Cost-effectiveness of carotid artery stenting vs endarterectomy: A simulation.

OBJECTIVE: Clinical trials conducted before the introduction of modern medical management to prevent stroke demonstrated that carotid endarterectomy (CEA) and carotid artery stenting (CAS) prevent stroke following transient ischemic attack (TIA). We compared the cost-effectiveness of CEA, CAS, and modern medical management in two secular settings of medical management in individuals with incident TIA and type 2 diabetes. METHODS: Using simulation modeling, our base-case analyses were performed from the healthcare sector perspective over a 20-year time horizon with an annual 3% discount rate applied to both costs and quality-adjusted life years (QALYs). Outcomes depended on age, sex, biomarkers associated with cardiovascular risk, and treatment effects based on a validated model of type 2 diabetes. Our simulation population was drawn from the National Health and Nutrition Examination Survey (NHANES) 2014 cohort. Costs for modern medical management were based on average wholesale prices, and revascularization costs were derived from published literature. One-way and probabilistic sensitivity analyses were conducted. RESULTS: Compared to all other strategies, historical medical management plus CEA was either cost-saving or cost-effective at a threshold of $100,000 per QALY gained. Modern medical management was cost-effective compared to historical medical management without revascularization at a $100,000 acceptability threshold. However, both revascularization approaches (plus medical management) were cost-saving compared to modern medical management alone. CONCLUSION: Among individuals requiring carotid revascularization, carotid endarterectomy is the cost-effective strategy to treat individuals with type 2 diabetes following a TIA. For individuals for whom revascularization is contraindicated, modern medical therapy is cost-effective.

[Distribution Characteristics and Risk Assessment of Antimony in Typical Urban Soil].

In order to study the distribution characteristics and potential risk of antimony (Sb) in urban soil, the concentrations of soil Sb in four different land use types were analyzed based on the data of 1670 soil samples with different vertical profiles in 102 plots in Shanghai. The risks were evaluated using the potential ecological risk index method and health risk assessment model. The results showed that the average ω(Sb) in the study area was 0.52 mg·kg-1, and the content of soil Sb gradually declined with the rise in soil profile depth. Sb was enriched in surface soil, which indicated that human activities had caused disturbance to the distribution of Sb in the soil. The content of Sb in the surface soil of industrial land was higher than that of residential land and commercial land, and the content of Sb in agricultural land was the lowest. The single-factor pollution index of industrial land was the highest, reaching a slight pollution level, whereas the residential land, commercial land, and agricultural land were at even-clean or clean levels, respectively. The whole region showed slight ecological risk, with the potential ecological risk index ranging from 4.23 to 7.61. The potential ecological risk level of industrial land was moderate, which needs to be addressed. The results of health risk assessment showed that the non-carcinogenic risk of Sb in the soil was low; however, it is of great concern to residents, especially children, when on residential land.

Monitoring, cross-resistance, inheritance, and fitness costs of brown planthoppers, Nilaparvata lugens, resistance to pymetrozine in China.

BACKGROUND: The brown planthopper, Nilaparvata lugens, is considered the most destructive pest of rice in many Asian countries including China. Use of pymetrozine in insect resistance management (IRM) has been one strategy to control this pest. In this study, we reported the status of pymetrozine resistance in Nilaparvata lugens (Stål) collected from China over the period 2017-2021 and selected a strain of N. lugens resistant to pymetrozine and evaluated the cross-resistance, inheritance and fitness costs of the resistance. RESULTS: Monitoring data (2017-2021) showed that field populations of N. lugens in China developed moderate- to high-level pymetrozine resistance during these 5 years. By continuous selection with pymetrozine in the lab, the pymetrozine selected N. lugens strain (Pym-R98 ) developed a 225.2-fold resistance compared to a susceptible strain. The Pym-R98 strain showed high cross-resistance to dinotefuran (66.6-fold) and low cross-resistance to nitenpyram (5.2-fold) and sulfoxaflor (5.8-fold). Inheritance pattern analysis of Pym-R93 revealed that resistance to pymetrozine was polygenic, autosomal and incompletely dominant. Fitness costs of pymetrozine resistance were present in Pym-R90 and WA2020 strains with a relative fitness of 0.72 and 0.60, respectively. The developmental duration of Pym-R90 and WA2020 was significantly longer and hatchability was significantly lower compared to pymetrozine-susceptible strain (Pym-S). CONCLUSIONS: N. lugens has developed high level of resistance to pymetrozine. Pymetrozine-resistance brown planthopper had cross-resistance with some of neonicotinoids such as dinotefuran, nitenpyram and sulfoxaflor. The autosomal, incompletely dominant and polygenic resistance to pymetrozine in N. lugens and the fitness costs associated with this resistance can be exploited in IRM strategies to preserve the lifetime of pymetrozine for control of N. lugens in China. © 2022 Society of Chemical Industry.

