Last data update: May 06, 2024. (Total: 46732 publications since 2009)
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Query Trace: Shao H[original query] |
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Some patients with type 2 diabetes may benefit from intensive glycaemic and blood pressure control: A post-hoc machine learning analysis of ACCORD trial data
Jiao T , Kianmehr H , Lin Y , Li P , Singh Ospina N , Ghayee HK , Ruzieh M , Fonseca V , Shi L , Zhang P , Shao H . Diabetes Obes Metab 2024 AIM: The action to control cardiovascular risk in diabetes (ACCORD) trial showed a neutral average treatment effect of intensive blood glucose and blood pressure (BP) controls in preventing major adverse cardiovascular events (MACE) in individuals with type 2 diabetes. Yet, treatment effects across patient subgroups have not been well understood. We aimed to identify patient subgroups that might benefit from intensive glucose or BP controls for preventing MACE. MATERIALS AND METHODS: As a post-hoc analysis of the ACCORD trial, we included 10 251 individuals with type 2 diabetes. We applied causal forest and causal tree models to identify participant characteristics that modify the efficacy of intensive glucose or BP controls from 68 candidate variables (demographics, comorbidities, medications and biomarkers) at the baseline. The exposure was (a) intensive versus standard glucose control [glycated haemoglobin (HbA1c) <6.0% vs. 7.0%-7.9%], and (b) intensive versus standard BP control (systolic BP <120 vs. <140 mmHg). The primary outcome was MACE. RESULTS: Compared with standard glucose control, intensive one reduced MACE in those with baseline HbA1c <8.5% [relative risk (RR): 0.79, 95% confidence interval (CI): 0.67-0.93] and those with estimated glomerular filtration rate ≥106 ml/min/1.73 m(2) (RR: 0.74, 95% CI: 0.55-0.99). Intensive BP control reduced MACE in those with normal high-density lipoprotein levels (women >55 mg/dl, men >45 mg/dl; RR: 0.51, 95% CI: 0.34-0.74). Risk reductions were not significant in other patient subgroups. CONCLUSIONS: Our findings suggest heterogeneous treatment effects of intensive glucose and BP control and could provide biomarkers for future clinical trials to identify more precise HbA1c and BP treatment goals for individualized medicine. |
Using electronic health records to enhance surveillance of diabetes in children, adolescents and young adults: a study protocol for the DiCAYA Network
Hirsch AG , Conderino S , Crume TL , Liese AD , Bellatorre A , Bendik S , Divers J , Anthopolos R , Dixon BE , Guo Y , Imperatore G , Lee DC , Reynolds K , Rosenman M , Shao H , Utidjian L , Thorpe LE . BMJ Open 2024 14 (1) e073791 INTRODUCTION: Traditional survey-based surveillance is costly, limited in its ability to distinguish diabetes types and time-consuming, resulting in reporting delays. The Diabetes in Children, Adolescents and Young Adults (DiCAYA) Network seeks to advance diabetes surveillance efforts in youth and young adults through the use of large-volume electronic health record (EHR) data. The network has two primary aims, namely: (1) to refine and validate EHR-based computable phenotype algorithms for accurate identification of type 1 and type 2 diabetes among youth and young adults and (2) to estimate the incidence and prevalence of type 1 and type 2 diabetes among youth and young adults and trends therein. The network aims to augment diabetes surveillance capacity in the USA and assess performance of EHR-based surveillance. This paper describes the DiCAYA Network and how these aims will be achieved. METHODS AND ANALYSIS: The DiCAYA Network is spread across eight geographically diverse US-based centres and a coordinating centre. Three centres conduct diabetes surveillance in youth aged 0-17 years only (component A), three centres conduct surveillance in young adults aged 18-44 years only (component B) and two centres conduct surveillance in components A and B. The network will assess the validity of computable phenotype definitions to determine diabetes status and type based on sensitivity, specificity, positive predictive value and negative predictive value of the phenotypes against the gold standard of manually abstracted medical charts. Prevalence and incidence rates will be presented as unadjusted estimates and as race/ethnicity, sex and age-adjusted estimates using Poisson regression. ETHICS AND DISSEMINATION: The DiCAYA Network is well positioned to advance diabetes surveillance methods. The network will disseminate EHR-based surveillance methodology that can be broadly adopted and will report diabetes prevalence and incidence for key demographic subgroups of youth and young adults in a large set of regions across the USA. |
Medical expenditure trajectory and HbA1c progression prior to and after clinical diagnosis of type 2 diabetes in a commercially insured population in the USA
Pagán L , Yang W , Shao H , Wang Y , Zhang P . BMJ Open Diabetes Res Care 2023 11 (6) INTRODUCTION: Medical expenditures of individuals with type 2 diabetes escalate before clinical diagnosis. How increases in medical expenditures are related to glucose levels remains unclear. We examined changes in HbA1c and medical expenditures in years prior to and shortly after type 2 diabetes diagnosis. RESEARCH DESIGN AND METHODS: Using insurance claims and laboratory test results from a commercially insured population in the USA, we built three (2014, 2015, 2016) longitudinal cohorts with type 2 diabetes up to 10 years before and 2 years after the diagnosis (index year). We identified diabetes diagnosis using International Classification of Diseases, Ninth Revision and Tenth Revision codes and antidiabetic medication use. We ran two individual fixed regression models with annual total medical expenditures and average HbA1c values as dependent variables and number of years from diagnosis as the main independent variable and examined the risk-adjusted movement of the outcomes. RESULTS: Our study included 9847 individuals (83 526 person-years). Medical expenditures and HbA1c levels increased before and peaked at the diagnosis year. Medical expenditures were $8644 lower 10 years and $5781 lower 1 year before diagnosis compared with the index year. HbA1c was 12.18 mmol/mol (1.11 percentage points) and 3.49 mmol/mol (0.32 percentage points) lower, respectively. Average annual increases in medical expenditures and HbA1c values over the prediagnosis period were $318 and 0.97 mmol/mol (0.09 percentage points), respectively. CONCLUSIONS: Medical expenditures and HbA1c values followed similar trajectories before and after diabetes diagnosis. Our results can inform economic evaluations of programs and policies aimed at preventing type 2 diabetes. |
Incremental burden on health-related quality of life, health service utilization and direct medical expenditures associated with cognitive impairment among non-institutionalized people with diabetes aged 65 years and older
