Association between heatwaves and risk and economic burden of injury related hospitalizations in China.

BACKGROUND: Public health is greatly affected by heatwaves, especially as a result of climate change. It is unclear whether heatwaves affect injury hospitalization, especially as developing countries facing the impact of climate change. OBJECTIVES: To assess the impact of heatwaves on injury-related hospitalization and the economic burden. METHODS: The daily hospitalizations and meteorological data from 2014 to 2019 were collected from 23 study sites in 11 meteorological geographic zones in China. We conducted a two-stage time series analysis based on a time-stratified case-crossover design, combined with DLNM to assess the association between heatwaves and daily injury hospitalization, and to further assess the regional and national economic losses resulting from hospitalization by calculating excess hospitalization costs (direct economic losses) and labor losses (indirect economic losses). To determine the vulnerable groups and areas, we also carried out stratified analyses by age, sex, and region. RESULTS: We found that 6.542% (95%CI: 3.939%, 9.008 %) of injury hospitalization were attributable to heatwaves during warm season (May to September) from 2014 to 2019. Approximately 361,447 injury hospitalizations were attributed to heatwaves each year in China, leading to an excess economic loss of 5.173 (95%CI: 3.104, 7.196) billion CNY, of which 3.114 (95%CI: 1.454, 4.720) billion CNY for males and 4.785 (95%CI: 3.203, 6.321) billion CNY for people aged 15-64 years. The attributable fraction (AF) of injury hospitalizations due to heatwaves was the highest in the plateau mountain climate zone, followed by the subtropical monsoon climate zone and the temperate monsoon climate zone. CONCLUSIONS: Heatwaves significantly increase the disease and economic burden of injury hospitalizations, and vary across populations and regions. Our findings implicate the necessity for targeted measures, including raising public awareness, improving healthcare infrastructure, and developing climate resilience policies, to reduce the threat of heatwaves to vulnerable populations and the associated disease and economic burden.

Budget Impact Analysis of Circulating Tumor DNA Testing for Colon Cancer in Commercial Health and Medicare Advantage Plans.

Importance: In a randomized clinical trial, treatment guided by tumor-informed circulating tumor (ct)DNA testing reduced adjuvant chemotherapy use without compromising recurrence-free survival in patients with stage II colon cancer. The potential effects of adopting ctDNA testing into routine patient care is unknown. Objective: To compare the total cost of patient care scenarios with and without the adoption of ctDNA testing. Design, Setting, and Participants: This budget impact analysis was conducted from the perspectives of US commercial health and Medicare Advantage payers. A decision-analytical model was populated with age-specific incidence of colon cancer, use of adjuvant chemotherapy, and use of single-agent or multiagent regimens. Total cost was estimated with the costs of ctDNA testing, drug acquisition, administration, surveillance, and adverse events. The analysis was conducted from September 2023 to January 2024. Exposures: The adoption of ctDNA testing. Main Outcomes and Measures: The incremental cost in the first year following the adoption of ctDNA testing, where testing will affect patient treatment and costs. Results: In hypothetical plans with 1 million individuals covered, 35 commercial health plan members and 102 Medicare Advantage members aged 75 years and younger were eligible for ctDNA testing. In the base case with a 50% adoption rate, total cost savings were $221 684 (equivalent to $0.02 per member per month [PMPM]) for a commercial payer and $116 720 (equivalent to $0.01 PMPM) for a Medicare Advantage payer. Cost savings were robust to variations in assumptions of all parameters in the commercial population but sensitive to variations in assumptions of adjuvant chemotherapy use rates in the Medicare Advantage population. The number needed to test to avoid 1 patient receiving adjuvant chemotherapy was 4 in the commercial population and 10 in the Medicare Advantage population. The budget-neutral cost for ctDNA testing was $16 202 for a commercial payer and $5793 for a Medicare Advantage payer. Conclusions and Relevance: Use of tumor-informed ctDNA testing to guide adjuvant chemotherapy in postsurgery patients with stage II colon cancer was projected to result in cost savings for both commercial and Medicare Advantage payers. Adoption of ctDNA testing is therefore advantageous from a budgetary perspective.