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.

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.

Fracture risk assessment in children with benign bone lesions of long bones.

BACKGROUND: Fracture risk assessment in children with benign bone lesions of long bones remains poorly investigated. AIM: To investigate the risk factors for pathological fracture in children with benign bone lesions and to propose a modified scoring system for quantitative analysis of the pathologic fracture risk. METHODS: We retrospectively reviewed 96 pediatric patients with benign bone lesions. We compared radiographic and clinical features between 40 patients who had fractures through a benign bone lesion and 56 who had no fracture. Information including histological diagnosis, anatomical site, radiographic appearance, severity of pain, and lesion size was recorded for the patients. A modified scoring system was proposed to predict the risk of fracture. RESULTS: The univariate comparisons showed a significant difference between the fracture and non-fracture groups in terms of lesion type, pain, lesion-to-bone width, and axial cortical involvement of the patients (P < 0.05). Lesion type, pain, lesion-to-bone width, and axial cortical involvement were independently correlated with an increased risk of fracture. The mean score of the fracture group was 7.89, whereas the mean score of the non-fracture group was 6.01. The optimum cut-off value of the score to predict pathological fracture was 7. The scoring system had a sensitivity of 70% and a specificity of 80% for detecting patients with fractures. The Youden index was 0.5, which was the maximum value. The area under the receiver operator characteristic was 0.814. CONCLUSION: Lesion type, pain, lesion-to-bone width, and axial cortical involvement are risk factors for pathological fracture. The modified scoring system can provide evidence for clinical decision-making in children with benign bone lesions. A bone lesion with a total score > 7 indicates a high risk of a pathologic fracture and is an indication for prophylactic internal fixation.

Cost-Effectiveness of a Diabetes Self-Management Education and Support Intervention Led by Community Health Workers and Peer Leaders: Projections From the Racial and Ethnic Approaches to Community Health Detroit Trial.

OBJECTIVE: To simulate the long-term cost-effectiveness of a peer leader (PL)-led diabetes self-management support (DSMS) program following a structured community health worker (CHW)-led diabetes self-management education (DSME) program in reducing risks of complications in people with type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: The trial randomized 222 Latino adults with T2D to 1) enhanced usual care (EUC); 2) a CHW-led, 6-month DSME program and 6 months of CHW-delivered monthly telephone outreach (CHW only); or 3) a CHW-led, 6-month DSME program and 12 months of PL-delivered weekly group sessions with telephone outreach to those unable to attend (CHW + PL). Empirical data from the trial and the validated Michigan Model for Diabetes were used to estimate cost and health outcomes over a 20-year time horizon from a health care sector perspective, discounting both costs and benefits at 3% annually. The primary outcome measure was the incremental cost-effectiveness ratio (ICER). RESULTS: Over 20 years, the CHW + PL intervention had an ICER of $28,800 and $5,900 per quality-adjusted life-year (QALY) gained compared with the EUC and CHW-only interventions, respectively. The CHW-only intervention had an ICER of $430,600 per QALY gained compared with the EUC intervention. In sensitivity analyses, the results comparing the CHW + PL with EUC and CHW-only interventions were robust to changes in intervention effects and costs. CONCLUSIONS: The CHW + PL-led DSME/DSMS intervention improved health and provided good value compared with the EUC intervention. The 6-month CHW-led DSME intervention without further postintervention CHW support was not cost effective in Latino adults with T2D.

Cost-effectiveness of Community-Based Depression Interventions for Rural and Urban Adults With Type 2 Diabetes: Projections From Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II.

