Risk prediction of heart failure in patients with ischemic heart disease using network analytics and stacking ensemble learning.

BACKGROUND: Heart failure (HF) is a major complication following ischemic heart disease (IHD) and it adversely affects the outcome. Early prediction of HF risk in patients with IHD is beneficial for timely intervention and for reducing disease burden. METHODS: Two cohorts, cases for patients first diagnosed with IHD and then with HF (N = 11,862) and control IHD patients without HF (N = 25,652), were established from the hospital discharge records in Sichuan, China during 2015-2019. Directed personal disease network (PDN) was constructed for each patient, and then these PDNs were merged to generate the baseline disease network (BDN) for the two cohorts, respectively, which identifies the health trajectories of patients and the complex progression patterns. The differences between the BDNs of the two cohort was represented as disease-specific network (DSN). Three novel network features were exacted from PDN and DSN to represent the similarity of disease patterns and specificity trends from IHD to HF. A stacking-based ensemble model DXLR was proposed to predict HF risk in IHD patients using the novel network features and basic demographic features (i.e., age and sex). The Shapley Addictive exPlanations method was applied to analyze the feature importance of the DXLR model. RESULTS: Compared with the six traditional machine learning models, our DXLR model exhibited the highest AUC (0.934 ± 0.004), accuracy (0.857 ± 0.007), precision (0.723 ± 0.014), recall (0.892 ± 0.012) and F1 score (0.798 ± 0.010). The feature importance showed that the novel network features ranked as the top three features, playing a notable role in predicting HF risk of IHD patient. The feature comparison experiment also indicated that our novel network features were superior to those proposed by the state-of-the-art study in improving the performance of the prediction model, with an increase in AUC by 19.9%, in accuracy by 18.7%, in precision by 30.7%, in recall by 37.4%, and in F1 score by 33.7%. CONCLUSIONS: Our proposed approach that combines network analytics and ensemble learning effectively predicts HF risk in patients with IHD. This highlights the potential value of network-based machine learning in disease risk prediction field using administrative data.

Study on the Decoupling and Interaction Effect between Industrial Structure Upgrading and Carbon Emissions under Dual Carbon Targets.

The issue of climate and environment has been paid more and more attention by countries all over the world, especially regarding carbon emissions. Many national policies and scholars' research contents have focused on this issue, which has become a hot topic in today's society. As the world's largest carbon emitter, it is vital for China to achieve green development, upgrade its industrial structure and explore the relationship between industrial structure upgrading and carbon emissions. To explore the decoupling and interactive effects of industrial structure upgrading and carbon emissions, this paper divides industrial structure upgrading into two aspects: rationalization of industrial structure and upgrading of industrial structure. Indicators related to industrial structure upgrading and carbon emissions are selected and the decoupling model of carbon emissions and industrial structure upgrading is constructed using panel data from 30 regions from 1997 to 2019. The core density function is used to analyze the decoupling distribution characteristics, and then the Gini coefficient decomposition method is used to analyze the carbon emissions decoupling index, revealing the regional differences and sources of carbon emissions decoupling index. Finally, spatial factors are included in the regression model to verify the spatial synergy effect of industrial structure upgrading on carbon emissions. The overall and local Moran indexes are used to reveal the spatial internal structure and agglomeration characteristics of industrial structure upgrading and carbon emissions, and, based on the research results, policy recommendations are put forward to promote sustainable and stable development of industrial structure upgrading in China. This provides a new perspective for understanding the relationship between industrial structure upgrading and carbon emissions and also provides a decision-making reference for promoting decoupling of industrial structure upgrading and carbon emissions under high-quality economic development and forcing low-carbon transformation of the industrial structure.

Gaseous air pollutants and hospitalizations for mental disorders in 17 Chinese cities: Association, morbidity burden and economic costs.