[Risk Management Analysis of Medical Device Registration Self-inspection].

Through the analysis of laws and policies related to registration self-inspection, visiting and researching enterprises, holding symposiums, and issuing nationwide questionnaires, the risks in the registration self-inspection process were summarized, analyzed, and evaluated. From the aspects of regulatory departments and manufacturing enterprises, we suggest to improve China's medical device registration regulations system and reduce the risks of all parties in the registration self-inspection work.

Heatwave and urinary hospital admissions in China: Disease burden and associated economic loss, 2014 to 2019.

BACKGROUND: Many studies have shown that heatwaves are associated with an increased prevalence of urinary diseases. However, few national studies have been undertaken in China, and none have considered the associated economic losses. Such information would be useful for health authorities and medical service providers to improve their policy-making and medical resource allocation decisions. OBJECTIVES: To explore the association between heatwaves and hospital admissions for urinary diseases and assess the related medical costs and indirect economic losses in China from 2014 to 2019. METHODS: Daily meteorological and hospital admission data from 2014 to 2019 were collected from 23 study sites with different climatic characteristics in China. We assessed the heatwave-hospitalization associations and evaluated the location-specific attributable fractions (AFs) of urinary-related hospital admissions due to heatwaves by using a time-stratified case-crossover method with a distributed lag nonlinear model. We then pooled the AFs in a meta-analysis and estimated the national excess disease burden and associated economic losses. We also performed stratified analyses by sex, age, climate zone, and urinary disease subtype. RESULTS: A significant association between heatwaves and urinary-related hospital admissions was found with a relative risk of 1.090 (95 % confidence interval (CI): 1.050, 1.132). The pooled AF was 8.27 % (95%CI: 4.77 %, 11.63 %), indicating that heatwaves during the warm season (May to September) caused 248,364 urinary-related hospital admissions per year, with 2.42 (95%CI: 1.35, 3.45) billion CNY in economic losses, including 2.23 (95%CI: 1.29, 3.14) billion in direct losses and 0.19 (95%CI, 0.06, 0.31) billion in indirect losses, males, people aged 15-64 years, residents of temperate continental climate zones, and patients with urolithiasis were at higher risk. CONCLUSION: Tailored community health campaigns should be developed and implemented to reduce the adverse health effects and economic losses of heatwave-related urinary diseases, especially in the context of climate change.

How does risk-taking affect the green technology innovation of high-tech enterprises in China: the moderating role of financial mismatch.

As a core driver for the high-tech enterprises, green technology innovation is crucial, even with high financial risk. Against this background, this paper empirically examines the impact of risk-taking on green technology innovation of high-tech enterprises, taking Chinese A-share listed companies from 2007 to 2020 as the research sample and considering the moderating effect of financial mismatch. Findings show the following: First, the effect of risk-taking on green technology innovation of high-tech enterprises is insignificant in most cases, and the inhibitory effect of financial mismatch is partly supported. Second, financial mismatch only counter-regulates the inhibitory effect of systematic risk-taking on the number of invention patents granted in the eastern sample. Third, the effect of risk-taking on green technology innovation is significantly heterogeneous in terms of property rights and regional heterogeneity, regardless of considering the moderating effect of financial mismatch or not. Finally, the policy implementations point out that the government should create a favorable investment environment, financial institutions should adjust the way of capital allocation, while high-tech enterprises should broaden the financing channels to enhance their risk-taking ability, and promote green technological innovation to achieve high-quality economic development.

Temperature and influenza transmission: Risk assessment and attributable burden estimation among 30 cities in China.

