Lixian Zhong

Background: The COVID-19 pandemic disrupted healthcare services, potentially affecting diabetes management and complications. Objective: To investigate the impact of the pandemic on lower extremity amputation (LEA) rates among individuals with type 1 and type 2 diabetes mellitus, focusing on social determinants of health. Methods: A retrospective observational cohort study using de-identified claims data from a large U.S. health plan. LEA rates were compared before and after the onset of the COVID-19 pandemic using interrupted time series analysis. Results: Individuals with type 2 diabetes experienced an initial decline in LEA rates followed by a significant increase (p=0.022) as delayed care needs were addressed. Individuals with type 1 diabetes showed no significant fluctuations in amputation rates. Social determinants were significantly associated with changes in LEA rates among individuals with type 2 diabetes. Lower-income (≤$40,000/year) and less educated individuals experienced significant increases in amputation rates (p=0.027 and p=0.043, respectively). Individuals aged 45-64 years showed a significant increase in LEA rates (p=0.013), while those aged 18-44 experienced a decrease (p=0.017). Metropolitan residents saw significant increases in LEA rates (p=0.021). Conclusions: The COVID-19 pandemic significantly disrupted healthcare access for individuals with type 2 diabetes, leading to increased LEA rates. Social determinants of health exacerbated existing disparities in diabetes outcomes. These findings underscore the need for targeted interventions to address healthcare disparities, especially during public health crises.

Background Type 2 diabetes mellitus (T2DM) is a prevalent chronic disease in the United States and healthcare resources used to manage the disease are disproportionately consumed by a small subset of users. Consequently, there is a potential to reduce the healthcare costs and to improve the health outcomes through the early detection and consistent management of high-cost users. Objective The objectives of this study were to characterize the pattern of medical utilization and cost of commercially-insured people with type 2 diabetes (T2DM) in Texas and to identify predictors of high-cost users. Methods Using claims data from a large commercial insurance plan spanning the period from 2016 to 2019, the total medical costs of a randomly selected 12-month period were analyzed for eligible commercially-insured people with T2DM, and the patients were categorized into the top 20% of high-cost users and the bottom 80% of lower-cost users. Descriptive analyses were conducted to describe the baseline characteristics of the people with T2DM, the patterns of healthcare utilization, and the costs of the two types of users. Multivariate logistic regression models were estimated to identify the predictors of being a high-cost T2DM user. Results The top 20% of high-cost users accounted for 83% of the total medical cost, with an average cost of $41,370 as compared to only $2064 for the bottom 80% of lower-cost users. Several chronic conditions were identified to be strong predictors of being a high-cost patient. Rural high-cost users had, on average, fewer specialist visits but more inpatient stays compared to the urban high-cost users. Conclusion Healthcare utilization and expenditures among commercially insured individuals with T2DM followed the 80–20 rule. High-cost users were strongly associated with worse health status. Residential rurality was not associated with high-cost use, though the patterns of resource utilization differed between urban and rural high-cost users.

Background and aims: Given the national opioid public health crisis, this study aimed to characterize the real-world healthcare resource utilization pattern and to quantify the economic burden associated with opioid misuse in Texas. Methods: A retrospective cross-sectional study was conducted using Texas statewide Inpatient, Outpatient, and Emergency Department (ED) administrative data. International Classification of Diseases, 10th Revision (ICD-10-CM) codes related to opioid abuse, adverse effects, dependence, and poisoning identified opioid-related clinical encounters. High-sensitivity and high-specificity definition criteria were used to capture the range of opioid-related clinical encounters. Descriptive statistics were applied to evaluate the resource utilization and economic burden in different clinical settings and by different types of opioid misuse. Multivariable logistic regression models were applied to identify the association with patients' characteristics. Results: The high-sensitivity definition identified three to six times more opioid-related clinical encounters related as compared to the high-specificity definition (31,901 vs 10,423 outpatient visits and 47,021 vs 7,444 inpatient visits). A greater proportion of these patients were aged 18-44, White, non-Hispanic, living in metro areas, and uninsured as compared to all-cause visits. EDs were heavily utilized with the outpatient visits predominantly through the ED (>90 percent) and between 49 and 78 percent of inpatient hospitalizations admitted through ED. The multivariable association between patient characteristics and opioid-related clinical encounters varied with clinical settings and the two definitions. High-sensitivity opioid-related clinical encounters were generally associated with higher charges as compared to high-specificity encounters. The total healthcare charge related to opioid misuse in 2016 was estimated to be USD 0.27 billion using the high-specificity definition and USD 2.6 billion using the high-sensitivity definition. Conclusions: Findings indicate opioid-related clinical encounters impose significant clinical and economic burdens in Texas. Study findings can help healthcare policymakers, professionals, and clinicians better classify opioid use disorder as a major but underreported condition in Texas.

