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This study examined health preference utility weights and utility decrements associated with different types of chronic conditions in the United States.We used the 2010-2015 Medical Expenditure Panel Survey data for persons aged ≥ 18 years with 12-Item Short-Form Survey Physical and Mental Component Summary scores. 12-Item Short-Form Survey scores were converted to Short-Form Six-Dimension (SF-6D) preference scores to measure utilities of different chronic diseases. We used the Clinical Classification Code to identify 30 chronic diseases from 12 categories, such as cardiovascular diseases, cerebrovascular diseases, hypertension, hyperlipidemia, obesity, cancers, musculoskeletal diseases, endocrine or metabolic diseases, oral diseases, respiratory diseases, and mental disorders. A generalized linear model was used to quantify the utility decrements for 30 chronic diseases, controlling for demographic characteristics.We identified 132 737 adults (mean age 47.2 years, 52.2% female, 80% white); 73% had at least one identified chronic disease, and the mean SF-6D was 0.786. Among 30 chronic diseases, the unadjusted mean SF-6D scores of patients with cognitive disorder (0.607) were the lowest, followed by congestive heart failure (0.629), rheumatoid arthritis (0.654), and lung cancer (0.662). After controlling for demographic variables (ie, age, sex) and comorbidities, cognitive disorders (-0.116), mood disorders (-0.099), rheumatoid arthritis (-0.090), liver cancer (-0.078), and stroke (-0.063) showed the highest decrements in the SF-6D scores (P.05).This study provides a nationally representative catalog of utility weights for major chronic diseases in the US general population. The utility decrements will enable researchers to calculate the health utilities of patients with multiple comorbid diseases.

To compare the risk of antihypertensive treatment intensification (TI) and major adverse cardiovascular events (MACE) with the initiation of serotonin norepinephrine reuptake inhibitors compared to selective serotonin reuptake inhibitors (SSRIs) in patients with stable hypertension and depression.Retrospective cohort study.IBM MarketScan® commercial claims database and Medicare Supplemental claims database from 2007 to 2019.Patients aged 18 years or older with stable treated hypertension and depression who newly initiate either serotonin norepinephrine reuptake inhibitors or SSRIs.Serotonin norepinephrine reuptake inhibitors versus SSRIs.The primary outcomes were: (1) TI (first occurrence of antihypertensive regimen augmentation or dose escalation); (2) MACE (first occurrence of stroke or acute myocardial infarction). Baseline risk between the two groups was balanced via 1:1 propensity score (PS) matching. A Cox proportional hazard regression model was used to estimate adjusted hazard ratio (aHR) and 95% confidence intervals (95% CI). After 1:1 PS matching, we included 19,160 patients in the study cohort (mean age: 52 years, 62% females) of which 9580 initiated serotonin norepinephrine reuptake inhibitors and 9580 initiated SSRIs. Patients who initiated serotonin norepinephrine reuptake inhibitors had 15 MACE events (incidence rate per 1000 person-years [IR], 3.9) and 1675 TI events (IR, 540.2), compared with 17 MACE events (IR, 4.0) and 1774 TI events (IR, 518.5) in the SSRI group. The risk of TI (aHR: 1.01, [95% CI: 0.94, 1.08]) and MACE (aHR: 0.98, [95% CI: 0.49, 1.96]) did not differ among patients initiated serotonin norepinephrine reuptake inhibitors versus SSRIs.Among patients with stable hypertension and depression, initiation of serotonin norepinephrine reuptake inhibitors had a similar risk of antihypertensive TI and MACE compared to initiation of SSRIs. Future study with a larger sample size is needed to confirm our findings.

One-third of opioid (OPI) overdose deaths involve concurrent benzodiazepine (BZD) use. Little is known about concurrent opioid and benzodiazepine use (OPI-BZD) most associated with overdose risk. We aimed to examine associations between OPI-BZD dose and duration trajectories, and subsequent OPI or BZD overdose in US Medicare.Retrospective cohort study.US Medicare.Using a 5% national Medicare data sample (2013-16) of fee-for-service beneficiaries without cancer initiating OPI prescriptions, we identified 37 879 beneficiaries (age ≥ 65 = 59.3%, female = 71.9%, white = 87.6%, having OPI overdose = 0.3%).During the 6 months following OPI initiation (i.e. trajectory period), we identified OPI-BZD dose and duration patterns using group-based multi-trajectory models, based on average daily morphine milligram equivalents (MME) for OPIs and diazepam milligram equivalents (DME) for BZDs. To label dose levels in each trajectory, we defined OPI use as very low ( 25 MME), low (25-50 MME), moderate (51-90 MME), high (91-150 MME) and very high (150 MME) dose. Similarly, we defined BZD use as very low ( 10 DME), low (10-20 DME), moderate (21-40 DME), high (41-60 DME) and very high ( 60 DME) dose. Our primary analysis was to estimate the risk of time to first hospital or emergency department visit for OPI overdose within 6 months following the trajectory period using inverse probability of treatment-weighted Cox proportional hazards models.We identified nine distinct OPI-BZD trajectories: group A: very low OPI (early discontinuation)-very low declining BZD (n = 10 598; 28.0% of the cohort); B: very low OPI (early discontinuation)-very low stable BZD (n = 4923; 13.0%); C: very low OPI (early discontinuation)-medium BZD (n = 4997; 13.2%); D: low OPI-low BZD (n = 5083; 13.4%); E: low OPI-high BZD (n = 3906; 10.3%); F: medium OPI-low BZD (n = 3948; 10.4%); G: very high OPI-high BZD (n = 1371; 3.6%); H: very high OPI-very high BZD (n = 957; 2.5%); and I: very high OPI-low BZD (n = 2096; 5.5%). Compared with group A, five trajectories (32.3% of the study cohort) were associated with increased 6-month OPI overdose risks: E: low OPI-high BZD [hazard ratio (HR) = 3.27, 95% confidence interval (CI) = 1.61-6.63]; F: medium OPI-low BZD (HR = 4.04, 95% CI = 2.06-7.95); G: very high OPI-high BZD (HR = 6.98, 95% CI = 3.11-15.64); H: very high OPI-very high BZD (HR = 4.41, 95% CI = 1.51-12.85); and I: very high OPI-low BZD (HR = 6.50, 95% CI = 3.15-13.42).Patterns of concurrent opioid and benzodiazepine use most associated with overdose risk among fee-for-service US Medicare beneficiaries initiating opioid prescriptions include very high-dose opioid use (MME 150), high-dose benzodiazepine use (DME 40) or medium-dose opioid with low-dose benzodiazepine use.

BACKGROUND: Patients with substance use disorders (SUD) and chronic hepatitis C virus infection (HCV) have limited access to direct-acting antivirals (DAAs) due to multilevel issues related to providers (eg, concern about reinfection); patients (eg, refusal); payers (eg, prior authorization); and health system structure, although clinical guidelines recommend timely DAA treatment for patients with SUD and HCV. Effects of DAAs on real-world health care utilization and costs among these patients is unknown. OBJECTIVE: To compare changes in medical service utilization and costs related to liver, SUD, and all-cause morbidity in patients with SUD and HCV treated with DAAs (DAA group) vs not treated with DAAs (non-DAA group). METHODS: We conducted a retrospective cohort study using MarketScan Commercial and Medicare Supplemental Claims databases (2012-2018) for newly diagnosed HCV treatment-naive adults with SUD. We used difference-in-differences analyses, stratified by cirrhosis status, to determine the adjusted ratio of rate ratio (RoRR) to assess the difference in the relative changes from the pre- to posttreatment periods between the 2 groups. RESULTS: 6,266 patients with SUD and HCV were identified. Of these patients who also had cirrhosis (n = 607), 49% (n = 298) initiated DAA therapy for HCV, whereas of those without cirrhosis (n = 5,659), 22% (n = 1,219) initiated DAAs. For patients with cirrhosis (n = 607), the liver-related costs decreased by $6,213 (95% CI = -$8,571, -$3,856) for the DAA group and $1,585 (95% CI = -$4,659, $1,490) for the non-DAA group. The relative decreases in the rate of liver-related costs were larger for the DAA group than for the non-DAA group, and the relative changes between groups were significantly different (RoRR = 0.37, 95% CI = 0.19-0.73). There was no difference in the relative changes after DAAs in the rate of SUD-related visits/costs or all-cause costs between the 2 groups. For patients without cirrhosis (n = 5,659), a similar association was observed. Besides, the relative decreases in the rate of SUD-related emergency department (ED) visits (RoRR = 0.54, 95% CI = 0.38-0.77); SUD-related long-term care visits (RoRR = 0.30, 95% CI = 0.13-0.73); all-cause ED visits (RoRR = 0.75, 95% CI = 0.64-0.88); and all-cause long term-care visits (RoRR = 0.36, 95% CI = 0.18-0.72) were larger in the DAA group than in the non-DAA group. CONCLUSIONS: DAAs are associated with a significant decrease in the rate of SUD-related ED visits and liver-related costs without increasing the rate of all-cause costs among patients with SUD and HCV, suggesting that the benefits of DAAs extended beyond liver-related outcomes, especially in this disadvantaged population. DISCLOSURES: Research reported in this publication was supported in part by the National Institute on Drug Abuse of the National Institutes of Health (K01DA045618). The funder did not have a role in the design, the execution, the analyses, the interpretation of the data, or the decision to submit the results of this study. The authors have no potential conflicts of interest.

BACKGROUND AND AIMS Our aim was to evaluate the impact of direct-acting antivirals (DAAs) on decompensated cirrhosis (DCC) and HCC in patients with chronic HCV and substance use disorder (SUD) compared with those without an SUD. APPROACH AND RESULTS This retrospective cohort study used the MarketScan database (2013-2018) to identify 29,228 patients with chronic HCV, where 22% (n = 6,385) had ≥1 SUD diagnosis. The inverse probability of treatment weighted multivariable Cox proportional hazard models were used to compare the risk of developing DCC and HCC. Among the those who were noncirrhotic, treatment reduced the DCC risk among SUD (adjusted hazard ratio [aHR] 0.13; 95% CI, 0.06-0.30) and non-SUD (aHR 0.11; 95% CI, 0.07-0.18), whereas the risk for HCC was not reduced for the SUD group (aHR 0.91; 95% CI, 0.33-2.48). For those with cirrhosis, compared with patients who were untreated, treatment reduced the HCC risk among SUD (aHR, 0.33; 95% CI, 0.13-0.88) and non-SUD (aHR, 0.40; 95% CI, 0.25-0.65), whereas the risk for DCC was not reduced for the SUD group (aHR, 0.64; 95% CI, 0.37-1.13). Among patients with cirrhosis who were untreated, the SUD group had a higher risk of DCC (aHR, 1.52; 95% CI, 1.03-2.24) and HCC (aHR, 1.69; 95% CI, 1.05-2.72) compared with non-SUD group. CONCLUSIONS Among the HCV SUD group, DAA treatment reduced the risk of DCC but not HCC for those who were noncirrhotic, whereas DAA treatment reduced the risk of HCC but not DCC for those with cirrhosis. Among the nontreated, patients with an SUD had a significantly higher risk of DCC and HCC compared with those without an SUD. Thus, DAA treatment should be considered for all patients with HCV and an SUD while also addressing the SUD.