BACKGROUND: Many studies have explored the epidemiological characteristics of influenza. However, most previous studies were conducted in a specific region without a national picture which is important to develop targeted strategies and measures on influenza control and prevention. OBJECTIVES: To explore the association between ambient temperature and incidence of influenza, to estimate the attributable risk from temperature in 30 Chinese cities with different climatic characteristics for a national picture, and to identify the vulnerable populations for national preventative policy development. METHODS: Daily meteorological and influenza incidence data from the 30 Chinese cities over the period 2016-19 were collected. We estimated the city-specific association between daily mean temperature and influenza incidence using a distributed lag non-linear model and evaluated the pooled effects using multivariate meta-analysis. The attributable fractions compared with reference temperature were calculated. Stratified analyses were performed by region, sex and age. RESULTS: Overall, an N-shape relationship between temperature and influenza incidence was found in China. The cumulative relative risk of the peak risk temperature (5.1 °C) was 2.13 (95%CI: 1.41, 3.22). And 60% (95%eCI: 54.3%, 64.3%) of influenza incidence was attributed to ambient temperature during the days with sensitive temperatures (1.6°C-14.4 °C). The ranges of sensitive temperatures and the attributable disease burden due to temperatures varied for different populations and regions. The residents in South China and the children aged ≤5 and 6-17 years had higher fractions attributable to sensitive temperatures. CONCLUSIONS: Tailored preventions targeting on most vulnerable populations and regions should be developed to reduce influenza burden from sensitive temperatures.

Optimization of an economical medium composition for the coculture of Clostridium butyricum and Bacillus coagulans.

Clostridium butyricum is a spore-forming probiotic which can promote the enhancement of beneficial bacteria and maintain intestinal microecological balance. However, it is difficult to improve the production level of C. butyricum by conventional fermentation process. In this study, a co-fermentation process of C. butyricum DL-1 and Bacillus coagulans ZC2-1 was established to improve the viable counts and spore yield of C. butyricum, and the formula of coculture medium was optimized by flask fermentation. The results showed that the optimum medium composition is 10 g/L bran, 15 g/L corn steep powder, 15 g/L peptone, 1 g/L K2HPO4 and 0.5 g/L MnSO4.Cultured stationarily in the optimal medium for 36 h, the number of viable bacteria of C. butyricum DL-1 reached 1.5 × 108 cfu/mL, Which was 375 times higher than that incubated in the initial medium. The sporulation rate reach 92.6%. The results revealed an economical and effective medium composition for the coculture of C. butyricum and B. coagulans, which achieved a 64.6% cost reduction. The co-fermentation process established in this study provides a new fermentation mode for the industrial production of other absolute anerobic bacteria.

Assessment of Regional Health Vulnerability to Extreme Heat - China, 2019.

What is already known on this topic? The health risk caused by high-temperatures depends on the interaction between high temperature exposure and the sensitivity and adaptability of the affected populations. What is added by this report? A comprehensive assessment model was established by principal component analysis using the data of 19 cities, 15 provincial-level administrative divisions and used to identify regional characteristics and major influencing factors of health vulnerability to extreme heat in China. What are the implications for public health practice? The results of the health vulnerability assessment could effectively identify the regions highly vulnerable to extreme heat in China and provide scientific evidence for the development of adaptive measures and resource allocation plans.

Assessment of the Association of Vitamin D Level With SARS-CoV-2 Seropositivity Among Working-Age Adults.

