Recommended 10-Year Follow-Up Strategy for Small Hepatocellular Carcinoma After Radiofrequency Ablation: A Cost-Effectiveness Evaluation.

INTRODUCTION: An optimal follow-up schedule for small (≤3-cm) hepatocellular carcinoma (HCC) after radiofrequency ablation (RFA) remains unclear in clinical guidelines. We aimed to assess the cost-effectiveness of follow-up strategies in patients with small HCC after RFA. METHODS: In total, 11,243 patients were collected from global institutions to calculate recurrence rates. Subsequently, a Markov model covering a 10-year period was developed to compare 25 surveillance strategies involving different surveillance techniques (computed tomography [CT], magnetic resonance imaging or ultrasonography [US], and α-fetoprotein [AFP]) and intervals (3 or 6 months). The study endpoint was incremental cost-effectiveness ratio (ICER), which represented additional cost per incremental quality-adjusted life year. Sensitivity analysis was conducted by varying the values of input parameters to observe the ICER. RESULTS: In a base case analysis, the dominant strategy was CT every 3 months during an initial 2 years, followed by semiannual CT, and then switch to biannual the combination of US screening and AFP testing after 5 years (m3_CT-m6_CT-m6_USAFP), with an ICER of $68,570.92 compared with the "not followed" strategy. One-way sensitivity analysis showed the ICER consistently remained below the willingness-to-pay threshold of $100,000.00. In a probabilistic sensitivity analysis, m3_CT-m6_CT-m6_USAFP was the most cost-effective approach in 95.6% of simulated scenarios at a willingness-to-pay threshold. DISCUSSION: For small HCC after RFA, the recommended follow-up strategy is CT, with scans scheduled every 3 months for the first 2 years, every 6 months thereafter, and transition to biannual the combination of US screening and AFP testing after 5 years.

Agricultural insurance and rural revitalization-an empirical analysis based on China's provincial panel data.

Agricultural insurance is a kind of compensation insurance designed to provide protection for the economic losses caused by insured accidents suffered by agricultural producers in agricultural production. Rural revitalization refers to the strategy of improving the level of rural economic, social and cultural development and achieving coordinated and sustainable development of urban and rural development. Agricultural insurance can effectively diversify risks and reduce losses for agricultural producers, which plays an important role in stabilizing farmers' income, helping rural economic development, and promoting rural revitalization. Based on the theoretical analysis of the mechanism of agricultural insurance on rural revitalization, this paper empirically studies the effect of agricultural insurance on rural revitalization by using panel data from various provinces in China from 2011 to 2020. In this paper, the TOPSIS entropy weight method, the system generalized method of moments (GMM) and the threshold model are used to calculate the actual development level of rural revitalization in each province of China, the promotion effect of agricultural insurance on the development level of rural revitalization and the promotion of rural revitalization in five dimensions, and whether there is a threshold effect of agricultural insurance on rural revitalization. The empirical results show that: (1) The level of rural revitalization in various provinces in China shows a dynamic trend of "overall slow rise, with obvious differences between provinces." (2) Improving the development level of agricultural insurance can drive the improvement of China's rural revitalization level, and every 1 unit increase in the development level of agricultural insurance will drive the level of China's rural revitalization to increase by 0.1633 units. At the same time, the role of agricultural insurance on social etiquette and civility is not significant, and the role of the remaining four rural revitalization goals is significant. (3) Agricultural insurance has a significant effect on the level of rural revitalization in eastern provinces, but does not play a significant role in rural revitalization in central and western provinces. (4) The role of agricultural insurance on rural revitalization has a double threshold effect. Accordingly, this paper puts forward some suggestions for increasing the capital investment in agricultural insurance, innovating the new mode of agricultural insurance operation, promoting the in-depth development of agricultural insurance according to local conditions, and reasonably adjusting the capital investment of agricultural insurance. Finally, because the data used in this paper do not cover the entire process of rural revitalization and the research is mainly carried out from a macro perspective, there are still some shortcomings in this paper.

Cost-effectiveness and prognostic model of hepatic arterial infusion chemotherapy for hepatocellular carcinoma with high tumor burden and/or Vp4 tumor thrombus compared with sorafenib: a post-hoc analysis of the FOHAIC-1 trial.