Guan D , Lewis MO , Li P , Zhang Y , Zhang P , Tang S , Brown J , Guo J , Zhang Y , Shao H . Diabetes Obes Metab 2023 26 (1) 275-282 AIMS: To quantify the incremental health and economic burden associated with cognitive impairment (CI) among non-institutionalized people with diabetes ≥65 years in the United States. MATERIALS AND METHODS: Using 2016-2019 Medical Expenditure Panel Surveys data, we identified participants ≥65 years with diabetes. We used propensity score weighting to quantify the CI-associated incremental burden on health-related quality of life measured by the 12-item Short Form Survey (SF-12), including the mental component summary score, physical component summary score and health utility. We also compared the annual health service utilization and expenditures on ambulatory visits, prescriptions, home care, emergency room (ER), hospitalizations and total annual direct medical expenditures. RESULTS: We included 5094 adults aged ≥65 with diabetes, of whom 804 had CI. After propensity score weighting, CI was associated with a lower mental component summary score (-8.4, p < .001), physical component summary score (-5.2, p < .001) and health utility (-0.12, p < .001). The CI group had more ambulatory visits (+4.4, p = .004) and prescriptions (+9.9, p < .001), with higher probabilities of having home care (+11.3%, p < .001) and ER visits (+8.2%, p = .001). People with CI spent $5441 (p < .001) more annually, $2039 (p = .002) more on prescriptions, $2695 (p < .001) more on home care and $118 (p < .001) more on ER visits. There is no statistically significant difference in the utilization and expenditure of hospitalizations. CONCLUSION: CI was associated with worse health-related quality of life, higher health service utilization and expenditures. Our findings can be used to monitor the health and economic burden of CI in non-institutionalized older persons with diabetes. |
A new type 2 diabetes microsimulation model to estimate long-term health outcomes, costs, and cost-effectiveness
Hoerger TJ , Hilscher R , Neuwahl S , Kaufmann MB , Shao H , Laxy M , Cheng YJ , Benoit S , Chen H , Anderson A , Craven T , Yang W , Cintina I , Staimez L , Zhang P . Value Health 2023 26 (9) 1372-1380 OBJECTIVE: To develop a microsimulation model to estimate the health effects, costs, and cost-effectiveness of public health and clinical interventions for preventing/managing type 2 diabetes. METHODS: We combined newly developed equations for complications, mortality, risk factor progression, patient utility, and cost-all based on U.S. studies-in a microsimulation model. We performed internal and external validation of the model. To demonstrate the model's utility, we predicted remaining life-years, quality-adjusted life-years (QALYs), and lifetime medical cost for a representative cohort of 10,000 U.S. adults with type 2 diabetes. We then estimated the cost-effectiveness of reducing HbA1c from 9% to 7% among adults with type 2 diabetes, using low-cost, generic, oral medications. RESULTS: The model performed well in internal validation; the average absolute difference between simulated and observed incidence for 17 complications was less than 8%. In external validation, the model was better at predicting outcomes in clinical trials than in observational studies. The cohort of U.S. adults with type 2 diabetes was projected to have an average of 19.95 remaining life-years (from mean age 61), incur $187,729 in discounted medical costs, and accrue 8.79 discounted QALYs. The intervention to reduce HbA1c increased medical costs by $1,256 and QALYs by 0.39, yielding an incremental cost-effectiveness ratio of $9,103 per QALY. CONCLUSIONS: Using equations exclusively derived from U.S. studies, this new microsimulation model achieves good prediction accuracy in U.S. POPULATIONS: The model can be used to estimate the long-term health impact, costs, and cost-effectiveness of interventions for type 2 diabetes in the United States. |
Recommended and prevalent use of glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors in a national population-based sample
Tang S , Shao H , Ali MK , Zhang P . Ann Intern Med 2023 176 (4) 582-583 Background: The 2022 consensus report from the American Diabetes Association and European Association for the Study of Diabetes recommended using glucagon-like peptide-1 receptor agonists (GLP-1 RAs) among persons with type 2 diabetes (T2D) who have established or are at high risk for atherosclerotic cardiovascular disease (ASCVD), and using sodium–glucose cotransporter-2 inhibitors (SGLT2is) among those with T2D who have established ASCVD, chronic kidney disease, or heart failure or are at high risk for ASCVD (level A evidence) (1). | | Objective: To estimate, using nationally representative data, the number and percentage of persons with T2D who would meet the recommended criteria and were using these medications in the United States. |
Medical costs associated with diabetes complications in Medicare beneficiaries aged 65 years or older with type 1 diabetes
Wang Y , Zhang P , Shao H , Andes LJ , Imperatore G . Diabetes Care 2023 46 (1) 149-155 OBJECTIVE: To estimate medical costs associated with 17 diabetes complications and treatment procedures among Medicare beneficiaries aged ≥65 years with type 1 diabetes. RESEARCH DESIGN AND METHODS: With use of the 2006-2017 100% Medicare claims database for beneficiaries enrolled in fee-for-service plans and Part D, we estimated the annual cost of 17 diabetes complications and treatment procedures. Type 1 diabetes and its complications and procedures were identified using ICD-9/ICD-10, procedure, and diagnosis-related group codes. Individuals with type 1 diabetes were followed from the year when their diabetes was initially identified in Medicare (2006-2015) until death, discontinuing plan coverage, or 31 December 2017. Fixed-effects regression was used to estimate costs in the complication occurrence year and subsequent years. The cost proportion of a complication was equal to the total cost of the complication, calculated by multiplying prevalence by the per-person cost divided by the total cost for all complications. All costs were standardized to 2017 U.S. dollars. RESULTS: Our study included 114,879 people with type 1 diabetes with lengths of follow-up from 3 to 10 years. The costliest complications per person were kidney failure treated by transplant ($77,809 in the occurrence year and $13,556 in subsequent years), kidney failure treated by dialysis ($56,469 and $41,429), and neuropathy treated by lower-extremity amputation ($40,698 and $7,380). Sixteen percent of the total medical cost for diabetes complications was for treating congestive heart failure. CONCLUSIONS: Costs of diabetes complications were large and varied by complications. Our results can assist in cost-effectiveness analysis of treatments and interventions for preventing or delaying diabetes complications in Medicare beneficiaries aged ≥65 years with type 1 diabetes. |
Changes in racial and ethnic disparities in glucose-lowering drug utilization and glycated haemoglobin A1c in US adults with diabetes: 2005-2018
Li P , Zhang P , Guan D , Guo J , Zhang Y , Pavkov ME , Bullard KM , Shao H . Diabetes Obes Metab 2023 25 (2) 516-525 AIM: To examine changes in racial and ethnic disparities in glucose-lowering drugs (GLD) use and glycated haemoglobin A1c in US adults with diabetes from 2005 to 2018. METHODS: We conducted pooled cross-sectional analysis using data from the 2005-2018 Medical Expenditure Panel Surveys, and the 2005-2018 National Health and Nutrition Examination Survey. Individuals ≥18 years with diabetes were included. Racial and ethnic disparities were measured in (a) newer non-insulin GLD use; (b) insulin analogue use; (c) non-insulin GLDs adherence; (d) insulin adherence; and (e) glucose management, along with (f) the proportion of the disparities explained by potential contributing factors. RESULTS: From 2005 to 2018, racial and ethnic disparities persisted in newer GLD use, non-insulin GLDs adherence, insulin analogue use and glucose management. In 2018, compared with non-Hispanic white adults, non-Hispanic black, Hispanic and other race/ethnicity groups had lower rates of using newer GLDs (adjusted risk ratio: 0.44, 0.52, 0.64, respectively; p < .05 for all) and insulin analogues (adjusted risk ratio: 0.93, 0.89, 0.95, respectively; p < .05 for all except other groups), lower non-insulin GLD adherence (proportion of days covered: -4.5%, -5.6%, -4.3%, respectively; p < .05 for all), higher glycated haemoglobin A1c (0.29%, 0.32%, 0.02%, respectively; p < .05 for all except other group), and similar insulin adherences. Socioeconomic and health status were the main contributors to these disparities. CONCLUSIONS: Our findings provide evidence of racial and ethnic disparities in newer GLD use and quality of care in glucose management. Our study results can inform decision-makers of the status of racial and ethnic disparities and identify ways to reduce these disparities. |