The short-term morbidity effects of gaseous air pollutants on mental disorders (MDs), and the corresponding morbidity and economic burdens have not been well studied. We aimed to explore the associations of ambient sulfur dioxide (SO2), nitrogen dioxide (NO2), ozone (O3) and carbon monoxide (CO) with MDs hospitalizations in 17 Chinese cities during 2015-2018, and estimate the attributable risk and economic costs of MDs hospitalizations associated with gaseous pollutants. City-specific relationships between gaseous pollutants and MDs hospitalizations were evaluated using over-dispersed generalized additive models, then combined to obtain the pooled effect. Concentration-response (C-R) curves of gaseous pollutants with MDs from each city were pooled to allow regional estimates to be derived. The morbidity and economic burdens of MDs hospitalizations attributable to gaseous pollutants were further assessed. A total of 171,939 MDs hospitalizations were included. We observed insignificant association of O3 with MDs. An interquartile range increase in SO2 at lag0 (9.1 µg/m³), NO2 at lag0 (16.7 µg/m³) and CO at lag2 (0.4 mg/m³) corresponded to a 3.02% (95%CI: 0.72%, 5.38%), 5.03% (95%CI: 1.84%, 8.32%) and 2.18% (95%CI: 0.40%, 4.00%) increase in daily MDs hospitalizations, respectively. These effects were modified by sex, season and cause-specific MDs. The C-R curves of SO2 and NO2 with MDs indicated nonlinearity and the slops were steeper at lower concentrations. Overall, using current standards as reference concentrations, 0.27% (95%CI: 0.07%, 0.48%) and 0.06% (95%CI: 0.02%, 0.10%) of MDs hospitalizations could be attributable to extra SO2 and NO2 exposures, and the corresponding economic costs accounted for 0.34% (95%CI: 0.08%, 0.60%) and 0.07% (95%CI: 0.03%, 0.11%) of hospitalization expenses, respectively. Moreover, using threshold values detected from C-R curves as reference concentrations, the above mentioned morbidity and economic burdens increased a lot. These findings suggest more strict emission control regulations are needed to protect mental health from gaseous pollutants.

Comparative Effectiveness of Persistent Use of a Name-Brand Levothyroxine (Synthroid®) vs. Persistent Use of Generic Levothyroxine on TSH Goal Achievement: A Retrospective Study Among Patients with Hypothyroidism in a Managed Care Setting.

INTRODUCTION: Levothyroxine monotherapy (Synthroid® or multiple generic levothyroxine [GL] formulations) is standard treatment for hypothyroidism. Our objective was to compare effectiveness (as measured by achievement of thyroid-stimulating hormone [TSH] levels) and economic outcomes of Synthroid vs. any one of multiple GLs in patients with hypothyroidism. METHODS: Data for this retrospective cohort study were obtained from the HealthCore Integrated Research Database®. All study patients had ≥ 2 claims between 1 January 2006 and 31 December 2017 with ICD-9/10-CM diagnosis codes for hypothyroidism; were persistent users of Synthroid vs. any GL; and had ≥ 1 TSH laboratory result during 12-month follow-up. Patients were divided into one of two cohorts based on index medication and were 1:1 matched using propensity scores. The primary outcome was the proportion of patients with last TSH laboratory result during follow-up within the reference range (0.3-4.12 mIU/L). Secondary outcomes included all-cause and hypothyroidism-related healthcare resource utilization (HCRU) and costs. RESULTS: After propensity score matching, the Synthroid and GL cohorts each contained 18,382 patients. At follow-up, significantly more patients receiving Synthroid were in the TSH reference range vs. GL (78.5% vs. 77.2%, respectively, p = 0.002). HCRU and costs were broadly similar between the cohorts in terms of all-cause inpatient hospitalizations, emergency department visits, outpatient services, and pharmacy fills. Irrespective of index medication, patients with TSH within the reference range had significantly lower hypothyroidism-related medical and total costs compared to those outside the range. CONCLUSIONS: This real-world data study showed Synthroid was associated with better TSH target achievement vs. GL in a US managed care population. Achieving TSH goals may provide substantial economic value by reducing hypothyroidism-related HCRU and costs.

Data Integration to Improve Real-world Health Outcomes Research for Non-Small Cell Lung Cancer in the United States: Descriptive and Qualitative Exploration.