OBJECTIVES: The phase III FOHAIC-1 trial revealed that hepatic arterial infusion of chemotherapy (HAIC) improved overall survival compared to sorafenib in the high-risk hepatocellular carcinoma (HCC). This study therefore set out to evaluate the cost-effectiveness and establish a prognostic clinico-radiological score of HAIC. MATERIALS AND METHODS: A total of 409 patients with high-risk HCC who received HAIC between 2014 and 2020 were included. A Markov model was applied in the cost-effectiveness analysis using data from the FOHAIC-1 trial. In prognosis analysis, a clinico-radiological score was developed using a Cox-regression model and subsequently confirmed in the internal validation and test cohorts. The area under the curve from receiver operator characteristic analysis was used to assess the performance of the clinico-radiological score. RESULTS: HAIC resulted in an incremental cost-effectiveness ratio of $10190.41/quality-adjusted life years compared to sorafenib, which was lower than the willingness-to-pay threshold. Probabilistic sensitivity analysis predicted a ≥99.9% probability that the incremental cost-effectiveness ratio was below the willingness-to-pay. The Cox analysis identified five factors, namely extrahepatic metastasis (m), arterial enhancing type (a), tumor number (nu), albumin-bilirubin index (a), and involved lobe (l), which together comprise the clinico-radiological score (HAIC-manual). Patients were classified into three groups based on the number of factors present, with cutoffs at 2 and 4 factors. The stratified median overall survival for these groups were 21.6, 10.0, and 5.9 months, respectively ( P <0.001). These findings were verified through internal validation and test cohorts with a significance level of P ≤0.01. The time-dependent area under the curve from receiver operator characteristic for the ability of the HAIC-manual to predict survival in 1, 2, and 3 years were 0.71, 0.76, and 0.78, which significantly outperformed existing staging systems. CONCLUSION: HAIC is a promising and cost-effective strategy for patients with high-risk HCC. The clinico-radiological score may be a simple prognostic tool for predicting HAIC treatment.

Environmental geochemical baseline determination and pollution assessment of heavy metals in farmland soil of typical coal-based cities: A case study of Suzhou City in Anhui Province, China.

Soil is the foundation of agricultural green development and human survival; the study of local environmental geochemical baselines can guide soil management and ensure the safe use of soil. In this study, a total of 100 shallow farmland soil samples were collected in each township of Yongqiao District, Suzhou City, Anhui Province, China. Herein, the contents of 10 heavy metal elements including As, Hg, Cd, Pb, Cr, Cu, Mn, Ni, Zn and Fe were determined. In addition, the geochemical baseline of heavy metals was calculated based on the relative cumulative frequency curve method, and the soil pollution status was evaluated. The results show that the average contents of As, Hg, Cd, Cu, Mn and Zn exceeded the soil background values of Anhui Province by 3.82%-64.74% (1.04-1.65 times), meanwhile, the average contents of Pb and Cr were lower than the soil background values of Anhui Province. The average contents of Cd, Cr, Cu, Mn and Ni exceeded the Chinese soil background values by 1.61%-64.74% (0.98-1.65 times). The geochemical baseline values of As, Hg, Cd, Pb, Cr, Cu, Mn, Ni, Zn and Fe were 9.585 mg/kg, 0.028 mg/kg, 0.112 mg/kg, 21.59 mg/kg, 53.66 mg/kg, 19.31 mg/kg, 543.8 mg/kg, 24.93 mg/kg, 50.57 mg/kg and 2.654%, respectively. The pollution assessment results also showed that most of the farmland soil samples in the study area were non-polluting or slightly polluted based on geochemical baselines. Hg and Cu in a few samples were moderately polluted, and Cd in only one sample was moderately intensely polluted. Combined with the distribution of pollution and field investigation, it is considered that Hg comes from atmospheric deposition and agricultural non-point source pollution of industrial pollution. Cu comes from animal husbandry and agricultural pollution. Meanwhile, Cd is related to natural sources, wood processing and agricultural fertiliser application. The study demonstrated that the calculation of soil geochemical background value should take full account of the differences between the various regions, combined with the current state, particularly the pre-consideration of the distribution of elements or pollutants. Then, reasonably select the evaluation standard value so that the evaluation results can truly reflect the state of soil pollution.

