Accelerating the integration of China into the global development of innovative anticancer drugs.

The aim of this Policy Review was to compare China's overall and synchronous participation in clinical trials for innovative anticancer drugs with that of the USA, the EU, Japan, and South Korea, and to assess changes in the participation rate trends in these five regions. Relevant data from the top 20 international pharmaceutical companies from 2011 to 2021 were systematically collected from the Trialtrove and Pharmaprojects databases. Among the 8260 trials for 954 new anticancer drugs identified, China was involved in 8·8% of the trials and with 20·4% of the drugs being trialled. These participation rates are significantly lower than those for South Korea (14·5% of trials and 36·3% of drugs), Japan (16·1% of trials and 38·7% of drugs), the EU (40·6% of trials and 67·7% of drugs), and the USA (65·7% of trials and 91·2% of drugs; p<0·0001 for all). Similar results were found for the synchronous participation rate, defined as the proportion of drugs or trials at the highest development stage internationally, for the 803 tested drugs, which ranged from 9·0% in China to 87·7% in the USA. China's participation rate in early phase trials (4·4%) and in synchronous trials (5·4%) was even lower, in stark contrast to that of the USA (66·1% for early phase trials and 89·1% for synchronous trials). The fastest growing annual rate of participation in trials was observed in China (15·7%), followed by South Korea (8·2%) and Japan (6·8%); no change was detected in the USA or the EU. This Policy Review shows that Chinese participation in the clinical development of innovative cancer drugs by international pharmaceutical companies has increased over the past decade, but an obvious gap persists in comparison with the USA, the EU, Japan, and South Korea, especially in its synchronous participation and early participation rates.

Microsatellite Instability Assessment by Immunohistochemistry in Acute Myeloid Leukemia: A Reappraisal and Review of the Literature.

BACKGROUND: Microsatellite instability (MSI) is caused by defects in DNA mismatch repair (MMR) components. Inactivation of any MMR gene(s), including hMLH1, hMSH2, hMSH6, and hPMS2, can result in MSI. Immunohistochemistry (IHC) is a sensitive and specific screening tool for MSI that can detect loss of expression of one or more MMR components. Of the four MMR markers, hMLH1 and hMSH2 are considered most informative of MSI status. There has been renewed interest in MSI status in view of its favorable association with response to immune checkpoint inhibitors in some cancers. MMR expression patterns in acute myeloid leukemia (AML) have not been evaluated systematically. METHODS: We used clinically-validated IHC assays to assess the expression of hMLH1, hMSH2, hMSH6, and/or hPMS2 in formalin-fixed paraffin-embedded tissue sections of bone marrow core biopsies from patients diagnosed with AML. Mutation profiling was performed using next-generation sequencing to assess for mutations in MMR genes. RESULTS: The study group included 236 patients with AML, including a cohort treated on a clinical trial of azacitidine and nivolumab (NCT02397720). In addition, hMSH6, and/or hPMS2 expression was assessed in 99 AML patients with diploid karyotype. All patients, except two, had retained expression of all MMR markers assessed: One patient from the azacytidine+nivolumab group had zonal patchy loss of staining of hMLH1 and, to a lesser extent, a similar staining pattern of hMSH2; and one patient from the AML with diploid karyotype group had loss of hMSH2 but retained expression of hMLH1, hMSH6 and hPMS2. In addition, a retrospective analysis on a separate cohort of 139 patients with primary AML, on which next generation sequencing profiling was performed, identified 14 cases with alterations in MMR genes. CONCLUSION AND REMARKS: MMR loss is a rare event in AML, thus does not appear to underlie response patterns to anti-PD1 therapy.

Intervention by clinical pharmacists can improve blood glucose fluctuation in patients with diabetes and acute myocardial infarction: A propensity score-matched analysis.