Background and aims: Given the national opioid public health crisis, this study aimed to characterize the real-world healthcare resource utilization pattern and to quantify the economic burden associated with opioid misuse in Texas. Methods: A retrospective cross-sectional study was conducted using Texas statewide Inpatient, Outpatient, and Emergency Department (ED) administrative data. International Classification of Diseases, 10th Revision (ICD-10-CM) codes related to opioid abuse, adverse effects, dependence, and poisoning identified opioid-related clinical encounters. High-sensitivity and high-specificity definition criteria were used to capture the range of opioid-related clinical encounters. Descriptive statistics were applied to evaluate the resource utilization and economic burden in different clinical settings and by different types of opioid misuse. Multivariable logistic regression models were applied to identify the association with patients' characteristics. Results: The high-sensitivity definition identified three to six times more opioid-related clinical encounters related as compared to the high-specificity definition (31,901 vs 10,423 outpatient visits and 47,021 vs 7,444 inpatient visits). A greater proportion of these patients were aged 18-44, White, non-Hispanic, living in metro areas, and uninsured as compared to all-cause visits. EDs were heavily utilized with the outpatient visits predominantly through the ED (>90 percent) and between 49 and 78 percent of inpatient hospitalizations admitted through ED. The multivariable association between patient characteristics and opioid-related clinical encounters varied with clinical settings and the two definitions. High-sensitivity opioid-related clinical encounters were generally associated with higher charges as compared to high-specificity encounters. The total healthcare charge related to opioid misuse in 2016 was estimated to be USD 0.27 billion using the high-specificity definition and USD 2.6 billion using the high-sensitivity definition. Conclusions: Findings indicate opioid-related clinical encounters impose significant clinical and economic burdens in Texas. Study findings can help healthcare policymakers, professionals, and clinicians better classify opioid use disorder as a major but underreported condition in Texas.

OBJECTIVES: The aim of this study was to evaluate the disease burden of prostate cancer (PC) and assess key influencing factors associated with the disease expenditures of PC in the United States.METHODS: The total deaths, incidence, prevalence, and disability-adjusted life-years of PC were obtained from the Global Burden of Disease Study 2019. The Medical Expenditure Panel Survey was used to estimate healthcare expenditures and productivity loss and to investigate patterns of payment and use of healthcare resources in the United States. A multivariable logistic regression model was conducted to identify key factors influencing expenditures.RESULTS: For patients aged 50 and older, the burden for all age groups showed a modest increase over the 6-year period. Annual medical expenditures were estimated to range from US$24.8 billion to US$39.2 billion from 2014 to 2019. The annual loss in productivity for patients was approximately US$1,200. The top 3 major components of medical costs were hospital inpatient stays, prescription medicines, and office-based visits. Medicare was the largest source of payments for survivors. In terms of drug consumption, genitourinary tract agents (57.0%) and antineoplastics (18.6%) were the main therapeutic drugs. High medical expenditures were positively associated with age (p=0.005), having private health insurance (p=0.016), more comorbidities, not currently smoking (p=0.001), and patient self-perception of fair/poor health status (p<0.001).CONCLUSIONS: From 2014 to 2019, the national real-world data of PC revealed that the disease burden in the United States continued to increase, which was partly related to patient characteristics.