BACKGROUND: Limited evidence exists regarding long-term effectiveness and safety of aldosterone antagonists (AAs) versus beta blockers (BBs) as fourth-line antihypertensive agents in patients with resistant hypertension (RH). We evaluated the comparative effectiveness and safety of aldosterone AA versus BB. METHODS: We conducted a real-world retrospective cohort study using IBM MarketScan commercial claims and Medicare Supplemental claims (2007–2019). Patients with RH entered the cohort (ie, index date) when they newly initiated either AA or BB. The effectiveness outcome was major adverse cardiovascular events. Safety outcomes were hyperkalemia, gynecomastia, and kidney function deterioration. Potential confounding was addressed by adjustment for baseline characteristics via stabilized inverse probability of treatment weighting (SIPTW) based on propensity scores. Cox proportional hazards regression with SIPTWs were used to estimate adjusted hazard ratio (aHR) and 95% CI comparing risk for outcomes between AA and BB groups. RESULTS: We identified 80 598 patients with RH (mean age: 61 years, 51% males), of which 6626 initiated AA and 73 972 initiated BB as the fourth antihypertensive agent. Among patients with RH, initiation of AA as a fourth-line antihypertensive agent did not significantly reduce major adverse cardiovascular event risk relative to BB initiation (aHR, 0.77 [95% CI, 0.50–1.19]) but did substantially increase the risk of hyperkalemia (aHR, 3.86 [95% CI, 2.78–5.34]), gynecomastia (aHR, 9.51 [95% CI, 5.69–15.89]), and kidney function deterioration (aHR, 1.63 [95% CI, 1.34–1.99]). CONCLUSIONS: Long-term clinical trials powered to assess major adverse cardiovascular events are necessary to understand the risk-benefit trade-off of AA as fourth-line therapy for RH.

Medicaid prior authorization (PA) policies for treatment of hepatitis C virus (HCV) with direct‐acting antiviral (DAA) therapy are changing. We aimed to evaluate effects of changes in PA requirements on treatment uptake and to determine the factors associated with DAA treatment among Florida Medicaid beneficiaries with HCV. This is a retrospective cohort analysis of Florida’s Medicaid administrative claims and electronic medical records (2013‐2018). A total of 14,063 newly diagnosed patients with HCV were grouped based on human immunodeficiency virus (HIV) co‐infection and/or a substance use disorder (SUD) (7,735 HCV mono‐infected with a SUD, 5,180 HCV mono‐infected without a SUD, 564 HCV/HIV co‐infected with a SUD, and 584 HCV/HIV co‐infected without a SUD). Although the treatment rate increased three‐fold after June 1, 2016, when a fibrosis‐stage restriction was eliminated, only 8% received DAAs. Compared to HCV mono‐infected without a SUD, HCV mono‐infected with a SUD and HCV/HIV co‐infected with a SUD were 47% (adjusted hazard ratio, 0.53; 95% confidence interval, 0.47‐0.60) and 59% (adjusted hazard ratio, 0.41; 95% confidence interval, 0.28‐0.61) less likely to initiate DAAs. Those with HCV/HIV/SUD did not experience a DAA initiation increase after a fibrosis‐stage restriction was eliminated. Compared with Whites, Blacks were less likely to receive DAAs but were more likely to complete treatment. Use of medication‐assisted therapy was low, despite those on medication‐assisted therapy being 60% more likely to initiate DAA therapy and no more likely to discontinue therapy. Conclusion: Despite changes in Florida’s Medicaid PA requirements for DAA treatment, only 8% received treatment. Disparities in treatment access were found among patients with HIV and a SUD, and who were Black., In our retrospective cohort study analysis using Florida Medicaid claims data (2013‐2018), we examined the effects of prior authorization policy on access to direct‐acting antiviral (DAA) treatment and identified factors associated with disparities among Florida Medicaid patients with hepatitis C virus (HCV). Our work shows that the number of Florida Medicaid patients treated for HCV has increased, but treatment rates are still very low (8%); compared to HCV mono‐infected patients without substance use disorders (SUD), HCV mono‐infected patients with SUD and HCV/HIV patients co‐infected with SUD were 47% and 59% less likely to initiate DAAs, but no difference was observed in HCV/HIV patients co‐infected without SUD. Disparities in access to treatment continue among patients with SUD, blacks, and pregnant women among Medicaid patients with HCV.

Background Clinical guidelines increasingly recommended ambulatory blood pressure monitoring (ABPM) for hypertension diagnosis and management. Yet, ABPM is used infrequently in the United States, possibly because of low insurance coverage and high patient costs. We sought to analyze out-of-pocket payments (OPPs) for ABPM among privately insured patients. Methods We conducted a retrospective analysis using IBM® MarketScan® commercial claims of beneficiaries aged ≥18 years receiving ABPM from January 2012 to December 2018. The date of first ABPM claim (Healthcare Common Procedure Coding System codes 93784, 93786, 93788, or 93790) was considered the index date. Patients with 12 months of continuous enrollment preindex and 30-day postindex were included. Per beneficiary OPP was calculated by aggregating all ABPM-related OPPs within the 30-day postindex window (ABPM episode). Results Of 22,317 beneficiaries receiving ABPM, 62% had $0 OPP and 38% had OPP >$0. Among the latter, median OPP per beneficiary for an ABPM episode was $23 (interquartile range [IQR], $14, $32), driven primarily by full ABPM claims (median, $22; IQR, $14, $24). Among individual components, scan analysis and report claims (median, $25; IQR, $13, $49) had the greatest OPP. The median OPP per ABPM episode did not change substantively from 2012 through 2018. Conclusions Among commercially insured in the United States, nearly 4-in-10 have an OPP for ABPM. Though most OPPs are relatively modest, some patients incur substantial OPP. Our findings highlight the need for policymakers to ensure adequate ABPM coverage in the commercial insurance marketplace.

Purpose Compared with conventional therapy (enoxaparin followed by warfarin), the direct-acting oral anticoagulant apixaban is thought to offer similar protection against recurrent venous thromboembolism (VTE) with lower bleeding risk. However, evidence regarding the heterogeneity of treatment effect from real-world data is lacking. The study described here aimed to compare the effectiveness and safety of use of apixaban versus warfarin in patients with VTE. Methods We conducted a retrospective cohort analysis of commercial and Medicare supplemental databases (data coverage period, 2014-2017) among patients with a diagnosis of VTE who were new users of apixaban or warfarin. We controlled for confounding using propensity score [PS] 1:4 matching. Cox proportional hazard models were used to obtain hazard ratios (HRs) and 95% confidence intervals (CIs). Heterogeneity of treatment effect was assessed among patients with provoked VTE versus unprovoked VTE. Results After PS matching, a total of 36,907 patients were included in the cohort (n = 8,094 apixaban users and n = 28,813 warfarin users). In Cox regression models, the use of apixaban versus warfarin was associated with lower risks of recurrent VTE (HR, 0.54; 95% CI, 0.45-0.65) and major bleeding events (HR, 0.67; 95% CI, 0.54-0.84); these results remained consistent in patients with provoked VTE and those with unprovoked VTE. Conclusion This population-based analysis of patients with VTE extends results of randomized clinical trials indicating lower risks of development of recurrent VTE and major bleeding events with use of apixaban versus warfarin in real-world settings. The observed benefits of apixaban extended to selected subgroups of the VTE population, including patients with provoked VTE.

We aimed to develop and validate machine learning algorithms to predict direct-acting antiviral (DAA) treatment failure among patients with hepatitis C virus (HCV) infection. We used HCV-TARGET registry data to identify HCV-infected adults receiving all-oral DAA treatment and having virologic outcome. Potential pre-treatment predictors (n=179) included sociodemographic, clinical characteristics, and virologic data. We applied multivariable logistic regression (MLR) as well as elastic net (EN), random forest (RF), gradient boosting machine (GBM), and feedforward neural network (FNN) machine learning algorithms to predict DAA treatment failure. Training (n=4,894) and validation (n=1,631) patient samples had similar sociodemographic and clinical characteristics (mean age, 57 years; 60% male; 66% White; 36% with cirrhosis). Of 6525 HCV-infected adults, 95.3% achieved sustained virologic response, whereas 4.7% experienced DAA treatment failure. In the validation sample, machine learning approaches performed similarly in predicting DAA treatment failure (C statistic [95% CI]: GBM, 0.69 [0.64–0.74]; RF, 0.68 [0.63–0.73]; FNN, 0.66 [0.60–0.71]; EN, 0.64 [0.59–0.70]), and all four outperformed MLR (0.51 [0.46–0.57]). Using the Youden index to identify the balanced risk score threshold, GBM had 66.2% sensitivity and 65.1% specificity, and 12 individuals were needed to evaluate to identify one DAA treatment failure. Over 55% of patients with treatment failure were classified by the GBM in the top three risk decile subgroups (positive predictive value: 6% to 14%). The top 10 GBM-identified predictors included albumin, liver enzymes (aspartate aminotransferase, alkaline phosphatase), total bilirubin levels, sex, HCV viral loads, sodium level, hepatocellular carcinoma, platelet levels, and tobacco use. CONCLUSIONS: Machine learning algorithms performed effectively for risk prediction and stratification of DAA treatment failure.