Acute phase hyperglycemia and exaggerated glucose fluctuation may be associated with poor outcomes in diabetic patients after acute myocardial infarction (AMI). This study aimed to determine whether intervention by clinical pharmacists can mitigate blood glucose and glucose fluctuations in these fragile patients. This retrospective study enrolled patients with diabetes and AMI, from 1 January 2019 to 30 June 2020 in our institution. Blood glucose and glucose fluctuations were calculated before and after the pharmacist's intervention and between patients who underwent intervention and those who did not. Propensity score matching (PSM) was used to reduce the impact of patient characteristics on the results. A total of 170 patients were included in our primary analysis, including 29 patients who received the pharmacist intervention and 141 patients who did not. After the pharmacist's intervention, blood glucose (fasting blood glucose-FBG, from 11.9 to 9.8; postprandial blood glucose-PBG, from 15.3 to 13.2; mean blood glucose-BG, 14.5 to 12.3 mmol/L; p < .001), and glucose fluctuations (standard deviation of blood glucose-SDBG, from 3.8 to 3.0, mmol/L, p = .005) were significantly improved. Before PSM, no clear effects were found in intervention versus nonintervention patients, in terms of blood glucose and glucose fluctuation indicators, except for FBG (9.3 vs. 8.0. mmol/L, p = .005). Further analysis indicated a high incidence of FBG <7.8 mmol/L in nonintervention versus intervention patients (51.5% vs. 27.6%, p = .003). After PSM, a significant reduction in blood glucose fluctuation (SDBG, 3.0 vs. 4.1, p = .031; PBGE, 2.1 vs. 4.1, p = .017; LAGE, 4.7 vs. 7.2, mmol/L, p = .004), and PBG (11.1 vs. 13.0, mmol/L, p = .048) was observed in the intervention group than in the nonintervention group. The clinical pharmacist intervention contributed to improved outcomes, specifically, in reducing blood glucose fluctuations and potential hypoglycemia risk.

Chronic Obstructive Pulmonary Disease Treatment and Pharmacist-Led Medication Management.

Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death across the globe. Its repeated exacerbation will seriously worsen the quality of life, aggravate the patients' symptoms, and bring a heavy burden on the patients and the society. Understanding the current status of drug therapy and the role of pharmaceutical care is essential for the management of COPD. In addition to the drugs already on the market, recent clinical trials also show that emerging novel drugs for treating COPD are being developed to prevent the symptoms, reduce the frequency of acute exacerbation, and improve the quality of life. Recent progress in new drug research should lead to novel treatment options for COPD patients in future clinical practice. The pharmaceutical care has shown significantly favourable impacts on addressing drug-related problems, supporting its vital role in the management of COPD, especially when there are a wide range of therapeutic agents. This review not only provides an overview of current treatment strategies but also further underlines the importance of new drug development and pharmaceutical care for patients with COPD.

Cost-Effectiveness Analysis of Camrelizumab Plus Chemotherapy vs. Chemotherapy Alone as the First-Line Treatment in Patients With IIIB-IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Without EGFR and ALK Alteration from a Perspective of Health - Care System in China.

Objective: The CAMEL clinical trial (412 patients were randomly assigned to either camrelizumab plus chemotherapy (n = 205) or chemotherapy alone (n = 207)) demonstrated that camrelizumab plus chemotherapy (CC) improved the overall survival time (OS) and progression-free survival time (PFS) of patients with metastatic nonsquamous non-small cell lung cancer (non-sq NSCLC) without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations (EGFRm and ALKm) vs. chemotherapy (C) alone. Our objective was to conduct a cost-effectiveness analysis of CC vs. C from a perspective of health - care system in China with a lifetime horizon to identify whether it will be cost-effective. Materials and Methods: A partitioned survival model (PSM) was applied for patients with IIIB-IV non-sq NSCLC without EGFRm and ALKm. Transition parameters and proportions of three health states were derived from the CAMEL trial. The model was designed using a lifetime horizon, a 21-day cycle, and a 5% discount rate of costs and outcomes. It was deemed cost-effective in China if the incremental cost-effectiveness ratio (ICER) value is less than $32,457 per quality adjusted life-year (QALY). Deterministic and probabilistic sensitivity analyses were performed to verify the influence of parameter uncertainty on the results. Results: In the base-case analysis, we found that the ICER of CC compared with C is $-7,382.72/QALY which meant that CC had lower costs and better outcomes. The results of the sensitivity analyses demonstrated that the result was robust for the ICERs never transcending the willingness-to-pay (WTP) threshold. Conclusion: Camrelizumab plus chemotherapy is an obviously cost-effective therapeutic regime for patients of IIIB-IV non-sq NSCLC without EGFRm and ALKm in China at a $32,457 WTP threshold.

