Disparities in communication among the inpatient homeless population at a safety-net hospital.

OBJECTIVE: To determine whether the homeless population experiences disparities in care and communication during inpatient hospitalizations in a safety-net hospital. METHODS: We administered a modified Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey to 112 age-sex- and education matched homeless and non-homeless adults at a university-affiliated-safety-net hospital from December 2017 through March 2018 and performed a retrospective review of medical records. Linear regression models were used to assess differences in responses to survey subscales, length of stay and other measures. RESULTS: Homeless participants trended toward poorer ratings for all HCAHPS subscales, reaching significance for the Communication about Medications subscale, with a mean score 1.2 (95% CI 0.48-1.76) points lower compared to non-homeless sample. Length of stay was not significantly different between homeless and non-homeless participants. CONCLUSION: In an urban safety-net hospital, disparities in communications regarding medications between hospital staff and patients were found based on housing status.

Cost-effectiveness and Budgetary Impact of Hepatitis C Virus Testing, Treatment, and Linkage to Care in US Prisons.

BACKGROUND: Hepatitis C virus (HCV) testing and treatment uptake in prisons remains low. We aimed to estimate clinical outcomes, cost-effectiveness (CE), and budgetary impact (BI) of HCV testing and treatment in United States (US) prisons or linkage to care at release. METHODS: We used individual-based simulation modeling with healthcare and Department of Corrections (DOC) perspectives for CE and BI analyses, respectively. We simulated a US prison cohort at entry using published data and Washington State DOC individual-level data. We considered permutations of testing (risk factor based, routine at entry or at release, no testing), treatment (if liver fibrosis stage ≥F3, for all HCV infected or no treatment), and linkage to care (at release or no linkage). Outcomes included quality-adjusted life-years (QALY); cases identified, treated, and cured; cirrhosis cases avoided; incremental cost-effectiveness ratios; DOC costs (2016 US dollars); and BI (healthcare cost/prison entrant) to generalize to other states. RESULTS: Compared to "no testing, no treatment, and no linkage to care," the "test all, treat all, and linkage to care at release" model increased the lifetime sustained virologic response by 23%, reduced cirrhosis cases by 54% at a DOC annual additional cost of $1440 per prison entrant, and would be cost-effective. At current drug prices, targeted testing and liver fibrosis-based treatment provided worse outcomes at higher cost or worse outcomes at higher cost per QALY gained. In sensitivity analysis, fibrosis-based treatment restrictions were cost-effective at previous higher drug costs. CONCLUSIONS: Although costly, widespread testing and treatment in prisons is considered to be of good value at current drug prices.

Cost-effectiveness of scaling-up HCV prevention and treatment in the United States for people who inject drugs.

AIMS: To examine the cost-effectiveness of hepatitis C virus (HCV) treatment of people who inject drugs (PWID), combined with medication-assisted treatment (MAT) and syringe-service programs (SSP), to tackle the increasing HCV epidemic in the United States. DESIGN: HCV transmission and disease progression models with cost-effectiveness analysis using a health-care perspective. SETTING: Rural Perry County, KY (PC) and urban San Francisco, CA (SF), USA. Compared with PC, SF has a greater proportion of PWID with access to MAT or SSP. HCV treatment of PWID is negligible in both settings. PARTICIPANTS: PWID data were collected between 1998 and 2015 from Social Networks Among Appalachian People, U Find Out, Urban Health Study and National HIV Behavioral Surveillance System studies. INTERVENTIONS AND COMPARATOR: Three intervention scenarios modeled: baseline-existing SSP and MAT coverage with HCV screening and treatment with direct-acting antiviral for ex-injectors only as per standard of care; intervention 1-scale-up of SSP and MAT without changes to treatment; and intervention 2-scale-up as intervention 1 combined with HCV screening and treatment for current PWID. MEASUREMENTS: Incremental cost-effectiveness ratios (ICERs) and uncertainty using cost-effectiveness acceptability curves. Benefits were measured in quality-adjusted life-years (QALYs). FINDINGS: For both settings, intervention 2 is preferred to intervention 1 and the appropriate comparator for intervention 2 is the baseline scenario. Relative to baseline, for PC intervention 2 averts 1852 more HCV infections, increases QALYS by 3095, costs $21.6 million more and has an ICER of $6975/QALY. For SF, intervention 2 averts 36 473 more HCV infections, increases QALYs by 7893, costs $872 million more and has an ICER of $11 044/QALY. The cost-effectiveness of intervention 2 was robust to several sensitivity analysis. CONCLUSIONS: Hepatitis C screening and treatment for people who inject drugs, combined with medication-assisted treatment and syringe-service programs, is a cost-effective strategy for reducing hepatitis C burden in the United States.

