ObjectiveTo provide a basis for timely adjustment of cancer prevention and control measures in China through timely understanding of the latest 2022 global cancer statistics reported in the CA: A Cancer Journal for Clinicians published “Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries”. MethodsThe statistical data of GLOBOCAN in 2022 were systematically analyzed and the incidence and mortality of cancer by age, sex, type, and region were comprehensively interpreted. The changing trends in cancer were compared between China and the rest of the world, and the potential risk factors as well as current cancer prevention and control measures were summarized. Results① Globally, for both sexes combined, there were an estimated 19.976 million new cases and 9.744 million cancer deaths in 2022. The age-standardized incidence rate (ASIR) was 196.9 per 100 000 and the age-standardized mortality rate (ASMR) was 91.7 per 100 000 in 2022. The ASIR of all cancers was highest in Europe (268.1 per 100 000) and lowest in South-East Asia (109.6 per 100 000), as well as the ASMR of all cancers was highest in Europe (106.3 per 100 000) and lowest in South-East Asia (71.0 per 100 000). The top three cancer types of newly diagnosed cancer cases were lung, breast, and colorectal cancer, while the top three leading causes of cancer deaths were lung, colorectal, and liver cancer. The incidence and mortality rates of all cancers increased with advancing age. The numbers of newly diagnosed cancer cases and cancer deaths, as well as the age-standardized rates were consistently higher among men compared to women. The lung cancer and breast cancer ranked first in terms of newly diagnosed cancer cases among men and women, respectively. Consistently, the lung cancer and breast cancer were also the leading causes of cancer-related deaths among men and women, respectively. ② In China, there were an estimated 4.825 million new cases and 2.574 million cancer deaths. The ASIR was 201.6 per 100 000 and the ASMR was 96.5 per 100 000 in 2022. The ASIR and ASMR both ranked 65th out of 185 countries. The top three cancer types among newly diagnosed cases were lung cancer, colorectal cancer, and thyroid cancer, while the top three leading causes of cancer deaths were lung cancer, liver cancer, and gastric cancer. ConclusionsThe cancers incidences and deaths worldwide in 2022 have declined from that in 2020 (196.9 per 100 000 versus 201.0 per 100 000, 91.7 per 100 000 versus 100.7 per 100 000, respectively). Lung cancer is the leading type of newly diagnosed cancer both in China and globally. However, the second and third most common cancers in China differ from the global picture. In China, colorectal cancer and thyroid cancer take the second and third spots, respectively; Whereas globally, breast cancer and colorectal cancer occupy these positions. Lung cancer is the first ranked leading cause of death in both China and globally. However, there are differences in the second and third most common causes. In China, liver cancer and gastic cancer take the second and third spots, respectively; While globally, colorectal cancer and liver cancer occupy these positions. This study analyzes the characteristics of the disease burden of cancer in China by comparing the epidemiological features of cancer in China and worldwide, aiming to provide scientific evidences for developing comprehensive cancer prevention and control measures tailored specifically to China’s national conditions.
ObjectiveTo analyze the limitations and challenges for the use of real-world data in the decision making of drug reimbursement through literature review and provide standard process and guideline for the real-world study supporting drug reimbursement. MethodsBy summarizing the relevant policies, regulations, and guiding principles of major drug regulatory agencies worldwide, the study analyzed the applicable conditions, framework, and reimbursement mode for using real-world evidence in the decision making of drug reimbursement. ResultsThe study found that the health technology assessment departments of major developed countries and Asian countries have used real -world evidence to evaluate the drug efficacy and safety. The application scope of real-world data for reimbursement decision included describing the treatment process of the disease, assessing economic burden, verifying economic models, and evaluating the efficacy and safety of drugs. Some developed countries including the United Kingdom and the United States had released guidelines or frameworks of the real-world study for reimbursement decision. The process and framework of using real-world data in reimbursement decision could be divided into three models: coverage with evidence development, outcome-based contract, and re-assessment. ConclusionReal-world data has been widely used in the process of health technology assessment. To adapt to the development of the pharmaceutical industry and to meet the needs of clinical patients, it is urgent to standardize the process of collecting real-world data and formulate the scope and process of using real-world data in the reimbursement process.