Lowering hemoglobin A1c level to less than 6.0% in people with type 2 diabetes may reduce major adverse cardiovascular events: a Bayesian's narrative
Shao H , Guo J , Laiteerapong N , Tang S , Fonseca V , Shi L , Zhang P . Curr Med Res Opin 2022 38 (11) 1-4 Whether lowering the hemoglobin A1c to <6.0% in patients with type 2 diabetes can reduce the risk of cardiovascular disease (CVD) remains under debate. The ACCORDION and the VADT studies both found reductions in the primary CVD composite associated with intensive glycemic control, though the difference is not statistically significant. However, the lack of significance is often overinterpreted as non-effective: a p-value >0.05 only implies that the study "failed to reject" the null hypothesis (i.e., lowering the A1c level to <6.0% results in no CVD benefit), which is different from concluding the null hypothesis being true. In this study, we used Bayesian analysis to reanalyze results from the ACCORDION and VADT-15 trials. Our results suggest achieving an A1c goal of <6.0% as compared to moderate control could result in a moderate risk reduction in MACE. |
Medical costs associated with diabetes complications in Medicare beneficiaries aged 65 years or older with type 2 diabetes
Wang Y , Zhang P , Shao H , Andes LJ , Imperatore G . Diabetes Care 2022 45 (11) 2570-2576 OBJECTIVE: To estimate medical costs associated with 17 major diabetes-related complications and treatment procedures among Medicare beneficiaries aged ≥65 years with type 2 diabetes. RESEARCH DESIGN AND METHODS: Claims data from 100% of Medicare beneficiaries enrolled in fee-for-service plans from 2006 to 2017 were analyzed. Records with type 2 diabetes and complications were identified using ICD-9, ICD-10, and diagnosis-related group codes. The index year was the year when a person was first identified as having diabetes with an inpatient claim or an outpatient claim plus another inpatient/outpatient claim in the 2 years following the first claim in Medicare. Included individuals were followed from index years until death, discontinuation of plan coverage, or 31 December 2017. Fixed-effects regression was used to estimate the cost in years when the complication event occurred and in subsequent years. The total cost for each complication was calculated for 2017 by multiplying the complication prevalence by the cost estimate. All costs were standardized to 2017 U.S. dollars. RESULTS: Our study included 10,982,900 beneficiaries with type 2 diabetes. Follow-up ranged from 3 to 10 years. The three costliest complications were kidney failure treated by transplant (occurring year $79,045, subsequent years $17,303), kidney failure treated by dialysis ($54,394, $38,670), and lower-extremity amputation ($38,982, $8,084). Congestive heart failure accounted for the largest share (18%) of total complication costs. CONCLUSIONS: Costs associated with diabetes complications were substantial. Our cost estimates provide essential information needed for conducting economic evaluation of treatment and programs to prevent and delay diabetes complications in Medicare beneficiaries. |
Potential gains in life expectancy associated with achieving treatment goals in US adults with type 2 diabetes
Kianmehr H , Zhang P , Luo J , Guo J , Pavkov ME , Bullard KM , Gregg EW , Ospina NS , Fonseca V , Shi L , Shao H . JAMA Netw Open 2022 5 (4) e227705 IMPORTANCE: Improvements in control of factors associated with diabetes risk in the US have stalled and remain suboptimal. The benefit of continually improving goal achievement has not been evaluated to date. OBJECTIVE: To quantify potential gains in life expectancy (LE) among people with type 2 diabetes (T2D) associated with lowering glycated hemoglobin (HbA1c), systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), and body mass index (BMI) toward optimal levels. DESIGN, SETTING, AND PARTICIPANTS: In this decision analytical model, the Building, Relating, Assessing, and Validating Outcomes (BRAVO) diabetes microsimulation model was calibrated to a nationally representative sample of adults with T2D from the National Health and Nutrition Examination Survey (2015-2016) using their linked short-term mortality data from the National Death Index. The model was then used to conduct the simulation experiment on the study population over a lifetime. Data were analyzed from January to October 2021. EXPOSURE: The study population was grouped into quartiles on the basis of levels of HbA1c, SBP, LDL-C, and BMI. LE gains associated with achieving better control were estimated by moving people with T2D from the current quartile of each biomarker to the lower quartiles. MAIN OUTCOMES AND MEASURES: Life expectancy. RESULTS: Among 421 individuals, 194 (46%) were women, and the mean (SD) age was 65.6 (8.9) years. Compared with a BMI of 41.4 (mean of the fourth quartile), lower BMIs of 24.3 (first), 28.6 (second), and 33.0 (third) were associated with 3.9, 2.9, and 2.0 additional life-years, respectively, in people with T2D. Compared with an SBP of 160.4 mm Hg (fourth), lower SBP levels of 114.1 mm Hg (first), 128.2 mm Hg (second), and 139.1 mm Hg (third) were associated with 1.9, 1.5, and 1.1 years gained in LE in people with T2D, respectively. A lower LDL-C level of 59 mg/dL (first), 84.0 mg/dL (second), and 107.0 mg/dL (third) were associated with 0.9, 0.7, and 0.5 years gain in LE, compared with LDL-C of 146.2 mg/dL (fourth). Reducing HbA1c from 9.9% (fourth) to 7.7% (third) was associated with 3.4 years gain in LE. However, a further reduction to 6.8% (second) was associated with only a mean of 0.5 years gain in LE, and from 6.8% to 5.9% (first) was not associated with LE benefit. Overall, reducing HbA1c from the fourth quartile to the first is associated with an LE gain of 3.8 years. CONCLUSIONS AND RELEVANCE: These findings can be used by clinicians to motivate patients in achieving the recommended treatment goals and to help prioritize interventions and programs to improve diabetes care in the US. |
Selecting a target population for type 2 diabetes lifestyle prevention programs: A cost-effectiveness perspective
Park J , Zhang P , Shao H , Laxy M , Imperatore G . Diabet Med 2022 39 (7) e14847 AIMS: Cost-effectiveness (CE) of lifestyle change programs (LCP) for type 2 diabetes (T2D) prevention is influenced by a participant's risk. We identified the risk threshold of developing T2D in the intervention population that was cost-effective for three formats of the LCP: delivered in-person individually or in groups, or delivered virtually. We compared the cost-effectiveness across program formats when there were more than one cost-effective formats. METHODS: Using the CDC-RTI T2D diabetes CE simulation model, we estimated CEs associated with three program formats in 8 population groups with an annual T2D incidence of 1% to 8%. We generated a nationally representative simulation population for each risk level using the 2011-2016 National Health and Nutrition Examination Survey data. We used an incremental cost-effectiveness ratio (ICER), cost per quality-adjusted life year (QALY) gained in 25-years, to measure the CEs of the programs. We took a health care system perspective RESULTS: To achieve an ICER of $50,000/QALY or lower, the annual T2D incidence of the program participant needed to be ≥5% for the in-person individual program, ≥4% for the digital individual program, and ≥3% for the in-person group program. For those with T2D risk of ≥4%, the in-person group program always dominated the digital individual program. The in-person individual program was cost-effective compared with the in-person group program only among persons with T2D risk of ≥8%. CONCLUSIONS: Our findings could assist decision-makers in selecting the most appropriate target population for different formats of lifestyle intervention programs to prevent T2D. |