Short-Term Effects and Long-Term Cost-Effectiveness of Universal Hepatitis C Testing in Prenatal Care.

OBJECTIVE: To estimate the clinical effects and cost-effectiveness of universal prenatal hepatitis C screening, and to calculate potential life expectancy, quality of life, and health care costs associated with universal prenatal hepatitis C screening and linkage to treatment. METHODS: Using a stochastic individual-level microsimulation model, we simulated the lifetimes of 250 million pregnant women matched at baseline with the U.S. childbearing population on age, injection drug use behaviors, and hepatitis C virus (HCV) infection status. Modeled outcomes included hepatitis C diagnosis, treatment and cure, lifetime health care costs, quality-adjusted life years (QALY) and incremental cost-effectiveness ratios comparing universal prenatal hepatitis C screening to current practice. We modeled whether neonates exposed to maternal HCV at birth were identified as such. RESULTS: Pregnant women with hepatitis C infection lived 1.21 years longer and had 16% lower HCV-attributable mortality with universal prenatal hepatitis C screening, which had an incremental cost-effectiveness ratio of $41,000 per QALY gained compared with current practice. Incremental cost-effectiveness ratios remained below $100,000 per QALY gained in most sensitivity analyses; notable exceptions included incremental cost-effectiveness ratios above $100,000 when assuming mean time to cirrhosis of 70 years, a cost greater than $500,000 per false positive diagnosis, or population HCV infection prevalence below 0.16%. Universal prenatal hepatitis C screening increased identification of neonates exposed to HCV at birth from 44% to 92%. CONCLUSIONS: In our model, universal prenatal hepatitis C screening improves health outcomes in women with HCV infection, improves identification of HCV exposure in neonates born at risk, and is cost-effective.

Monitoring the hepatitis C care cascade using administrative claims data.

OBJECTIVES: With the availability of curative therapies, it is important to ensure that individuals infected with hepatitis C virus (HCV) receive recommended testing, care, and treatment. We sought to evaluate insurance claims data as a source for monitoring progression along the HCV care cascade. STUDY DESIGN: Longitudinal evaluation of disease progression, from diagnosis to treatment, among commercially insured enrollees with chronic HCV. METHODS: We validated and used algorithms derived from standardized procedure and diagnosis codes to identify enrollees with chronic HCV in large insurance claims databases to describe the HCV care cascade, including the proportion engaged in HCV-specific care (13 possible definitions), the proportion prescribed HCV treatment, and the proportion who received an HCV RNA test 30 or more days after initiating treatment. RESULTS: Approximately 90% of individuals with an HCV RNA test procedure code followed by either 3 or more chronic HCV diagnosis codes on different service dates or 2 or more chronic HCV diagnosis codes separated by more than 60 days truly had chronic HCV. Using these algorithms, we identified 5791 HCV cases from January 1, 2013, to June 30, 2014. Among enrollees with HCV, 95% were engaged in HCV care, but only 49% initiated treatment and 43% received a follow-up HCV RNA test 30 or more days after initiating treatment. CONCLUSIONS: With validated case-finding algorithms, insurance claims data can be used to describe and monitor portions of the HCV care cascade. Although nearly all enrollees with HCV were engaged in HCV care, only half received treatment, indicating that even commercially insured enrollees may find it challenging to access treatment.

Hepatitis B Virus Testing and Care among Pregnant Women Using Commercial Claims Data, United States, 2011-2014.