Importance: Low vitamin D levels have been reported to be associated with increased risk of SARS-CoV-2 infection. Independent, well-powered studies could further our understanding of this association. Objective: To examine whether low levels of vitamin D are associated with SARS-CoV-2 seropositivity, an indicator of previous infection. Design, Setting, and Participants: This is a cohort study of employees and spouses who elected to be tested for SARS-CoV-2 IgG as part of an annual employer-sponsored health screening program conducted in August to November 2020. This program includes commonly assessed demographic, biometric, and laboratory variables, including total vitamin D measurement. Baseline (prepandemic) levels of vitamin D and potential confounders were obtained from screening results from the previous year (September 2019 to January 2020). Data analysis was performed from December 2020 to March 2021. Exposures: Low total serum 25-hydroxyvitamin D, defined as either less than 20 ng/mL or less than 30 ng/mL. Main Outcomes and Measures: The main outcome was SARS-CoV-2 seropositivity, as determined with US Food and Drug Administration emergency use-authorized assays. The association of SARS-CoV-2 seropositivity with vitamin D levels was assessed by multivariable logistic regression analyses and propensity score analyses. Results: The 18 148 individuals included in this study had test results for SARS-CoV-2 IgG in 2020 and vitamin D levels from the prepandemic and pandemic periods. Their median (interquartile range) age was 47 (37-56) years, 12 170 (67.1%) were women, 900 (5.0%) were seropositive, 4498 (24.8%) had a vitamin D level less than 20 ng/mL, and 10 876 (59.9%) had a vitamin D level less than 30 ng/mL before the pandemic. In multivariable models adjusting for age, sex, race/ethnicity, education, body mass index, blood pressure, smoking status, and geographical location, SARS-CoV-2 seropositivity was not associated with having a vitamin D level less than 20 ng/mL before (odds ratio [OR], 1.04; 95% CI, 0.88-1.22) or during (OR, 0.93; 95% CI, 0.79-1.09) the pandemic; it was also not associated with having a vitamin D level less than 30 ng/mL before (OR, 1.09; 95% CI, 0.93-1.27) or during (OR, 1.05; 95% CI, 0.91-1.23) the pandemic. Similar results were observed in propensity score analyses. SARS-CoV-2 seropositivity was associated with obesity (OR, 1.26; 95% CI, 1.08-1.46), not having a college degree (OR, 1.40; 95% CI, 1.21-1.62), and Asian (OR, 1.46; 95% CI, 1.13-1.87), Black (OR, 2.74; 95% CI, 2.25-3.34), Hispanic (OR, 2.65; 95% CI, 2.15-3.27), American Indian or Alaska Native, and Native Hawaiian or other Pacific Islander (OR, 2.01; OR, 1.54-2.62) race/ethnicity, and was inversely associated with high blood pressure (OR, 0.82; 95% CI, 0.70-0.96), smoking (OR, 0.60; 95% CI, 0.47-0.78), and residing in the US Northeast (OR, 0.75; 95% CI, 0.62-0.92) and West (OR, 0.54; 95% CI, 0.44-0.67). Conclusions and Relevance: In this cohort study, SARS-CoV-2 seropositivity was not associated with low levels of vitamin D independently of other risk factors.

Temperatures and health costs of emergency department visits: A multisite time series study in China.

BACKGROUND: Evidence is limited regarding the association between temperatures and health costs. OBJECTIVES: We tried to investigate the association between temperatures and emergency department visits (EDVs) costs in China. METHODS: Daily data on EDVs costs, weather, air pollution were collected from 17 sites in China during 2014-2018. A quasi-Poisson generalized additive regression with distributed lag nonlinear model was applied to assess the temperature-EDVs cost association. Random-effect meta-analysis was used to pool the estimates from each site. Attributable fractions and national attributable EDVs costs due to heat and cold were calculated. RESULTS: Relative risk (RR) due to extreme heat over 0-7 lag days was 1.14 [95% confidence intervals (CI): 1.08-1.19] and 1.11 (95% CI: 1.07-1.16) for EDVs examination (including treatment) and medicine cost, respectively. People aged 18-44 and those with genitourinary diseases were at higher risk from heat. 0.72% of examination cost and 0.57% of medicine cost were attributed to extreme heat, costing 274 million Chinese Yuan annually. Moderate heat had lower RR but higher attributable fraction of EDVs costs. Exposure to extreme cold over 0-21 lag days increased the risk of medicine cost for people aged 18-44 [RR: 1.30 (95% CI: 1.10-1.55)] and those with respiratory diseases [RR: 1.56 (95% CI: 1.14-2.14)], but had non-statistically significant attributable fraction of the total EDVs cost. CONCLUSIONS: Exposure to heat and cold resulted in remarkable health costs. More resources and preparedness are needed to tackle such a challenge as our climate is rapidly changing.

Daily mean temperature and HFMD: risk assessment and attributable fraction identification in Ningbo China.