Co-benefits of Energy-Efficient Air Conditioners in the Residential Building Sector of China.

Electricity demand for room air conditioners (ACs) has been growing significantly in China in response to rapid economic development and mounting impacts of climate change. In this study, we use the bottom-up model approach to predict the penetration rate of room ACs in the residential building sector of China at the provincial level, with the consideration of the urban-rural heterogeneity. In addition, we assess co-benefits associated with enhanced energy efficiency improvement of AC systems and the adoption of low-global-warming-potential (low-GWP) refrigerants in AC systems. The results indicate that the stock of room ACs in China grows from 568 million units in 2015 to 997 million units in 2030 and 1.1 billion units in 2050. The annual electricity saving from switching to more efficient ACs using low-GWP refrigerants is estimated at almost 1000 TWh in 2050 when taking account of the full technical energy efficiency potential. This is equivalent to approximately 4% of the expected total energy consumption in the Chinese building sector in 2050 or the avoidance of 284 new coal-fired power plants of 500 MW each. The cumulative CO2eq mitigation associated with both the electricity savings and the substitution of high-GWP refrigerants makes up 2.6% of total business-as-usual CO2eq emissions in China over the period 2020 to 2050. The transition toward the uptake of low-GWP refrigerants is as vital as the energy efficiency improvement of new room ACs, which can help and accelerate the ultimate goal of building a low-carbon society in China.

Evaluation of different proton pump inhibitors combined with bismuth quadruple regimens in Helicobacter pylori eradication.

To evaluate the efficacy and economics of different proton pump inhibitors (PPIs) combined with bismuth quadruple regimens for Helicobacter pylori (Hp) eradication, a retrospective analysis method was used to collect Hp-positive patients who were treated with a bismuth-containing quadruple regimen (PPIs + amoxicillin + furazolidone + colloid pectin bismuth) from the outpatient department of gastroenterology in our hospital from January to June 2017. A total of 1410 patients were included in the study and divided into four groups according to different PPIs: group A (pantoprazole sodium enteric-coated capsules, 352 cases), group B (esomeprazole magnesium enteric-coated tablets, 462 cases), group C (pantoprazole sodium enteric-coated tablets, 392 cases) and group D (rabeprazole sodium enteric-coated tablets, 204 cases). The eradication rate of Hp and cost-saving in each group were then compared. There were no significant differences of gender (P = 0.526) and age (P = 0.366) between each Hp treatment regimen. The eradication rates of groups A, B, C and D were 91.48%, 89.83%, 86.73% and 90.69%, respectively. No statistical differences of Hp eradication rates were observed between each group yet (P > 0.05). However, the cost of group A was the lowest. In the present study, the Hp eradication rates between different PPIs regimens were similar in treating Hp infection. Nevertheless, the point in favor of pantoprazole capsules is the slightly higher Hp eradication rate and lower drug cost than other PPIs, which provides a significant evidence for the clinical medication decision in treating Hp infection.

Pharmacoeconomic Evaluation of Cancer Biosimilars Worldwide: A Systematic Review.

Background and Purpose: The availability of oncology biosimilars is deemed as a fundamental strategy to achieve sustainable health care. However, there is scarce systematic evidence on economic effectiveness of cancer biosimilars. We aimed to synthesize evidence from pharmacoeconomic evaluation of oncology biosimilars globally, provide essential data and methodological reference for involved stakeholders. Materials and Methods: This systematic review was conducted in PubMed, embase, the Cochrane library, CRD, ISPOR and NICE utill December 31, 2019. Information on basic characteristics, evaluation methodology and results were extracted. Quality of included studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards Checklist. Results: For 17 studies identified (13 from Europe and four from United States), the overall quality was generally acceptable. A total of seven biological molecules involved with filgrastim, EPOETIN α, and trastuzumab leading the three. The mostly common evaluation perspective was payer, but the time horizon varied greatly. There were ten studies which adopted cost minimization analysis to evaluate efficiency while seven studies adopted budget impact analysis to address affordability, with cost ratio and cost saving being its corresponding primary endpoint. Although the comparability of included studies was limited and specific results were largely affected by uptake and price discount rates of the oncology biosimilar, the comprehensive results consistently favored its promotion. Conclusion: Globally, the economic evaluation of cancer biosimilars is in its initial phase. However, limited evidence from developed countries consistently supported both cost-effectiveness of efficiency and affordability of oncology biosimilars, while they were largely affected by uptake and price discount rate.