OBJECTIVE: We estimated the cost-effectiveness of the Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II community-based exercise (EXER), cognitive behavioral therapy (CBT), and EXER+CBT interventions in adults with type 2 diabetes and depression relative to usual care (UC) and each other. RESEARCH DESIGN AND METHODS: Data were integrated into the Michigan Model for Diabetes to estimate cost and health outcomes over a 10-year simulation time horizon from the health care sector and societal perspectives, discounting costs and benefits at 3% annually. Primary outcome was cost per quality-adjusted life-year (QALY) gained. RESULTS: From the health care sector perspective, the EXER intervention strategy saved $313 (USD) per patient and produced 0.38 more QALY (cost saving), the CBT intervention strategy cost $596 more and gained 0.29 more QALY ($2,058/QALY), and the EXER+CBT intervention strategy cost $403 more and gained 0.69 more QALY ($585/QALY) compared with UC. Both EXER and EXER+CBT interventions dominated the CBT intervention. Compared with EXER, the EXER+CBT intervention strategy cost $716 more and gained 0.31 more QALY ($2,323/QALY). From the societal perspective, compared with UC, the EXER intervention strategy saved $126 (cost saving), the CBT intervention strategy cost $2,838/QALY, and the EXER+CBT intervention strategy cost $1,167/QALY. Both EXER and EXER+CBT interventions still dominated the CBT intervention. In comparison with EXER, the EXER+CBT intervention strategy cost $3,021/QALY. Results were robust in sensitivity analyses. CONCLUSIONS: All three Program ACTIVE II interventions represented a good value for money compared with UC. The EXER+CBT intervention was highly cost-effective or cost saving compared with the CBT or EXER interventions.

Costs implications of pneumococcal vaccination of adults aged 30-60 with a recent diagnosis of diabetes.

OBJECTIVE: The 23-valent pneumococcal polysaccharide vaccine is routinely recommended for adults with diabetes, but little is known about adherence to this recommendation and how vaccination of these adults affects costs related to pneumococcal disease. RESEARCH DESIGN AND METHODS: We used data from a commercial insurance claims dataset to examine a cohort of non-elderly adults with a new diagnosis of diabetes and adults with no diagnosis of diabetes from 2005 to 2014. We examined rates of pneumococcal polysaccharide vaccination and the relationship between vaccination and pneumococcal disease costs, comparing results for persons with a diagnosis of diabetes and those with no diagnosis of diabetes. RESULTS: Overall rates of pneumococcal polysaccharide vaccination among adults 30-60 years old were <1%/year. Rates of pneumococcal polysaccharide vaccination were higher for adults with diabetes. Pneumococcal polysaccharide vaccination rates more than doubled from 2.9% per year in 2005 to 6.0% per year in 2014 for adults vaccinated during the same year as their diabetes diagnosis. Using a two-part differences-in-differences model on a propensity-score matched dataset, pneumococcal polysaccharide vaccination may reduce average annual per-person pneumococcal disease costs by $90.54 [95% CI: $183.59, -$2.49, (p = 0.056)] in persons with diabetes from two years before to two years after vaccination. CONCLUSIONS: Non-elderly adults with diabetes have low but rising rates of pneumococcal polysaccharide vaccination. Pneumococcal polysaccharide vaccination has a modest impact reducing overall costs of pneumococcal disease in this population.

Evaluating the Ability of Economic Models of Diabetes to Simulate New Cardiovascular Outcomes Trials: A Report on the Ninth Mount Hood Diabetes Challenge.

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.

Contextualizing tuberculosis risk in time and space: comparing time-restricted genotypic case clusters and geospatial clusters to evaluate the relative contribution of recent transmission to incidence of TB using nine years of case data from Michigan, USA.