Ambulatory blood pressure monitoring (ABPM) is increasingly recommended for confirming hypertension diagnosis and ongoing hypertension monitoring. However, reimbursement in the United States is variable and low compared with other advanced health care systems. We examined the reimbursement of ABPM and factors associated with successful reimbursement. A retrospective analysis of IBM MarketScan® commercial claims database was conducted for patients ≥18 years with ≥1 ABPM claim from January 2012 to December 2016. The date of first the ABPM claim was used as the index date. Per-beneficiary ABPM episode reimbursements were calculated by aggregating all ABPM-related reimbursements within a 30-day post-index window, considered as an ABPM episode. Multivariable logistic regression was used to identify predictors of successful reimbursement. Of 20 875 beneficiaries with ABPM claims, 16 920 (81.0%) were reimbursed. The median reimbursement per beneficiary for an ABPM episode was $89 (Inter Quartile Range [IQR], $62, $132), driven primarily by reimbursement for the full procedure (median, $86; IQR, $66, $110). Comparing benefit plan types, consumer-directed health plans provided the highest median reimbursement ($96; IQR, $61, $175). Successful reimbursement was associated with female patient sex (adjusted OR [aOR], 1.20; 95% CI, 1.11-1.28), having a health maintenance organization (aOR 2.11; 95% CI, 1.82-2.43) or point of service (aOR 2.08; 95% CI, 1.74-2.49) as benefit plan types, claim filing by a specialist (aOR 1.26; 95% CI, 1.14-1.40) and services provided at an outpatient hospital (aOR 1.17; 95% CI, 1.01-1.35). Among commercially insured Americans, our data suggest significant variability in successful reimbursement. Accordingly, more uniform criteria for ABPM reimbursement may facilitate greater use of guideline-recommended monitoring.

Liver cirrhosis is a substantial health burden in the USA, but population-based data regarding the trend and medical expenditure are limited and outdated. We investigated the trends of inpatient admissions, costs, and inpatient mortality from 2005 to 2015 among cirrhotic patients. A retrospective analysis was conducted using the National Inpatient Sample database. We adjusted the costs to 2015 US dollars using a 3% inflation rate. National estimates of admissions were determined using discharge weights. We identified 1,627,348 admissions in cirrhotic patients between 2005 and 2015. From 2005 to 2015, the number of weighted admissions in cirrhotic patients almost doubled (from 505,032 to 961,650) and the total annual hospitalization cost in this population increased three times (from 5.8 to 16.3 billion US dollars). Notably, admission rates varied by liver disease etiology, decreasing from 2005 to 2015 among patients with hepatitis C virus (HCV)-related cirrhosis while increasing (almost tripled) among patients with nonalcoholic fatty liver disease (NAFLD)-related cirrhosis. The annual inpatient mortality rate per 1000 admissions overall decreased from 63.8 to 58.2 between 2005 and 2015 except for NAFLD (27.2 to 35.8) (P

Purpose Few studies have reported an association between proton pump inhibitor (PPI) use and tuberculosis. Tuberculosis incidence is relatively high in Asian people, and an increase in PPI prescriptions has been reported in South Korea. Thus, we investigated the association between PPI use and tuberculosis development. Methods We conducted a case-control study on 25 672 newly diagnosed tuberculosis patients using the National Health Insurance Service-National Sample Cohort (NHIS-NSC) database (2002-2013). We selected a control group without tuberculosis using 1:1 exact matching based on age, sex, index year, insurance type, and income level. We investigated PPI exposure 2 years prior to the index date and classified the subjects into nonuser, continuous user, recent user, and former user groups. Odds ratios (ORs) and 95% confidence intervals (CIs) for tuberculosis development were calculated using conditional logistic regression. Results A total of 51 344 cases and controls were analyzed. Recent PPI use (adjusted odds ratio [aOR], 1.28; 95% CI, 1.18-1.39) and continuous PPI use (aOR, 1.13; 95% CI 1.10-1.28) were significantly associated with tuberculosis development, compared with nonuse of PPIs. An increased tuberculosis incidence was not observed in the former use group compared with the nonuse group (aOR 1.05, 95% CI 0.95-1.17). Conclusions In this case-control study, we found that recent PPI use and continuous PPI use were associated with increased tuberculosis development. Although further investigation is needed, the tuberculosis risk accompanying PPI treatment should be considered.

Approved treatment for hepatitis C virus (HCV) with all-oral direct-acting antivirals (DAA) therapy is now entering into its fourth year; however, little has been reported on the real-world clinical (decompensated cirrhosis [DCC] and hepatocellular carcinoma [HCC]) and economic outcomes. A retrospective cohort analysis of the Truven Health MarketScan Database (2012-2016) was conducted. In a cohort of 26,105 patients with newly diagnosed HCV, 30% received all-oral DAA therapy (DAA group) and 70% were not treated (untreated group). Multivariate Cox proportional hazards models were used to compare the risk of developing HCC and DCC, stratified by cirrhosis status. Among patients with cirrhosis (n = 2157), DAA therapy was associated with a 72% and a 62% lower incidence of HCC (hazard ratio [HR], 0.28; 95% confidence interval [CI], 0.15-0.52) and DCC (HR, 0.38; 95% CI, 0.26-0.56). Similarly, DAA therapy was associated with a 57% and a 58% lower incidence of HCC (HR, 0.43; 95% CI, 0.26-0.71) and DCC (HR, 0.42; 95% CI, 0.30-0.58) in patients with noncirrhotic HCV (n = 23,948). A propensity score-matched cohort of 8064 HCV-infected patients who had at least a 12-month follow-up after HCV treatment was included for economic analysis. For patients with cirrhosis in the DAA group, the mean adjusted liver-related costs ($1749 vs. $4575; P < 0.001) and all-cause medical costs ($19,300 vs. $33,039; P < 0.001) were significantly lower compared with those in the untreated group. The mean adjusted costs were not statistically different between the two groups among patients without cirrhosis. Conclusion: In the short term, all-oral DAA treatment for HCV infection was associated with a decreased risk of developing HCC and DCC, resulting in decreased health care costs, especially in patients with cirrhosis. A longitudinal study is necessary to confirm our findings.

Introduction Hepatitis C virus testing is recommended for people at high risk for infection, including those with substance use disorders. Little is known about the cascade of hepatitis C virus care (including testing, diagnosis, and treatments) among patients with substance use disorders in real-world clinical practice. This study aims to characterize the hepatitis C virus cascade of care and identify the factors associated with hepatitis C virus testing and diagnosis among Florida Medicaid beneficiaries with substance use disorders. Methods A retrospective cohort analysis of Florida Medicaid data (2013–2018) was conducted in 2020 for patients aged 18–64 years with newly diagnosed substance use disorders (year 2012 was used to ascertain 1-year previous enrollment). A generalized estimating equation identified the factors associated with hepatitis C virus testing; a multivariable logistic model identified the factors associated with hepatitis C virus diagnosis. Results Of the 156,770 patients with substance use disorders, 18% were tested for hepatitis C virus at least once. Among the tested patients, 8% had hepatitis C virus diagnoses. Among the 2,177 patients having a hepatitis C virus diagnosis, 11% initiated hepatitis C virus treatments, and 96% of them completed the hepatitis C virus treatments. Factors associated with being less likely to receive hepatitis C virus testing included being male (AOR=0.73, 95% CI=0.71, 0.75) and White (AOR=0.85, 95% CI=0.83, 0.87), whereas individuals who were male (AOR=1.49, 95% CI=1.35, 1.66) and White (AOR=2.71, 95% CI=2.38, 3.08) were more likely to be diagnosed with hepatitis C virus. The odds of receiving hepatitis C virus testing significantly increased annually (AOR=1.06, 95% CI=1.05, 1.07). Conclusions Future studies are warranted to investigate the barriers to access hepatitis C virus testing and treatment among Florida Medicaid beneficiaries with substance use disorders, especially for White male individuals.

Regular monitoring/surveillance for liver complications is crucial to reduce morbidity and mortality in patients with cirrhosis. Recommendations from professional societies are available but adherence is not well studied, especially outside of academic centers. We aimed to determine the frequencies and factors associated with laboratory monitoring, and hepatocellular carcinoma (HCC) and esophageal varices (EV) surveillance in patients with cirrhosis.We identified 82,427 patients with cirrhosis (43,280 compensated and 39,147 decompensated) from the Truven Health MarketScan Research Database®, 2007-2016. We calculated the proportion of patients with cirrhosis with various frequencies of procedures/testing: laboratory (complete blood count, comprehensive metabolic panel, and prothrombin time), HCC and EV surveillance. We also used multivariable logistic regression to determine factors associated with having procedures.The proportions of patients undergoing HCC surveillance (8.78%), laboratory testing (29.72%) at least every 6-12 months, or EV surveillance (10.6%) at least every 1-2 years were suboptimal. The majority did not have HCC (45.4%) or EV (80.3%) surveillance during the entire study period. On multivariable regression, age 41-55 (vs.41) years, preferred provider organization (vs. health maintenance organization) insurance plan, specialist care (vs. primary care and other specialties), diagnosis between 2013-2016 (vs. 2007-2009), decompensated (vs. compensated) cirrhosis, non-alcoholic fatty liver disease (vs. viral hepatitis), and higher Charlson comorbidity index were associated with significantly higher odds of undergoing procedures/testing every 6-12 months and EV surveillance every 1-2 years.Despite modest improvements in more recent years, routine monitoring and surveillance for patients with cirrhosis is suboptimal. Further efforts including provider awareness, patient education, and system/incentive-based quality improvement measures are urgently needed.Patients with cirrhosis should undergo health monitoring for liver complications to achieve early detection and treatment. In a large nationwide cohort of 82,427 patients with cirrhosis in the United States, we found a low rate of adherence (well less than half) to routine blood test monitoring and surveillance for liver cancer and esophageal varices (swollen blood vessels in the abdomen that could lead to fatal bleeding). Adherence has increased in the recent years, but much more improvement is needed.

Since the 1990s, the number of bariatric surgeries has dramatically increased, including the number of bariatric centers in the United States; no recent studies have yet assessed trends of bariatric surgery. This study aims to assess the trends of bariatric surgery and the change in utilization by the type of surgery, from 2006 to 2015, using real-world data.A cross-sectional analysis of MarketScan databases of privately insured beneficiaries aged equal to or more than 18 years, to assess the annual incidence rate of bariatric surgery type of surgery from 2006 to 2015. Linear regression analysis was used to assess the significance of bariatric surgery changes over time.A gradual increase in overall bariatric surgery was observed from 43.5 per 100,000 in 2006 to 70.6 per 100,000 in 2009. This increasing trend plateaued from 2010 to 2015. Among all bariatric surgeries performed, the sleeve gastrectomy showed a significant increase from (n = 596) 11% in 2006 to (n = 15,425) 70% in 2015 (P.001), whereas there was a decrease in Roux-en-Y from (n = 10,129) 45% in 2010 to (n = 5074) 24% in 2015 (P.001).Utilization of bariatric surgery showed a gradual increase in the first 5 years, with steady rates in the last 5 years of the study period. Sleeve gastrectomy and Roux-en-Y remain the most performed bariatric procedures. Laparoscopic surgery continues to dominate bariatric surgery compared with open surgery.