BACKGROUND: The integration of data from disparate sources could help alleviate data insufficiency in real-world studies and compensate for the inadequacies of single data sources and short-duration, small sample size studies while improving the utility of data for research. OBJECTIVE: This study aims to describe and evaluate a process of integrating data from several complementary sources to conduct health outcomes research in patients with non-small cell lung cancer (NSCLC). The integrated data set is also used to describe patient demographics, clinical characteristics, treatment patterns, and mortality rates. METHODS: This retrospective cohort study integrated data from 4 sources: administrative claims from the HealthCore Integrated Research Database, clinical data from a Cancer Care Quality Program (CCQP), clinical data from abstracted medical records (MRs), and mortality data from the US Social Security Administration. Patients with lung cancer who initiated second-line (2L) therapy between November 01, 2015, and April 13, 2018, were identified in the claims and CCQP data. Eligible patients were 18 years or older and received atezolizumab, docetaxel, erlotinib, nivolumab, pembrolizumab, pemetrexed, or ramucirumab in the 2L setting. The main analysis cohort included patients with claims data and data from at least one additional data source (CCQP or MR). Patients without integrated data (claims only) were reported separately. Descriptive and univariate statistics were reported. RESULTS: Data integration resulted in a main analysis cohort of 2195 patients with NSCLC; 2106 patients had CCQP and 407 patients had MR data. The claims-only cohort included 931 eligible patients. For the main analysis cohort, the mean age was 62.1 (SD 9.27) years, 48.56% (1066/2195) were female, the median length of follow-up was 6.8 months, and for 37.77% (829/2195), death was observed. For the claims-only cohort, the mean age was 66.6 (SD 12.69) years, 52.1% (485/931) were female, the median length of follow-up was 8.6 months, and for 29.3% (273/931), death was observed. The most frequent 2L treatment was immunotherapy (1094/2195, 49.84%), followed by platinum-based regimens (472/2195, 21.50%) and single-agent chemotherapy (441/2195, 20.09%); mean duration of 2L therapy was 5.6 (SD 4.9, median 4) months. We describe challenges and learnings from the data integration process, and the benefits of the integrated data set, which includes a richer set of clinical and outcome data to supplement the utilization metrics available in administrative claims. CONCLUSIONS: The management of patients with NSCLC requires care from a multidisciplinary team, leading to a lack of a single aggregated data source in real-world settings. The availability of integrated clinical data from MRs, health plan claims, and other sources of clinical care may improve the ability to assess emerging treatments.

Impacts of age, diabetes, gender, and access type on costs associated with vascular access among Chinese patients on hemodialysis.

OBJECTIVES: Examine the impacts of age, diabetes, gender, and access type on vascular access (VA) associated costs among Chinese hemodialysis (HD) patients. METHODS: We retrospectively included patients whose first permanent VA was created at the West China Hospital. Clinical characteristics, maturation, intervention, utilization, and exchange of every VA, as well as VA-related infection were collected. The study period for each patient was from HD initiation to the last follow-up. VA-related costs, including those for placement and intervention procedures, were calculated according to the standards set in 2019 for Chinese tertiary hospitals. Mann-Whitney U and Chi-square tests were conducted for comparisons between groups. RESULTS: A total of 358 Chinese HD patients experienced functionally 143 arteriovenous fistula (AVF), 22 arteriovenous graft (AVG), and 439 tunneled cuffed central venous catheter (tcCVC) during a median study period of 26 (IQR 13-44) months, of which 42.5% used more than one permanent VA. The median annual VA-related cost in the groups of age >75 years and ⩽75 years, diabetes and non-diabetes, male and female, was $525 and $397 (p = 0.016), $459 and $462 (p = 0.64), $476 and $445 (p = 0.94), respectively. The median monthly costs for AVF ($18), AVG ($289), and tcCVC ($37) were significantly different. CONCLUSION: HD patients aged >75 years had significantly higher annual VA-related costs. However, the annual VA-related costs did not differ across the diabetes groups or the gender groups. AVF was the most cost-effective permanent VA type in China, partly due to the inexpensive materials used compared to AVG or tcCVC.