BACKGROUND: Hand, foot, and mouth disease (HFMD) remains a significant public health issue, especially in developing countries. Many studies have reported the association between environmental temperature and HFMD. However, the results are highly heterogeneous in different regions. In addition, there are few studies on the attributable risk of HFMD due to temperature. OBJECTIVES: The study aimed to assess the association between temperature and HFMD incidence and to evaluate the attributable burden of HFMD due to temperature in Ningbo China. METHODS: The research used daily incidence of HFMD from 2014 to 2017 and distributed lag non-linear model (DLNM) to investigate the effects of daily mean temperature (Tmean) on HFMD incidence from lag 0 to 30 days, after controlling potential confounders. The lag effects and cumulative relative risk (CRR) were analyzed. Attributable fraction (AF) of HFMD incidence due to temperature was calculated. Stratified analysis by gender and age were also conducted. RESULTS: The significant associations between Tmean and HFMD incidence were observed in Ningbo for lag 0-30. Two peaks were observed at both low (5-11 °C) and high (16-29 °C) temperature scales. For low temperature scale, the highest CRR was 2.22 (95% CI: 1.61-3.07) at 7 °C on lag 0-30. For high temperature scale, the highest CRR was 3.54 (95% CI: 2.58-4.88) at 24 °C on lag 0-30. The AF due to low and high temperature was 5.23% (95% CI: 3.10-7.14%) and 39.55% (95% CI: 30.91-45.51%), respectively. There was no significant difference between gender- and age-specific AFs, even though the school-age and female children had slightly higher AF values. CONCLUSIONS: The result indicates that both high and low temperatures were associated with daily incidence of HFMD, and more burdens were caused by heat in Ningbo.

Cost-effectiveness of nucleic acid amplification testing to guide treatment for vaginitis: a decision-modeling analysis.

We evaluated the cost-effectiveness of test-and-treat scenarios for vaginitis, scenarios based on clinical and microscopic examination (CME), nucleic acid amplification testing (NAAT), or nonamplified nucleic acid probe (probe) testing. The symptom resolution outcome and the payer cost of diagnosis and treatment were estimated in decision analytical models in a hypothetical patient population. Compared with probe testing, NAAT resulted in symptom resolution in more patients (615 versus 475 per 1000 tested) at a cost of $210 per incremental symptom resolution, a cost lower than the willingness to pay for symptom resolution ($871) implied by payer coverage for probe testing. Following a negative CME, the NAAT scenario resulted in symptom resolution in more patients (650 per 1000 patients tested) than did either CME (525) or the CME probe testing-based scenario (602) at incremental cost-effectiveness ratios lower than the willingness to pay implied by coverage for CME. Therefore, NAAT is likely to cost-effectively improve health outcomes for patients with vaginitis.

Outreach and Connection to Care for Chronic Kidney Disease in a Workplace Wellness Setting: A Cost-Effectiveness Analysis.

Because chronic kidney disease (CKD) is underdiagnosed, many patients do not receive care that could slow or prevent progression. Potential CKD patients can be identified during employee wellness events and referred into care by a CKD outreach program. This study assessed the health and economic benefits associated with a CKD outreach program. A model-based cost-effectiveness analysis was conducted for a cohort of patients at risk for CKD under 2 scenarios: wellness events with a CKD outreach program and wellness events without outreach. The outreach program identified potential CKD patients based on estimated glomerular filtration rates. Health outcomes and total cost to payers were estimated with Markov models using 1-year cycles. Because outreach could be offered to either patients with diabetes or to all potential CKD patients, these groups were modeled separately. The authors assumed 40% percent of potential CKD patients accepted the invitation to participate in the CKD outreach program. Model parameters were taken from peer-reviewed literature. The study was conducted from the perspective of self-insured employers over a 5-year time horizon. The study found that the CKD outreach program resulted in a gain of 2.3 quality-adjusted life-years and saved $500,211 when 1000 potential CKD patients with diabetes were invited. When potential CKD patients were invited without regard for diabetes status, 0.8 quality-adjusted life-years were gained at a cost savings of $34,161. The authors concluded that CKD outreach programs can improve health outcomes for patients with CKD and save costs for payers.