Differentiation of benign and malignant spinal schwannoma using guided attention inference networks on multi-source MRI: comparison with radiomics method and radiologist-based clinical assessment.

BACKGROUND: Differentiating diagnosis between the benign schwannoma and the malignant counterparts merely by neuroimaging is not always clear and remains still confounding in many cases because of atypical imaging presentation encountered in clinic and the lack of specific diagnostic markers. PURPOSE: To construct and validate a novel deep learning model based on multi-source magnetic resonance imaging (MRI) in automatically differentiating malignant spinal schwannoma from benign. MATERIAL AND METHODS: We retrospectively reviewed MRI imaging data from 119 patients with the initial diagnosis of benign or malignant spinal schwannoma confirmed by postoperative pathology. A novel convolutional neural network (CNN)-based deep learning model named GAIN-CP (Guided Attention Inference Network with Clinical Priors) was constructed. An ablation study for the fivefold cross-validation and cross-source experiments were conducted to validate the novel model. The diagnosis performance among our GAIN-CP model, the conventional radiomics model, and the radiologist-based clinical assessment were compared using the area under the receiver operating characteristic curve (AUC) and balanced accuracy (BAC). RESULTS: The AUC score of the proposed GAIN method is 0.83, which outperforms the radiomics method (0.65) and the evaluations from the radiologists (0.67). By incorporating both the image data and the clinical prior features, our GAIN-CP achieves an AUC score of 0.95. The GAIN-CP also achieves the best performance on fivefold cross-validation and cross-source experiments. CONCLUSION: The novel GAIN-CP method can successfully classify malignant spinal schwannoma from benign cases using the provided multi-source MR images exhibiting good prospect in clinical diagnosis.

Machine Learning Algorithms for Rupture Risk Assessment of Intracranial Aneurysms: A Diagnostic Meta-Analysis.

OBJECTIVE: Several machine learning algorithms have been increasingly applied to predict the rupture risk of intracranial aneurysms. We performed the present diagnostic meta-analysis to comprehensively evaluate the diagnostic value of machine learning algorithms for assessing the rupture risk of intracranial aneurysms. METHODS: We systematically searched 3 electronic databases, including Medline (via PubMed), the Cochrane Register of Controlled Trials (via Ovid), and Embase (via Elsevier), to retrieve eligible studies from the databases' inception through March 2021. The latest update was performed in June 2021. StataMP, version 14, was used to estimate all pooled diagnostic values. RESULTS: A total of 4 studies involving 6 reports were considered to meet the inclusion criteria. Our diagnostic meta-analysis generated the following pooled diagnostic values: sensitivity, 0.84 (95% confidence interval [CI], 0.75-0.90); specificity, 0.78 (95% CI, 0.68-0.85); positive likelihood ratio, 3.8 (95% CI, 2.4-5.9); negative likelihood ratio, 0.21 (95% CI, 0.12-0.35), diagnostic odd ratio, 18 (95% CI, 7-46), and area under the summary receiver operating characteristic curve, 0.88 (95% CI, 0.85-0.90). CONCLUSIONS: Our findings have demonstrated that the diagnostic performance of machine learning algorithms for the rupture risk assessment of AIs is excellent. Considering that the negative effects resulted from the limited number of eligible studies, we suggest developing more well-designed studies with larger sample sizes to validate our findings.

General recommendation for assessment and management on the risk of glucocorticoid-induced osteonecrosis in patients with COVID-19.