Complications and Costs of Peripherally Inserted Central Venous Catheters Compared With Implantable Port Catheters for Cancer Patients: A Meta-analysis.

BACKGROUND: Peripherally inserted central catheters (PICCs) and implantable port catheters (IPCs) are 2 most common central venous access for cancer patients receiving chemotherapy. However, no specific evidence exists to guide practitioners on safety and less cost. OBJECTIVE: To compare the differences of complications and costs of PICC and IPC in the treatment of cancer patients with chemotherapy and to provide a basis for better clinical decision making. METHODS: All the cohort studies were searched in the Cochrane Library, JBI, PubMed, Elsevier, Web of Science, CINAHL, CBM, and CNKI from inception to July 2018. Two reviewers screened and selected trials, evaluated quality, and extracted data. Meta-analysis and description of the outcomes were performed by using the RevMan 5.3 software. RESULTS: A total of 761 articles were retrieved, with 15 articles meeting eligibility criteria. Outcome analysis showed no difference in 1-puncture success rate. Peripherally inserted central catheter use was associated with higher complication rates than IPC, including occlusion, infection, malposition, catheter-related thrombosis, extravasation, phlebitis, and accidental removal rate. The life span of IPC was longer than that of PICC, and the costs of IPC were lower. CONCLUSIONS: Implantable port catheter has advantages over PICC in reducing cancer patients' complications and less cost in terms of long-term cancer chemotherapy. IMPLICATIONS FOR PRACTICE: In terms of safety, the results provide evidence for practitioners to choose which type of central venous catheters is better for cancer chemotherapy patients. In terms of costs, practitioners need to make decisions about which type of central venous catheters has less cost.

The Liver Toxicity Knowledge Base (LKTB) and drug-induced liver injury (DILI) classification for assessment of human liver injury.

INTRODUCTION: Drug-induced liver injury (DILI) is challenging for drug development, clinical practice and regulation. The Liver Toxicity Knowledge Base (LTKB) provides essential data for DILI study. Areas covered: The LTKB provided various types of data that can be used to assess and predict DILI. Among much information available, several reference drug lists with annotated human DILI risk are of important. The LTKB DILI classification data include DILI severity concern determined by the FDA drug labeling, DILI severity score from the NIH LiverTox database, and other DILI classification schemes from the literature. Overall, ~1000 drugs were annotated with at least one classification scheme, of which around 750 drugs were flagged for some degree of DILI risk. Expert commentary: The LTKB provides a centralized repository of information for DILI study and predictive model development. The DILI classification data in LTKB could be a useful resource for developing biomarkers, predictive models and assessing data from emerging technologies such as in silico, high-throughput and high-content screening methodologies. In coming years, streamlining the prediction process by including DILI predictive models for both DILI severity and types in LTKB would enhance the identification of compounds with the DILI potential earlier in drug development and risk assessment.

Changes in Waist Circumference and Abdominal Obesity among Chinese Adults over a Ten-year Period.

