Houten, Holly K. Van

Abstract Background: Direct acting antiviral medications (DAA) have become the mainstay for treatment of chronic hepatitis C virus (HCV) infection. However, some studies have suggested an increased risk of HCC development following use of DAAs for HCV compared with use of interferon-based medications (IFN), while other studies, mostly in Veterans Administration population in the United States, did not show an increase in HCC risk after the use of DAA in patients with HCV. To address these conflicting reports, we investigated the association between use of DAA for HCV and subsequent development of HCC in a large, longitudinal data with broad representation of individuals from various ages, ethnicities, and geographic regions across the United States. Methods: A retrospective cohort study was performed using medical and pharmacy claims from the OptumLabs® Data Warehouse. The study included 9,532 incident HCV cases (2010-2016) of ages 18 years or older treated with DAA or IFN and did not have a prior diagnosis of HCC before initiation of the antiviral therapy. The participants were categorized into DAA-only or IFN-only groups. To account for confounding by indication, inverse probability of treatment weighting (IPTW) was performed to ensure balance in sociodemographic and treatment related factors between treatment groups. Cox proportional hazard models were used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) for HCC risk, comparing DAA-only regimen with IFN-only regimen (reference). Results: Median follow-up for the entire study cohort was 1.4 years, with a slightly longer follow-up for individuals in the IFN-only group (1.8 years) than for those in the DAA-only group (1.4 years). One hundred and seventy-one incident HCC cases developed during follow-up, with a higher occurrence of HCC in the DAA-only group (n=155; 11.9 cases per 1,000 person-years) than in the IFN-only group (n=16; 8.3 cases per 1,000 person-years). Compared with IFN-only treatment, use of DAA-only for HCV was not associated with an increase in HCC risk (HR=1.47, 95% CI: 0.89-2.42). Similarly, no association was found between use of DAA-only regimen and HCC risk among individuals with cirrhosis (HR=1.28, 95% CI: 0.71-2.31) or those without cirrhosis (HR =1.80, 95% CI: 0.64-5.03). When stratified by sustained virologic response (SVR), a measure of complete viral clearance, we noted a higher HCC risk associated with DAA-only regimen among individuals with SVR (HR=7.83, 95% CI: 1.54-39.88) and a lower risk for DAA-only regimen among those without SVR (HR=0.12, 95% CI: 0.02-0.95); however, the CIs are substantially wide, reflecting the small numbers in these subgroup analyses. Conclusion: Despite some prior reports of increased risk of HCC development following use of DAA for HCV, this ethnically and geographically diverse study did not find compelling evidence indicating an increased HCC risk associated with use of DAA in patients with HCV when compared with use of IFN. Citation Format: Samuel O. Antwi, Holly K. Van Houten, Lindsey R. Sangaralingham, Tushar Patel. Risk of de novo hepatocellular carcinoma development following use of direct acting antiviral medications for treatment of chronic hepatitis C virus infection [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr LB-150.

Objective The aim of this study was to evaluate national patterns of care for women with overactive bladder (OAB) in an administrative data set and identify potential areas for improvement. Methods We performed an analysis using the OptumLabs Data Warehouse, which contains deidentified administrative claims data from a large national US health insurance plan. The study included women, older than 18 years, with a new OAB diagnosis from January 1, 2007, to June 30, 2017. We excluded those with an underlying neurologic etiology, with interstitial cystitis/painful bladder syndrome, were pregnant, or did not have continuous enrollment for 12 months before and after OAB diagnosis. Trends in management were assessed via the Cochran-Armitage test. Time to discontinuation among medications was compared using t test. Results Of 1.4 million women in the database during the study time frame, 60,246 (4%) were included in the study. Median age was 61 years [interquartile range (IQR), 50–73], and median follow-up was 2.6 years (IQR, 1.6–4.2). Overall, 37% were treated with anticholinergics, 5% with beta-3 agonists, 7% with topical estrogen, and 2% with pelvic floor physical therapy; 26% saw a specialist; and 2% underwent third-line therapy. Median time to cessation of prescription filling was longer for beta-3 agonists versus anticholinergics [median, 4.1 months (IQR, 1–15) vs 3.6 months (IQR, 1–10); P < 0.0001]. Use of third-line therapies significantly increased over the study time frame, from 1.1% to 2.2% ( P < 0.0001). Conclusions Most of the patients do not continue filling prescriptions for OAB medications, and a minority of patients were referred for specialty evaluation. Although third-line therapy use is increasing, it is used in a small proportion of women with OAB. Given these patterns, there may be underutilization of specialist referral and other OAB therapies.