While renal risk associated with short-term use of non-steroidal anti-inflammatory drugs (NSAID) has been anecdotally documented, no conclusive evidence is available on the renal safety, especially among hospitalized patients with reduced renal function. This study is to evaluate the risk of acute kidney injury (AKI) associated with NSAID use in hospital. A retrospective matched cohort study utilizing electronic health records from two large academic tertiary-care hospitals was conducted. We defined AKI based on changes in SCr according to published AKI criteria. The hospital acquired AKI risk associated with inpatient NSAID use was assessed using a time-dependent Cox proportional hazard regression in pooled cohort as well as two sub cohorts stratified by baseline renal function. A total of 18,794 admissions were included in the final cohort. Of 9397 admissions exposed to NSAIDs, 7914 and 1483 admissions were in the “without” and “with baseline renal impairment” cohort, with the same number of matching non-exposed admissions in each of the stratified cohort. The AKI incidences were 6 and 22 events per 1000 patient-days in “without” and “with preexisting renal impairment” cohort, respectively. The adjusted analyses suggested that NSAID use increased AKI risk in patients with preexisting renal impairment (hazard ratio [HR]: 1.38 [1.04–1.83]) but not in the patients without preexisting renal impairment (HR: 0.83 [95% CIs: 0.63–1.08]) or in the pooled cohort (HR: 1.01 [95% CIs: 0.83–1.24]). Our findings suggested that NSAID use is associated with an increased risk of AKI in the hospitalized patients with preexisting renal impairment but the association is not statistically significant in those who have preserved renal function. Further randomized controlled trials are needed to validate these observational findings.

This systematic review and meta-analysis evaluates the immune checkpoint inhibitor regimens used along with the incidence of adverse events reported in randomized clinical trials for treatment of advanced melanoma., Key Points Question Does the risk of immune-related adverse events differ across immune checkpoint inhibitors used by patients with advanced melanoma? Findings In this systematic review and network meta-analysis of randomized clinical trials of advanced melanoma treatment, the risk of immune-related adverse events varied by the immune checkpoint inhibitors used and by the different doses of these same immune checkpoint inhibitors. Pembrolizumab, 2 mg/kg, every 3 weeks and 10 mg/kg every 3 weeks as well as nivolumab, 3 mg/kg, every 2 weeks were the 3 immune checkpoint inhibitor regimens associated with the lowest risk of any or severe immune-related adverse events. Meaning Results of this study suggest that network analysis comparing different treatment regimens for advanced melanoma may be valuable for clinical decision-making in the absence of evidence from randomized clinical trials with head-to-head comparisons., Importance Since 2011, immune checkpoint inhibitors (ICIs) have been effective treatment options for advanced melanoma. Little is known about how risks of immune-related adverse events (irAEs) vary by ICIs. Objective To compare the risk of irAEs across different treatment regimens for advanced melanoma using network meta-analysis. Data Sources PubMed/MEDLINE, Embase, Web of Science, and Scopus were searched for all randomized clinical trial (RCT) articles published from January 1, 2010, through June 30, 2019. Study Selection Studies included phases 2 and 3 RCTs in the treatment of advanced melanoma that compared ICIs (ipilimumab, nivolumab, and pembrolizumab) with chemotherapy drugs (eg, dacarbazine, carboplatin, and paclitaxel) or different ICI regimens. Data Extraction and Synthesis Different treatment regimens were compared using bayesian network meta-analysis with Markov chain Monte Carlo simulation with noninformative prior distribution and random-effects generalized linear models. Main Outcomes and Measures Primary outcomes were the cumulative incidence of any irAEs (regardless of severity) and severe irAEs (grades 3-5). Based on the pooled odds ratios (ORs) and 95% credible intervals (95% CrI), the probability of being associated with the lowest irAE risks was estimated for each treatment regimen. Results Nine RCTs with 8 different treatment regimens for advanced melanoma and involving a total of 5051 patients were included. Overall, the 3 ICI treatment regimens associated with the lowest risk of any or severe irAEs were pembrolizumab, 2 mg/kg, every 3 weeks; nivolumab, 3 mg/kg, every 2 weeks; and pembrolizumab, 10 mg/kg, every 3 weeks. Compared with ipilimumab, 10 mg/kg, every 3 weeks, only nivolumab, 3 mg/kg, every 2 weeks, was associated with a decreased risk for any irAEs (OR, 0.34; 95% CrI, 0.13-0.94). A decreased risk for severe irAEs was observed for ipilimumab, 3 mg/kg, every 3 weeks (OR, 0.35; 95% CrI, 0.14-0.74); pembrolizumab, 10 mg/kg, every 2 weeks (OR, 0.22; 95% CrI, 0.05-0.95) and 10 mg/kg every 3 weeks (OR, 0.20; 95% CrI, 0.06-0.68); and nivolumab, 3 mg/kg, every 2 weeks (OR, 0.20; 95% CrI, 0.07-0.48) compared with ipilimumab, 10 mg/kg, every 3 weeks. An increased risk for severe irAEs was associated with nivolumab, 1 mg/kg, every 3 weeks combined with ipilimumab, 3 mg/kg, every 3 weeks compared with other ICI regimens (ORs ranging from 4.09 [95% CrI, 1.73-10.99] to 7.40 [95% CrI, 1.12-49.29]) except ipilimumab, 10 mg/kg, every 3 weeks. Conclusions and Relevance These findings suggest that for patients with advanced melanoma at high risk of irAEs, pembrolizumab, 2 mg/kg, every 3 weeks, nivolumab, 3 mg/kg, every 2 weeks, and pembrolizumab, 10 mg/kg, every 3 weeks may be the preferred treatment regimens (with respect to irAE risks) among the ICI regimens reported, whereas ipilimumab, 10 mg/kg, every 3 weeks alone and nivolumab, 1 mg/kg, every 3 weeks combined with ipilimumab, 3 mg/kg, every 3 weeks should be used with caution. A network analysis may be valuable for clinical decision-making when evidence from head-to-head comparisons is lacking.

Nonalcoholic fatty liver disease (NAFLD) is the fastest-growing chronic liver disease. However, little is known about NAFLD inpatient resource utilization and clinical outcomes.The aim of this study was to quantify inpatient NAFLD encounters using patient-level data over time.This was a retrospective analysis of de-identified data for NAFLD patients from the California Patient Discharge Database from 2006 to 2013. NAFLD patients were identified by ICD9 codes 571.40, 571.41, 571.49, 571.8, and 571.9.NAFLD patients (n = 91,558) were predominantly female (60%), 45-65 years old (44%), and white (53%). Inpatient encounters increased from 8153 in 2006 to 16,457 in 2013 and were associated with a 207% increase in charges ($686 million in 2006 to $1.42 billion in 2013) and average increase in charges of 9.8% per year adjusting for inflation. Comorbidities (obesity, diabetes, hyperlipidemia, cardiovascular disease, other cancer, and renal disease) increased significantly over time (all P 0.05). From 2006 to 2011, there were 11,463 deaths (1849 for liver-related hospitalizations) (mean follow-up 4.00 ± 2.13 years). The most significant predictors of death were age 75 (aHR 3.9, P 0.0001), male gender (aHR 1.10, P 0.0001), white race (aHR 1.2, P 0.0001), decompensated cirrhosis (aHR 2.1, P 0.0001), and cancer other than HCC (aHR 3.2, P 0.0001). Within the liver-related hospitalization cohort, mortality predictors were similar, except for Hispanic race (aHR 0.92, P 0.0096) and renal disease (aHR 1.50, P 0.0001).The number of NAFLD inpatient encounters increased significantly from 2006 to 2013, as did the inflation-adjusted inpatient charges. The most significant predictors of death were non-liver cancers (HR 3.11, P 0.0001, CI 3.06-3.16) and age 75 years (HR 3.94, P 0.0001, HR 3.86-4.03).

Objectives To evaluate the risk of new-onset depression in a cohort of US adult patients initiating lipophilic statin therapy compared to hydrophilic statin therapy. Design Retrospective cohort study. Setting Large US commercial claims database Participants 1:1 propensity score matched cohort of lipophilic (atorvastatin, lovastatin and simvastatin) and hydrophilic (pravastatin and rosuvastatin) statin initiators between January 2009 to June 2015. Outcome New onset of depression. Results In a propensity-score matched cohort of 299,298 statin initiators, the crude incidence of depression in the hydrophilic and lipophilic group was 136.6 and 142.8 per 10,000 person-years respectively. Compared to hydrophilic statin use, lipophilic statin use was not associated with a statistically significant increase in the risk of depression, adjusted HR 1.05 (95% CI, 1.00–1.10, p = 0.078) and excess incidence of 6.3 (95% CI, -0.7–13.7) per 10,000 person-years. Findings were consistent across the subgroups of patients with history of psychiatric conditions HR 1.05 (95% CI, 0.94–1.16, p = 0.41), and those initiating statins for primary or secondary prevention, HR 1.03 (95% CI, 0.97–1.10, p = 0.33) and 1.07 (95% CI, 0.99–1.16, p = 0.10) respectively. Within individual lipophilic statins, only simvastatin was associated with a moderate increase in the risk of depression HR 1.09 (95% CI, 1.02–1.16, p = 0.003), followed by lovastatin HR 1.07 (95% CI, 0.93–1.24, p = 0.34) and atorvastatin HR 1.05 (95% CI, 0.97–1.13, p = 0.27). Limitations Findings are generalizable to patients with commercial insurance. Conclusions Lipophilic statin use was not associated with a significant increase in the risk of incident depression.