Introduction: Pregnant women should receive hepatitis B virus (HBV) testing with hepatitis B surface antigen (HBsAg), but it is unclear whether HBV-infected pregnant women are linked to care. Methods: We analyzed MarketScan™ commercial insurance claims. We included pregnant women, aged 10-50 years, with 42 weeks of continuous enrollment before (predelivery) and 6 months after (postdelivery) the first delivery claim for each unique pregnancy between 1/1/2011 and 6/30/2014. We identified claims for HBsAg testing by CPT code and described the care continuum among pregnancies with an associated ICD-9 HBV diagnosis code by demographic and clinical characteristics, including HBV-directed care ([HBV DNA or hepatitis B e antigen] and ALT test codes) and antiviral treatment (claims for tenofovir, entecavir, lamivudine, adefovir, or telbivudine) pre- and postdelivery. Results: There were 870,888 unique pregnancies (819,752 women) included. Before delivery, 714,830 (82%) pregnancies had HBsAg test claims, but this proportion decreased with subsequent pregnancies (p < 0.0001): second (80%), third (71%), and fourth (61%). We identified 1,190 (0.14%) pregnancies with an associated HBV diagnosis code: most were among women aged ≥ 30 years (76%) residing in the Pacific (34%) or Middle Atlantic (18%) regions. Forty-two percent of pregnancies with an HBV diagnosis received HBV-directed care (42% predelivery and 39% postdelivery). Antiviral treatment was initiated before delivery in 128 (13%) of 975 pregnancies and postdelivery in 16 (1.6%) pregnancies. Conclusions: While most of these commercially insured pregnant women received predelivery HBV screening, we identified gaps in HBV testing and the HBV care continuum which highlight potential targets for public health interventions.

Population-level Outcomes and Cost-Effectiveness of Expanding the Recommendation for Age-based Hepatitis C Testing in the United States.

Background: The US Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force recommend one-time hepatitis C virus (HCV) testing for persons born 1945-1965 and targeted testing for high-risk persons. This strategy targets HCV testing to a prevalent population at high risk for HCV morbidity and mortality, but does not include younger populations with high incidence. To address this gap and improve access to HCV testing, age-based strategies should be considered. Methods: We used a simulation of HCV to estimate the effectiveness and cost-effectiveness of HCV testing strategies: 1) standard of care (SOC) - recommendation for one-time testing for all persons born 1945-1965, 2) recommendation for one-time testing for adults ≥40 years (≥40 strategy), 3) ≥30 years (≥30 strategy), and 4) ≥18 years (≥18 strategy). All strategies assumed targeted testing of high-risk persons. Inputs were derived from national databases, observational cohorts and clinical trials. Outcomes included quality-adjusted life expectancy, costs, and cost-effectiveness. Results: Expanded age-based testing strategies increased US population lifetime case identification and cure rates. Greatest increases were observed in the ≥18 strategy. Compared to the SOC, this strategy resulted in an estimated 256,000 additional infected persons identified and 280,000 additional cures at the lowest cost per QALY gained (ICER = $28,000/QALY). Conclusions: In addition to risk-based testing, one-time HCV testing of persons 18 and older appears to be cost-effective, leads to improved clinical outcomes and identifies more persons with HCV than the current birth cohort recommendations. These findings could be considered for future recommendation revisions.

Hepatitis C Antibody Testing in a Commercially Insured Population, 2005-2014.