BACKGROUND: Breast cancer is the most prevalent type of cancer in women in the United States. Ribociclib plus fulvestrant combination therapy gained US Food and Drug Administration approval to treat postmenopausal women with hormone receptor–positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer in 2018. OBJECTIVE: To determine the cost-effectiveness of ribociclib plus fulvestrant vs placebo plus fulvestrant therapy in the target population from a US payer perspective. METHODS: A partitioned survival analysis model composed of 3 health states (progression free, progressed disease, and death) was constructed to evaluate the cost-effectiveness of ribociclib plus fulvestrant vs placebo plus fulvestrant. The progression-free survival and the overall survival data points were extracted from published Kaplan-Meier curves in the MONALEESA-3 study and fitted to parametric curves. The safety and efficacy of the treatment was referenced from the MONALEESA-3 trial. Costs were obtained from standard sources including the Red Book for medication costs, Medicare Clinical Laboratory/Physician Fee Schedule for clinical utilization, and the literature for costs of managing adverse events, subsequent therapy, and end-of-life care. Utility and disutility values were obtained from literature to calculate quality-adjusted life-years (QALYs). One-way and probabilistic sensitivity analyses were conducted to test the model robustness. Several scenario analyses were also investigated. RESULTS: In the base case, the ribociclib plus fulvestrant arm was associated with $522,844 and 3.25 QALYs compared with $50,395 and 2.14 QALYs in the placebo plus fulvestrant arm, leading to an incremental cost-effectiveness ratio of $425,951/QALY. The cost of ribociclib had the biggest impact on the model and constituted 84% of the total cost for the ribociclib plus fulvestrant arm. The probabilistic sensitivity analysis projected that the ribociclib plus fulvestrant treatment would have a net benefit over the placebo plus fulvestrant therapy at a willingness-to-pay (WTP) threshold of $405,600/QALY. CONCLUSIONS: At a WTP threshold of $150,000/QALY, the addition of ribociclib to fulvestrant is not considered to be cost-effective in postmenopausal women with HR+/HER2- advanced or metastatic breast cancer. The findings send a strong price signal to the manufacturer and can be used to facilitate payers with price negotiation in making coverage decisions.

Objective: The purpose of this study was to explore physicians’ attitudes toward different strategies for supporting pain management and opioid prescribing and to identify factors related to their attitudes toward the support strategies. Design/setting/participants/measures: This preliminary cross-sectional study collected and analyzed online survey responses from physicians in Texas and Minnesota (N = 69) between December 2017 and February 2018. Primary outcomes were physicians’ interest in online continuing medical education (CME), mHealth patient monitoring system, and short, non-CME YouTube informational briefs about pain management and opioid prescribing. Multiple logistic regression models were used to examine the associations between physicians’ characteristics, attitudes, training, experience, practice setting, and their interest in three different support strategies. Results: About 51-58 percent of physicians indicated moderate-to-extreme interest in online CME (54 percent), mHealth monitoring (58 percent), and short, non-CME YouTube informational briefs (51 percent). Physicians, who practiced in a medium or large practice setting, were less likely to be interested in online CME or short, non-CME YouTube informational briefs. Physicians who prescribed a small number of Schedule II opioids were more likely to be interested in short, non-CME YouTube informational briefs and mHealth monitoring. Conclusions: Findings suggest that physicians may have different preferences in strategies for supporting their pain management and opioid prescribing practices. Future studies are needed to better understand the mechanisms underlying physicians’ interest in different support strategies.  