OBJECTIVE: The aim of this study was to describe changes in waist circumference (WC) and prevalence of abdominal obesity over a period of 10 years among Chinese adults in different socio-economic status (SES). METHODS: Data derived from the China Nutrition and Health Surveillance during 2002 and 2010-2012. We calculated the mean WC and the prevalence of abdominal obesity by gender, place of residence, SES indicators (education, income, and marital status), and body mass index (BMI) categoriesand used pooled t-tests to assess the differences between the two time periods. RESULTS: 26.0% of men and 25.3% of women had abdominal obesity in 2010-2012. The age-adjusted mean WC increased by 2.7 cm among men and 2.1 cm among women; the age-adjusted prevalence of abdominal obesity increased by 7.7% among men and 5.3% among women. The rising trends were observed in all subgroups except for a negative growth in high-income women. People living in rural areas with low education and income and with a BMI of 18.5 to 23.9 kg/m2 had a greater absolute and relative increase in WC. People living in rural areas with low income had a greater relative increase in abdominal obesity. CONCLUSION: The mean WC and prevalence of abdominal obesity among Chinese adults have increased during the past 10 years. Gender differences were noted using various SES indicators.

Oral health status in Sichuan Province: findings from the oral health survey of Sichuan, 2015-2016.

To investigate oral health status in the residents of Sichuan Province, southwest China, a cross-sectional study was performed using the latest Oral Health Survey Basic Methods recommended by the World Health Organization. A multistage stratified random cluster-sampling method was used to enroll participants from the following three groups: children aged 3-5 years, adolescents aged 12 years, and people aged 65-74 years. In these three groups, the mean numbers of teeth that were affected by caries were 3.28, 0.86 and 5.13, respectively, resulting in a prevalence of 63.47%, 37.20% and 83.20%, respectively. Relative to the high rate of decayed teeth, the prevalence of fillings was very low in all age groups (0.97%, 7.24% and 5.43%, respectively). In the 12-year-old adolescent group, only 3.61% had good pit and fissure sealing. In addition, the rate of dental fluorosis was 24.80%, and the Community Fluorosis Index value was 0.39. In the elder group, the community periodontal index was 2.92. The prevalence in the elderly of having lost at least one tooth was 75.54%. Additionally, 4.44% of these participants were edentulous. The incidence of dental prosthesis was 51.75%, the proportion with a removable partial denture, a fixed denture, full dentures, dental implants and an informal fixed bridge was 21.59%, 11.45%, 4.64%, 0 and 16.67%, respectively. In this study, 8.2% of the elderly participants were affected by different types of oral mucosal lesions. Among such lesions, recurrent aphthous ulcers were most prevalent (2.69%) and oral lichen planuses were second (1.6%). The conclusion presented in this survey is that oral diseases, especially dental caries and periodontal disease, are frequent and common in Sichuan province, China. Moreover, the treatment rate is very low, and primary prevention and treatment options are therefore urgently needed in this population.

Socioeconomic Drivers of Greenhouse Gas Emissions in the United States.

Existing studies examined the U.S.'s direct GHG emitters and final consumers driving upstream GHG emissions, but overlooked the U.S.'s primary suppliers enabling downstream GHG emissions and relative contributions of socioeconomic factors to GHG emission changes from the supply side. This study investigates GHG emissions of sectors in the U.S. from production-based (direct emissions), consumption-based (upstream emissions driven by final consumption of products), and income-based (downstream emissions enabled by primary inputs of sectors) viewpoints. We also quantify relative contributions of socioeconomic factors to the US's GHG emission changes during 1995-2009 from both the consumption and supply sides, using structural decomposition analysis (SDA). Results show that income-based method can identify new critical sectors leading to GHG emissions (e.g., Renting of Machinery & Equipment and Other Business Activities and Financial Intermediation sectors) which are unidentifiable by production-based and consumption-based methods. Moreover, the supply side SDA reveals new factors for GHG emission changes: mainly production output structure representing product allocation pattern and primary input structure indicating sectoral shares in primary inputs. In addition to production-side and consumption-side GHG reduction measures, the U.S. should also pay attention to supply side measures such as influencing the behaviors of product allocation and primary inputs.

[An assessment of association of thyroid volume with growth indicators and comparison of different thyroid volume indexes in school-aged children].