High temperatures and emergency department visits in 18 sites with different climatic characteristics in China: Risk assessment and attributable fraction identification.

BACKGROUND: Health impacts of high temperatures on hospital emergency department visits (EDVs) have been less reported, especially from developing countries. OBJECTIVES: To investigate high temperature-EDVs relationship in various regions with different climatic characteristics, to explore the regional differences, to identify vulnerable populations, and to provide scientific evidence for climate change adaptation strategies in China. METHODS: Daily data on weather, air pollution and EDVs were collected from 18 sites in China from June to August during 2014-2017. A quasi-Poisson generalized additive regression model was applied to examine the high temperature-EDVs relationship in each site. Site-specific risks of EDVs were pooled using a random effect meta-analysis model. Stratified analyses were performed by gender, age-groups, cause-specific EDVs and regions. Attributable fractions of EDVs due to high temperatures were calculated in different regions. RESULTS: 1 °C increase in daily mean temperature was associated with 1.07% (95% CI, 0.46-1.67%) increase in EDVs across all study regions. The negative health effects from high temperatures were worse for the people living in southern China, in subtropical monsoon climate zone or in counties, with percentage change of 1.96% (95% CI, 0.92-3.02%), 1.35% (95% CI, 0.95-1.76%) and 1.41% (95% CI, 0.48-2.34%), respectively. People under 18 were more vulnerable to high temperatures. Exposure to high temperatures increased EDVs risks from endocrine, respiratory, and digestive diseases and injury. The attributable fraction due to high temperatures was 8.64% for overall EDVs, 11.70% for the people living in southern China, 10.80% for people living in subtropical monsoon climate zone and 12.65% for the county population. CONCLUSIONS: Exposure to high temperatures resulted in extra burden to China's already overloaded hospital emergency departments. More resources are needed to meet increasing demands and effective preventative measurements are warranted to tackle such a challenge. Further studies should pay more attention to both heat and cold-related EDVs risks and socioeconomic cost for better climate change adaptation.

Cost Effectiveness of Karyotyping, Chromosomal Microarray Analysis, and Targeted Next-Generation Sequencing of Patients with Unexplained Global Developmental Delay or Intellectual Disability.

BACKGROUND: Genetic diagnosis of unexplained global developmental delay and intellectual disability (GDD/ID) often ends the diagnostic odyssey and can lead to changes in clinical management. OBJECTIVE: The objective of this study was to investigate the cost effectiveness of testing scenarios involving several methods used to diagnose GDD/ID: karyotyping, chromosomal microarray analysis (CMA), and targeted next-generation sequencing (NGS). METHODS: We used decision-tree models to estimate the number of genetic diagnoses, the cost from a payers' perspective in the USA, and the incremental cost per additional genetic diagnosis. Model parameters were taken from peer-reviewed literature and governmental fee schedules. RESULTS: CMA testing results in more genetic diagnoses at an incremental cost of US $2692 per additional diagnosis compared with karyotyping, which has an average cost per diagnosis of US $11,033. Performing both tests sequentially results in the same number of diagnoses, but the total cost is less when CMA testing is done first and karyotyping second. Furthermore, when CMA testing yields a variant of unknown significance, additional genetic diagnoses can be obtained at an incremental cost of US $4220 by CMA testing of both parents, and when parents are not available or the patient had a normal CMA result, targeted NGS of the patient can add diagnoses at a further incremental cost of US $12,295. CONCLUSION: These results provide a cost effectiveness rationale for the use of CMA as the first-tier test for the genetic diagnosis of unexplained GDD/ID and further indicate that testing of both parents may be cost effective when a variant of unknown significance is detected in the patient.

A Multigene Test Could Cost-Effectively Help Extend Life Expectancy for Women at Risk of Hereditary Breast Cancer.