BACKGROUND/OBJECTIVE: Coronavirus disease 2019 (COVID-19) is a disaster in human medical history and glucocorticoids remain the most promising therapy. Osteonecrosis is a disease caused by reduced intraosseous blood flow to bones in the joints, which will rapidly induce joint destruction. Approximately one-third patients with severe acute respiratory syndrome (SARS) who received high cumulative doses and long treatment durations of glucocorticoids occurred osteonecrosis. Considering the similarity of SARS and COVID-19 on their pathogen, clinical characteristics, and therapeutic strategies, it is particularly desirable to investigate whether osteonecrosis will become a common sequela among convalescent COVID-19 patients. METHODS: This multi-strategy study was designed by integrating different research methods, such as meta-analysis, systematic review, and cross-sectional investigations to address above study objectives. At first, two meta-analyses were performed on the osteonecrosis incidence among SARS patients and the clinical data of glucocorticoid exposure among COVID-19 patients. Then, a systematic review of low-dosage glucocorticoid associated osteonecrosis and a cross-sectional investigation of glucocorticoid exposure of COVID-19 patients in Wuhan city of China were also conducted. Moreover, the pathogenesis, diagnosis, prevention, and treatment options for osteonecrosis patients with COVID-19 infection were further presented and discussed. RESULTS: Our meta-analysis showed that 32% of SARS patients had developed osteonecrosis after receiving glucocorticoid treatment with high dose, and our system review supported that low level glucocorticoid exposure might also lead to the occurrence of osteonecrosis. Similarly, 40% of COVID-19 patients had undergone glucocorticoid treatment according to our meta-analysis. The cross-sectional investigation in Wuhan city of China found that the average of cumulative glucocorticoid exposure level was 504 â€‹mg calculated by the dosage of methylprednisolone. Notably, a confirmed osteonecrosis case was identified from 1406 patients with COVID-19 during our cross-sectional investigation, implying that preventive management of osteonecrosis should be better started with regular clinical follow-up observation. CONCLUSION: Growing evidence of the glucocorticoid therapy for COVID-19 patients prompts us to establish risk-classification-based early screening and to introduce early prevention protocol of its associated osteonecrosis that will be of clinical significance in favor of improved prognosis of this disease. THE TRANSLATIONAL POTENTIAL OF THIS ARTICLE: To establish risk-classification-based early screening and to introduce early prevention protocol of glucocorticoid-induced osteonecrosis will be of clinical significance in favor of improved prognosis of COVID-19.

Safety assessment of subtilisin QK in rats.

BACKGROUND: Subtilisin QK is a serine protease in the subtilisin family, and is fermented by Bacillus subtilis QK02. The fibrinolytic activity of subtilisin QK was measured by detecting low molecular weight degradation products using a spectrophotometric method developed by Japan Bio Science Laboratory Co., Ltd. Subtilisin QK powder can maintain its fibrinolytic activity for more than 24 months when it is stored at room temperature and protected from light. Our previous results showed that subtlisin QK directly degraded cross-linked fibrins in the fibrin plate assay and effectively inhibited thrombosis in the mouse thrombus model. The aim of this study was to determine the acute toxicity, potential subchronic toxicity, and safety pharmacology of subtilisin QK in Sprague-Dawley (SD) rats. METHODS: In the acute toxicity study, a single oral dose of 100,000 FU/kg was administered to 10 female and 10 male SD rats. In the 28-day subchronic toxicity, 60 female and 60 male SD rats were randomly assigned to four experimental groups (daily oral dose of 0, 2500, 7500 and 25,000 FU/kg). In the safety pharmacology study, 20 female and 20 male SD rats were randomly assigned to four experimental groups (single oral dose of 0, 500, 1500 and 5000 FU/kg). RESULTS: No death occurred and no adverse effects were observed in the acute toxicity study at a dose of 100,000 FU/kg. In the 28-day subchronic toxicity study, several hematological and blood biochemical parameters showed increases or decreases; however, due to the lack of a dose-response relationship, these differences were considered unrelated to treatment. In the safety pharmacology study, no adverse effects were observed on the central nervous of SD rats post-administration up to a dose of 5000 FU/kg subtilisin QK. CONCLUSION: The results showed that oral consumption of subtilisin QK is of low toxicological concern. No adverse effects were observed at doses of 2500, 7500, and 25,000 FU/kg in the 28-day subchronic toxicity, and the no-observed-adverse-effect level (NOAEL) of subtilisin QK was 25,000 FU/kg.

The highly rearranged mitochondrial genomes of three economically important scale insects and the mitochondrial phylogeny of Coccoidea (Hemiptera: Sternorrhyncha).