PURPOSE: Novel approaches must address the underlying factors sustaining the tuberculosis (TB) epidemic in the United States, specifically what maintains new Mycobacterium tuberculosis (Mtb) transmission. METHODS: Culture-confirmed TB cases reported to the Michigan Department of Health and Human Services (2004-2012) were analyzed for time-restricted genotypic and/or geospatial clustering. Cases with both types of clustering were used as a proxy for recent, local transmission. Modified, multivariate Poisson regression models were fit to estimate this prevalence in relation to various individual- and neighborhood-level demographic and socio-economic variables. RESULTS: Those individuals that were spatially clustered were 1.7 times as likely to also be time-restricted genotypically clustered. The prevalence of recent, local transmission was higher among U.S.-born cases, males, and non-Hispanic blacks. Moreover, people living in neighborhoods in the highest poverty quartile had 13.8 times the prevalence of recent, local transmission compared with those in the lowest poverty neighborhoods. CONCLUSIONS: Our results suggest geographic areas with high concentration of TB cases are likely driven by ongoing transmission, rather than enclaves of individuals who have reactivated a case of latent TB. Furthermore, efforts to continue reducing Mtb transmission in the United States, and other low-incidence settings, must better identify community-level sources of risk, manifested through the complex social interactions among people and their environments.

The Challenge of Transparency and Validation in Health Economic Decision Modelling: A View from Mount Hood.

Transparency in health economic decision modelling is important for engendering confidence in the models and in the reliability of model-based cost-effectiveness analyses. The Mount Hood Diabetes Challenge Network has taken a lead in promoting transparency through validation with biennial conferences in which diabetes modelling groups meet to compare simulated outcomes of pre-specified scenarios often based on the results of pivotal clinical trials. Model registration is a potential method for promoting transparency, while also reducing the duplication of effort. An important network initiative is the ongoing construction of a diabetes model registry (https://www.mthooddiabeteschallenge.com). Following the 2012 International Society for Pharmacoeconomics and Outcomes Research and the Society of Medical Decision Making (ISPOR-SMDM) guidelines, we recommend that modelling groups provide technical and non-technical documentation sufficient to enable model reproduction, but not necessarily provide the model code. We also request that modelling groups upload documentation on the methods and outcomes of validation efforts, and run reference case simulations so that model outcomes can be compared. In this paper, we discuss conflicting definitions of transparency in health economic modelling, and describe the ongoing development of a registry of economic models for diabetes through the Mount Hood Diabetes Challenge Network, its objectives and potential further developments, and highlight the challenges in its construction and maintenance. The support of key stakeholders such as decision-making bodies and journals is key to ensuring the success of this and other registries. In the absence of public funding, the development of a network of modellers is of huge value in enhancing transparency, whether through registries or other means.

Computer Modeling of Diabetes and Its Transparency: A Report on the Eighth Mount Hood Challenge.

OBJECTIVES: The Eighth Mount Hood Challenge (held in St. Gallen, Switzerland, in September 2016) evaluated the transparency of model input documentation from two published health economics studies and developed guidelines for improving transparency in the reporting of input data underlying model-based economic analyses in diabetes. METHODS: Participating modeling groups were asked to reproduce the results of two published studies using the input data described in those articles. Gaps in input data were filled with assumptions reported by the modeling groups. Goodness of fit between the results reported in the target studies and the groups' replicated outputs was evaluated using the slope of linear regression line and the coefficient of determination (R2). After a general discussion of the results, a diabetes-specific checklist for the transparency of model input was developed. RESULTS: Seven groups participated in the transparency challenge. The reporting of key model input parameters in the two studies, including the baseline characteristics of simulated patients, treatment effect and treatment intensification threshold assumptions, treatment effect evolution, prediction of complications and costs data, was inadequately transparent (and often missing altogether). Not surprisingly, goodness of fit was better for the study that reported its input data with more transparency. To improve the transparency in diabetes modeling, the Diabetes Modeling Input Checklist listing the minimal input data required for reproducibility in most diabetes modeling applications was developed. CONCLUSIONS: Transparency of diabetes model inputs is important to the reproducibility and credibility of simulation results. In the Eighth Mount Hood Challenge, the Diabetes Modeling Input Checklist was developed with the goal of improving the transparency of input data reporting and reproducibility of diabetes simulation model results.

Individual- and neighborhood-level contextual factors are associated with Mycobacterium tuberculosis transmission: genotypic clustering of cases in Michigan, 2004-2012.