Aims To determine the association between cardiovascular diseases (CVD) and SGLT2 inhibitors compared to sulfonylureas and dipeptidyl peptidase-4 (DPP4) inhibitors and to examine within-class effects of SGLT2 inhibitors. Methods A retrospective cohort analysis was conducted using Truven Health MarketScan. New users of SGLT2 inhibitors, sulfonylureas or DPP-4 inhibitors were included. Primary outcome was incident CVD, defined as non-fatal myocardial infarction or non-fatal stroke; secondary outcomes were hospitalization because of heart failure and lower extremity amputation. Proportional hazards models, after propensity score matching, were used to obtain hazard ratios (HR) and 95% confidence intervals (CI). Results In fully adjusted models, use of SGLT2 inhibitors was associated with a decreased risk of developing CVD compared with use of sulfonylureas (HR, 0.50; 95% CI, 0.45, 0.55) and DPP-4 inhibitors (HR, 0.57; 95% CI, 0.52, 0.62), respectively. Analyses revealed no evidence of within-class effects: dapagliflozin vs sulfonylureas (HR, 0.55; 95% CI, 0.43, 0.70) or DPP-4 inhibitors (HR, 0.57; 95% CI, 0.46, 0.70); and canagliflozin vs sulfonylureas (HR, 0.61; 95% CI, 0.54, 0.69) or DPP-4 inhibitors (HR, 0.66; 95% CI, 0.54, 0.71). Additionally, SGLT2 inhibitors were associated with lower risk of hospitalization because of heart failure compared to both sulfonylureas and DPP-4 inhibitors, as well as lower risk of lower extremity amputation compared to sulfonylureas. Conclusion Using population-based data, incident use of SGLT-2 inhibitors was associated with a decreased incidence of CVD compared to use of sulfonylureas and DPP-4 inhibitors. These findings were consistent between dapagliflozin and canagliflozin, suggesting that CVD reduction is a class effect for SGLT2 inhibitors. In addition, SGLT2 inhibitors portended lower risk of hospitalization because of heart failure (vs sulfonylureas and DPP-4 inhibitors) and lower risk of lower extremity amputation (vs sulfonylureas).

Key Points Question What were the utilization trends associated with granulocyte colony-stimulating factors for primary prophylaxis of febrile neutropenia (FN) among patients with cancer receiving myelosuppressive chemotherapy from 2014 to 2019? Findings This cross-sectional study of 119 129 chemotherapy courses found that among commercially and federally insured populations, use of granulocyte colony-stimulating factors increased among patients receiving high–FN risk regimens, from 75% to 83% for the commercially insured population and from 75% to 86% for the Medicare population. Meaning This study found that there were increases in the use of granulocyte colony-stimulating factors among patients with high FN risk, but 14% to 17% of patients with high FN risk still did not receive preventive treatment., This cross-sectional study assesses granulocyte colony-stimulating factor utilization trends among US adults with cancer overall and stratified by regimen febrile neutropenia risk level., Importance The introduction of biosimilars and novel delivery devices between 2014 and 2019 may have changed the utilization of granulocyte colony-stimulating factors (G-CSF). Objective To assess utilization trends of G-CSFs for primary prophylaxis of febrile neutropenia (FN) among patients with cancer receiving myelosuppressive chemotherapy with commercial or Medicare insurance. Design, Setting, and Participants This cross-sectional study assessed G-CSF utilization trends overall and stratified by regimen febrile neutropenia risk level. Associations between patient characteristics and G-CSF use were evaluated. Patients with cancer, including breast, lung, colorectal, esophageal and gastric, pancreatic, prostate, ovarian, and non-Hodgkin lymphomas, initiating myelosuppressive chemotherapy courses were included from the 2014 to 2019 commercial insurance and 2014 to 2018 Medicare fee-for-service claims databases. Data were analyzed from March to June 2021. Exposures Year of chemotherapy initiation. Main Outcomes and Measures The main outcomes were use and trends of G-CSFs for primary prophylaxis, from completion to 3 days after in the first chemotherapy cycle. Results In total, 86 731 chemotherapy courses (mean [SD] age, 57.7 [11.5] years; 57 838 [66.7%] women and 28 893 [33.3%] men) were identified from 82 410 patients in the commercial insurance database and 32 398 chemotherapy courses (mean [SD] age, 71.8 [8.3] years; 18 468 [57.0%] women and 13 930 [43.0%] men) were identified from 30 279 patients in the Medicare database. Among the commercially insured population, 39 639 patients (45.7%) received G-CSFs, and 12 562 patients (38.8%) received G-CSFs among Medicare insured patients. Overall G-CSF use increased significantly throughout the study period in both populations, from 45.1% (95% CI, 44.4%-45.7%) of patients in 2014 to 47.5% (95% CI, 46.5%-48.5%) of patients in 2019 (P = .001) in the commercially insured population and from 36.0% (95% CI, 34.2%-38.0%) of patients in 2014 to 39.1% (95% CI, 38.1%-40.1%) of patients in 2018 (P

We assessed the risk of chronic kidney disease (CKD) in chronic hepatitis C virus (HCV)-infected patients and the incidence reduction of CKD after receipt of HCV treatment. We also evaluated the risk of membranoproliferative glomerulonephritis (MPGN) and cryoglobulinemia in chronic HCV patients. A retrospective cohort analysis of the Truven Health MarketScan Database (2008-2015) in the United States was conducted. In a cohort of 56,448 HCV-infected patients and 169,344 propensity score (1:3)-matched non-HCV patients, we examined the association of HCV infection with the incidence of CKD. Of 55,818 HCV patients, 6.6 % (n = 3666), 6.3% (n = 3534), and 8.3% (n = 4628) patients received either interferon-based dual, triple, or all-oral direct acting antiviral agent therapy, respectively, whereas 79% of patients did not receive any HCV treatment. Cox proportional hazards models were used to compare the risk of developing CKD in HCV patients compared with non-HCV patients and treated patients compared with untreated HCV patients. In a multivariate time-varying Cox regression model, HCV-infected patients had a 27% increased risk of CKD compared with non-HCV patients (hazard ratio [HR], 1.27; 95% confidence interval [CI], 1.18-1.37). Among HCV patients, individuals who received the minimally effective HCV treatment for dual, triple, or all-oral therapy had a 30% decreased risk of developing CKD (HR, 0.70; 95% CI, 0.55-0.88). In addition, HCV-infected patients experienced a twofold and a nearly 17-fold higher risk of MPGN (HR, 2.23; 95% CI, 1.84-2.71) and cryoglobulinemia (HR, 16.91; 95% CI, 12.00-23.81) respectively, compared with non-HCV patients. Conclusion: HCV-infected individuals in the United States are at greater risk of developing CKD, MPGN, and cryoglobulinemia. Minimally effective treatment of HCV infection can prevent the development of CKD, although the association was not significant for all-oral therapy. (Hepatology 2018;67:492-504).

BACKGROUND: Despite the high efficacy and safety associated with direct-acting antivirals (DAAs), access to HCV treatment has been frequently restricted because of the high DAA drug costs. OBJECTIVES: To (1) compare HCV treatment initiation rates between HCV monoinfected and HCV/HIV coinfected patients before (pre-DAA period) and after (post-DAA period) all-oral DAAs became available; and to (2) estimate the HCV treatment costs for payers and patients. RESEARCH DESIGN AND METHODS: A retrospective analysis of the MarketScan® Databases (2009–2016) was conducted for newly diagnosed HCV patients. Multivariable logistic regression was used to estimate the odds ratio (OR) of initiating HCV treatments during the pre-DAA and post-DAA periods. Kruskal-Wallis test was used to compare drug costs for dual, triple and all-oral therapies. RESULTS: 15,063 HCV patients (382 [2.5%] HIV coinfected) in the pre-DAA period and 14,896 (429 [2.9%] HIV coinfected) in the post-DAA period were included. HCV/HIV coinfected patients had lower odds of HCV treatment uptake compared to HCV monoinfected patients during the pre-DAA period (OR, 0.59; 95% confidence interval [CI], 0.45–0.78), but no significant difference in odds of HCV treatment uptake was observed during the post-DAA period (OR, 1.08; 95% CI, 0.87–1.33). From 2009–2016, average payers’ treatment costs (dual, $20,820; all-oral DAAs, $99,661; p

Background As the prevalence of nonalcoholic fatty liver disease (NAFLD) escalates, understanding its potential impact on the development of chronic kidney disease (CKD) is needed. Objective To determine the longitudinal association of NAFLD with the development of advanced CKD in the United States. Methods A retrospective cohort analysis of the Truven Health MarketScan Database (2006-2015) was conducted. We used Cox proportional hazards models to compare the risk of developing CKD stages 3-5 in patients with NAFLD versus non-NAFLD, identified by ICD-9 codes, after 1:3 propensity score (PS) matching. Results In a cohort of 262 619 newly diagnosed patients with NAFLD and 769 878 PS (1:3)-matched non-NAFLD patients, we identified 5766 and 8655 new advanced (stage 3-5) CKD cases, respectively. The crude CKD incidence rate was 8.2 and 5.5 per 1000 person-years in NAFLD and non-NAFLD groups, respectively. In multivariable Cox model, patients with NAFLD had a 41% increased risk of developing advanced CKD compared with non-NAFLD patients [adjusted hazard ratio (aHR), 1.41; 95% confidence interval (CI), 1.36-1.46]. In the sensitivity analysis adjusting for time-varying covariates after NAFLD diagnosis, NAFLD persisted as a significant CKD risk factor (aHR, 1.58; 95% CI, 1.52-1.66) and the association remained significant when stratified by age, gender and pre-existing comorbidities. The risk of CKD increased in NAFLD with compensated cirrhosis (aHR, 1.47; 95% CI, 1.36-1.59) and decompensated cirrhosis (aHR, 2.28; 95% CI, 2.12-2.46). Conclusion Nonalcoholic fatty liver disease was independently associated with an increased risk of advanced CKD development suggesting renal function screening and regular monitoring are needed in this population.

STUDY OBJECTIVE To compare the effectiveness and safety of ticagrelor versus prasugrel in preventing recurrent cardiovascular disease (CVD) and major bleeding events in patients with acute coronary syndrome (ACS). DESIGN Retrospective cohort analysis. DATA SOURCE Truven Commercial and Medicare Supplemental claims database (2011-2016). PATIENTS Study consisted of adults with ACS who newly initiated ticagrelor or prasugrel within 7 days of their first ACS diagnosis and had no prior use for at least 12 months; after propensity score matching, 10,073 patients were in each group. METHODS The primary study outcomes, first occurrence of a recurrent nonfatal CVD event (composite of myocardial infarction and stroke) and occurrence of a major bleeding event, were compared between the ticagrelor and prasugrel groups. Secondary outcomes included occurrence of minor bleeding events, defined based on the presence of bleeding events in outpatient claims. Cox proportional hazards models after propensity score matching were used to obtain the hazard ratio (HR) and 95% confidence interval (CI). In the Cox proportional hazards model, the use of ticagrelor was associated with a decreased risk of recurrent nonfatal CVD events (HR 0.80, 95% CI 0.70-0.92) and major bleeding events (HR 0.54, 95% CI 0.41-0.70) compared with prasugrel. Additionally, the use of ticagrelor was associated with a lower risk of minor bleeding events compared with prasugrel (HR 0.71, 95% CI 0.65-0.78). CONCLUSION In this population-based cohort of incident ACS patients, ticagrelor was associated with a reduced rate of recurrent nonfatal CVD events, major and minor bleeding events compared with prasugrel.