The mitochondrial genomes (mitogenomes) of scale insects are less known in comparison to other insects, which hinders the phylogenetic and evolutionary studies of Coccoidea and higher taxa. Herein, the complete mitogenomes of Unaspis yanonensis, Planococcus citri and Ceroplastes rubens were sequenced for Coccoidea. The 15,220-bp long mitogenome of U. yanonensis contained the typical set of 37 genes including 13 PCGs, 22 tRNA genes and two rRNA genes; the 15,549-bp long mitogenome of P. citri lacked the tRNA gene trnV; the 15,387-bp long mitogenome of C. rubens exhibited several shortened PCGs and lacked five tRNA genes. The mitochondrial gene arrangement of the three mitogenomes was different from other scale insects and Drosophila yakuba. Most PCGs used standard ATN (ATA, ATT, ATC and ATG) start codons and complete TAN (TAA or TAG) termination codons. The ND4L had the highest evolutionary rate but COX1 and CYTB were the lowest. Most tRNA genes had cloverleaf secondary structures, whereas the reduction of dihydrouridine (DHU) arms and TψC arms were detected. Tandem repeats, stem-loop (SL) structures and poly-[TA]n stretch were found in the control regions (CRs) of the three mitogenomes. The phylogenetic analyses using Bayesian inference (BI) and maximum likelihood methods (ML) showed identical results, both supporting the inner relationship of Coccoidea as Coccidae + (Pseudococcidae + Diaspididae).

Assessment, Distribution and Regional Geochemical Baseline of Heavy Metals in Soils of Densely Populated Area: A Case Study.

To understand the content, pollution, distribution and source and to establish a geochemical baseline of heavy metal elements in soil under the influence of high-density population, the concentrations of heavy metal elements Cr, Mn, Co, Ni, Cu, Zn, As, Cd, Hg, Pb and Fe were determined in 23 soil samples in Suzhou University, and geo-accumulation index, enrichment factor, principal component analysis, spatial analysis and regression analysis were completed. The results showed the following: The elements Cu and As were slightly polluted, while the other heavy metal elements were not. The elements Cd, Cu, Ni and As in soils were mainly caused by agricultural activities of chemical fertilizer, whereas the elements Zn and Hg were impacted by the chemicals and batteries. The heavy metal elements in the north were lower than in the south of the campus, as a whole. The enrichment of elements Cu, As and Cd was caused by the east-west river on the campus, and the enrichment of the elements Mn, Ni and Zn was induced by the reservoir. Biochemical experiments and vehicle parking influenced the spatial enrichment of Cr, Co and Pb, while domestic waste led to the spatial differentiation of Hg concentrations. The regression curve between heavy metal elements and Fe was established, and the background values of the heavy metals Cr, Mn, Co, Ni, Cu, Zn, As, Cd, Hg and Pb are 50.90, 489.37, 11.76, 37.74, 55.70, 58.22, 20.07, 0.09, 0.08 and 24.13 mg/kg, respectively.

Release risk assessment of trace metals in urban soils using in-situ DGT and DIFS model.

Urbanization and urban construction lead to entensive environmental deterioration. Trace metals in urban soils pose a threat to urban water bodies and local populations. However, the release ability of labile metals and their release risk in urban soils remains unclear. Here, soils were collected from different functional zones in the Pingshan District (PSD) of Shenzhen. Based on results of soil properties, total contents of trace metals, geochemical index (Igeo), and risk assessment code (RAC), diffusive gradients in thin films (DGT) and DGT-induced fluxes in soil (DIFS) model were further used to assess the release risk of trace metals in urban soils. The results showed that the average total concentrations of trace metals (As, Cr, Cu, Pb, and V) were higher than the local soil background values, implying that trace metals accumulated in urban soils. However, the distributions of labile metals determined by DGT were not similar to those of total metal concentrations. Except for As, urban soils from PSD sites exhibited "uncontaminated to moderately contaminated" levels based on the average values of Igeo. Moreover, the pollution and migration of Cu in urban soils are problematic as evidenced by the Igeo and RAC assessments. Release ability of Cu was assessed using parameters of DIFS model (i.e., bioavailability concentrations (CE), resupply ability (R), response time (Tc), desorption rate (k-1), and sorption rate (k1)). Residential areas showed high CE values for Cu, while the resupply ability was low. Furthermore, considering the influences of R, Tc, k-1, and k1, membership function value was used to re-calculate the order of CE in urban soils. The final results suggested that the agricultural zone exhibited the highest release risk among soils from various functional zones. Therefore, DGT and DIFS model should be effective tools to assess the release risk of trace metals in urban soils.