Objectives/HypothesisTo evaluate trends, outcomes, and healthcare utilization following medialization laryngoplasty (ML) with or without arytenoid adduction (AA) over 10 years.Study DesignRetrospective observational study.MethodsUsing OptumLabs Data Warehouse, trends, outcomes, and healthcare utilization from 2006 to 2015 were examined with a focus on discharge type (same day or not). Predictors of postoperative emergency department (ED) use and hospitalization were determined by multivariable logistic regression.ResultsOverall rate of ML was 1.09 per 100 thousand enrollees per year. Of these, 7.8% ML were combined with an AA. Outpatient same‐day discharge represented 62.0% (1,142 of 1,843) of total patients, steadily increasing over the 10‐year period (P < 0.01). There was a 5.9% revision ML rate and 1.0% rate of tracheotomy within 1 day of ML. A total of 5.6% visited an ED, and 5.4% were admitted to a hospital following initial discharge within 30 days. Same‐day discharge was found to be a predictor of hospitalization within 30 days after ML (odds ratio [OR] 1.74, P = 0.0452), along with Elixhauser comorbidity index of 4 + (OR 5.74, P = 0.0001). Pulmonary embolism, pulmonary hypertension, and weight loss were top predictors of ED visit or hospitalization.ConclusionTo our knowledge, this is the first search evaluating national claims data for ML with or without AA. Overall rate of ML is low, and same‐day discharge has become more common over a 10‐year period, with an associated higher 30‐day hospital admission risk. Correct patient selection criteria for disposition status cannot be fully determined based on current data, but a high Elixhauser comorbidity index clearly carries increased risk for hospitalization after initial discharge.Level of Evidence4 Laryngoscope, 129:952–960, 2019

The prevalence of nonalcoholic fatty liver disease (NAFLD) is increasing. The health care burden resulting from the multidisciplinary management of this complex disease is unknown. We assessed the total health care cost and resource utilization associated with a new NAFLD diagnosis, compared with controls with similar comorbidities. We used OptumLabs Data Warehouse, a large national administrative claims database with longitudinal health data of over 100 million individuals enrolled in private and Medicare Advantage health plans. We identified 152,064 adults with a first claim for NAFLD between 2010 and 2014, of which 108,420 were matched 1:1 by age, sex, metabolic comorbidities, length of follow‐up, year of diagnosis, race, geographic region, and insurance type to non‐NAFLD contemporary controls from the OptumLabs Data Warehouse database. Median follow‐up time was 2.6 (range 1‐6.5) years. The final study cohort consisted of 216,840 people with median age 55 (range 18‐86) years, 53% female, 78% white. The total annual cost of care per NAFLD patient with private insurance was $7,804 (interquartile range [IQR] $3,068‐$18,688) for a new diagnosis and $3,789 (IQR $1,176‐$10,539) for long‐term management. These costs are significantly higher than the total annual costs of $2,298 (IQR $681‐$6,580) per matched control with similar metabolic comorbidities but without NAFLD. The largest increases in health care utilization that may account for the increased costs in NAFLD compared with controls are represented by liver biopsies (relative risk [RR] = 55.00, 95% confidence interval [CI] 24.48‐123.59), imaging (RR = 3.95, 95% CI 3.77‐4.15), and hospitalizations (RR = 1.87, 95% CI 1.73‐2.02). Conclusion: The costs associated with the care for NAFLD independent of its metabolic comorbidities are very high, especially at first diagnosis. Research efforts shouldfocus on identification of underlying determinants of use, sources of excess cost, and development of cost‐effective diagnostic tests.