INTRODUCTION: In the U.S., the burden of hepatitis C virus (HCV) infection and associated sequelae is substantial. HCV prevalence is highest among those born in 1945-1965 (Birth Cohort). Newly diagnosed infections are increasing in younger people concurrent with rising opioid/heroin use. The Centers for Disease Control and Prevention (2012) and U.S. Preventive Services Task Force (2013) recommend HCV testing for at-risk individuals and one-time testing for the Birth Cohort. This study describes national trends in HCV antibody testing from 2005 to 2014. METHODS: Using commercial and Medicare supplemental insurance claims data, people were identified who were continuously enrolled for ≥2 years during the 10-year study period, without prior HCV diagnosis (N=190,926,299). Current Procedural Terminology codes identified 3,382,267 unique antibody tests. Temporal trends in annual testing were evaluated using the Cochran-Armitage test, and primary ICD-9-CM diagnosis codes used at the time of testing were described. Data were analyzed in 2015 and 2016. RESULTS: Testing was highest among those aged 18-29 and 30-39 years, increasing by 123% (1.66% to 3.71%) and 108% (1.99% to 4.13%), respectively (p<0.0001). Among the Birth Cohort, there was a 136% increase in HCV antibody testing from 2005 to 2014, with a 91% increase from 1.71% in 2011 to 3.26% 2014 (p<0.0001). CONCLUSIONS: Although the increased HCV antibody testing observed among the Birth Cohort from 2011 to 2014 likely reflects early adoption of updated national testing recommendations, overall testing remains low in this commercially insured population, indicating a clear need for improvement.

Uptake of hepatitis C screening, characteristics of patients tested, and intervention costs in the BEST-C study.

From December 2012 to March 2014, three randomized trials, each implementing a unique intervention in primary care settings (repeated mailing, an electronic health record best practice alert [BPA], and patient solicitation), evaluated hepatitis C virus (HCV) antibody testing, diagnosis, and costs for each of the interventions compared with standard-of-care testing. Multilevel multivariable models were used to estimate the adjusted risk ratio (aRR) for receiving an HCV antibody test, and costs were estimated using activity-based costing. The goal of this study was to estimate the effects of interventions conducted as part of the Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C study on HCV testing and costs among persons of the 1945-1965 birth cohort (BC). Intervention resulted in substantially higher HCV testing rates compared with standard-of-care testing (26.9% versus 1.4% for repeated mailing, 30.9% versus 3.6% for BPA, and 63.5% versus 2.0% for patient solicitation) and significantly higher aRR for testing after controlling for sex, birth year, race, insurance type, and median household income (19.2 [95% confidence interval (CI), 9.7-38.2] for repeated mailing, 13.2 [95% CI, 3.6-48.6] for BPA, and 32.9 [95% CI, 19.3-56.1] for patient solicitation). The BPA intervention had the lowest incremental cost per completed test ($24 with fixed startup costs, $3 without) and also the lowest incremental cost per new case identified after omitting fixed startup costs ($1691). CONCLUSION: HCV testing interventions resulted in an increase in BC testing compared with standard-of-care testing but also increased costs. The effect size and incremental costs of BPA intervention (excluding startup costs) support more widespread adoption compared with the other interventions. (Hepatology 2017;65:44-53).

Birth Cohort Testing for Hepatitis C Virus - Indian Health Service 2012-2015.

Hepatitis C virus (HCV) infection is a substantial and largely unrecognized public health problem. An estimated 3.5 million persons in the United States are currently living with HCV infection, at least half of whom are unaware of their infection (1-3). Persons born during 1945-1965 (the "baby boomer" birth cohort) have a sixfold higher prevalence (2.6%) than adults of other ages, and represent 81% of all persons chronically infected with HCV (4). Therefore, in addition to recommending testing for all persons at risk for HCV infection, CDC and the U.S. Preventive Services Task Force (USPSTF) recommend one-time HCV testing for the birth cohort (5,6). Compared with the national average, American Indian/Alaska Native (AI/AN) persons have approximately twofold the rate of acute HCV incidence and HCV associated mortality (2). In June 2012, the Indian Health Service (IHS) implemented HCV testing in the 1945-1965 birth cohort and created a nationally standardized performance measure to monitor implementation of the recommendation. As of June 2015, the proportion of the birth cohort screened for HCV increased from a baseline of 7.9% (14,402/182,503) to 32.5% (68,514/211,014) among the AI/AN population served by IHS nationwide; provider training and the use of clinical decision tools were associated with increases in HCV testing. With this fourfold increase in testing in just 3 years, IHS needs to prepare for the challenges associated with increased identification of persons living with HCV infection.

Identification and Clinical Management of Persons with Chronic Hepatitis C Virus Infection - Cherokee Nation, 2012-2015.