PURPOSE: Using genotyping data of Mycobacterium tuberculosis isolates from new cases reported to the tuberculosis (TB) surveillance program, we evaluated risk factors for recent TB transmission at both the individual- and neighborhood- levels among U.S.-born and foreign-born populations. METHODS: TB cases (N = 1236) reported in Michigan during 2004 to 2012 were analyzed using multivariable Poisson regression models to examine risk factors for recent transmission cross-sectionally for U.S.-born and foreign-born populations separately. Recent transmission was defined based on spoligotype and 12-locus-mycobacterial interspersed repetitive unit-variable number tandem repeat typing matches of bacteria from cases that were diagnosed within 1 year of each other. Four classes of predictor variables were examined: demographic factors, known TB risk factors, clinical characteristics, and neighborhood-level factors. RESULTS: Overall, 22% of the foreign-born cases resulted from recent transmission. Among the foreign-born, race and being a contact of an infectious TB case were significant predictors of recent transmission. More than half (52%) of U.S.-born cases resulted from recent transmission. Among the U.S.-born, recent transmission was predicted by both individual- and neighborhood-level sociodemographic characteristics. CONCLUSIONS: Interventions aimed at reducing TB incidence among foreign-born should focus on reducing reactivation of latent infection. However, reducing TB incidence among the U.S.-born will require decreasing transmission among socially disadvantaged groups at the individual- and neighborhood- levels. This report fills an important knowledge gap regarding the contemporary social context of TB in the United States, thereby providing a foundation for future studies of public health policies that can lead to the development of more targeted, effective TB control.

Race and nativity are major determinants of tuberculosis in the U.S.: evidence of health disparities in tuberculosis incidence in Michigan, 2004-2012.

BACKGROUND: The incidence of TB in Michigan was 1.5 per 100,000 people in 2012, roughly half the U.S. incidence. Despite successes in TB control, disparities in TB still exist in Michigan, particularly by race, age, and nativity. A major challenge in understanding disparities in TB burden is distinguishing between TB cases resulting from recent transmission and those resulting from reactivation of latent TB infection, information critical to tailoring control strategies. We examined nine-year trends in tuberculosis (TB) incidence patterns for the entire population of Michigan, and within demographic subgroups. METHODS: Using a cross-sectional study of TB surveillance data, we analyzed 1254 TB cases reported in Michigan during 2004-2012. Cases included were those for whom both spoligotyping and 12-locus-MIRU-VNTR results were available. Using a combination of the genotyping information and time of diagnosis, we then classified cases as resulting from either recent transmission or reactivation of latent TB infection. We used multivariable negative binomial regression models to study trends in the TB incidence rate for the entire population and by race, nativity, gender, and age. RESULTS: Overall, the incidence rate of TB declined by an average of 8% per year-11% among recently transmitted cases, and 9% among reactivation cases. For recently transmitted disease, Blacks had an average incidence rate 25 times greater than Whites, after controlling for nativity, gender, and age. For disease resulting from latent TB infection Asians had an average incidence rate 24 times greater than Whites, after controlling for nativity, gender, and age. CONCLUSIONS: Disparities in incidence persist despite ongoing TB control efforts. Greater disparities were observed by race and nativity demonstrating some of the ways that TB incidence is socially patterned. Reducing these disparities will require a multi-faceted approach encompassing the social and environmental contexts of high-risk populations.

Initial assessment of the infant with neonatal cholestasis-Is this biliary atresia?

INTRODUCTION: Optimizing outcome in biliary atresia (BA) requires timely diagnosis. Cholestasis is a presenting feature of BA, as well as other diagnoses (Non-BA). Identification of clinical features of neonatal cholestasis that would expedite decisions to pursue subsequent invasive testing to correctly diagnose or exclude BA would enhance outcomes. The analytical goal was to develop a predictive model for BA using data available at initial presentation. METHODS: Infants at presentation with neonatal cholestasis (direct/conjugated bilirubin >2 mg/dl [34.2 µM]) were enrolled prior to surgical exploration in a prospective observational multi-centered study (PROBE-NCT00061828). Clinical features (physical findings, laboratory results, gallbladder sonography) at enrollment were analyzed. Initially, 19 features were selected as candidate predictors. Two approaches were used to build models for diagnosis prediction: a hierarchical classification and regression decision tree (CART) and a logistic regression model using a stepwise selection strategy. RESULTS: In PROBE April 2004-February 2014, 401 infants met criteria for BA and 259 for Non-BA. Univariate analysis identified 13 features that were significantly different between BA and Non-BA. Using a CART predictive model of BA versus Non-BA (significant factors: gamma-glutamyl transpeptidase, acholic stools, weight), the receiver operating characteristic area under the curve (ROC AUC) was 0.83. Twelve percent of BA infants were misclassified as Non-BA; 17% of Non-BA infants were misclassified as BA. Stepwise logistic regression identified seven factors in a predictive model (ROC AUC 0.89). Using this model, a predicted probability of >0.8 (n = 357) yielded an 81% true positive rate for BA; <0.2 (n = 120) yielded an 11% false negative rate. CONCLUSION: Despite the relatively good accuracy of our optimized prediction models, the high precision required for differentiating BA from Non-BA was not achieved. Accurate identification of BA in infants with neonatal cholestasis requires further evaluation, and BA should not be excluded based only on presenting clinical features.