Uncertainty assessment of gamma-aminobutyric acid concentration of different brain regions in individual and group using residual bootstrap analysis.

The aim of this work is to quantify individual and regional differences in the relative concentration of gamma-aminobutyric acid (GABA) in human brain with in vivo magnetic resonance spectroscopy. Spectral editing Mescher-Garwood point resolved spectroscopy (MEGA-PRESS) sequence and GABA analysis toolkit (Gannet) were used to detect and quantify GABA in anterior cingulate cortex (ACC) and occipital cortex (OCC) of healthy volunteers. Residual bootstrap, a model-based statistical analysis technique, was applied to resample the fitting residuals of GABA from the Gaussian fitting model (referred to as GABA+ thereafter) in both individual and group data of ACC and OCC. The inter-subject coefficient of variation (CV) of GABA+ in OCC (20.66 %) and ACC (12.55 %) with residual bootstrap was lower than that of a standard Gaussian model analysis (21.58 % and 16.73 % for OCC and ACC, respectively). The intra-subject uncertainty and CV of OCC were lower than that of ACC in both analyses. The residual bootstrap analysis thus provides a more robust uncertainty estimation of individual and group GABA+ detection in different brain regions, which may be useful in our understanding of GABA biochemistry in brain and its use for the diagnosis of related neuropsychiatric diseases.

Who funds their health savings account and why?

Health savings account (HSA) enrollment has increased markedly in the last several years, but little is known about the factors affecting account funding decisions. We use a unique data set containing from a bank that exclusively services HSA funds linked to health status, benefit design, plan coverage, and enrollee characteristics from a very large national health insurance company to examine the factors associated with HSA contribution. We found that even small employer contributions had an apparently large effect on the decision to open an account: the account-opening rate was 50 % higher when employers contributed to the account. Conditional on opening an HSA, employee contributions were negatively associated with the amount of employer contribution, contributions rose with age, income, education, and health care need.

Flow cytometric assessment of the protectants for enhanced in vitro survival of probiotic lactic acid bacteria through simulated human gastro-intestinal stresses.

The aim of this study was to apply flow cytometric (FCM) analysis to assess the use of sucrose and lecithin vesicles for the protection of probiotic lactic acid bacteria in response to the challenge of gastric acidity and bile salts. FCM analysis in combination with fluorescent probes carboxyfluorescein (cF) and propidium iodide was used to reveal the physiological heterogeneity in the stressed bacteria population. Three subpopulations (intact, stressed, and damaged) were differentiated by FCM in all six examined strains. Significant changes were observed in the presence of the selected protectants. The addition of 20 mM sucrose in the simulated gastric fluid substantially increased the number of intact cells over 20 folds and reduced the damaged subpopulation by half. The presence of 2 % (w/v) lecithin vesicles was shown to protect 50 % more intact cells from the challenge of bile salts. The improved survival as evaluated by FCM analysis was further assessed for the proliferation capacity by sorting a number of cells from each subpopulation on nutrient agar plate. The result confirmed conformity between the proliferation-based cultivability and the probe-indicated viability in the samples of the intact and the damaged subpopulations. However, it also revealed the complexities of the stressed (injured) subpopulation. In conclusion, FCM analysis confirmed that the selected protectants could improve the survival of the probiotic strains in the simulated GI environments. The FCM analysis also proved to be a useful analytical tool for the probiotics research.

Who values information from a health plan Internet-based decision tool and why: a demographic and utilization analysis.