Socioeconomic Factors Play a More Important Role than Clinical Needs in the Use of SGLT2 Inhibitors and GLP-1 Receptor Agonists in People With Type 2 Diabetes
Shao H , Li P , Guo J , Fonseca V , Shi L , Zhang P . Diabetes Care 2022 45 (2) e32-e33 Growing evidence from clinical trials and observational studies has demonstrated cardiac and renal benefits of two newer glucose-lowering drug classes, sodium–glucose cotransporter 2 inhibitors (SGLT2i) (including exenatide, liraglutide, dulaglutide, albiglutide, lixisenatide, and semaglutide) and glucagon-like peptide 1 receptor agonists (GLP-1RAs) (including canagliflozin, empagliflozin, dapagliflozin, and ertugliflozin) (1). The American Diabetes Association recommends these two drug classes for people with type 2 diabetes (T2D) who are at increased risk for or who have established atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), and chronic kidney disease (CKD) (2). Our previous study documented a rapid increase in the use of the two classes in commercially insured populations between 2010 and 2018 (3). In contrast, a recent study suggested that use of the new drug classes remained low in other populations, such as Medicare beneficiaries (4). Medicare beneficiaries have higher risks of ASCVD, HF, and CKD than the commercially insured population due to their older age and longer diabetes duration and, thus, could benefit more from the new drug classes. However, the low utilization rate in the Medicare population suggests other factors play a more prominent role than clinical need. The objectives of this study were to examine factors associated with the use of the two new drug classes and estimate the contributions of these factors to use of the drugs |
Exploring Structural Uncertainty and Impact of Health State Utility Values on Lifetime Outcomes in Diabetes Economic Simulation Models: Findings from the Ninth Mount Hood Diabetes Quality-of-Life Challenge
Tew M , Willis M , Asseburg C , Bennett H , Brennan A , Feenstra T , Gahn J , Gray A , Heathcote L , Herman WH , Isaman D , Kuo S , Lamotte M , Leal J , McEwan P , Nilsson A , Palmer AJ , Patel R , Pollard D , Ramos M , Sailer F , Schramm W , Shao H , Shi L , Si L , Smolen HJ , Thomas C , Tran-Duy A , Yang C , Ye W , Yu X , Zhang P , Clarke P . Med Decis Making 2021 42 (5) 272989x211065479 BACKGROUND: Structural uncertainty can affect model-based economic simulation estimates and study conclusions. Unfortunately, unlike parameter uncertainty, relatively little is known about its magnitude of impact on life-years (LYs) and quality-adjusted life-years (QALYs) in modeling of diabetes. We leveraged the Mount Hood Diabetes Challenge Network, a biennial conference attended by international diabetes modeling groups, to assess structural uncertainty in simulating QALYs in type 2 diabetes simulation models. METHODS: Eleven type 2 diabetes simulation modeling groups participated in the 9th Mount Hood Diabetes Challenge. Modeling groups simulated 5 diabetes-related intervention profiles using predefined baseline characteristics and a standard utility value set for diabetes-related complications. LYs and QALYs were reported. Simulations were repeated using lower and upper limits of the 95% confidence intervals of utility inputs. Changes in LYs and QALYs from tested interventions were compared across models. Additional analyses were conducted postchallenge to investigate drivers of cross-model differences. RESULTS: Substantial cross-model variability in incremental LYs and QALYs was observed, particularly for HbA1c and body mass index (BMI) intervention profiles. For a 0.5%-point permanent HbA1c reduction, LY gains ranged from 0.050 to 0.750. For a 1-unit permanent BMI reduction, incremental QALYs varied from a small decrease in QALYs (-0.024) to an increase of 0.203. Changes in utility values of health states had a much smaller impact (to the hundredth of a decimal place) on incremental QALYs. Microsimulation models were found to generate a mean of 3.41 more LYs than cohort simulation models (P = 0.049). CONCLUSIONS: Variations in utility values contribute to a lesser extent than uncertainty captured as structural uncertainty. These findings reinforce the importance of assessing structural uncertainty thoroughly because the choice of model (or models) can influence study results, which can serve as evidence for resource allocation decisions.HighlightsThe findings indicate substantial cross-model variability in QALY predictions for a standardized set of simulation scenarios and is considerably larger than within model variability to alternative health state utility values (e.g., lower and upper limits of the 95% confidence intervals of utility inputs).There is a need to understand and assess structural uncertainty, as the choice of model to inform resource allocation decisions can matter more than the choice of health state utility values. |
Towards a newborn screening common data model: The utah newborn screening data model
Jones D , Shao J , Wallis H , Johansen C , Hart K , Pasquali M , Gouripeddi R , Rohrwasser A . Int J Neonatal Screen 2021 7(4) (4) As newborn screening programs transition from paper-based data exchange toward automated, electronic methods, significant data exchange challenges must be overcome. This article outlines a data model that maps newborn screening data elements associated with patient demographic information, birthing facilities, laboratories, result reporting, and follow-up care to the LOINC, SNOMED CT, ICD-10-CM, and HL7 healthcare standards. The described framework lays the foundation for the implementation of standardized electronic data exchange across newborn screening programs, leading to greater data interoperability. The use of this model can accelerate the implementation of electronic data exchange between healthcare providers and newborn screening programs, which would ultimately improve health outcomes for all newborns and standardize data exchange across programs. Copyright © 2021 by the authors. Licensee MDPI, Basel, Switzerland. |
Trends in total and out-of-pocket payments for insulin among privately insured U.S. adults with diabetes from 2005 to 2018
Laxy M , Zhang P , Benoit SR , Imperatore G , Cheng YJ , Gregg EW , Yang S , Shao H . Diabetes Care 2021 More than 30 million people in the U.S. have diabetes, and approximately 7.4 million (30% of those with diabetes) regularly use one or more insulin formulations. For those who rely on it, i.e., all patients with type 1 diabetes and many patients with type 2 diabetes, insulin is a lifesaving medication. Between 2007 and 2016, the average annual total Medicare Part D payment on insulin per person increased by 358%, which resulted in an 81% increase for the out-of-pocket (OOP) payment (1). The consequences of unaffordability for insulin can be severe and costly. High OOP payments may force individuals to choose between purchasing their medication and paying for other necessities. To date, there are limited data on how total insulin payment and the corresponding OOP payment changed in the commercially insured population within the same period. The objective of this study is to delineate total and patients’ OOP payment trends for insulin among privately insured U.S. adults. |