The Michigan Model for Coronary Heart Disease in Type 2 Diabetes: Development and Validation.

OBJECTIVES: The aim of this study was to develop and validate a computer simulation model for coronary heart disease (CHD) in type 2 diabetes mellitus (T2DM) that reflects current medical and surgical treatments. RESEARCH DESIGN AND METHODS: We modified the structure of the CHD submodel in the Michigan Model for Diabetes to allow for revascularization procedures before and after first myocardial infarction, for repeat myocardial infarctions and repeat revascularization procedures, and for congestive heart failure. Transition probabilities that reflect the direct effects of medical and surgical therapies on outcomes were derived from the literature and calibrated to recently published population-based epidemiologic studies and randomized controlled clinical trials. Monte Carlo techniques were used to implement a discrete-state and discrete-time multistate microsimulation model. Performance of the model was assessed using internal and external validation. Simple regression analysis (simulated outcome=b(0)+b(1)×published outcome) was used to evaluate the validation results. RESULTS: For the 21 outcomes in the six studies used for internal validation, R(2) was 0.99, and the slope of the regression line was 0.98. For the 16 outcomes in the five studies used for external validation, R(2) was 0.81, and the slope was 0.84. CONCLUSIONS: Our new computer simulation model predicted the progression of CHD in patients with T2DM and will be incorporated into the Michigan Model for Diabetes to assess the cost-effectiveness of alternative strategies to prevent and treat T2DM.

[Survey on common pediatric drugs for renal diseases].

OBJECTIVE: Development and use of better medicine for children is a worldwide problem recently, especially in China. The current situation of drugs for children's renal diseases is far from well-understood now. This survey focused on drugs for pediatric renal diseases including immunosuppressants, corticosteroids, diuretics, anticoagulants, hypotensives and antilipemic agents.Information regarding the dosage, form, precaution, usage and administration in inserts was collected in this study. METHOD: Drugs for pediatric renal diseases were selected according to the guidelines established by the Chinese Society of Pediatric Nephrology. The detailed information about the dosage, form of drugs was searched on the website of China-State Food and Drug (SFDA). The information of the precaution, usage and administration was obtained from the China Pharmaceutical Reference, the first edition. RESULT: In this study, there were 5 categories of medicine including immunosuppressants, corticosteroids, diuretics, anticoagulants, hypotensives and antilipemic agents, and 89 kinds of medicine for renal diseases. Among these medicines, 65.2% were found not suitable for children in terms of drug dosage and form, 19.1% did not indicate the precaution, 51.7% did not indicate clearly the safety and effectiveness for children, and 56.2% lacked the detailed information about the usage and administration for children. There were only 4 kinds of these medicines which were studied via clinical trials in children population. CONCLUSION: There is a lack of drugs for children with renal diseases. Most of the time, the medicines used by doctors are not specially manufactured for children. The safety and efficacy of drugs that are currently used to treat pediatric renal diseases are not clear and definite.In addition, few clinical trials have been conducted for evaluation of drugs for pediatric renal diseases.In clinic, the situation of off-label drug treatment is very serious.

Racial and ethnic differences in hypertension risk: new diagnoses after age 50.