OBJECTIVE: To analyze the association between thyroid volume and physical growth of school-age children, and to compare volume indexes of individual thyroids for reference of selection of assessment indicators. METHODS: All the students of the 12 classes of grades 3-5 at a primary school in Minhang district, Shanghai were rounded up with a multi-stage cluster sampling, for physical examinations to measure their height, weight, Body mass index (BMI) and body surface area (BSA), followed by B-ultrasonography to measure their thyroid volume. Data of the measurements were calculated to learn their height corrected volume index (HVI), weight and height corrected volume index (WHVI), BMI corrected volume (BMIV), and BSA corrected volume (BSAV) individually. Their urine and salt samples were collected to measure iodine concentration in urine and salt. Individual indexes were studied for their association with the growth and development indexes of children. RESULTS: Thyroid volume data were collected for 485 students, including 258 boys (53.2%) and 227 girls (46.8%). Their height, weight, BMI and BSA were found to be positively correlated with their age (P < 0.05). For children of the same age group, their thyroid volume was also positively correlated with their physical development indexes. Of all the thyroid indexes, the difference between BSAV physical development factors had no statistical association (with partial-correlation coefficients for age, gender, height, and weight being 0.07, 0.05, 0.01 and 0.02 respectively), and their thyroid volume, HVI, BMI and weight were correlated to age, height and weight. CONCLUSION: Thyroid volume was associated with age and weight. It was inappropriate to diagnose goiter with criteria of age, gender and thyroid volume. BSAV was recommended for its non-association with age, gender and weight and its stability.

An integrated extrapolation of long-term outcomes in systemic lupus erythematosus: analysis and simulation of the Hopkins lupus cohort.

OBJECTIVE: The aim of this study was to develop an SLE disease model that simulates long-term outcomes of SLE to estimate the long-term effectiveness and cost-effectiveness of SLE treatments. METHODS: Longitudinal data from 1354 patients from the Hopkins Lupus Cohort were included in the analysis. Statistical models were created to estimate disease activity [Safety of Estrogen in Lupus Erythematosus National Assessment (SELENA) SLEDAI scale] and prednisone dose over time using linear regression. Survival models for organ damage and mortality were created. The models were combined in a predictive simulation of SLE organ damage and mortality. Predictions were assessed against the Hopkins Lupus Cohort data. RESULTS: The analyses found that change in the annual average SLEDAI score was associated with the previous annual average SLEDAI score, renal involvement, age, male gender, African American ethnicity, anaemia, haematological involvement, increased DNA binding and low complement. The annual average prednisone dose increased for every unit increase in annual average SLEDAI. Organ damage and mortality modelling demonstrated that adjusted mean SLEDAI and binary SLEDAI organ involvement indicators predicted mortality, cardiovascular, renal, neuropsychiatric, pulmonary, gastrointestinal, ocular and skin damage. The cumulative average prednisone dose was associated with risk of cardiovascular, ocular, musculoskeletal, neuropsychiatric and gastrointestinal damage, gonadal failure and diabetes mellitus. The simulation reproduced mean SLEDAI and organ damage scores from the Hopkins Lupus Cohort. CONCLUSION: Longitudinal modelling of an SLE cohort confirmed relationships between risk factors and long-term outcomes in SLE. The models serve to estimate the probability of SLE outcomes over time and can be used to estimate the effectiveness and cost-effectiveness of new treatments.

[Cost-effectiveness analysis of two breast cancer screening modalities in Shanghai, China].