An estimated 3.5 million persons in the United States are living with hepatitis C virus (HCV) infection, resulting in approximately 20,000 deaths each year, primarily from cirrhosis or hepatocellular carcinoma (1,2). American Indian/Alaska Native (AI/AN) populations have the highest incidence of acute HCV infection among all U.S. racial/ethnic groups and are at greater risk for HCV-related mortality compared with the general population (3). In 2013, new antiviral drugs became available that make possible 8-12 week treatment regimens with fewer adverse events and are able to achieve sustained virologic response (SVR) in >90% of treated patients (4), equivalent to a cure of HCV infection. Also of note, HCV testing recommendations were expanded in 2012 by CDC and in 2013 by the U.S. Preventive Services Task Force to include one-time testing of persons born during 1945-1965 (the "baby boomer" cohort) in addition to anyone at increased risk for HCV infection (5,6). Given the availability of new HCV drugs, expanded testing recommendations, and high incidence of HCV infection in AI/AN populations, in October 2012, Cherokee Nation Health Services (CNHS) implemented a tribal HCV testing policy.* As part of the policy, CNHS added a reminder in the electronic health record (EHR) for clinical decision support and provided HCV education to primary care clinicians. From October 2012 to July 2015, among 92,012 persons with at least one CNHS clinic encounter, the cumulative number who received HCV screening for the first time increased from 3,337 (3.6%) to 16,772 (18.2%). The largest percentage of HCV screening was among persons born during 1945-1965. Of 715 persons who tested positive for HCV antibodies, 488 (68.3%) were tested for HCV RNA; among those 488 persons, 388 (79.5%) were RNA positive and were thus confirmed to have chronic HCV infection. Treatment was initiated for 223 (57.5%) of the 388 with chronic infection; 201 (90.1%) completed treatment, of whom 180 (89.6%) achieved SVR. CNHS has successfully increased HCV testing and treatment and is now collaborating with CDC and other external partners to develop an HCV elimination program for the Cherokee Nation that might serve as a model for similar settings.

Clinical assessment of serious adverse events in children receiving 2009 H1N1 vaccination.

BACKGROUND: Monovalent 2009 H1N1 influenza vaccines were licensed and administered in the United States during the H1N1 influenza pandemic between 2009 and 2013. METHODS: Vaccine Adverse Event Reporting System received reports of adverse events following immunization (AEFI) after H1N1 vaccination. Selected reports were referred to the Centers for Disease Control and Prevention's Clinical Immunization Safety Assessment network for additional review. We assessed causality using modified World Health Organization criteria. RESULTS: There were 3,928 reports of AEFI in children younger than age 18 years after 2009 H1N1 vaccination received by January 31, 2010. Of these, 214 (5.4%) were classified as serious nonfatal and 109 were referred to Clinical Immunization Safety Assessment for further evaluation. Ninety-nine (91%) had sufficient initial information to begin investigation and are described here. The mean age was 8 years (range, 6 months-17 years) and 38% were female. Median number of days between vaccination and symptom onset was 2 (range, -11 days to +41 days). Receipt of inactivated, live attenuated, or unknown type of 2009 H1N1 vaccines was reported by 68, 26 and 5 cases, respectively. Serious AEFI were categorized as neurologic events in 47 cases, as hypersensitivity in 15 cases and as respiratory events in 10 cases. At the time of evaluation, recovery was described as complete (61), partial (16), no improvement (1), or unknown (21). Causality assessment yielded the following likelihood of association with 2009 H1N1 vaccination: 8 definitely; 8 probably; 21 possibly; 43 unlikely; 17 unrelated; and 2 unclassifiable. CONCLUSIONS: Most AEFI in children evaluated were not causally related to vaccine and resolved without sequelae. Detailed clinical assessment of individual serious AEFI can provide reassurance of vaccine safety.

Disparities in prevalence of key chronic diseases by gender and race/ethnicity among antiretroviral-treated HIV-infected adults in the US.