Healthcare utilization and total costs of care among patients with advanced metastatic gastric and esophageal cancer.

Aim: Study first-line (1L) treatment patterns and economic outcomes among patients with advanced metastatic gastric cancer (GC) and esophageal cancer (EC). Materials & methods: Newly diagnosed patients with systemic GC and EC treatments were identified between 1 January 2011 and 31 July 2017; costs were presented as per patient per month (PPPM) basis. Results: Study included 392 GC and 436 EC patients. Most frequently used 1L regimens were: 5-fluorouracil (5-FU) + oxaliplatin (22.5%) and epirubicin + cisplatin + 5-FU (ECF)/ECF modifications (21.9%) in patients with GC; and carboplatin + paclitaxel (29.6%) and 5-FU + oxaliplatin (11.5%) in EC patients. Mean all-cause costs were US$16,242 PPPM for GC, and $18,384 PPPM for EC during 1L treatment. Conclusion: GC and EC were resource intensive and costly. High costs and short treatment durations underscored a gap in care in 1L treatment.

Coarse particles (PM2.5-10) and cause-specific hospitalizations in southwestern China: Association, attributable risk and economic costs.

The short-term morbidity effects of the coarse particle (diameter in 2.5-10 µm, PM2.5-10), as well as the corresponding morbidity burden and economic costs, remain understudied, especially in developing countries. This study aimed to examine the associations of PM2.5-10 with cause-specific hospitalizations in a multi-city setting in southwestern China and assess the attributable risk and economic costs. City-specific associations were firstly estimated using generalized additive models with quasi-poisson distribution to handle over-dispersion, and then combined to obtain the regional average association. City-specific and pooled concentration-response (C-R) associations of PM2.5-10 with cause-specific hospitalizations were also modeled. Subgroup analyses were performed by age, sex, season and region. The health and economic burden of hospitalizations for multiple outcomes due to PM2.5-10 were further evaluated. A total of 4,407,601 non-accidental hospitalizations were collected from 678 hospitals. The estimates of percentage change in hospitalizations per 10 µg/m³ increase in PM2.5-10 at lag01 was 0.68% (95%CI: 0.33%-1.03%) for non-accidental causes, 0.86% (95% CI: 0.36%-1.37%) for circulatory diseases, 1.52% (95% CI: 1.00%-2.05%) for respiratory diseases, 1.08% (95% CI: 0.47%-1.69%) for endocrine diseases, 0.66% (95% CI: 0.12%-1.21%) for nervous system diseases, and 0.84% (95% CI: 0.42%-1.25%) for genitourinary diseases, respectively. The C-R associations of PM2.5-10 with cause-specific hospitalizations suggested some evidence of nonlinearity, except for endocrine diseases. Meanwhile, the adverse effects were modified by age and season. Overall, about 0.70% (95% CI: 0.35%-1.06%) of non-accidental hospitalizations and 0.78% (95% CI: 0.38%-1.17%) of total hospitalization expenses could be attributed to PM2.5-10. The largest morbidity burden and economic costs were observed in respiratory diseases. Our findings indicate that PM2.5-10 exposure may increase the risk of hospitalizations for multiple outcomes, and account for considerable morbidity and economic burden.

Clinical and economic outcomes among injection-naïve patients with type 2 diabetes initiating dulaglutide compared with basal insulin in a US real-world setting: the DISPEL Study.