OBJECTIVE: To evaluate the cost-effectiveness of two breast cancer screening modalities conducted in Minhang district of Shanghai, China. METHODS: An organized and an opportunistic breast screening programs were implemented among women aged 35-74 years in Minhang district of Shanghai between May 2008 and Oct 2010, and were compared with the results obtained without screening. Costs related to screening were obtained by access to finance data of the screening programs, and costs of first treatment were collected through patient survey and medical reimbursement system query. Information on breast cancer stage was obtained from Shanghai Cancer Registry and confirmed by medical chart review. The effectiveness of screening was evaluated by breast cancer stage improvement.Cost-effectiveness ratios (CERs) were computed as costs of gaining a stage improvement from a specified screening strategy when compared with the results obtained without screening. Incremental cost-effectiveness (ICER) which compares the two screening strategies was calculated by dividing the difference in total net costs and the difference in stages improved between the two screening strategies. RESULTS: Thirty-five, one hundred and ninety-three and four hundred and seventy-nine breast cancer cases were identified in the organized screening, opportunistic screening and control groups, with an early detection rate of 46.9%, 40.7% and 38.9%, respectively. The costs of screening were 208 yuan per person or 72 453 yuan per case detected in the organized screening group and were 21 yuan per person or 11 640 yuan per case detected in the opportunistic screening group. The total cost was 103 650 yuan per case in the organized screening group, significantly higher than 50 712 yuan in the opportunistic screening group and 35 413 yuan in the control group. However, the average direct medical cost was significantly lower in the organized screening group than that in the opportunistic screening group and control group, with median costs of 11 024 yuan, 13 465 yuan and 14 243 yuan per case, respectively (P<0.001). The additional cost per case detected was 68 237 yuan for the organized screening and 15 299 yuan for opportunistic screening. The CERs were 135 291 yuan and 152 179 yuan per stage improved in the organized screening and opportunistic screening relative to the control group, with ICER of organized versus opportunistic screening being 131 086 yuan per stage improved. CONCLUSIONS: The organized screening modality and the opportunistic one are both effective in early detecting breast cancer in Chinese women. The organized screening costs more than opportunistic screening, but with a better cost-effectiveness. It may be used as an option in economically developed areas of China.

Improved self-management skills in Chinese diabetes patients through a comprehensive health literacy strategy: study protocol of a cluster randomized controlled trial.

BACKGROUND: Diabetes self-management often involves the interpretation and application of oral, written, or quantitative information. Numerous diabetes patients in China have limited health literacy, which likely leads to poorer clinical outcomes. This study is designed to examine the efficacy and cost-effectiveness of addressing health literacy to improve self-management skills and glycemic control in Chinese diabetes patients. METHODS/DESIGN: This is a cluster randomized controlled trial (RCT) conducted in 20 community healthcare sites in Shanghai, China. Overall, 800 diabetes patients will be randomized into intervention and control arms and will have a baseline hemoglobin A1c (HbA1c) assay and undergo a baseline survey which includes measures of health literacy and diabetes numeracy using revised Chinese versions of the Health Literacy Management Scale and Diabetes Numeracy Test Scale. During the 1-year period of intervention, while the control group will receive usual care, the intervention group will be supplemented with a comprehensive health literacy strategy which includes i) training healthcare providers in effective health communication skills that address issues related to low literacy, and ii) use of an interactive Diabetes Education Toolkit to improve patient understanding and behaviors. Assessments will be conducted at both patient and healthcare provider levels, and will take place upon admission and after 3, 6, 12, and 24 months of intervention. The primary outcome will be the improvement in HbA1c between Intervention group and Control group patients. Secondary outcomes at the patient level will include improvement in i) clinical outcomes (blood pressure, fasting lipids, body mass index, weight, smoking status), ii) patient reported self-management behaviors, and iii) patient-reported self-efficacy. Outcomes at the provider level will include: i) provider satisfaction and ii) intensity and type of care provided. The effects of the intervention will be examined in multivariable general linear models. Both cost-effectiveness and cost-utility analyses will be performed. DISCUSSION: The main strengths of this study are its large sample size and RCT design, involvement of both patients and healthcare providers, and the long term follow-up (24-months). This project will help to demonstrate the value of addressing health literacy and health communication to improve self-management and clinical outcomes among Chinese diabetes patients. TRIAL REGISTRATION: ISRCTN76130594, Registration date: Sept 22, 2014.

Joint longitudinal and survival-cure models in tumour xenograft experiments.

In tumour xenograft experiments, treatment regimens are administered, and the tumour volume of each individual is measured repeatedly over time. Survival data are recorded because of the death of some individuals during the observation period. Also, cure data are observed because of a portion of individuals who are completely cured in the experiments. When modelling these data, certain constraints have to be imposed on the parameters in the models to account for the intrinsic growth of the tumour in the absence of treatment. Also, the likely inherent association of longitudinal and survival-cure data has to be taken into account in order to obtain unbiased estimators of parameters. In this paper, we propose such models for the joint modelling of longitudinal and survival-cure data arising in xenograft experiments. Estimators of parameters in the joint models are obtained using a Markov chain Monte Carlo approach. Real data analysis of a xenograft experiment is carried out, and simulation studies are also conducted, showing that the proposed joint modelling approach outperforms the separate modelling methods in the sense of mean squared errors.