A liposome-displayed hemagglutinin vaccine platform protects mice and ferrets from heterologous influenza virus challenge
Sia ZR , He X , Zhang A , Ang JC , Shao S , Seffouh A , Huang WC , D'Agostino MR , Teimouri Dereshgi A , Suryaprakash S , Ortega J , Andersen H , Miller MS , Davidson BA , Lovell JF . Proc Natl Acad Sci U S A 2021 118 (22) Recombinant influenza virus vaccines based on hemagglutinin (HA) hold the potential to accelerate production timelines and improve efficacy relative to traditional egg-based platforms. Here, we assess a vaccine adjuvant system comprised of immunogenic liposomes that spontaneously convert soluble antigens into a particle format, displayed on the bilayer surface. When trimeric H3 HA was presented on liposomes, antigen delivery to macrophages was improved in vitro, and strong functional antibody responses were induced following intramuscular immunization of mice. Protection was conferred against challenge with a heterologous strain of H3N2 virus, and naive mice were also protected following passive serum transfer. When admixed with the particle-forming liposomes, immunization reduced viral infection severity at vaccine doses as low as 2 ng HA, highlighting dose-sparing potential. In ferrets, immunization induced neutralizing antibodies that reduced the upper respiratory viral load upon challenge with a more modern, heterologous H3N2 viral strain. To demonstrate the flexibility and modular nature of the liposome system, 10 recombinant surface antigens representing distinct influenza virus strains were bound simultaneously to generate a highly multivalent protein particle that with 5 ng individual antigen dosing induced antibodies in mice that specifically recognized the constituent immunogens and conferred protection against heterologous H5N1 influenza virus challenge. Taken together, these results show that stable presentation of recombinant HA on immunogenic liposome surfaces in an arrayed fashion enhances functional immune responses and warrants further attention for the development of broadly protective influenza virus vaccines. |
Trends in total and out-of-pocket payments for noninsulin glucose-lowering drugs among U.S. adults with large-employer private health insurance from 2005 to 2018
Shao H , Laxy M , Benoit SR , Cheng YJ , Gregg EW , Zhang P . Diabetes Care 2021 44 (4) 925-934 OBJECTIVE: To estimate trends in total payment and patients' out-of-pocket (OOP) payments of noninsulin glucose-lowering drugs by class from 2005 to 2018. RESEARCH DESIGN AND METHODS: We analyzed data for 53 million prescriptions from adults aged >18 years with type 2 diabetes under fee-for-service plans from the 2005-2018 IBM MarketScan Commercial Databases. The total payment was measured as the amount that the pharmacy received, and the OOP payment was the sum of copay, coinsurance, and deductible paid by the beneficiaries. We applied a joinpoint regression to evaluate nonlinear trends in cost between 2005 and 2018. We further conducted a decomposition analysis to explore the drivers for total payment change. RESULTS: Total annual payments for older drug classes, including metformin, sulfonylurea, meglitinide, α-glucosidase inhibitors, and thiazolidinedione, have declined during 2005-2018, ranging from -$271 (-53.8%) (USD) for metformin to -$2,406 (-92.2%) for thiazolidinedione. OOP payments for these drug classes also reduced. In the same period, the total annual payments for the newer drug classes, including dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists, and sodium-glucose cotransporter 2 inhibitors, have increased by $2,181 (88.4%), $3,721 (77.6%), and $1,374 (37.0%), respectively. OOP payment for these newer classes remained relatively unchanged. Our study findings indicate that switching toward the newer classes for noninsulin glucose-lowering drugs was the main driver that explained the total payment increase. CONCLUSIONS: Average annual payments and OOP payment for noninsulin glucose-lowering drugs have increased significantly from 2005 to 2018. The uptake of newer drug classes was the main driver. |
Patient health utility equations for a type 2 diabetes model
Neuwahl SJ , Zhang P , Chen H , Shao H , Laxy M , Anderson AM , Craven TE , Hoerger TJ . Diabetes Care 2020 44 (2) 381-389 OBJECTIVE: To estimate the health utility impact of diabetes-related complications in a large, longitudinal U.S. sample of people with type 2 diabetes. RESEARCH DESIGN AND METHODS: We combined Health Utilities Index Mark 3 data on patients with type 2 diabetes from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) and Look AHEAD (Action for Health in Diabetes) trials and their follow-on studies. Complications were classified as events if they occurred in the year preceding the utility measurement; otherwise, they were classified as a history of the complication. We estimated utility decrements associated with complications using a fixed-effects regression model. RESULTS: Our sample included 15,252 persons with an average follow-up of 8.2 years and a total of 128,873 person-visit observations. The largest, statistically significant (P < 0.05) health utility decrements were for stroke (event, -0.109; history, -0.051), amputation (event, -0.092; history, -0.150), congestive heart failure (event, -0.051; history, -0.041), dialysis (event, -0.039), estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m(2) (event, -0.043; history, -0.025), angina (history, -0.028), and myocardial infarction (MI) (event, -0.028). There were smaller effects for laser photocoagulation and eGFR <60 mL/min/1.73 m(2). Decrements for dialysis history, angina event, MI history, revascularization event, revascularization history, laser photocoagulation event, and hypoglycemia were not significant (P ≥ 0.05). CONCLUSIONS: With use of a large study sample and a longitudinal design, our estimated health utility scores are expected to be largely unbiased. Estimates can be used to describe the health utility impact of diabetes complications, improve cost-effectiveness models, and inform diabetes policies. |
Cost-effectiveness of the new 2018 American College of Physicians Glycemic Control Guidance Statements Among US Adults With Type 2 Diabetes
Shao H , Laxy M , Gregg EW , Albright A , Zhang P . Value Health 2020 24 (2) 227-235 Objectives: This study aims to estimate the national impact and cost-effectiveness of the 2018 American College of Physicians (ACP) guidance statements compared to the status quo. Methods: Survey data from the 2011-2016 National Health and Nutrition Examination were used to generate a national representative sample of individuals with diagnosed type 2 diabetes in the United States. Individuals with A1c <6.5% on antidiabetic medications are recommended to deintensify their A1c level to 7.0% to 8.0% (group 1); individuals with A1c 6.5% to 8.0% and a life expectancy of <10 years are recommended to deintensify their A1c level >8.0% (group 2); and individuals with A1c >8.0% and a life expectancy of >10 years are recommended to intensify their A1c level to 7.0% to 8.0% (group 3). We used a Markov-based simulation model to evaluate the lifetime cost-effectiveness of following the ACP recommended A1c level. Results: 14.41 million (58.1%) persons with diagnosed type 2 diabetes would be affected by the new guidance statements. Treatment deintensification would lead to a saving of $363 600 per quality-adjusted life-year (QALY) lost for group 1 and a saving of $118 300 per QALY lost for group 2. Intensifying treatment for group 3 would lead to an additional cost of $44 600 per QALY gain. Nationally, the implementation of the guidance would add 3.2 million life-years and 1.1 million QALYs and reduce healthcare costs by $47.7 billion compared to the status quo. Conclusions: Implementing the new ACP guidance statements would affect a large number of persons with type 2 diabetes nationally. The new guidance is cost-effective. |