OBJECTIVES: Our study examines the differences in estimated risk of developing hypertension in Whites, Blacks, and Mexican-Americans aged > or = 50 for a period of 11 years. DESIGN, SETTING, AND PARTICIPANTS: Data came from 9,259 respondents who reported being hypertension-free at the baseline in the Health and Retirement Study (HRS) with up to five time intervals (1998-2006). Discrete-time survival models were used to analyze ethnic variations in the probability of developing hypertension. MAIN OUTCOME MEASURE: Estimated odds of developing hypertension. RESULTS: The risk of newly diagnosed hypertension increased between 1995 and 2006 for HRS participants aged > or = 50. After adjusting for demographic and health status, the probability of incident hypertension among Black Americans was .10 during the period of 1995/96-1998, which increased steadily to .17 in 2004-2006, with cumulative incidence over the 11-year period at 51%. In contrast, among White Americans the risk was .07 during 1995/96-1998 and .13 in 2004-2006, with cumulative incidence at 43%. For Mexican-Americans, the probability also increased from .08 during 1995/ 96-1998 to .14 during 2004-2006, with cumulative incidence at 42%. CONCLUSIONS: Relative to White and Mexican-Americans, Black Americans had an elevated risk of incident hypertension throughout the 11-year period of observation. These variations persisted even when differences in health behaviors, socioeconomic status, demographic, and time-varying health characteristics were accounted for.

Validation of the activities assessment scale in women undergoing pelvic reconstructive surgery.

OBJECTIVE: The Activities Assessment Scale (AAS) is a 13-item postoperative functional activity scale validated in men who underwent hernia surgery. We evaluated the psychometric characteristics of the AAS in women who underwent vaginal surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). METHODS: Participants included 163 women with POP and SUI enrolled in a randomized trial comparing sacrospinous ligament fixation to uterosacral vault suspension with and without perioperative pelvic floor muscle training. Participants completed the AAS and SF-36 at baseline and 2 weeks and 6 months postoperatively. Internal reliability of the AAS was evaluated using Cronbach α. Construct validity and responsiveness were examined in cross-sectional and longitudinal data using Pearson correlation coefficient and analysis of variance. The AAS is scored from zero to 100 (higher scores=better function). RESULTS: Mean (SD) baseline AAS score was 87 (17.3) (range, 25-100). Functional activity declined from baseline to 2 weeks postoperatively (mean change, -4.5; 95% confidence interval, -7.6 to -1.42) but improved above baseline at 6 months (mean change, +10.9; 95% confidence interval, 7.8-14.0). Internal reliability of the AAS was excellent (Cronbach α=0.93). Construct validity was demonstrated by a correlation of 0.59 to 0.60 between the AAS and SF-36 physical functioning scale (P<0.0001) and lower correlations between the AAS and other SF-36 scales. Patients who improved in physical functioning based on the SF-36 between 2 weeks and 6 months postoperatively showed an effect size of 0.86 for change in the AAS over the same period. CONCLUSIONS: The AAS is a valid, reliable, and responsive measure for evaluation of physical function in women after pelvic reconstructive surgery.

How does the trajectory of multimorbidity vary across Black, White, and Mexican Americans in middle and old age?

OBJECTIVES: This research examines intra- and interpersonal differences in multiple chronic conditions reported by Americans aged 51 and older for a period up to 11 years. It focuses on how changes in multimorbidity vary across White, Black, and Mexican Americans. METHODS: Data came from 17,517 respondents of the Health and Retirement Study (1995-2006) with up to 5 repeated observations. Hierarchical linear models were employed to analyze ethnic variations in temporal changes of reported comorbidities. FINDINGS: Middle-aged and older Americans have on average nearly 2 chronic diseases at the baseline, which increased to almost 3 conditions in 11 years. White Americans differ from Black and Mexican Americans in terms of level and rate of change of multimorbidity. Mexican Americans demonstrate lower initial levels and slower accumulation of comorbidities relative to Whites. In contrast, Blacks showed an elevated level of multimorbidity throughout the 11-year period of observation, although their rate of change slowed relative to Whites. DISCUSSION: These results suggest that health differences between Black Americans and other ethnic groups including White and Mexican Americans persist in the trajectory of multimorbidity even when population heterogeneity is adjusted. Further research is needed concerning the impact of health disadvantages and differential mortality that may have occurred before middle age as well as exploring the role of nativity, the nature of self-reported diseases, and heterogeneity underlying the average trajectory of multimorbidity for ethnic elders.