The US Preventive Services Task Force recommends use of preexposure prophylaxis (PrEP) for individuals at risk of acquiring HIV 1 The Centers for Disease Control and Prevention estimated that 1 1 million US individuals might benefit from PrEP,2 but only 7% of those used it in 2016 3 Clinicians have been slow to prescribe PrEP, citing concerns regarding its effectiveness outside a clinical trial setting, unintended consequences, and ambiguity surrounding which type of clinician is best suited to prescribe PrEP 4 Using a commercial insurance database, this study examined trends in the number of persons prescribed PrEP, prescriptions for PrEP, and specialty of prescribing clinicians

Background The objective of the study was to examine overall anemia management trends in non-dialysis patients with chronic kidney disease (CKD) from 2006 to 2015, and to evaluate the impact of Trial to Reduced Cardiovascular Events with Ananesp Therapy (TREAT)‘s study results (October 2009) and the US Food and Drug Administration (FDA)’s (June 2011) safety warnings and guidelines on the use of ESA therapy in the current treatment of anemia. Methods A retrospective cohort analysis of anemia management in CKD patients using Truven MarketScan Commercial and Medicare Supplemental databases was conducted. Monthly rates and types of anemia treatment for post-TREAT and post-FDA safety warning periods were compared to pre-TREAT period. Anemia management included ESA, intravenous iron, and blood transfusion. A time-series analysis using Autoregressive Integrated Moving Average (ARIMA) model and a Generalized Estimating Equation (GEE) model were used. Results Between 2006 and 2015, CKD patients were increasingly less likely to be treated with ESAs, more likely to receive intravenous iron supplementation, and blood transfusions. The adjusted probabilities of prescribing ESAs were 31% (odds ratio (OR) = 0.69, 95% confidence interval (CI): 0.67–0.71) and 59% (OR = 0.41, 95% CI: 0.40, 0.42) lower in the post-TREAT and post-FDA warning periods compared to pre-TREAT period. The probability of prescribing intravenous iron was increased in the post-FDA warning period (OR = 1.11, 95% CI: 1.03–1.19) although the increase was not statistically significant in the post-TREAT period (OR = 1.03, 95% CI: 0.94–1.12). The probabilities of prescribing blood transfusion during the post-TREAT and post-FDA warning periods increased by 14% (OR = 1.14, 95% CI: 1.06–1.23) and 31% (OR = 1.31, 95% CI: 1.22–1.39), respectively. Similar trends of prescribing ESAs and iron supplementations were observed in commercially insured CKD patients but the use of blood transfusions did not increase. Conclusions After the 2011 FDA safety warnings, the use of ESA continued to decrease while the use of iron supplementation continued to increase. The use of blood transfusions increased significantly in Medicare patients while it remained stable in commercially insured patients. Results suggest the TREAT publication had effected treatment of anemia prior to the FDA warning but the FDA warning solidified TREAT’s recommendations for anemia treatment for non- dialysis dependent CKD patients. Electronic supplementary material The online version of this article (10.1186/s12882-018-1119-7) contains supplementary material, which is available to authorized users.

Background Incretin-based therapies including dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon like peptide-1 (GLP-1) receptor agonists are novel medications for type 2 diabetes management. Several studies have found cardioprotective effects of incretin-based therapies; however, it remains unclear whether there is any difference in heart failure (HF) risk between the two incretin-based therapies (DPP-4 inhibitors and GLP-1 receptor agonists). We aimed to assess the risk of hospitalization due to HF with the use of DPP-4 inhibitors compared to GLP-1 receptor agonists. Methods Using Truven Health Marketscan data, we conducted a retrospective cohort study of patients with type 2 diabetes, who were newly initiated on DPP-4 inhibitors or GLP-1 agonists. Follow-up continued from drug initiation until the first occurrence of: HF hospitalization (primary outcome), discontinuation of therapy (i.e. no fill for 7 days), switch to the comparator, end of enrollment, or end of study (December 2013). Cox proportional hazards models with propensity-score-matching were used to compare the risk of HF hospitalization between DPP-4 inhibitors and GLP-1 agonists. Results A total of 321,606 propensity score-matched patients were included in the analysis (n = 160,803 for DPP-4 inhibitors; n = 160,803 for GLP-1 agonists). After adjusting for baseline characteristics and disease risk factors, the use of DPP-4 inhibitors was associated with a 14% decreased risk of HF hospitalization compared to GLP-1 agonists use [hazard ratio (HR), 0.86; 95% confidence interval (CI) 0.83, 0.90]. The results were consistent in patients without baseline HF (HR, 0.85; 95% CI 0.82, 0.89), but the association was not statistically significant for patients with baseline HF (HR, 0.90; 95% CI 0.74, 1.07). Conclusion In this retrospective matched cohort of patients with type 2 diabetes, the use of DPP-4 inhibitors was associated with a reduced risk of HF hospitalization compared to GLP-1 agonists. However, the association was not statistically significant in patients who had HF prior to the use of DPP-4 inhibitors. Electronic supplementary material The online version of this article (10.1186/s12933-018-0746-4) contains supplementary material, which is available to authorized users.

Both cirrhosis and acute respiratory illness (ARI) carry substantial disease and financial burden. To compare hospitalized patients with cirrhosis with ARI to cirrhotic patients without ARI, a retrospective cohort study was conducted using the California Office of Statewide Health Planning and Development database. To balance the groups, propensity score matching (PSM) was used. We identified a total of 46,192 cirrhotic patients during the three study periods (14,049, 15,699, and 16,444 patients, respectively). Among patients hospitalized with cirrhosis, the ARI prevalence was higher in older age groups (p p p p = 0.028 to

Background Economic burden of HBV and HCV infection are trending upwards. Aims Compare hepatitis B virus (HBV) and hepatitis C virus (HCV) related hospital admission rates, charges, mortality rates, causes of death in a US population-based study. Methods Retrospective cohort analysis of HBV and HCV patients from the California Office of Statewide Health Planning and Development (2006–2013) database. Results A total of 23,891 HBV and 148,229 HCV patients were identified. Across the 8-year period, the mean increase for all-cause ($1,863 vs $1,388) and liver-related hospitalization charges ($1,175 vs $675) were significantly higher for the HBV cohort compared to the HCV cohort. HBV patients had significantly higher liver-related hospital charges per person per year than HCV patients after controlling for covariates ($123,239 vs $111,837; p = 0.002). Compared to HCV patients, adjusted mortality hazard ratio was slightly lower in HBV patients (relative risk = 0.96; 95% CI 0.94–0.99). The major causes and places of death were different. The three major causes of death for HBV were: other malignant neoplasms (35%), cardiovascular disease/other circulatory disorders (17%), and liver-related disease (15%) whereas for HCV patients were: liver-related disease (22%), other malignant neoplasms (20%), and cardiovascular disease (16%). Regarding the place of death, 53% of HBV patients and 44% of HCV patients died in hospital inpatient, respectively. Conclusions HBV patients incurred higher liver-related hospital charges and higher mean increase for all-cause and liver-related hospitalization charges over the 8-year period compared to HCV patients. HBV patients had slightly lower mortality rate and their major causes and places of death were noticeably different from HCV patients.

High out-of-pocket costs for prescription medications have been associated with poor patient outcomes. A previous study found that the Part D coverage gap was significantly associated with decreases in adherence and persistence for medications frequently used in patients undergoing dialysis. It is not known what effect the decreased use of prescription drugs associated with the coverage gap had on utilization and spending for other medical care. To determine the relationship between the Part D prescription drug cost-sharing structure and health and economic outcomes in Medicare beneficiaries on dialysis.A retrospective analysis using data from the United States Renal Data System (2006-2008) was conducted for Medicare-eligible patients receiving dialysis. Patients were grouped in 1 of 4 cohorts based on low-income subsidy (LIS) receipt and benefit phase in 2007: Cohort 1 (non-LIS and did not reach the coverage gap); Cohort 2 (non-LIS and reached the coverage gap); Cohort 3 (non-LIS and reached catastrophic coverage after the gap); and Cohort 4 (received an LIS, and none of the LIS patients reached the coverage gap). Outcomes included medical care utilization, direct medical costs, and mortality. A total of 11,732 subjects met the inclusion criteria. Patients in Cohorts 1, 2, and 3 had $3,222 lower, $2,457 lower, and $1,182 higher adjusted pharmacy costs (P less than 0.001), but their adjusted hospitalization costs were $1,499 (P = 0.09), $2,287 (P = 0.01), and $2,959 (P = 0.01) higher, respectively, compared with Cohort 4 (LIS). In the propensity score-matched cohorts, patients who reached the coverage gap (Cohort 2) had higher rates of hospitalization (relative risk [RR] = 1.02, 95% CI = 0.94-1.10), outpatient visits (RR = 1.16, 95% CI = 1.08-1.25), and other visits (RR = 1.17, 95% CI = 1.03-1.32) compared with those who had an LIS (Cohort 4). Patients in Cohort 3 had a higher rate of outpatient visits compared with those in Cohort 4 (RR = 1.14, 95% CI = 1.03-1.25). There were no differences in medical care utilization between patients in Cohort 1 and Cohort 4. Compared with patients in Cohort 4 (LIS), patients in Cohort 2 (those who reached the coverage gap) had 9% higher hospitalization costs (RR = 1.09, 95% CI = 1.01-1.18) and 6% higher outpatient costs (RR = 1.06, 95% CI = 0.97-1.17), respectively. During the 1-year follow-up period, patients in Cohort 2 had a 20% (HR = 1.20, 95% CI = 1.05-1.37) and a 22% (HR = 1.22, 95% CI = 1.01-1.47) increased risk of all-cause and cardiovascular-related mortality compared with those in Cohort 4, respectively. Our findings suggest that reaching the Part D coverage gap was associated with unfavorable clinical and economic outcomes in patients undergoing dialysis.