ObjectiveTo systematically review the difference in 30-day readmission rates among acute heart failure patients between real-world studies vs. randomized controlled trials (RCTs). MethodsPubMed, EMbase, The Cochrane Library, CNKI, CBM, VIP and WanFang Data databases were electronically searched to collect clinical studies on 30-day readmission rates in patients with acute heart failure from inception to April 12th, 2021. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using Stata 16.0 software. ResultsA total of 33 real-world studies and 11 RCTs involving 106 722 subjects were included. The results of meta-analysis showed that the 30-day heart failure-related readmission rates in the real-world studies and RCTs were 10.8% (95%CI 9.3% to 12.3%) and 6.9% (95%CI 5.3% to 8.4%), respectively. The 30-day all-cause readmission rates in real-world studies and randomized controlled studies were 18.6% (95%CI 15.7% to 21.4%) and 14.2% (95%CI 12.0% to 16.3%), respectively. There were statistically significant differences between two kinds of studies (P<0.05). ConclusionsCurrent evidence suggests that the 30-day heart failure-related and all-cause readmission rates in patients of acute heart failure in real-world studies are significantly higher than those in patients of RCTs. Due to the limited quality and quantity of included studies, more high-quality studies are required to verify the above conclusions.
ObjectiveTo evaluate the safety, efficacy, and cost-effectiveness of different uses of oxidized regenerated cellulose (ORC) in video-assisted thoracoscopic surgery (VATS) for lung cancer resection to provide a reference for the selection, clinical use, and rational utilization of absorbable hemostatic materials. MethodsA retrospective analysis of relevant data from inpatients who underwent VATS for lung cancer resection at a tertiary hospital from July 2019 to January 2020 and from July 2020 to December 2020 was conducted. Patients were divided into two groups based on the use of ORC: 1) combined use group (ORC and collagen sponge) and 2) sole-use group (ORC). Safety, efficacy, and economic outcome indicators were compared between the two groups. ResultsThe main analysis included a total of 904 patients, with 466 in the combined use group and 438 in the sole-use group. Compared to the combined use group, the sole-use group had a significantly longer hospital stay, used fewer hemostatic drugs, had a lower average cost of hemostatic materials, and a lower median total hospitalization cost (P<0.05). No statistically significant difference was found between the two groups in terms of intraoperative blood loss volume, massive blood loss rate, perioperative transfusion rate, reoperation rate, postoperative 48-hour drainage volume, bloody drainage fluid rate, or postoperative laboratory test indicators. ConclusionThere was no significant difference in the safety or efficacy of VATS for lung cancer resection between the sole use of ORC and the combined use of ORC, but the sole use of ORC was associated with a lower cost of hemostatic materials and a lower total hospitalization cost. The sole use of hemostatic gauze in VATS for lung cancer resection may be a more cost-effective choice.
Objectives To estimate the elasticity of demand price elasticity and demand income of urban and rural residents’ self-purchase drug use and expenditure, and to analyze the sensitivity of self-purchase drug use and expenditure to the price change of drug purchase, resident income and medical institutions. Methods The data were derived from the fifth health service survey in Heilongjiang province in 2013. The Probit model was used to obtain the partial regression coefficients of the control variables in the regression model, and the demand elasticity of the self-purchase drug use was further measured by the partial regression coefficients, and the demand elasticity of self-purchase expenditure was obtained by the logarithmic regression model. Results A total of 5 289 households (14 431 persons) were included. The demand for self-purchase drug use of Heilongjiang province was 0.374 (P=0.000), the cross-price elasticity of self-purchase drug utilization and service was –0.184 (P=0.000), and the income elasticity was 0.083 (P=0.172). Since the price elasticity of the self-purchase drug expenditure was 0.675 (P=0.000), the income elasticity was 0.144 (P=0.069). Conclusions The use of self-purchased drugs in Heilongjiang province lacks price elasticity and is a necessity. There is a complementary relationship between the use of self-purchase drugs and medical institutions.