AbstractBackgroundFood is the leading cause of anaphylaxis in children seen in emergency departments in the United States, yet data on emergency department visits and hospitalizations related to food‐induced anaphylaxis are limited. The objective of our study was to examine national time trends of pediatric food‐induced anaphylaxis‐related emergency department visits and hospitalizations.MethodsWe conducted an observational study using a national administrative claims database from 2005 through 2014. Participants were younger than 18 years with an emergency department visit or hospitalization for food‐induced anaphylaxis. Outcome measures of our study included time trends of pediatric food‐induced anaphylaxis‐related emergency department visits and hospitalizations, including observations (in an emergency department or a hospital unit), inpatient admissions, and intensive care unit admissions.ResultsDuring the study period, participants had 7310 food‐induced anaphylaxis‐related emergency department visits. Emergency department visits for food‐induced anaphylaxis increased by 214% (P < .001); the highest rates were in infants and toddlers (age 0‐2 years). Rates of emergency department visits significantly increased in all age‐groups, with the highest increase in adolescents (age 13‐17 years: 413%; P < .001). Peanuts accounted for the highest rates (5.85 per 100 000 in 2014) followed by tree nuts/seeds (4.62 per 100 000 in 2014). The greatest increase in rates of emergency department visits for food‐induced anaphylaxis occurred with tree nuts/seeds (373.0% increase during the study period).ConclusionsThe incidence of food‐induced anaphylaxis has significantly increased over time in children of all ages. Food‐induced anaphylaxis in children is an important national public health concern.

Background: Individualized diabetes management would benefit from prospectively identifying well-controlled patients at risk of losing glycemic control. Objectives: To identify patterns of hemoglobin A1c (HbA1c) change among patients with stable controlled diabetes. Research Design: Cohort study using OptumLabs Data Warehouse, 2001–2013. We develop and apply a machine learning framework that uses a Bayesian estimation of the mixture of generalized linear mixed effect models to discover glycemic trajectories, and a random forest feature contribution method to identify patient characteristics predictive of their future glycemic trajectories. Subjects: The study cohort consisted of 27,005 US adults with type 2 diabetes, age 18 years and older, and stable index HbA1c <7.0%. Measures: HbA1c values during 24 months of observation. Results: We compared models with k=1, 2, 3, 4, 5 trajectories and baseline variables including patient age, sex, race/ethnicity, comorbidities, medications, and HbA1c. The k=3 model had the best fit, reflecting 3 distinct trajectories of glycemic change: (T1) rapidly deteriorating HbA1c among 302 (1.1%) youngest (mean, 55.2 y) patients with lowest mean baseline HbA1c, 6.05%; (T2) gradually deteriorating HbA1c among 902 (3.3%) patients (mean, 56.5 y) with highest mean baseline HbA1c, 6.53%; and (T3) stable glycemic control among 25,800 (95.5%) oldest (mean, 58.5 y) patients with mean baseline HbA1c 6.21%. After 24 months, HbA1c rose to 8.75% in T1 and 8.40% in T2, but remained stable at 6.56% in T3. Conclusions: Patients with controlled type 2 diabetes follow 3 distinct trajectories of glycemic control. This novel application of advanced analytic methods can facilitate individualized and population diabetes care by proactively identifying high risk patients.

5 Background: The 11/2009 USPSTF breast cancer screening update recommended against routine screening mammography for women age 40-49, created confusion and prompted organizations to release opposing statements. We aimed to determine if the USPSTF update for breast cancer screening impacted screening mammography utilization in women age 40-49. Methods: We conducted a time-series analysis utilizing administrative claims data from over 100 health plans. Women ages 40-64 with at least one month of enrollment from 01/2006-12/2010 were included. Medicare claims are not included and thus women ≥65 were excluded. The start date of 01/2006 was chosen to account for possible effects of the recent recession. We developed claims-based algorithms to identify the number of monthly screening mammograms. Time series models were fit using SAS PROC AUTOREG; strong seasonal fluctuations were adjusted by including an autoregressive error of order 12. Results: Over 7.9 million women were included. Prior to the intervention, the baseline monthly mammography rate was 40.9/1,000 women for the 40-49 group and 47.4/1,000 women for the 50-64 group. Based on projections from pre-intervention trends, the update was associated with a 5.72% (1.27,10.18) and 4.97% (1.11,8.84) decrease in mammography rate at 3 and 10 months post-intervention, respectively in the 40-49 group. The intervention had no effect on mammography rates in the 50-64 group. This translates to 53,969 fewer mammograms performed in the year following the update for women ages 40-49 in this dataset. Conclusions: We present the first estimates of the impact of the USPSTF breast cancer screening update using a large nationally representative database. The update was associated with a small but significant decrease in mammography rates for women ages 40-49, while no change was seen for women ages 50-64, which is consistent with the context of the guideline change. A modest effect is also in line with public backlash and the release of numerous conflicting guidelines. These findings underscore the need for further research on benefits and risks of screening mammography as it is difficult to act on numerous sources of contradictory information.