Aims: To report 1-year clinical and economic outcomes from the retrospective DISPEL (Dulaglutide vs Basal InSulin in Injection Naïve Patients with Type 2 Diabetes: Effectiveness in ReaL World) Study. Materials and methods: This observational claims study included patients with type 2 diabetes (T2D) and ≥1 claim for dulaglutide or basal insulin between November 2014 and April 2017 (index date=earliest fill date). Propensity score matching was used to address treatment selection bias. Change from baseline in hemoglobin A1c (HbA1c) was compared between the matched cohorts using analysis of covariance; diabetes-related costs were analyzed using generalized linear models. Results: Matched cohorts (903 pairs total; 523 pairs with complete cost data) were balanced in baseline characteristics with mean HbA1c 8.6%, mean age 54 years. At 1 year postindex, dulaglutide patients had significantly greater reduction in HbA1c than basal insulin (-1.12% vs -0.51%, p<0.01), lower medical costs ($3753 vs $7604, p<0.01), higher pharmacy costs ($9809 vs $6175, p<0.01), and similar total costs ($13 562 vs $13 779, p=0.76). Medical and total costs per 1% HbA1c reduction were lower for dulaglutide than basal insulin (medical: $3128 vs $12 673, p<0.01; total: $11 302 vs $22 965, p<0.01), while pharmacy costs per 1% HbA1c reduction were lower without reaching statistical significance ($8174 vs $10 292, p=0.15). Conclusions: In this real-world study, patients with T2D initiating dulaglutide demonstrated greater HbA1c reduction compared with those initiating basal insulin. Although total diabetes-related costs were similar, the total diabetes-related costs per HbA1c reduction were lower for dulaglutide, highlighting the importance of evaluating effectiveness along with the economic impact of medications.

Assessment of Iodine Status among Pregnant Women and Neonates Using Neonatal Thyrotropin (TSH) in Mainland China after the Introduction of New Revised Universal Salt Iodisation (USI) in 2012: A Re-Emergence of Iodine Deficiency?

Iodine deficiency during pregnancy can cause iodine deficiency disorders (IDD). However, it is unclear about iodine and thyroid status of Chinese pregnant women and neonates after the implementation of the revised universal salt iodisation (USI) level in 2012. Therefore, the aim of the cross-sectional study was to determine iodine nutrition and thyroid status among pregnant women and their neonates in China after the implementation of USI. Medical records of pregnant women and neonates in Northern Jiangsu People's Hospital between January 2016 and December 2017 were reviewed and included. We included 3060 mother-and-newborn pairs in the study. Mean age of participants was 28.2 ± 4.1 years. TSH, FT3, and FT4 of participants were within normal reference range. The overall mean neonatal TSH, birth weight, and prevalence of low birth weight (LBW) were 4.86 ± 2.06 mIU/L, 3358 ± 455 g, and 3.2%, respectively. The prevalence of neonatal TSH values >5 mIU/L was 29.3%, suggesting iodine deficiency in the region. In conclusion, our results indicated iodine deficiency in the region, according to the neonatal TSH cutoff recommended by WHO/UNICEF/IGD. More efforts are urgently required to improve iodine status of pregnant women in the region in order to prevent a re-emergence of iodine deficiency.

Identification of the Differential Effect of City-Level on the Gini Coefficient of Health Service Delivery in Online Health Community.

Inequality of health services for different specialty categories not only occurs in different areas in the world, but also happens in the online service platform. In the online health community (OHC), health services often display inequality for different specialty categories, including both online views and medical consultations for offline registered services. Moreover, how the city-level factors impact the inequality of health services in OHC is still unknown. We designed a causal inference study with data on distributions of serviced patients and online views in over 100 distinct specialty categories on one of the largest OHCs in China. To derive the causal effect of the city-levels (two levels inducing 1 and 0) on the Gini coefficient, we matched the focus cases in cities with rich healthcare resources with the potential control cities. For each of the specialty categories, we first estimated the average treatment effect of the specialty category's Gini coefficient (SCGini) with the balanced covariates. For the Gini coefficient of online views, the average treatment effect of level-1 cities is 0.573, which is 0.016 higher than that of the matched group. Similarly, for the Gini coefficient of serviced patients, the average treatment effect of level-1 cities is 0.470, which is 0.029 higher than that of the matched group. The results support the argument that the total Gini coefficient of the doctors in OHCs shows that the inequality in health services is still very serious. This study contributes to the development of a theoretically grounded understanding of the causal effect of city-level factors on the inequality of health services in an online to offline health service setting. In the future, heterogeneous results should be considered for distinct groups of doctors who provide different combinations of online contributions and online attendance.

Real-World Characteristics and Treatment Patterns in Patients with Urticaria Initiating Omalizumab in the United States.