The Lancet Commission on diabetes: using data to transform diabetes care and patient lives
Chan JCN , Lim LL , Wareham NJ , Shaw JE , Orchard TJ , Zhang P , Lau ESH , Eliasson B , Kong APS , Ezzati M , Aguilar-Salinas CA , McGill M , Levitt NS , Ning G , So WY , Adams J , Bracco P , Forouhi NG , Gregory GA , Guo J , Hua X , Klatman EL , Magliano DJ , Ng BP , Ogilvie D , Panter J , Pavkov M , Shao H , Unwin N , White M , Wou C , Ma RCW , Schmidt MI , Ramachandran A , Seino Y , Bennett PH , Oldenburg B , Gagliardino JJ , Luk AOY , Clarke PM , Ogle GD , Davies MJ , Holman RR , Gregg EW . Lancet 2020 396 (10267) 2019-2082 2020 will go down in history as the year when the global community was awakened to the fragility of human health and the interdependence of the ecosystem, economy, and humanity. Amid the COVID-19 pandemic, the vulnerability of people with diabetes during a public health emergency became evident by their at least 2 times increased risk of severe disease or death, especially in individuals with poorly controlled diabetes, comorbidities, or both. The disease burden caused by COVID-19, exacerbated by chronic conditions like diabetes, has inflicted a heavy toll on health-care systems and the global economy. | | In this Lancet Commission on diabetes, which embodies 4 years of extensive work on data curation, synthesis, and modelling, we urge policy makers, payers, and planners to collectively change the ecosystem, build capacity, and improve the clinical practice environment. Such actions will enable practitioners to systematically collect data during routine practice and to use these data effectively to diagnose early, stratify risks, define needs, improve care, evaluate solutions, and drive changes at patient, system, and policy levels to prevent and control diabetes and other non-communicable diseases. Emerging evidence regarding the possible damaging effects of severe acute respiratory syndrome coronavirus 2 on pancreatic islets implies the potential worsening of the COVID-19 pandemic and the diabetes epidemic, adding to the urgency of these collective actions. | | Prevention, early detection, prompt diagnosis, and continuing care with regular monitoring and ongoing evaluation are key elements in reducing the growing burden of diabetes. Given the silent and progressive nature of diabetes, it is epidemiological analyses that have provided a framework for identifying populations and subgroups at risk of diabetes and its complications. Although the total prevalence of diabetes reflects disease burden, incidence rates might reflect the effects of interventions among determinant factors that include, but are not limited to, political, socioeconomical, and technological changes within a population, area, or both. | | In 2019, 463 million people had diabetes worldwide, with 80% from low-income and middle-income countries. Over 70% of global deaths are due to non-communicable diseases, including diabetes, cardiovascular disease, cancer, and respiratory disease. On average, diabetes reduces life expectancy in people aged 40–60 years by 4–10 years and independently increases the risk of death from cardiovascular disease, renal disease, and cancer by 1·3–3·0 times. Diabetes is among the leading causes of non-traumatic lower extremity amputation and blindness, especially in people of working age. The co-occurrence of these morbidities severely impairs quality of life, reduces productivity, and causes major suffering. |
Estimating costs of diabetes complications in people <65years in the U.S. using panel data
Yang W , Cintina I , Hoerger T , Neuwahl SJ , Shao H , Laxy M , Zhang P . J Diabetes Complications 2020 34 (12) 107735 AIMS: To estimate the cost of diabetes complications in the United States (U.S.). METHODS: We constructed longitudinal panel data using one of the largest claims databases in the U.S. for privately insured Type 1 (T1DM) and type 2 (T2DM) diabetes patients with a follow-up time of one to ten years. Complication costs were estimated both in years of the first occurrence and in subsequent years, using individual fixed-effects models. All costs were in 2016 dollars. RESULTS: 47,166 people with T1DM and 608,237 with T2DM were included in our study. Aside from organ transplants, which were rare, the estimated average costs for the top three most costly conditions in the first vs. subsequent years were: end stage renal disease ($73,534 vs. $97,431 for T1DM; $94,231 vs. $98,981 for T2DM), congestive heart failure ($41,681 vs. $14,855 for T1DM; $31,202 vs. $7062 for T2DM), and myocardial infarction ($40,899 vs. $9496 for T1DM; $45,251 vs. $8572 for T2DM). For both diabetes types, retinopathy and neuropathy tend to have the lowest cost estimates. CONCLUSIONS: Our study provides the latest and most comprehensive cost estimates for a broad set of diabetes complications needed to evaluate the long-term cost-effectiveness of interventions for preventing and managing diabetes. |
Within-trial cost-effectiveness of lifestyle intervention using a 3-tier shared care approach for pregnancy outcomes in Chinese women with gestational diabetes
Li W , Zhang C , Leng J , Shao P , Tian H , Zhang F , Dong L , Yu Z , Chan JCN , Hu G , Zhang P , Yang X . PLoS One 2020 15 (8) e0237738 This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM). SC consisted of an individualized dietary advice and physical activity counseling program. The UC was a one-time group education program. The effectiveness was measured by number needed to treat (NNT) to prevent one macrosomia/large for gestational age (LGA) infant. The cost-effectiveness was measured by incremental cost-effectiveness ratio in terms of cost (2012 Chinese Yuan/US dollar) per case of macrosomia and LGA prevented. The study took both a health care system and a societal perspective. This study found that the NNT was 16/14 for macrosomia/LGA. The incremental cost for treating a pregnant woman was ¥1,877 ($298) from a health care system perspective and ¥2,056 ($327) from a societal perspective. The cost of preventing a case of macrosomia/LGA from the two corresponding perspectives were ¥30,032/¥26,278 ($4,775/$4,178) and ¥32,896/¥28,784 ($5,230/$4,577), respectively. Considering the potential severe adverse health and economic consequences of a macrosomia/LGA infant, our findings suggest that implementing this lifestyle intervention for women with GDM is an efficient use of health care resources. |
Evaluating the ability of economic models of diabetes to simulate new cardiovascular outcomes trials: A report on the Ninth Mount Hood Diabetes Challenge