Assessing the clinical value of pharmaceuticals is crucial for comprehensive evaluation in clinical practice and plays a vital role in supporting decision-making for drug supply assurance. Real-world data (RWD) offers valuable insights into the actual diagnosis and treatment processes, serving as a significant data source for evaluating the clinical demand, effectiveness, and safety of drugs. This technical guidance aims to elucidate the scope of application of RWD for the clinical value assessment of pharmaceuticals, as well as the key considerations for conducting value assessment research. These considerations include identifying the dimensions of clinical value that necessitate RWD and effectively utilizing RWD for evaluation purposes. Additionally, this guidance provides essential points for implementing pharmaceutical clinical value assessment based on real-world data, with a specific focus on study design and statistical analysis. By doing so, this guidance assists researchers in accurately comprehending and standardizing the utilization of real-world research in conducting pharmaceutical clinical research.
Diabetic retinopathy (DR), which is a common complication of diabetic and the main cause of blindness, brings not only a heavy economic burden to society, but also seriously threatens to the patients’ quality of life. Clinical researches on the therapies of DR are active at present, but how to perform a good clinical research with scientific design should be considered with high priority. The randomized controlled trial (RCT) is considered to be the gold standard for evidence-based medicine, but RCT is not always perfect. Limitations still exist in certain circumstance and the conclusions from RCTs also need to be interpreted by an objective point of view before clinical practice. Real world study (RWS) bridges the gap between RCT and clinical practice, in which the data can be easily collected without much cost, and results might be obtained within a short period. However, RWS is also faced with the challenge of not having standardized data and being susceptible to confounding bias. The standardized single disease database for DR and propensity score matching method can provide a wide range of data sources and avoid of bias for RWS in DR.
With the acceleration of global innovative drug development, selecting safe, effective, and cost-effective products from numerous drugs has posed new challenges for the decision-making process of medical insurance drug access and dynamic updating of insurance directory. Real-world data (RWD) provides a new perspective for evaluation of clinical and economic value of drugs, but there are still uncertainties regarding the scope, quality standards, and evidence categories of RWD that can be used. Based on the current status of domestic and international RWD supporting the assessment of the clinical and economic value of drugs, this paper, in collaboration with national RWD and healthcare experts, has developed the key considerations for using real-world data to evaluate the clinical and economic value of drugs. This paper first clarifies the scope of RWD that can be used to evaluate the clinical and economic value of drugs evaluate; secondly, provides specific requirements and guidance on data attribution, data governance, and quality standards for RWD; finally, summarizes the evidence categories of RWD supporting evaluate the clinical and economic value of drugs evaluate.
Recently, real world studies (RWS) have received increasing attentions. Such studies typically involve patient information, and their results may have potentially significant impact on patient well-being and safety. When reviewing the protocol of real world studies, ethical issues should be carefully considered and assessed. This paper discussed three issues, including the overview of bioethics and its application to classic clinical trials, key features of RWS, and medical ethical considerations on RWS.
ObjectiveTo study the clinical characteristics of patients with partial and transitional atrioventricular septal defects (P/TAVSDs) in our hospital, and to evaluate the early follow-up outcomes from a real-world research perspective.MethodsThe clinical data of all patients diagnosed with P/TAVSDs from January 1, 2018 to July 12, 2020, in our hospital were collected, and all patients' examination results were used as the real-world follow-up data, univariable Cox risk proportional model was used to analyze the outcomes. A total of 93 patients were finally included in the analysis, 72 with partial and 21 with transitional AVSD. There were 38 males and 55 females at age of 182.0 months (20.0 d to 779.5 months).ResultsUnivariable Cox proportional risk model suggested that at least one cardiac malformation (HR=15.00, 95%CI 3.00 to 75.00, P=0.001), preoperative moderate or greater mitral regurgitation (HR=6.60, 95%CI 1.70 to 26.00, P=0.007), and preoperative moderate or greater tricuspid regurgitation (HR=13.00, 95%CI 3.10 to 51.00, P<0.0001) were risk factors for moderate or greater postoperative atrioventricular valve regurgitation.ConclusionChildren with coarctation of the aorta or partial pulmonary vein connection, moderate or greater preoperative mitral regurgitation, and moderate or greater preoperative tricuspid regurgitation need to be alerted to the risk of moderate or greater postoperative atrioventricular valve regurgitation. Real-world data, with relaxed statistical P values and combined expertise, can suggest clinical conclusions that are close to those of high-quality retrospective studies.