[Current status and urban-rural comparison of clinical agency of detection, management, and health insurance for hypertensive patients in communities of five provinces in China in 2010].

OBJECTIVE: To investigate the status of the clinical agency of detection, management, and health insurance for hypertensive patients in urban and rural communities of five provinces in China in 2010, in order to provide fundamental data for implementation and evaluation of community health management of hypertensive patients in basic public health service. METHODS: From Jiangsu, Shandong, Hebei, Sichuan and Gansu provinces, cities and districts (counties) were selected according to economic development level and 10 survey sites were finally determined. In each survey site, 3-4 communities or townships were selected by cluster sampling methods in 2010. A total of 8326 eligible hypertensive patients (4363 in urban and 3963 in rural) were included. The urban-rural difference of clinical agency and health insurance was compared for hypertensive patients. RESULTS: In urban areas, 43.74% (1867/4268) hypertensive patients were first diagnosed at hospitals of district level or above, 25.07% (1070/4268) at community health service centers (CHSC), and 20.20% (862/4268) at community health service stations (CHSS), respectively; 30.72% (1274/4147) and 31.11% (1290/4147) patients chose CHSC and CHSS for their follow-up visiting, respectively; 60.23% (3073/5102) antihypertensive medication was obtained from pharmacies. In rural areas, 54.58% (2133/3908) hypertensive patients were first diagnosed at village clinics, 22.36% (874/3908) at township hospitals, and 18.86% (737/3908) at hospitals of county level or above; 70.49% (2695/3823) patients chose village clinics for their follow-up visiting; 46.23% (2116/4577) antihypertensive medication was obtained from village clinics, and 36.29% (1661/4577) from pharmacies. The main reasons for choosing clinical agency for both urban and rural patients were convenience (45.79%, 6276/13 706) and low cost (11.78%, 1614/13 706). The proportions of reimbursements for hospitalization expenses and total medical expenses for hypertensive patients in urban in the past year were 66.67% and 34.78%, respectively, which were much higher than those in rural (35.71% and 9.50%) (Z value was -12.13 and -17.56, P < 0.01). CONCLUSION: Community-based hypertension detection and routine blood pressure measurement during clinical visiting should be further strengthened to improve early diagnosis of hypertension. The development of community-based clinical agency should be able to provide convenient and low cost health service for hypertensive patients to improve treatment, follow-up and control of hypertension.

Low socioeconomic status is associated with cardiovascular risk factors and outcomes in systemic lupus erythematosus.

OBJECTIVE: Accelerated atherosclerosis is a major cause of death in systemic lupus erythematosus (SLE), yet little is known about the effect of socioeconomic status. We investigated whether education or income levels are associated with cardiovascular risk factors and outcomes in SLE. METHODS: Our study involved a longitudinal cohort of all patients with SLE enrolled in the Hopkins Lupus Cohort from 1987 through September 2011. Socioeconomic status was measured by education level (≥ 12 years or < 12) and income tertiles (> $60,000, $25,000-$60,000, or < $25,000). RESULTS: A total of 1752 patients with SLE were followed prospectively every 3 months. There were 1052 whites and 700 African Americans. Current smoking, obesity, hypertension, and diabetes mellitus were more common in African Americans (p < 0.01 for all), but there was no statistical difference in the frequency of myocardial infarction or stroke. In multivariate analyses stratified by ethnicity, low income was strongly associated with most traditional cardiovascular risk factors in whites, but only with smoking and diabetes in African Americans. In whites, low income increased the risk of both myocardial infarction (OR 3.24, 95% CI 1.41-7.45, p = 0.006) and stroke (OR 2.85, 95% CI 1.56-5.21, p = 0.001); in African Americans, these relationships were not seen. Low education, in contrast, was associated with smoking in both ethnic groups. CONCLUSION: Low income, not low education, is the socioeconomic status variable associated with cardiovascular risk factors and events. This association is most clearly demonstrable in whites.