BACKGROUND: Certain sociodemographic subgroups of HIV-infected patients may experience more chronic disease than others due to behavioural risk factors, advanced HIV disease or complications from extended use of combination antiretroviral therapy (cART), but recent comparative data are limited. METHODS: We studied HIV-infected adult patients in care during 2006-2010 who had been prescribed ≥ 6 months of cART. We analysed the prevalence of selected key chronic conditions and polymorbidity (having 2 or more out of 10 key conditions) by gender and race/ethnicity. RESULTS: Of the 3,166 HIV-infected patients (median age 47 years, CD4⁺ T-cell count 496 cells/mm³, duration of cART use 6.8 years), 21% were female, 57% were non-Hispanic White and over half were current or former tobacco smokers. The five most frequent conditions among women (median age 45 years) were dyslipidaemia (67.3%), hypertension (57.4%), obesity (31.7%), viral hepatitis B or C coinfection (29.0%) and low high-density lipoprotein cholesterol (HDLc; 27.3%). The five most frequent conditions in men (median age 47 years) were dyslipidaemia (81.2%), hypertension (54.4%), low HDLc (41.1%), elevated triglycerides (32.3%) and elevated non-HDLc (26.8%). In multivariable analyses, Hispanic patients had higher prevalence of obesity and diabetes than White patients; Black patients had higher prevalence of obesity and hypertension but lower rates of lipid abnormalities. Of all patients, 73.7% of women and 66.8% of men had polymorbidity, with no evidence of disparities by race/ethnicity. CONCLUSIONS: Among contemporary cART-treated HIV-infected adults, chronic conditions and polymorbidity were common, underscoring the importance of chronic disease prevention and management among ageing HIV-infected patients.

Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination.

BACKGROUND: Adverse events occurring after vaccination are routinely reported to the Vaccine Adverse Event Reporting System (VAERS). We studied serious adverse events (SAEs) of a neurologic nature reported after receipt of influenza A (H1N1) 2009 monovalent vaccine during the 2009-2010 influenza season. Investigators in the Clinical Immunization Safety Assessment (CISA) network sought to characterize these SAEs and to assess their possible causal relationship to vaccination. METHODS: Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) physicians reviewed all SAE reports (as defined by the Code of Federal Regulations, 21CFR§314.80) after receipt of H1N1 vaccine reported to VAERS between October 1, 2009 and March 31, 2010. Non-fatal SAE reports with neurologic presentation were referred to CISA investigators, who requested and reviewed additional medical records and clinical information as available. CISA investigators assessed the causal relationship between vaccination and the event using modified WHO criteria as defined. RESULTS: 212 VAERS reports of non-fatal serious neurological events were referred for CISA review. Case reports were equally distributed by gender (50.9% female) with an age range of 6 months to 83 years (median 38 years). The most frequent diagnoses reviewed were: Guillain-Barré Syndrome (37.3%), seizures (10.8%), cranial neuropathy (5.7%), and acute disseminated encephalomyelitis (3.8%). Causality assessment resulted in classification of 72 events as "possibly" related (33%), 108 as "unlikely" related (51%), and 20 as "unrelated" (9%) to H1N1 vaccination; none were classified as "probable" or "definite" and 12 were unclassifiable (6%). CONCLUSION: The absence of a specific test to indicate whether a vaccine component contributes to the pathogenesis of an event occurring within a biologically plausible time period makes assessing causality difficult. The development of standardized protocols for providers to use in evaluation of adverse events following immunization, and rapid identification and follow-up of VAERS reports could improve causality assessment.

Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines.

Because of the advent of a new influenza A H1N1 strain, many countries have begun mass immunisation programmes. Awareness of the background rates of possible adverse events will be a crucial part of assessment of possible vaccine safety concerns and will help to separate legitimate safety concerns from events that are temporally associated with but not caused by vaccination. We identified background rates of selected medical events for several countries. Rates of disease events varied by age, sex, method of ascertainment, and geography. Highly visible health conditions, such as Guillain-Barré syndrome, spontaneous abortion, or even death, will occur in coincident temporal association with novel influenza vaccination. On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21.5 cases of Guillain-Barré syndrome and 5.75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86.3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination.