated with HBV flare (OR, 2.55; 95% CI, 1.04‐6.20). HBV DNA was measured in 55% of patients, and only 50% were referred for HBV specialty care. Conclusions: Pregnancy‐associated hepatitis B flare occurred in 14% during pregnancy and 16% post‐delivery and rarely led to hepatic decompensation. Positive HBeAg was the main risk factor identified. Women did not have adequate HBV monitoring or follow‐up during pregnancy. [ABSTRACT FROM AUTHOR]

Purpose Identification of acute liver failure (ALF) is important for post-marketing surveillance of medications, but the validity of using ICD-9 diagnoses and laboratory data to identify these events within electronic health records is unknown. We examined positive predictive values (PPVs) of hospital ICD-9 diagnoses and laboratory tests of liver dysfunction for identifying ALF within a large, community-based integrated care organization. Methods We identified Kaiser Permanente Northern California health plan members (2004-2010) with a hospital diagnosis suggesting ALF (ICD-9 570, 572.2, 572.4, 572.8, 573.3, 573.8, or V42.7) plus an inpatient international normalized ratio ≥1.5 (off warfarin) and total bilirubin ≥5.0 mg/dL. Hospital records were reviewed by hepatologists to adjudicate ALF events. PPVs for confirmed outcomes were determined for individual ICD-9 diagnoses, diagnoses plus prescriptions for hepatic encephalopathy treatment, and combinations of diagnoses in the setting of coagulopathy and hyperbilirubinemia. Results Among 669 members with no pre-existing liver disease, chart review confirmed ALF in 62 (9%). Despite the presence of co-existing coagulopathy and hyperbilirubinemia, individual ICD-9 diagnoses had low PPVs (range, 5-15%); requiring prescriptions for encephalopathy treatment did not increase PPVs of these diagnoses (range, 2-23%). Hospital diagnoses of other liver disorders (ICD-9 573.8) plus hepatic coma (ICD-9 572.2) had high PPV (67%; 95%CI, 9-99%) but only identified two (3%) ALF events. Conclusions Algorithms comprising relevant hospital diagnoses, laboratory evidence of liver dysfunction, and prescriptions for hepatic encephalopathy treatment had low PPVs for confirmed ALF events. Studies of ALF will need to rely on medical records to confirm this outcome. [ABSTRACT FROM AUTHOR]

Background and aims Despite the use of administrative data to perform epidemiological and cost-effectiveness research on patients with hepatitis B or C virus (HBV, HCV), there are no data outside of the Veterans Health Administration validating whether International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) codes can accurately identify cirrhotic patients with HBV or HCV. The validation of such algorithms is necessary for future epidemiological studies. Methods We evaluated the positive predictive value (PPV) of ICD-9-CM codes for identifying chronic HBV or HCV among cirrhotic patients within the University of Pennsylvania Health System, a large network that includes a tertiary care referral center, a community-based hospital, and multiple outpatient practices across southeastern Pennsylvania and southern New Jersey. We reviewed a random sample of 200 cirrhotic patients with ICD-9-CM codes for HCV and 150 cirrhotic patients with ICD-9-CM codes for HBV. Results The PPV of 1 inpatient or 2 outpatient HCV codes was 88.0% (168/191, 95% CI: 82.5-92.2%), while the PPV of 1 inpatient or 2 outpatient HBV codes was 81.3% (113/139, 95% CI: 73.8-87.4%). Several variations of the primary coding algorithm were evaluated to determine if different combinations of inpatient and/or outpatient ICD-9-CM codes could increase the PPV of the coding algorithm. Conclusions ICD-9-CM codes can identify chronic HBV or HCV in cirrhotic patients with a high PPV and can be used in future epidemiologic studies to examine disease burden and the proper allocation of resources. Copyright © 2014 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Renal dysfunction prior to liver transplantation has a marked impact on post-transplant kidney outcomes. Aim The aim of this study was to assess post-transplant renal function in patients with chronic kidney disease ( CKD) receiving orthotopic liver transplantation ( OLT) alone. Methods Retrospective review of 40 OLT recipients with pre-transplant CKD (serum creatinine ≥2 mg/dL for at least three months) at the University of Pennsylvania from February 2002 to July 2010. Primary outcome was estimated glomerular filtration rate (e GFR) up to three years post-transplant. Secondary outcomes included incidence of stage 4 CKD (e GFR < 30 mL/min), need for renal replacement therapy ( RRT), meeting criteria for kidney transplant listing (e GFR ≤ 20 mL/min), and mortality. Results Median patient age was 56.5 yr and 48% patients had pre-transplant diabetes. Median serum creatinine at transplant was 2.7 mg/dL (e GFR = 24 mL/min). Median e GFR at one, two, and three yr post-transplant was 35, 34, and 37 mL/min, respectively. Twelve patients (30%) required RRT at a median of 1.21 yr post-transplant and 16 (40%) achieved an e GFR ≤ 20 mL/min at 1.09 yr post-transplant. Mortality was 35% at a median of 1.60 years post-transplant. Conclusions OLT recipients with pre-transplant CKD have a substantial burden of post-transplant renal dysfunction and high short-term mortality, questioning the rationale for OLT alone in this population. [ABSTRACT FROM AUTHOR]

ABSTRACT Purpose The validity of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes to identify diagnoses of severe acute liver injury (SALI) is not well known. We examined the positive predictive values (PPVs) of hospital ICD-9-CM diagnoses in identifying SALI among health plan members in the Mini-Sentinel Distributed Database (MSDD) for patients without liver/biliary disease and for those with chronic liver disease (CLD). Methods We selected random samples of members (149 without liver/biliary disease; 75 with CLD) with a principal hospital diagnosis suggestive of SALI (ICD-9-CM 570, 572.2, 572.4, 572.8, 573.3, 573.8, or V42.7) in the MSDD (2009-2010). Medical records were reviewed by hepatologists to confirm SALI events. PPVs of codes and code combinations for confirmed SALI were determined by CLD status. Results Among 105 members with available records and no liver/biliary disease, SALI was confirmed in 26 (PPV, 24.7%; 95%CI, 16.9−34.1%). Combined hospital diagnoses of acute hepatic necrosis (570) and liver disease sequelae (572.8) had high PPV (100%; 95%CI, 59.0-100%) and identified 7/26 (26.9%) events. Among 46 CLD members with available records, SALI was confirmed in 19 (PPV, 41.3%; 95%CI, 27.0-56.8%). Acute hepatic necrosis (570) or hepatorenal syndrome (572.4) plus any other SALI code had a PPV of 83.3% (95%CI, 51.6-97.9%) and identified 10/19 (52.6%) events. Conclusions Most individual hospital ICD-9-CM diagnoses had low PPV for confirmed SALI events. Select code combinations had high PPV but did not capture all events. Copyright © 2013 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Purpose Before using computerized databases to study hepatitis C virus (HCV) epidemiology, the validity of the diagnosis must be assessed. We determined the accuracy of HCV diagnostic codes within The Health Improvement Network (THIN), an electronic database containing medical record data from general medical practices in the United Kingdom. Methods Patients with initial diagnostic codes for HCV infection and nonspecific viral hepatitis between 2000 and 2007 in the THIN database were identified. Questionnaires were mailed to general practitioners caring for a random sample of 150 of these patients (75 with an HCV code; 75 with a nonspecific viral hepatitis code) to collect information on HCV and other hepatitis diagnoses. We determined the positive predictive value of the database's HCV diagnostic codes and its ability to identify the date of a new HCV diagnosis. Results Usable surveys were returned for 146 (97%) patients. Among 74 patients with an HCV code and questionnaire data, HCV was confirmed in 64 (positive predictive value, 86%; 95%CI, 77-93%). In 40 (63%), the first recorded diagnosis in THIN was within 30 days of the date reported in the questionnaire (median difference, 11 days; interquartile range, 0-362 days). Among 72 patients with a nonspecific viral hepatitis code, 16 (22%) had HCV, but manual review of the database's electronic records correctly identified 12/16 (75%). Conclusions In THIN, the HCV-specific diagnostic codes are highly predictive of HCV infection. After manual review, few patients with a nonspecific viral hepatitis code were misclassified as having HCV infection. Copyright © 2009 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background The utility of electronic medical record databases for clinical research relies on the validity and completeness of the recorded medical diagnoses. This study assessed whether the recorded incidence of cancer among patients in The Health Improvement Network (THIN) database is comparable to that expected in the UK based on national cancer registry data. Methods We examined incidence rates of any cancer other than non-melanoma skin cancer and the specific cancers colorectal, lung, pancreas, and lymphoma from 1992 to 2007. Indirect standardization was used to calculate standardized incidence ratios (SIR) using age- and sex-specific rates from the UK cancer registry for England and Wales for the corresponding years. Results Recording of the incidence of all cancers combined in THIN was very close to the expected rates from 2001 to 2007, that is, SIR within 10% of unity. Recording of the solid cancers was less than the expected based on cancer registry data, but with SIRs > 0.80 in 2007 for each cancer. Recording of lymphoma was close to the expected rate for the entire follow-up period. Time and experience with Vision software emerged as important factors in reported incidence rates for all cancers. Conclusions For all cancers combined and for lymphoma the observed rates in THIN are very close to those reported in cancer registry data for the years 2001-2007. However, for solid cancers the observed rates in THIN are below those reported in cancer registry data. This may reflect the use of non-specific codes to record solid cancers. Copyright © 2009 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: Despite a survival benefit from transplantation and acceptable outcomes, patients with human immunodeficiency virus (HIV+) face barriers to kidney transplantation. Little is known about the acceptance or decline of organ offers on their behalf because waitlist registry data do not include HIV serostatus. Methods: We performed a retrospective cohort study using match run data from the Organ Procurement and Transplantation Network, including every kidney offer from May 1, 2007, to July 3, 2013. HIV and hepatitis C virus (HCV) serostatus were obtained by merging the match run with clinical data from a large dialysis provider. We used Cox proportional hazards modeling to evaluate differences in time to the first organ offer and to transplantation. A total of 35 646 uninfected, 2213 HCV+, 418 HIV+, and 71 HIV+/HCV+ candidates received organ offers during the study period. Results: Compared to uninfected candidates, HIV+ candidates had a significantly lower likelihood of receiving a first offer (adjusted hazard ratio [aHR] 0.88, 95% confidence interval [CI] 0.79‐0.99) and undergoing transplantation (aHR 0.82, 95% CI: 0.68‐0.98) after receiving a first offer; HCV+ candidates had a similar likelihood of receiving a first offer (aHR 0.98, 95% CI: 0.92‐1.03) and greater likelihood of transplantation after receiving a first offer (aHR 1.23, 95% CI: 1.12‐1.36). Conclusions: HIV+ candidates had a significantly longer wait until their first organ offer and to transplantation. Efforts to increase their access to transplantation are needed. [ABSTRACT FROM AUTHOR]