OBJECTIVES: The aim of this study was to investigate factors associated with utilization of health plan Internet-based decision tools. DATA SOURCES AND STUDY SETTING: Enrollment, claims, plan design, and web transaction data during 2008 provided by a national health insurer for 253,398 subscribers from 919 employers. STUDY DESIGN: Multivariate models of the effects of demographic, health, employer, and plan benefit design characteristics on the use of the tool and its individual function categories. DATA EXTRACTION METHODS: Subscribers, who were either an individual member or a family, were included if at least one family member had 12 months of coverage in 2008. Members older than 65 and those with multiple insurance carriers were excluded. PRINCIPAL FINDINGS: Higher education, higher income, younger age, female gender, higher co-morbidity risk, prevalence of chronic conditions, Caucasian race, and English as the primary language were positively associated with using the tool. Plan benefit characteristics such as free preventive coverage, higher deductible, moderate coinsurance rate, family coverage, and enrollment in health savings accounts were also associated with higher likelihood of using the tool. CONCLUSIONS: Insurers provide consumers information on cost efficiency, quality, and wellness through Internet-based decision tools, but more effort is needed to reach certain demographics.

Medication adherence and enrollment in a consumer-driven health plan.

OBJECTIVE: To evaluate the impact of enrolling in a consumer-driven health plan (CDHP) on adherence to maintenance drugs. STUDY DESIGN: Two-year retrospective cohort study. METHODS: Consumer-driven health plan patients were enrolled in a traditional managed care plan in 2005 (pre-year) and a full-replacement CDHP in 2006 (post-year). Traditional-plan patients voluntarily enrolled in a traditional plan in both years. Adherence measures included (1) post-year continuation rate among continuous users, (2) time to refill the first prescription in the post-year, (3) change in the compliance rate from the pre- to the post-year, and (4) total days with continuous drug supply in the post-year. Analysis was conducted on 8 drug classes. RESULTS: The CDHP patients had a slightly higher illness burden and used more medication in the pre-year. The continuation rate was relatively high for all drug classes, although the CDHP cohort had a lower probability of continuing cardiac and cholesterol drugs. Consumer-driven health plan patients took slightly longer on average to refill their first prescription in the post-year for cardiac, hypertension, cholesterol, and thyroid drugs. The compliance rate dropped over time in both cohorts, but the reduction was bigger among CDHP patients for 3 drug classes (adjusted ratio of the odds ratios was 0.77, 0.78, and 0.69 for asthma, cardiac, and cholesterol drugs, respectively). The CDHP patients also terminated their continuous drug supply 21 days earlier for epilepsy drugs and 27 days earlier for cholesterol drugs. CONCLUSIONS: Adherence was lower for a few drug classes among CDHP patients.

[Incidence, risk factors and management of pericardial effusion post radiofrequency catheter ablation in patients with atrial fibrillations].

OBJECTIVE: Pericardial effusion (PE) is a major complication of atrial fibrillation ablation (AFB). We analyzed the incidence, risk factors and managements of PE post AFB (radiofrequency catheter ablation). METHODS: A total of 156 consecutive patients with AF [male 108, paroxysmal AF 114, (57.6 +/- 11.3) years], who underwent AFB guided by a three-dimensional mapping system (CARTO or CARTO-Merge, Biosense-Webster Inc., Diamond Bar, California) and a circular mapping catheter (Lasso, Biosense-Webster Inc., Diamond Bar, California), were included in this study. The ablation strategy included circumferential pulmonary veins isolation (CPVI), linear ablation and/or complex fractionated atrial electrograms (CFAEs) ablation. Electrophysiological data and vital signs of patients were recorded by a multiple physiological recorder (Prucka, GE Medical Systems) during ablation. Ablation process, sites, duration and other related factors were also recorded. Echocardiography and other examinations were performed for diagnosing and monitoring PE. RESULTS: CPVI were achieved in all 156 patients. Incidence of PE was 10.3% (16/156) post AFB. One patient developed acute cardiac tamponade and emergency drainage of the pericardial effusion was performed through a median sternotomy and patient recovered without complications during the 18 months follow-up. The rest 15 PE patients with small PE received outpatient care and no invasive treatment was needed and PE disappeared after 3 months in 6 patients and after 6 months in 9 patients. Univariate analysis showed that the composition of gender (P < 0.01), ablation in coronary sinus (CS, P = 0.026), ablation of CFAEs (P = 0.037) and superior vena cava (SVC, P = 0.041) were risk factors for PE. Logistic regression analysis showed that female gender [beta = 3.594, exp (b) = 36.4, 95% confidence interval (CI): 4.2 - 312.1, P = 0.001] and ablation in CS [beta = 2.419, exp (b) = 11.2, 95% CI: 1.0 - 124.6, P = 0.049] were independent risk factors for PE post AFB. CONCLUSIONS: PE is a common complication of AFB, female gender and ablation in CS were independent risk factors for PE. Most PE patients experienced spontaneous recovery but emergency treatment was needed for patient with cardiac tamponade.