BACKGROUND: The National Comprehensive Cancer Network recommends that women who carry gene variants that confer substantial risk for breast cancer consider risk-reduction strategies, that is, enhanced surveillance (breast magnetic resonance imaging and mammography) or prophylactic surgery. Pathogenic variants can be detected in women with a family history of breast or ovarian cancer syndromes by multigene panel testing. OBJECTIVES: To investigate whether using a seven-gene test to identify women who should consider risk-reduction strategies could cost-effectively increase life expectancy. METHODS: We estimated effectiveness and lifetime costs from a payer perspective for two strategies in two hypothetical cohorts of women (40-year-old and 50-year-old cohorts) who meet the National Comprehensive Cancer Network-defined family history criteria for multigene testing. The two strategies were the usual test strategy for variants in BRCA1 and BRCA2 and the seven-gene test strategy for variants in BRCA1, BRCA2, TP53, PTEN, CDH1, STK11, and PALB2. Women found to have a pathogenic variant were assumed to undergo either prophylactic surgery or enhanced surveillance. RESULTS: The incremental cost-effectiveness ratio for the seven-gene test strategy compared with the BRCA1/2 test strategy was $42,067 per life-year gained or $69,920 per quality-adjusted life-year gained for the 50-year-old cohort and $23,734 per life-year gained or $48,328 per quality-adjusted life-year gained for the 40-year-old cohort. In probabilistic sensitivity analysis, the seven-gene test strategy cost less than $100,000 per life-year gained in 95.7% of the trials for the 50-year-old cohort. CONCLUSIONS: Testing seven breast cancer-associated genes, followed by risk-reduction management, could cost-effectively improve life expectancy for women at risk of hereditary breast cancer.

Cost Effectiveness of Sequencing 34 Cancer-Associated Genes as an Aid for Treatment Selection in Patients with Metastatic Melanoma.

OBJECTIVE: To determine whether a next-generation sequencing (NGS) panel of 34 cancer-associated genes would cost-effectively aid in the treatment selection for patients with metastatic melanoma, compared with a single-site BRAF V600 mutation test. METHODS: A decision model was developed to estimate the costs and health outcomes of the two test strategies. The cost effectiveness of these two strategies was analyzed from a payer perspective over a 2-year time horizon with model parameters taken from the literature. RESULTS: In the base case, the gene sequencing panel strategy resulted in a cost of US$120,022 and 0.721 quality-adjusted life years (QALYs) per patient, whereas the single-site mutation test strategy resulted in a cost of US$128,965 and 0.704 QALYs. Thus, the gene sequencing panel strategy cost US$8943 less per patient and increased QALYs by 0.0174 per patient. Sensitivity analyses showed that, compared with the single-site mutation test strategy, the gene sequencing panel strategy had a 90.9% chance of having reduced costs and increased QALYs, with the cost of the gene sequencing panel test having minimal effect on the incremental cost. CONCLUSION: Compared with the single-site mutation test, the use of an NGS panel of 34 cancer-associated genes as an aid in selecting therapy for patients with metastatic melanoma reduced costs and increased QALYs. If the base-case results were applied to the 8900 patients diagnosed with metastatic melanoma in the USA each year, the gene sequencing panel strategy could result in an annual savings of US$79.6 million and a gain of 155 QALYs.

Edible safety requirements and assessment standards for agricultural genetically modified organisms.

This paper describes the background, principles, concepts and methods of framing the technical regulation for edible safety requirement and assessment of agricultural genetically modified organisms (agri-GMOs) for Shenzhen Special Economic Zone in the People's Republic of China. It provides a set of systematic criteria for edible safety requirements and the assessment process for agri-GMOs. First, focusing on the degree of risk and impact of different agri-GMOs, we developed hazard grades for toxicity, allergenicity, anti-nutrition effects, and unintended effects and standards for the impact type of genetic manipulation. Second, for assessing edible safety, we developed indexes and standards for different hazard grades of recipient organisms, for the influence of types of genetic manipulation and hazard grades of agri-GMOs. To evaluate the applicability of these criteria and their congruency with other safety assessment systems for GMOs applied by related organizations all over the world, we selected some agri-GMOs (soybean, maize, potato, capsicum and yeast) as cases to put through our new assessment system, and compared our results with the previous assessments. It turned out that the result of each of the cases was congruent with the original assessment.