Chronic obstructive pulmonary disease (COPD) is a leading and costly cause of readmissions to the hospital, with one of the highest rates reported in Florida. From 2009 to 2014, strategies such as readmission reduction programs, as well as updated guidelines for COPD management, were instituted to reduce readmission rates for patients with COPD. Thus, the question has been raised whether COPD-related 30-day hospital readmission rates in Florida have decreased and whether COPD-related readmission costs during this period have changed. In addition, we examined trends in length of stay, hospital charges, and in-hospital mortality associated with COPD, as well as identified patient-level risk factors associated with 30-day readmissions.A retrospective analysis of adult patients (≥18 years of age) with COPD was conducted by using the Healthcare Cost and Utilization Project Florida State Inpatient Database, 2009 to 2014. Weighted least squares regression was used to assess trends in the COPD readmission rate on a yearly basis, as well as other outcomes of interest. A multivariable logistic regression was used to identify patient characteristics that were associated with 30-day COPD readmissions.Overall, 268,084 adults were identified as having COPD. Between 2009 and 2014, more than half of patients aged 65-84 years, most were white, 55% were female, and 73% had Medicare. The unadjusted rate for COPD-related 30-day readmissions did not change (8.04% to 7.85%; P = 0.434). However, the mean total charge for 30-day COPD-related readmissions was significantly higher in 2014 ($40,611) compared with that in 2009 ($36,714) (P = 0.011). The overall unadjusted in-hospital mortality of COPD-related hospitalizations significantly decreased from 1.83% in 2009 to 1.34% in 2014 (P0.001). In a multivariable logistic regression model, patients with COPD were 2% less likely to be readmitted to the hospital for each additional year (odds ratio [OR], 0.98 [95% confidence interval (CI), 0.97-0.99]). Factors associated with significantly higher odds of COPD-related readmission were: older age (45 ≤ age ≤ 64 years; OR, 1.91 [95% CI, 1.70-2.14]), being male (OR, 1.14 [95% CI, 1.10-1.17]), and being a Medicaid beneficiary (OR, 1.28 [95% CI, 1.21-1.35]).Although the adjusted odds of COPD readmissions slightly decreased, as did the length of stay and all-cause in-patient mortality, the financial burden increased substantially. Future strategies to further reduce readmissions of patients with COPD and curb financial burden in Florida are needed.

The implementation of Medicare Part D provided insurance coverage for outpatient medications, but when persons reach the "gap," they have very limited or no medication insurance coverage until they reach a second threshold for catastrophic coverage. In addition, some patients have a low-income subsidy (LIS), and their out-of-pocket costs do not reach the threshold for the gap. Little is known about how these Part D types (LIS versus non-LIS) and benefit phases (before the gap, during the gap, after the gap) affect medication adherence and persistence of dialysis patients. To examine medication use, adherence, and persistence for Medicare-eligible dialysis patients by Part D benefit type and benefit phase. A retrospective cohort study using data from the U.S. Renal Data System (USRDS) was conducted for Medicare-eligible dialysis patients. Outcomes included medication use, adherence, and persistence. Patients were categorized into 4 cohorts based on their Part D benefit phase that the beneficiaries reached at the end of the year and LIS receipt in 2007: Cohort 1 = non-LIS and did not reach the coverage gap; Cohort 2 = non-LIS and reached the coverage gap; Cohort 3 = non-LIS and reached catastrophic coverage after the gap; and Cohort 4 = received an LIS and none of the LIS patients reached the coverage gap. Outcomes were measured separately for 5 therapeutic classes of outpatient prescription drugs: antihyperglycemics, antihypertensives, antilipidemics, phosphate binders, and calcimimetics. A total of 11,732 patients met the study inclusion criteria. Patients were distributed among the cohorts as follows: 3,678 (31.3%) patients in Cohort 1 who did not reach the coverage gap; 4,349 (37.1%) patients in Cohort 2 who reached the coverage gap but not catastrophic coverage; 1,310 (11.2%) patients in Cohort 3 who reached catastrophic coverage; and 2,395 (20.4%) patients in Cohort 4 who had an LIS (none of whom reached the gap). Overall, the percentage of patients who were adherent to their medications (≥ 80% medication possession ratio) was low: 39% for antihyperglycemics, 59% for antihypertensives, 54% for antilipidemics, 22% for phosphate binders, and 35% for cinacalcet. There were wide ranges in adherence rates depending on the cohort. For patients on antihyperglycemics, antihypertensives, antilipidemics, phosphate binders, and cinacalcet, the odds ratios for adherence to therapy were 0.76 (95% C I =0.63-0.92), 1.06 (0.94-1.19), 0.80 (0.67-0.95), 0.65 (0.55-0.76), and 0.39 (0.30-0.49), respectively; the hazard ratios for discontinuation of therapy were 1.18 (95% CI 1.06-1.31), 1.01 (0.93-1.10), 1.25 (1.12-1.40), 1.13 (1.05-1.21), and 1.61 (1.75-1.82), respectively, for Cohort 2 patients who reached the coverage gap compared with those in Cohort 4 who received an LIS. In addition, when comparing adherence before and after the benefit gap, patients in Cohort 2 were significantly more likely to be nonadherent to medications for diabetes (relative risk (RR) = 1.71, 95% CI = 1.48-1.99), hypertension (RR = 1.69, 95% CI = 1.54-1.85), hyperlipidemia (RR = 2.01, 95% CI = 1.76-2.29), hyperphosphatemia (RR = 1.74, 95% CI = 1.55-1.95), and hyperparathyroidism (RR = 2.08, 95% CI = 1.66-2.60) after reaching the coverage gap. More than half of Medicare beneficiaries on dialysis reached the Part D coverage gap in 2007. Our findings suggest that the Part D coverage gap was significantly associated with decreases in adherence and persistence for medications frequently used in patients undergoing dialysis. Patients who reached the coverage gap (Cohort 2) often decreased use of or discontinued critical medications after reaching the coverage gap. Compared with patients who had an LIS (Cohort 4), patients in Cohort 2 had significantly lower medication adherence and persistence levels. The negative impact of the Part D coverage gap (high out-of-pocket cost sharing) on medication adherence and persistence for Medicare-eligible dialysis patients has implications for currently proposed Medicare end-stage renal disease bundled reimbursement payment and requires more research.

Measures of correlates of youth smoking should be invariant. We examined the measurement invariance of smoking-related self-efficacy, beliefs, and intention across gender, race (White vs. Black), ethnicity (non-Hispanic vs. Hispanic), and grade level (9th/10th vs. 11th/12th grade) for 2767 high school current smokers. Strong factorial invariance was found in the factors across gender (NNFI:0.959; CFI:0.959; RMSEA:0.085), grade (NNFI:0.962; CFI:0.962; RMSEA: 0.079), race (NNFI: 0.967; CFI: 0.967; RMSEA: 0.074), and ethnicity (NNFI: 0.965; CFI: 0.965; RMSEA: 0.078). Smoking-related self-efficacy, beliefs, and intention measures may be confidently used to understand attitudinal differences across gender, race, ethnicity, and grade level for youth smokers.

Studies of hepatitis C virus (HCV) regimens have documented substantially reduced effectiveness in sustained virologic response (SVR) in the context of real-world clinical practice compared with clinical trials. Real-world and clinical trial SVR and cost-per-SVR data have not been reported for the all-oral, peginterferon-free and ribavirin (RBV)-free ledipasvir/sofosbuvir (LDV/SOF) regimen. Our objective was to compare the rates of SVR achievement and cost per SVR between pooled data from clinical studies of LDV/SOF and from real-world clinical practice.Data were derived from the Hepatitis C Therapeutic Registry and Research Network (HCV-TARGET), a real-world, multicenter, prospective, observational study; and from the TRIO Network, a retrospective database of HCV-treated patients. The 1-year cost per SVR was calculated as the total cost of an SVR ([cost of treatment regimen, adverse events, and monitoring costs] per SVR) during the first year of treatment.After 12 weeks, the SVR rates obtained in real-world studies ranged from 94% to 98%, comparing favorably with the SVRs achieved in the ION-1 and ION-3 trials (94% and 95%-99% with 8 and 12 weeks of RBV-free therapy, respectively). A single SVR, on average, cost $84,989 among patients enrolled in the ION-3 trial, with higher costs ($101,204) among patients with compensated cirrhosis compared with noncirrhotic patients ($81,668). In the pooled TARGET/TRIO population, the average cost of an SVR was $84,770, with costs of $101,380 and $81,368 in patients with compensated cirrhosis and patients without cirrhosis, respectively.Unlike the results obtained with prior HCV regimens, this study suggests that similar SVR rates are achieved with LDV/SOF in clinical trial-based studies and real-world studies. Further, achieving an SVR in real-world clinical practice was not associated with excess costs.

Background & Aims Hepatitis C virus (HCV) infection has hepatic and extrahepatic manifestations with various costs and impairments to health-related quality of life (HRQL). We performed a meta-analysis to determine the prevalence of extrahepatic manifestations in patients with HCV infection, how these impair HRQL, and their costs. Methods We performed systematic reviews of the literature using MEDLINE, CINAHL, and the Cochrane Systematic Review Database, from 1996 through December 2014, to identify studies of the following extrahepatic manifestations of HCV infection: mixed cryoglobulinemia, chronic kidney or end-stage renal disease, type 2 diabetes, B-cell lymphoma, lichen planus, Sjogren's syndrome, porphyria cutanea tarda, rheumatoid-like arthritis, or depression. We performed a separate meta-analysis for each condition to determine prevalence rates of extrahepatic manifestations of HCV infection and their effects on HRQL. We determined the annual costs (inpatient, outpatient, and pharmacy) associated with extrahepatic manifestations of HCV infection. Results In an analysis of data from 102 studies, we found the most common extrahepatic manifestations to be diabetes (in 15% of patients) and depression (in 25% of patients). HRQL data showed that HCV infection had negative effects on overall physical and mental health. Total direct medical costs of extrahepatic manifestations of HCV infection, in 2014 US dollars, were estimated to be $1506 million (range, $922 million–$2208 million in sensitivity analysis). Conclusions In a systematic review and meta-analysis we determined the prevalence, risks, and costs associated with extrahepatic manifestations of HCV infection. These estimates should be added to the liver-related burden of disease to obtain a more accurate assessment of the total burden of chronic HCV infection. Prospective, real-world studies are needed to increase our understanding of the total clinical and economic effects of HCV infection and treatment on patients and society.