Effects of a consumer driven health plan on pharmaceutical spending and utilization.

OBJECTIVES: To compare pharmaceutical spending and utilization in a consumer driven health plan (CDHP) with a three-tier pharmacy benefit design, and to examine whether the CDHP creates incentives to reduce pharmaceutical spending and utilization for chronically ill patients, generic or brand name drugs, and mail-order drugs. STUDY DESIGN: Retrospective insurance claims analysis from a large employer that introduced a CDHP in 2001 in addition to a point of service (POS) plan and a preferred provider organization (PPO), both of which used a three-tier pharmacy benefit. METHODS: Difference-in-differences regression models were estimated for drug spending and utilization. Control variables included the employee's income, age, and gender, number of covered lives per contract, election of flexible spending account, health status, concurrent health shock, cohort, and time trend. Results. CDHP pharmaceutical expenditures were lower than those in the POS cohort in 1 year without differences in the use of brand name drugs. We find limited evidence of less drug consumption by CDHP enrollees with chronic illnesses, and some evidence of less generic drug use and more mail-order drug use among CDHP members. CONCLUSIONS: The CDHP is cost-neutral or cost-saving to both the employer and the employee compared with three-tier benefits with no differences in brand name drug use.

Self-microemulsifying drug delivery system (SMEDDS) of vinpocetine: formulation development and in vivo assessment.

A new self-microemulsifying drug delivery system (SMEDDS) has been developed to increase the solubility, dissolution rate and oral bioavailability of vinpocetine (VIP), a poor water-soluble drug. The formulations of VIP-SMEDDS were optimized by solubility assay, compatibility tests, and pseudo-ternary phase diagrams analysis. The optimal ratio in the formulation of SMEDDS was found to be Labrafac : oleic acid : Cremophor EL : Transcutol P=40 : 10 : 40 : 10 (w/w). The average particle diameter of VIP was less than 50 nm. In vitro dissolution study indicated that the dialysis method in reverse was better than the ultrafiltration method and the dialysis method in simulating the drug in vivo environment. Comparing with VIP crude drug power and commercial tablets, (-)VIP-SMEDDS caused a 3.4- and 2.9-fold increase in the percent of accumulated dissolution at 3 h. Further study on the absorption property of VIP-SMEDDS employing in situ intestine of rats demonstrated that VIP in SMEDDS could be well-absorbed in general intestinal tract without specific absorption sites. In addition, the developed SMEDDS formulations significantly improved the oral bioavailability of VIP in rats. Relative bioavailability of (-)VIP-SMEDDS and (+)VIP-SMEDDS increased by 1.85- and 1.91-fold, respectively, in relative of VIP crude powder suspension. The mechanisms of enhanced bioavailability of VIP might contribute to the improved release, enhanced lymphatic transport, and increased intestinal permeability of the drug.

Sequential estimation in line transect surveys.

This article considers using sequential procedures to determine the amount of survey effort required in a line transect survey in order to achieve a certain precision level in estimating the abundance of a biological population. Sequential procedures are constructed for both parametric and nonparametric animal abundance estimators. The criterion used to derive the stopping rules is the width of confidence intervals for the animal abundance. For each estimator considered, we develop stopping rules based on the asymptotic distributions and the bootstrap. A sequential analysis on an aerial survey of the southern bluefin tuna indicates substantial saving of survey effort can be made by employment of the proposed sequential procedures. This savings of survey effort is also observed in a simulation study designed to evaluate the empirical performance of the proposed sequential procedures.