BACKGROUND: Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) in patients aged 12 years or older with persistent hives that are not adequately controlled by H1 antihistamines. While its safety and efficacy in CIU patients have been evaluated in multiple clinical trials, real-world use of omalizaumab in CIU has not been well characterized. OBJECTIVE: To assess demographics, clinical characteristics, and treatment patterns of CIU patients who initiated omalizumab to better understand the usage of this agent in CIU management in the real world. METHODS: This retrospective cohort study used medical and pharmacy claims data in the United States from the HealthCore Integrated Database to identify patients with CIU newly treated with omalizumab (≥ 4 omalizumab claims within 6 months of the initial claim) between March 21, 2014, and October 31, 2015 (study intake period). The index date was defined as the date of the first claim for omalizumab during the study intake period. Demographic and clinical characteristics were described for patients treated with omalizumab, as were treatment patterns associated with omalizumab and concomitant medications associated with CIU treatment. Descriptive and inferential statistics were reported. The Kaplan-Meier method was used to examine omalizumab treatment patterns. RESULTS: This study included 298 omalizumab-treated patients (mean [SD] age of 43.5 [13.64] years; 70.8% female); approximately 84% were seen by an allergist/immunologist. All patients had ≥ 12 months of continuous enrolment and a subset of 138 patients had ≥ 18 months of follow-up. For patients with ≥ 12 months of post-index follow-up, 12.1% (n = 36), 28.5% (n = 85), and 32.9% (n = 98) discontinued omalizumab within the 6-month, 12-month, and the entire post-index periods (mean 530 days), respectively; the mean number of days patients were continuously treated with omalizumab was 443.1 (95% CI = 425.0-461.3); the probabilities of continuous treatment (95% CI) were 0.879 (0.836-0.911), 0.711 (0.656-0.759), and 0.647 (0.585-0.703) for the 6-, 12-, and 18-month post-index periods, respectively. For the 98 patients who discontinued omalizumab during the entire post-index period, 28.6% restarted omalizumab after the first discontinuation within the post-index period (mean time from first discontinuation to first restart=329 days). Use of medications such as oral corticosteroids, montelukast, cyclosporine, and prescription H1 and H2 antihistamines decreased during the 1- to 6-month and 7- to 12-month post-index periods compared with those within the 6-month pre-index period. CONCLUSIONS: In this cohort of CIU patients who were newly prescribed omalizumab, the majority were treated by allergists/immunologists as expected, and approximately 60% of patients continued on therapy beyond 18 months. Concomitant medication use decreased after omalizumab initiation. These data on the real-world use of omalizumab for CIU may help to better inform decision-making processes for health care payers by quantifying omalizumab and concomitant medication treatment patterns over a longer time frame relative to previous studies. DISCLOSURES: This study was sponsored by Novartis Pharmaceuticals, which provided funding support for the conduct of the study. Kavati, Ortiz, and Paknis are employees of Novartis Pharmaceuticals. Ke, Wertz, Huang, Wang, Willey, and Stephenson are employees of HealthCore, an independent research organization that received funding from Novartis Pharmaceuticals for the conduct of this study. Beck is an employee of the University of Rochester Medical Center, who was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports grants from Genentech, outside the currently submitted work. Bernstein is affiliated with Bernstein Clinical Research Center, which was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports receiving grants and personal fees from Novartis Pharmaceuticals, grants and personal fees from Genentech outside of the submitted work, and is an author on the Joint Task Force for Practice Parameters for Urticaria and the GALEN international guidelines for urticaria under preparation. Selected study data were presented in a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22nd Annual International Meeting on May 20-24, 2017, in Boston, MA. A poster based on this dataset was presented at the 2017 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26-30, 2017, in Boston, MA.

Electronic Health Record Driven Prediction for Gestational Diabetes Mellitus in Early Pregnancy.