Epidemiological studies have reported conflicting results regarding hepatitis C virus (HCV) infection and the risk of chronic kidney disease (CKD). We systematically reviewed the literature to determine the risk of developing CKD in HCV-infected individuals compared to uninfected individuals. MEDLINE and PUBMED were searched to identify observational studies that had reported an association between HCV and CKD or end-stage renal disease (ESRD) through January 2015. Quantitative estimates [hazard ratio (HR) or odds ratio (OR)] and their 95% confidence intervals (CI) were extracted from each study. A random-effects meta-analysis was performed. Fourteen studies evaluating the risk of developing CKD/ESRD in HCV-infected individuals (n = 336,227) compared to uninfected controls (n = 2,665,631) were identified- nine cohort studies and five cross-sectional studies. The summary estimate indicated that individuals with HCV had a 23% greater risk of presenting with CKD compared to uninfected individuals (risk ratio = 1.23; 95% CI: 1.12-1.34). Results were similar by study type, for cohorts (HR = 1.26; 95% CI: 1.12-1.40) and cross-sectional studies (OR = 1.21; 95% CI: 1.09-1.32). Country-stratified analysis demonstrated a significantly increased risk between HCV and CKD in the Taiwanese subgroup (risk ratio = 1.28; 95% CI: 1.12-1.34) and the US subgroup (risk ratio = 1.17; 95% CI: 1.01-1.32). Egger regression revealed no evidence of publication bias. HCV infection is associated with a greater risk of developing and progression of CKD compared to uninfected controls.

This study aimed to assess how pneumonia incidence, health care resource utilization, costs, and hospital length of stay differ by age category in the United States.A retrospective cross-sectional analysis of the Medical Expenditure Panel Survey database was conducted from 2007 to 2011 for patients with pneumonia. Study outcomes were pneumonia incidence, annual health care utilization, and expenditures across 5 age groups. Early trends of outcomes in the period after introduction of the 13-valent pneumococcal conjugate vaccine (PCV13) (2011) were compared with the pre-PCV13 period (2007-2009).Pneumonia incidence rates for the 1790 patients ranged from 9.2 to 33.0 per 1000 patients. Patients5 years old had the highest incidence rate at 33.0 per 1000 patients, followed by patients ≥65 years old (27.2 per 1000 patients) and patients ≥45 to65 years old (14.4 per 1000 patients). The percentages of patients with pneumonia-related hospitalization were 26%, 7%, 15%, 24%, and 46%, respectively (P0.0001). Mean (SD) days in hospital stay were 1.73 (0.08), 0.31 (0.50), 0.58 (0.10), 1.86 (0.29), and 3.05 (0.33), respectively (P0.05), for patients5, ≥5 to18, ≥18 to45, ≥45 to65, and ≥65 years old. Mean total pneumonia-related medical costs in patients aged5 years ($3376; P = 0.009), ≥45 to ≤65 years ($4726; P0.0001), and65 years ($7206; P0.0001) were significantly higher compared with patients ≥5 to18 years old ($1175) after controlling for covariates. Compared with the pre-PCV13 period (2007-2009; n = 1075), a 16% decrease in incidence, a 27% decrease length of stay in hospital, and a 22% decrease in medical costs were observed in the post-PCV13 period (2011; n = 382), although these differences were not statistically significant (P0.05).Pneumonia remains a disease with significant burden in the United States, and clinical and economic outcomes varied widely by age. Hospitalization for pneumonia has a considerable effect on economic burden, particularly for the very young (5 years old), middle-aged (≥45 to65 years old), and elderly (≥65 years old) populations. A trend toward reductions in pneumonia incidence and associated medical costs was observed after the PCV13 was introduced, although these findings were not statistically significant.

To determine the impact of a telephone call reminder program provided by a campus-based medication therapy management call center on medication adherence in Medicare Advantage Part D (MAPD) beneficiaries with hypertension.The reminder call services were offered to eligible MAPD beneficiaries, and they included a live interactive conversation with patients to assess the use of their medications. This study used a quasi-experimental design for comparing the change in medication adherence between the intervention and matched control groups. Adherence, defined by proportion of days covered (PDC), was measured using incurred medication claims 6 months before and after the adherence program was implemented. A difference-in-differences approach with propensity score matching was used.After propensity score matching, paired samples included 563 patients in each of the intervention and control groups. The mean PDC (standard deviation) increased significantly during postintervention period by 17.3% (33.6; P0.001) and 13.8% (32.3; P0.001) for the intervention and the control groups, respectively; the greater difference-in-differences increase of 3.5% (36.3) in the intervention group over the control group was statistically significant (P = 0.022). A generalized estimating equation model adjusting for covariates further confirmed that the reminder call group had a significant increase in pre-post PDC (P = 0.021), as compared with the control group.Antihypertensive medication adherence increased in both reminder call and control groups, but the increase was significantly higher in the intervention group. A telephonic outreach program was effective in improving antihypertensive medication adherence in MAPD beneficiaries.

SummaryBackground An all-oral, pegylated interferon (pegIFN)-free and ribavirin (RBV)-free single-tablet of ledipasvir (LDV) and sofosbuvir (SOF) is now approved for the treatment of patients infected with hepatitis C virus (HCV) genotype 1. Aim To estimate the health economic outcomes for LDV/SOF compared with current treatments in US patients infected with HCV genotype 1. Methods A hybrid decision-tree and Markov state-transition model was developed. For a cohort of 10 000 patients, the model captured outcomes for several pairings of LDV/SOF with comparators, including long-term health outcomes, number need to treat, life-years gained, quality-adjusted life-years (QALYS) gained, incremental cost-effectiveness ratios and costs per sustained virologic response (SVR). Patients with different levels of treatment experience and different cirrhosis stages were included. Results LDV/SOF decreased the number of advanced liver disease cases by 0–93% compared with current regimens or no treatment in treatment-naive patients. In treatment-experienced [pegIFN plus ribavirin (PR) or protease inhibitor (PI) + PR] patients, treatment with LDV/SOF decreased the incidence of advanced liver disease complications in most of the cases analysed, except SOF + SMV. For all patient sub-cohorts, LDV/SOF was associated with the lowest 1-year costs per SVR and, with regard to lifetime incremental costs per QALY gained, was either dominant or the most cost-effective treatment. Overall, treatment initiation at earlier stages of liver fibrosis resulted in improved health economic outcomes. Conclusion LDV/SOF is associated with more favourable short- and long-term health economic outcomes compared with current therapies for patients across all levels of treatment experience and cirrhosis stages.

Purpose. To examine the factorial validity and measurement invariance of scales that measure smoking-related self-efficacy, beliefs, and intention between daily and intermittent adolescent smokers. Design. Cross-sectional survey design. Setting. Selected high schools in eastern Texas. Subjects. Subjects were 2888 high school current smokers; mean age 16.2 years; 53.5% male; 67.4% White, 17.8% Hispanic, 6.2% Black, 8.6% “other.” Daily smokers comprised 37.9% of the sample (i.e., smoked at least one cigarette every day 30 days prior to the survey). Measures. Smoking-related self-efficacy and intention were measured by three items; beliefs were measured by four items. Analysis. Confirmatory factor analyses were conducted to test the invariance of the measures between daily and intermittent smokers. Fit indices included comparative fit index (CFI), nonnormed fix index (NNFI), and root mean square error of approximation (RMSEA). Results. The three-factor measurement model had good fit for daily (CFI = .97, NNFI = .95, RMSEA = .09) and intermittent (CFI = .96, NNFI = .95, RMSEA = .09) smokers. Evidence of strong factorial invariance was found for the factors between the smoking subgroups (CFI = .96, NNFI = .96, RMSEA = .08). Conclusion. These measures may be used to capture and compare scores on self-efficacy to resist smoking, beliefs about benefits of smoking, and intention to smoke between daily and intermittent adolescent smokers.

Objective Texas House Bill 790 resulted in the expansion of the newborn screening panel from 7 disorders to 27 disorders. Implementation of this change began in 2007. The objective of this study was to estimate the incremental cost-effectiveness of the expanded newborn screening program compared with the previous standard screening in Texas. Methods A Markov model (for a hypothetical cohort of Texas births in 2007) was constructed to compare lifetime costs and quality-adjusted life-years (QALYs) between the expanded newborn screening and preexpansion newborn screening. Estimates of costs, probabilities of sequelae, and utilities for disorder categories were obtained from a combination of Texas statistics, the literature, and expert opinion. A baseline discount rate of 3% was used for both costs and QALYs, with a range of 0% to 5%. Analyses were conducted from a payer's perspective, and so only direct medical cost estimates were included. Results The lifetime incremental cost-effectiveness ratio for expanded versus preexpansion screening was about $11,560 per QALY. The results remained robust to both deterministic and probabilistic sensitivity analyses. Conclusions Expanded newborn screening does result in additional expenses to the payer, but it also improves patient outcomes by preventing avoidable morbidity and mortality. The screened population benefits from greater QALYs as compared with the unscreened population. Overall, expanded newborn screening in Texas was estimated to be a cost-effective option as compared with unexpanded newborn screening.

The prevalence of gout has been increasing. Serum uric acid (sUA) levels ≥6 mg/dL have been associated with high morbidity and increased health care utilization.To assess the costs and patterns of health care resource utilization for patients with gout, categorized into 3 cohorts based on sUA levels.We retrospectively analyzed laboratory, pharmacy, and medical service claims data (January 2005 to June 2010) for patients ≥18 years old. Inclusion criteria were at least 2 sUA levels and at least 1 primary gout diagnosis (International Classification of Disease-9th revision code 274.xx), and/or at least 1 prescription for gout-specific medications. Outcomes including costs, health care resource utilization, and medication adherence and persistence were assessed for the 1-year postindex period and summarized for the 3 cohorts based on sUA levels:6 mg/dL, 6 to 8.99 mg/dL, and ≥9 mg/dL. Costs were adjusted based on preindex utilization and baseline characteristics.Three hundred fifty-two patients met the inclusion criteria: cohort 1 (sUA6 mg/dL), n = 38, mean age 59 years; cohort 2 (sUA 6-8.99 mg/dL), n = 231, mean age 61 years; and cohort 3 (sUA ≥9 mg/dL), n = 83, mean age 62 years. Mean adjusted gout-related health care costs were $332, $353, and $663, respectively (P0.05); mean adjusted all-cause health care costs were $11,365, $11,551, and $14,474, respectively, for the 3 cohorts (P0.05). sUA levels were positively associated with the percent of patients who had at least 1 hospitalization and the mean number of hospitalizations and emergency department visits (P0.05). Significantly more patients with sUA6 mg/dL achieved adherence rates of ≥80% and had a longer mean duration of continuous treatment compared with patients with sUA between 6 and 8.99 mg/dL or ≥9.0 mg/dL (P0.05).Patients with high levels of sUA had higher gout-related and all-cause health care costs, more all-cause hospitalizations, and emergency department visits, but they also exhibited poorer adherence and persistence.