Si L , Willis MS , Asseburg C , Nilsson A , Tew M , Clarke PM , Lamotte M , Ramos M , Shao H , Shi L , Zhang P , McEwan P , Ye W , Herman WH , Kuo S , Isaman DJ , Schramm W , Sailer F , Brennan A , Pollard D , Smolen HJ , Leal J , Gray A , Patel R , Feenstra T , Palmer AJ . Value Health 2020 23 (9) 1163-1170 Objectives: The cardiovascular outcomes challenge examined the predictive accuracy of 10 diabetes models in estimating hard outcomes in 2 recent cardiovascular outcomes trials (CVOTs) and whether recalibration can be used to improve replication. Methods: Participating groups were asked to reproduce the results of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) and the Canagliflozin Cardiovascular Assessment Study (CANVAS) Program. Calibration was performed and additional analyses assessed model ability to replicate absolute event rates, hazard ratios (HRs), and the generalizability of calibration across CVOTs within a drug class. Results: Ten groups submitted results. Models underestimated treatment effects (ie, HRs) using uncalibrated models for both trials. Calibration to the placebo arm of EMPA-REG OUTCOME greatly improved the prediction of event rates in the placebo, but less so in the active comparator arm. Calibrating to both arms of EMPA-REG OUTCOME individually enabled replication of the observed outcomes. Using EMPA-REG OUTCOME–calibrated models to predict CANVAS Program outcomes was an improvement over uncalibrated models but failed to capture treatment effects adequately. Applying canagliflozin HRs directly provided the best fit. Conclusions: The Ninth Mount Hood Diabetes Challenge demonstrated that commonly used risk equations were generally unable to capture recent CVOT treatment effects but that calibration of the risk equations can improve predictive accuracy. Although calibration serves as a practical approach to improve predictive accuracy for CVOT outcomes, it does not extrapolate generally to other settings, time horizons, and comparators. New methods and/or new risk equations for capturing these CV benefits are needed. |
Factors contributing to the rising national cost of glucose-lowering medicines for diabetes during 2005-2007 and 2015-2017
Zhou X , Shrestha SS , Shao H , Zhang P . Diabetes Care 2020 43 (10) 2396-2402 OBJECTIVE: We examined changes in glucose-lowering medication spending and quantified the magnitude of factors that are contributing to these changes. RESEARCH DESIGN AND METHODS: Using the Medical Expenditure Panel Survey, we estimated the change in spending on glucose-lowering medications during 2005-2007 and 2015-2017 among adults aged ≥18 years with diabetes. We decomposed the increase in total spending by medication groups: for insulin, by human and analog; and for noninsulin, by metformin, older, newer, and combination medications. For each group, we quantified the contributions by the number of users and cost-per-user. Costs were in 2017 U.S. dollars. RESULTS: National spending on glucose-lowering medications increased by $40.6 billion (240%), of which insulin and noninsulin medications contributed $28.6 billion (169%) and $12.0 billion (71%), respectively. For insulin, the increase was mainly associated with higher expenditures from analogs (156%). For noninsulin, the increase was a net effect of higher cost for newer medications (+88%) and decreased cost for older medications (-34%). Most of the increase in insulin spending came from the increase in cost-per-user. However, the increase in the number of users contributed more than cost-per-user in the rise of most noninsulin groups. CONCLUSIONS: The increase in national spending on glucose-lowering medications during the past decade was mostly associated with the increased costs for insulin, analogs in particular, and newer noninsulin medicines; and cost-per-user had a larger effect than the number of users. Understanding the factors contributing to the increase helps identify ways to curb the growth in costs. |
Implementing lifestyle change interventions to prevent type 2 diabetes in US Medicaid programs: Cost effectiveness, and cost, health, and health equity impact
Laxy M , Zhang P , Ng BP , Shao H , Ali MK , Albright A , Gregg EW . Appl Health Econ Health Policy 2020 18 (5) 713-726 BACKGROUND: Lifestyle change interventions (LCI) for prevention of type 2 diabetes are covered by Medicare, but rarely by US Medicaid programs that constitute the largest public payer system in the USA. We estimate the long-term health and economic implications of implementing LCIs in state Medicaid programs. METHODS: We compared LCIs modeled after the intervention of the Diabetes Prevention Program versus routine care advice using a decision analytic simulation model and best available data from representative surveys, cohort studies, Medicaid claims data, and the published literature. Target population were non-disability-based adult Medicaid beneficiaries aged 19-64 years at high risk for type 2 diabetes (BMI >/=25 kg/m(2) and HbA1c >/= 5.7% or fasting plasma glucose >/= 110 mg/dl) from eight study states (Alabama, California, Connecticut, Florida, Iowa, Illinois, New York, Oklahoma) that represent around 50% of the US Medicaid population. Incremental cost-effectiveness ratios (ICERs) measured in cost per quality-adjusted life years (QALYs) gained, and population cost and health impact were modeled from a healthcare system perspective and a narrow Medicaid perspective. RESULTS: In the eight selected study states, 1.9 million or 18% of non-disability-based adult Medicaid beneficiaries would belong to the eligible high-risk target population - 66% of them Hispanics or non-Hispanic black. In the base-case analysis, the aggregated 5- and 10-year ICERs are US$226 k/QALY and US$34 k/QALY; over 25 years, the intervention dominates routine care. The 5-, 10-, and 25-year probabilities that the ICERs are below US$50 k (US$100 k)/QALY are 6% (15%), 59% (82%) and 96% (100%). From a healthcare system perspective, initial program investments of US$800 per person would be offset after 13 years and translate to US$548 of savings after 25 years. With a 20% LCI uptake in eligible beneficiaries, this would translate to upfront costs of US$300 million, prevent 260 thousand years of diabetes and save US$205 million over a 25-year time horizon. Cost savings from a narrow Medicaid perspective would be much smaller. Minorities and low-income groups would over-proportionally benefit from LCIs in Medicaid, but the impact on population health and health equity would be marginal. CONCLUSIONS: In the long-term, investments in LCIs for Medicaid beneficiaries are likely to improve health and to decrease healthcare expenditures. However, population health and health equity impact would be low and healthcare expenditure savings from a narrow Medicaid perspective would be much smaller than from a healthcare system perspective. |
First international external quality assessment scheme of nucleic acid amplification tests for the detection of Schistosoma and soil-transmitted helminths, including Strongyloides: A pilot study
Cools P , van Lieshout L , Koelewijn R , Addiss D , Ajjampur SSR , Ayana M , Bradbury RS , Cantera JL , Dana D , Fischer K , Imtiaz R , Kabagenyi J , Lok J , McCarthy J , Mejia R , Mekonnen Z , Njenga SM , Othman N , Shao H , Traub R , Van Esbroeck M , Vercruysse J , Vlaminck J , Williams SA , Verweij JJ , van Hellemond JJ , Levecke B . PLoS Negl Trop Dis 2020 14 (6) e0008231 BACKGROUND: Nucleic acid amplification tests (NAATs) are increasingly being used as diagnostic tools for soil-transmitted helminths (STHs; Ascaris lumbricoides, Trichuris trichiura, Necator americanus, Ancylostoma duodenale and A. ceylanicum), Strongyloides stercoralis and Schistosoma in human stool. Currently, there is a large diversity of NAATs being applied, but an external quality assessment scheme (EQAS) for these diagnostics is lacking. An EQAS involves a blinded process where test results reported by a laboratory are compared to those reported by reference or expert laboratories, allowing for an objective assessment of the diagnostic performance of a laboratory. In the current study, we piloted an international EQAS for these helminths (i) to investigate the feasibility of designing and delivering an EQAS; (ii) to assess the diagnostic performance of laboratories; and (iii) to gain insights into the different NAAT protocols used. METHODS AND PRINCIPAL FINDINGS: A panel of twelve stool samples and eight DNA samples was validated by six expert laboratories for the presence of six helminths (Ascaris, Trichuris, N. americanus, Ancylostoma, Strongyloides and Schistosoma). Subsequently this panel was sent to 15 globally dispersed laboratories. We found a high degree of diversity among the different DNA extraction and NAAT protocols. Although most laboratories performed well, we could clearly identify the laboratories that were poorly performing. CONCLUSIONS/SIGNIFICANCE: We showed the technical feasibility of an international EQAS for the NAAT of STHs, Strongyloides and Schistosoma. In addition, we documented that there are clear benefits for participating laboratories, as they can confirm and/or improve the diagnostic performance of their NAATs. Further research should aim to identify factors that explain poor performance of NAATs. |