Gestational diabetes mellitus (GDM) is conventionally confirmed with oral glucose tolerance test (OGTT) in 24 to 28 weeks of gestation, but it is still uncertain whether it can be predicted with secondary use of electronic health records (EHRs) in early pregnancy. To this purpose, the cost-sensitive hybrid model (CSHM) and five conventional machine learning methods are used to construct the predictive models, capturing the future risks of GDM in the temporally aggregated EHRs. The experimental data sources from a nested case-control study cohort, containing 33,935 gestational women in West China Second Hospital. After data cleaning, 4,378 cases and 50 attributes are stored and collected for the data set. Through selecting the most feasible method, the cost parameter of CSHM is adapted to deal with imbalance of the dataset. In the experiment, 3940 samples are used for training and the rest 438 samples for testing. Although the accuracy of positive samples is barely acceptable (62.16%), the results suggest that the vast majority (98.4%) of those predicted positive instances are real positives. To our knowledge, this is the first study to apply machine learning models with EHRs to predict GDM, which will facilitate personalized medicine in maternal health management in the future.

Real-World Characteristics and Treatment Patterns in Patients with Urticaria Initiating Omalizumab in the United States.

BACKGROUND: Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) in patients aged 12 years or older with persistent hives that are not adequately controlled by H1 antihistamines. While its safety and efficacy in CIU patients have been evaluated in multiple clinical trials, real-world use of omalizaumab in CIU has not been well characterized. OBJECTIVE: To assess demographics, clinical characteristics, and treatment patterns of CIU patients who initiated omalizumab to better understand the usage of this agent in CIU management in the real world. METHODS: This retrospective cohort study used medical and pharmacy claims data in the United States from the HealthCore Integrated Database to identify patients with CIU newly treated with omalizumab (≥ 4 omalizumab claims within 6 months of the initial claim) between March 21, 2014, and October 31, 2015 (study intake period). The index date was defined as the date of the first claim for omalizumab during the study intake period. Demographic and clinical characteristics were described for patients treated with omalizumab, as were treatment patterns associated with omalizumab and concomitant medications associated with CIU treatment. Descriptive and inferential statistics were reported. The Kaplan-Meier method was used to examine omalizumab treatment patterns. RESULTS: This study included 298 omalizumab-treated patients (mean [SD] age of 43.5 [13.64] years; 70.8% female); approximately 84% were seen by an allergist/immunologist. All patients had ≥ 12 months of continuous enrolment and a subset of 138 patients had ≥ 18 months of follow-up. For patients with ≥ 12 months of post-index follow-up, 12.1% (n = 36), 28.5% (n = 85), and 32.9% (n = 98) discontinued omalizumab within the 6-month, 12-month, and the entire post-index periods (mean 530 days), respectively; the mean number of days patients were continuously treated with omalizumab was 443.1 (95% CI = 425.0-461.3); the probabilities of continuous treatment (95% CI) were 0.879 (0.836-0.911), 0.711 (0.656-0.759), and 0.647 (0.585-0.703) for the 6-, 12-, and 18-month post-index periods, respectively. For the 98 patients who discontinued omalizumab during the entire post-index period, 28.6% restarted omalizumab after the first discontinuation within the post-index period (mean time from first discontinuation to first restart=329 days). Use of medications such as oral corticosteroids, montelukast, cyclosporine, and prescription H1 and H2 antihistamines decreased during the 1- to 6-month and 7- to 12-month post-index periods compared with those within the 6-month pre-index period. CONCLUSIONS: In this cohort of CIU patients who were newly prescribed omalizumab, the majority were treated by allergists/immunologists as expected, and approximately 60% of patients continued on therapy beyond 18 months. Concomitant medication use decreased after omalizumab initiation. These data on the real-world use of omalizumab for CIU may help to better inform decision-making processes for health care payers by quantifying omalizumab and concomitant medication treatment patterns over a longer time frame relative to previous studies. DISCLOSURES This study was sponsored by Novartis Pharmaceuticals, which provided funding support for the conduct of the study. Kavati, Ortiz, and Paknis are employees of Novartis Pharmaceuticals. Ke, Wertz, Huang, Wang, Willey, and Stephenson are employees of HealthCore, an independent research organization that received funding from Novartis Pharmaceuticals for the conduct of this study. Beck is an employee of the University of Rochester Medical Center, who was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports grants from Genentech, outside the currently submitted work. Bernstein is affiliated with Bernstein Clinical Research Center, which was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports receiving grants and personal fees from Novartis Pharmaceuticals, grants and personal fees from Genentech outside of the submitted work, and is an author on the Joint Task Force for Practice Parameters for Urticaria and the GALEN international guidelines for urticaria under preparation. Study concept and design were primarily contributed by Kavati, Ortiz, and Paknis, with assistance from the other authors. Huang, Wang, and Ke took the lead in data collection, with assistance from Wertz, Willey, and Stephenson. Data interpretation was performed by Ke, Wertz, and Willey, assisted by the other authors. The manuscript was written by Stephenson, Ke, and Wang, along with Willey, Wertz, and Huang, and revised by Bernstein and Beck, with assistance from the other authors. Selected study data were presented in a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22nd Annual International Meeting on May 20-24, 2017, in Boston, Massachusetts. A poster based on this dataset was presented at the 2017 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26-30, 2017, in Boston, Massachusetts.