Aim: Systemic sclerosis (SSc) is a rare, chronic autoimmune disease associated with a substantial economic burden. This study aimed to assess the costs associated with SSc and to identify major cost drivers.Methods: A systematic search was conducted in MEDLINE and Embase to identify relevant studies. Two independent reviewers evaluated studies based on inclusion/exclusion criteria and performed data extraction. Costs were converted into 2017 US dollars by purchasing power parity. The review was conducted following the Preferred Reporting Items for Systematic Review and Meta‐analysis (PRISMA) guideline.Results: The original literature search identified 113 potentially relevant citations, of which 10 articles met all the inclusion/exclusion criteria and were included in the data extraction and analysis. The identified studies evaluated costs associated with SSc in 11 countries from North America, Europe, and Australia published between 2009 and 2018. Eight studies reported direct costs and seven studies reported indirect costs. Direct costs varied from $3356 (Hungary) to $27 032 (Germany) with hospitalization and medication being two of the biggest components of direct medical costs in most studies. The indirect costs for lost productivity varied from $2433 (Italy) to $20 663 (UK), accounting for a significant portion of the total economic burden.Conclusions: Large variations existed in annual costs of SSc, but all studies found that SSc imposed a substantial economic burden on patients and their families. The identified studies were mostly from high‐income countries and there is still a knowledge gap regarding the cost of SSc in other parts of the world.

Purpose: To evaluate the cost-effectiveness of adding ribociclib to endocrine therapy for pre/perimenopausal women with hormone receptor-positive (HR+), human epidermal receptor 2-negative (HER2-) advanced breast cancer from the US payer perspective. Methods: A partitioned survival analysis model with three health states (progression-free, progressed disease, and death) was developed to compare the cost and effectiveness of ribociclib in combination with endocrine therapy versus endocrine therapy alone based on clinical data from the MONALEESA-7 phase 3 randomized clinical trials. Life years (LYs), quality-adjusted life-years (QALYs), and total costs were estimated and used to calculate incremental cost-effectiveness ratio (ICER) over a lifetime. Deterministic and probabilistic sensitivity analyses were conducted to test the uncertainties of model inputs. Additional scenario analyses were performed. Results: In the base-case, ribociclib plus endocrine therapy was more effective than endocrine therapy with an additional 1.39 QALYs but also more costly with an ICER of $282,996/QALY. One-way deterministic sensitivity analysis showed that overall survival associated with the treatments and the cost of ribociclib had the greatest impact on the ICER. The probabilistic sensitivity analysis showed that only beyond a willingness-to-pay (WTP) threshold of $272,867, ribociclib plus endocrine therapy would surpass endocrine therapy alone as a cost-effective option. Conclusions: From the US payer perspective, ribociclib plus endocrine therapy for pre/perimenopausal patients with HR+/HER2- advanced breast cancer is not cost-effective at a WTP threshold of $100,000 or $150,000 per QALY in comparison of endocrine therapy alone.

Objective: Systemic sclerosis (SSc) is a rare debilitating autoimmune disease of the connective tissue. This study aimed to assess the recent prevalence and incidence of SSc across the world.Methods: Using a systematic search strategy, PubMed/MEDLINE and EMBASE were searched to identify relevant studies published between 2006 and 2016. Two reviewers independently evaluated studies for inclusion based on inclusion/exclusion criteria and performed data extraction. The review was conducted and reported following the Preferred Reporting Items for Systematic Review and Meta‐analysis (PRISMA) statement. The pooled prevalence of SSc was calculated by meta‐analysis using a random‐effects model.Results: There were 1364 references retrieved using the initial searching strategy, and 20 epidemiological publications were selected for data extraction. The identified studies reported prevalence ranging from 3.8 per 100 000 in Taiwan to 50 per 100 000 in the USA. The prevalence was 23 per 100 000 (95% CI: 16‐29 per 100 000; 18 studies) in a pooled sample of 11 574 individuals. Incidence rate of SSc ranges from 0.77 per 100 000 person‐years in the Netherlands to 5.6 per 100 000 person‐years in the USA. SSc predominates in females with higher prevalence and incidence rates. It is important to note that different methodologies were used to derive these numbers so comparisons were made with caution.Conclusion: This review provides an assessment of the current estimates of disease prevalence and incidence of SSc. The epidemiological burdens of SSc vary among different regions of the world. The epidemiological data need to be interpreted with caution considering the methodological differences in deriving these estimates.