Selecting the optimal risk threshold of diabetes risk scores to identify high-risk individuals for diabetes prevention: a cost-effectiveness analysis
Muhlenbruch K , Zhuo X , Bardenheier B , Shao H , Laxy M , Icks A , Zhang P , Gregg EW , Schulze MB . Acta Diabetol 2019 57 (4) 447-454 AIMS: Although risk scores to predict type 2 diabetes exist, cost-effectiveness of risk thresholds to target prevention interventions are unknown. We applied cost-effectiveness analysis to identify optimal thresholds of predicted risk to target a low-cost community-based intervention in the USA. METHODS: We used a validated Markov-based type 2 diabetes simulation model to evaluate the lifetime cost-effectiveness of alternative thresholds of diabetes risk. Population characteristics for the model were obtained from NHANES 2001-2004 and incidence rates and performance of two noninvasive diabetes risk scores (German diabetes risk score, GDRS, and ARIC 2009 score) were determined in the ARIC and Cardiovascular Health Study (CHS). Incremental cost-effectiveness ratios (ICERs) were calculated for increasing risk score thresholds. Two scenarios were assumed: 1-stage (risk score only) and 2-stage (risk score plus fasting plasma glucose (FPG) test (threshold 100 mg/dl) in the high-risk group). RESULTS: In ARIC and CHS combined, the area under the receiver operating characteristic curve for the GDRS and the ARIC 2009 score were 0.691 (0.677-0.704) and 0.720 (0.707-0.732), respectively. The optimal threshold of predicted diabetes risk (ICER < $50,000/QALY gained in case of intervention in those above the threshold) was 7% for the GDRS and 9% for the ARIC 2009 score. In the 2-stage scenario, ICERs for all cutoffs >/= 5% were below $50,000/QALY gained. CONCLUSIONS: Intervening in those with >/= 7% diabetes risk based on the GDRS or >/= 9% on the ARIC 2009 score would be cost-effective. A risk score threshold >/= 5% together with elevated FPG would also allow targeting interventions cost-effectively. |
Development and characterization of a reverse genetics system for influenza D virus.
Yu J , Liu R , Zhou B , Chou TW , Ghedin E , Sheng Z , Gao R , Zhai SL , Wang D , Li F . J Virol 2019 93 (21) Influenza D virus (IDV) of the Orthomyxoviridae family has a wide host range and a broad geographical distribution. Recent IDV outbreaks in swine along with serological and genetic evidence of IDV infection in humans have raised concerns regarding the zoonotic potential of this virus. To better study IDV at the molecular level, a reverse-genetics system (RGS) is urgently needed, but to date, no RGS had been described for IDV. In this study, we rescued the recombinant influenza D/swine/Oklahoma/1314/2011 (D/OK) virus by using a bidirectional seven-plasmid-based system and further characterized rescued viruses in terms of growth kinetics, replication stability, and receptor-binding capacity. Our results collectively demonstrated that RGS-derived viruses resembled the parental viruses for these properties, thereby supporting the utility of this RGS to study IDV infection biology. In addition, we developed an IDV minigenome replication assay and identified the E697K mutation in PB1 and the L462F mutation in PB2 that directly affected the activity of the IDV ribonucleoprotein (RNP) complex, resulting in either attenuated or replication-incompetent viruses. Finally, by using the minigenome replication assay, we demonstrated that a single nucleotide polymorphism at position 5 of the 3' conserved noncoding region in IDV and influenza C virus (ICV) resulted in the inefficient cross-recognition of the heterotypic promoter by the viral RNP complex. In conclusion, we successfully developed a minigenome replication assay and a robust reverse-genetics system that can be used to further study replication, tropism, and pathogenesis of IDV.IMPORTANCE Influenza D virus (IDV) is a new type of influenza virus that uses cattle as the primary reservoir and infects multiple agricultural animals. Increased outbreaks in pigs and serological and genetic evidence of human infection have raised concerns about potential IDV adaptation in humans. Here, we have developed a plasmid-based IDV reverse-genetics system that can generate infectious viruses with replication kinetics similar to those of wild-type viruses following transfection of cultured cells. Further characterization demonstrated that viruses rescued from the described RGS resembled the parental viruses in biological and receptor-binding properties. We also developed and validated an IDV minireplicon reporter system that specifically measures viral RNA polymerase activity. In summary, the reverse-genetics system and minireplicon reporter assay described in this study should be of value in identifying viral determinants of cross-species transmission and pathogenicity of novel influenza D viruses. |
Influence of diabetes complications on HbA1c treatment goals among older U.S. Adults: A cost-effectiveness analysis
Shao H , Lin J , Zhuo X , Rolka DB , Gregg EW , Zhang P . Diabetes Care 2019 42 (11) 2136-2142 OBJECTIVE: Guidelines on the standard care of diabetes recommend that glycemic treatment goals for older adults consider the patient's complications and life expectancy. In this study, we examined the influence of diabetes complications and associated life expectancies on the cost-effectiveness (CE) of HbA1c treatment goals. RESEARCH DESIGN AND METHODS: We used data from the 2011 to 2016 National Health and Nutrition Examination Survey (NHANES) to generate nationally representative subgroups of older individuals with diabetes with various health states. We used the Centers for Disease Control and Prevention-RTI International diabetes CE model to estimate the long-term consequences of two treatment goals-a stringent control goal (HbA1c <7.5%) and a moderate control goal (HbA1c <8.5%)-on health and cost. Our simulation population represented typical patients, and all individuals in each health subgroup had average characteristics, which did not account for person-level variations. The CE study was conducted from a health system perspective and followed the study samples over a lifetime. We used $50,000 per quality-adjusted life year (QALY) as the incremental CE threshold. RESULTS: A stringent goal was, on average, cost-effective for individuals with no complications ($10,007 per QALY) or only microvascular complications (excluding renal failure; $19,621 per QALY), but it was not cost-effective for individuals with one or more macrovascular complications (all >$82,413 per QALY). Further, a stringent goal was not cost-effective when an individual had less than 7 years of life remaining. CONCLUSIONS: Our findings support the guideline recommendation that glycemic goals for older adults should consider the complexity of their complications and their life expectancy from a CE perspective. |
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