Impact of lung function on exacerbations, health care utilization, and costs among patients with COPD.

OBJECTIVE: To evaluate the impact of lung function, measured as forced expiratory volume in 1 second (FEV1) % predicted, on health care resource utilization and costs among patients with COPD in a real-world US managed-care population. METHODS: This observational retrospective cohort study utilized administrative claim data augmented with medical record data. The study population consisted of patients with one or more medical claims for pre- and postbronchodilator spirometry during the intake period (July 1, 2012 to June 30, 2013). The index date was the date of the earliest medical claim for pre- and postbronchodilator spirometry. Spirometry results were abstracted from patients' medical records. Patients were divided into two groups (low FEV1% predicted [,50%] and high FEV1% predicted [≥50%]) based on the 2014 Global Initiative for Chronic Obstructive Lung Disease report. Health care resource utilization and costs were based on the prevalence and number of discrete encounters during the 12-month postindex follow-up period. Costs were adjusted to 2014 US dollars. RESULTS: A total of 754 patients were included (n=297 low FEV1% predicted group, n=457 high FEV1% predicted group). COPD exacerbations were more prevalent in the low FEV1% predicted group compared with the high group during the 12-month pre- (52.5% vs 39.6%) and postindex periods (49.8% vs 36.8%). Mean (standard deviation) follow-up all-cause and COPD-related costs were $27,380 ($38,199) and $15,873 ($29,609) for patients in the low FEV1% predicted group, and $22,075 ($28,108) and $10,174 ($18,521) for patients in the high group. In the multivariable analyses, patients in the low FEV1% predicted group were more likely to have COPD exacerbations and tended to have higher COPD-related costs when compared with patients in the high group. CONCLUSION: Real-world data demonstrate that patients with COPD who have low FEV1% predicted levels use more COPD medications, have more COPD exacerbations, and incur higher COPD-related health care costs than those with high FEV1% predicted levels.

Trends of out-of-pocket expenditure for influenza in China Health and Nutrition Survey during 1989-2006.

OBJECTIVES: To examine the trends of out-of-pocket expenditure for influenza during 1989-2006 in China. METHODS: Data were extracted from the China Health and Nutrition Survey (CHNS) during 1989-2006 (in seven waves). A fixed effect model with robust standard errors was employed to examine trends of out-of-pocket expenditure (adjusted to 2006 Chinese RMB). RESULTS: The out-of-pocket expenditure increased from 11.92 RMB in 1989 to 50.75 RMB in 2006. The final sample for fixed effect model was 23,050 households. Income elasticity of out-of-pocket expenditure was 1.6%. Using 1989 as reference, the predicted increase was 242.23% [95% confidence interval (CI): 225.79-259.50%] in 2006; it was 143.54% in city hospitals [95% CI: 130.43-157.40%] compared to village clinics. CONCLUSIONS: Adjusted for inflation and income elasticity, Chinese households experienced an increase of more than double the out-of-pocket expenditure during 1989-2006. The expenditure was higher in higher-level facilities. Policy implications include the government fixed-budget financing to health providers could contribute to the rapidly increased financial burden; a referral system should be rebuilt; private health providers may play an important role in containing healthcare price in China.