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.
ObjectiveTo compare the effectiveness of haemocoagulase agkistrodon and tranexamic acid and sodium chloride in the prevention and treatment of perioperative bleeding in a real world setting. MethodsA research database was constructed based on the records of inpatient visits using haemocoagulase agkistrodon and tranexamic acid and sodium chloride according to the SuValue® database from January 1, 2016 to December 31, 2020. The patients were divided into two groups according to the different interventions. After matching with a 1∶1 propensity score, the effectiveness of two groups was compared. ResultsA total of 858 patients were included in each of the two groups, and there was no statistically significant difference in baseline characteristics between the two groups (P>0.05). Research results showed that patients using haemocoagulase agkistrodon had significantly reduced length of hospital stay, decrease in hematocrit, average estimated surgical bleeding, and decrease in hemoglobin (P<0.01). ConclusionHaemocoagulase agkistrodon has better effectiveness than tranexamic acid and sodium chloride for reducing perioperative blood loss based on current real world evidence.
Structured template and reporting tool for real world evidence (STaRT-RWE) was developed by a team led by professor Shirley V Wang of Brigham and Women's Hospital, Harvard Medical School, which is to plan and report on the implementation of real world evidence (RWE) studies on the safety and efficacy of treatments. The template, published in the journal BMJ in January 2021, has been endorsed by the International Society of PharmacoEpidemiology and the Transparency Initiative promoted by the International Society of Pharmacoeconomics and Outcome Research. This article interprets its entries to promote the understanding and application of STaRT-RWE by domestic scholars engaged in real world study, and help to improve the transparency, repeatability, and accuracy of RWE research.
ObjectiveTo construct a strategy for classification of clinical research data security for real-world research, based on the features of clinical research data.MethodsBased on the laws, regulations, and data security classification method in relevant fields, the clinical research data was classified into five security levels. Then, the method was gradually perfected through three times of revisions, which followed the advice from experts who were experienced in many relative areas, such as clinical medicine, clinical research methodology, clinical research management, ethics, genetics and public health data application and management.ResultsExperts’ opinions gradually converged through several times of consultation. The clinical research data was finally classified into five security levels with explicit definition and security policy for each security level. Thirty-three data categories, which covered demographic information, clinical examination, diagnosis, treatment information, genetic information, health economics information, medical data and information on research processes that have been published, were included in the five security levels.ConclusionsSince there is an increasing trend of data scale and the data security classification and management are necessary to ensure the data security and appropriately utilization of data. The method of clinical research data classification proposed in this paper can provide beneficial references for the further improvement of data security in the future.
Objectives To evaluate the clinical outcomes and identify its associated factors in patients with acute coronary syndromes (ACS) in Tianjin city. Methods Data were obtained from Tianjin urban employee basic medical insurance database. Adult patients who were discharged alive after the first ACS-related hospitalization (the index hospitalization) during January, 2012 to December, 2014 and without malignant tumor were included. Clinical outcomes were measured by subsequent major adverse cardiovascular events (MACE) including hospitalization for myocardial infarction (MI) or stroke, all-cause death, or their composite endpoint. Cox model was used to explore the factors associated with MACE. Results 22 041 patients were identified, in which 9.5% experienced MACE during follow-up with a mean number of 1.3 MACEs. 3.1% of patients had MI, 5.7% had stroke and 1.4% had all-cause death. Among patients who experienced MACEs, the average time from index discharge to the 1st MACE was 143.2 days. Patients being older, male or had higher Charlson Comorbidity Index (CCI) were more likely to experience MACE. Patients who had prior stroke and prior all-cause hospitalization were also more likely to experience MACE, whereas patients who had prior angina, prior β-blockers utilization and received percutaneous coronary intervention (PCI) during index event were less likely to experience MACE. Conclusion Stroke is the most common type of MACE among ACS patients in Tianjin, China. Almost half of the 1st MACE occur within the 3 months after ACS. Patients who are older, male, have higher CCI or have prior stroke are at higher risk of MACE.
ObjectivesTo analyze the active areas of real world studies on traditional Chinese medicine in China.MethodsCBM, CNKI, WanFang Data, PubMed and EMbase databases were electronically searched to collect real world studies on traditional Chinese medicine in China from inception to 26th April, 2018. The main research contents (research direction, data sources, and research methods) by Excel were extracted, together with the primary information by BICOMS-2 software and production of the network figures by NetDraw 2.084 software.ResultsEventually, 373 real world studies in traditional Chinese medicine were included, in which the initial one was punished in 2008. The top three ranking of authors involved in real world studies on traditional Chinese were Xie Yanming, Zhuang Yan, Yang Wei, and the top three ranking of institutions were Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences, School of Statistics of Renmin University of China, and the PLA Navy General Hospital. The amount of related studies in Beijing accounted for 74.26%. It was found that the active areas involve real world, hospital information system, real world study, drug combination, and propensity score method. In terms of the main studied contents on the use of traditional Chinese medicine in the real world, in which the top three were Fufang Kushen injection, Dengzhanxixin injection, and Shuxuetong injection. Digestive system disease, nervous system disease and cardiovascular disease received the highest attention rate, specifically stroke, coronary heart disease, virus hepatitis and hypertension. 58.18% studies were retrospective studies, 49.60% of the information were from the hospital information system, and 56.30% studies used data mining to carry out statistical analysis.ConclusionsMost real world studies on traditional Chinese medicine are based on HIS, and use data mining to study Chinese medicine preparations. The research attention on Chinese medicine is higher than that of the method of diagnosis and treatment, similarly the Chinese medicine preparations is higher than traditional Chinese medicine. In future, attention should be paid to traditional Chinese medicine, prescription and traditional methods of diagnosis and treatment, such as moxibustion and scraping.
ObjectiveTo analyze the status of real world studies (RWS) through registration information of the Chinese Clinical Trials Registry (ChiCTR). MethodsThe website of ChiCTR was searched with the real world as the search term to collect relevant registered items in the real world from inception to May 4, 2022. Descriptive analysis method was used. ResultsA total of 642 registered items were included. The median sample size was 482 cases. RWS were mainly observational studies, and the number of intervention studies was increasing year by year. There were 267 studies (41.59%) at the stage of post-marketing drugs or phase Ⅳ clinical trials. Most of the main measures were endpoints (56.23%), and the most commonly used was overall survival (15.79%). 62.15% of the registered projects met the minimum requirements for registration. ConclusionThe number of RWS registered by ChiCTR shows an increasing trend. At present, the research purpose of RWSs is unclear, and the completeness of registered studies and the overall content compliance of the studies need to be improved.
High-quality randomized controlled trials (RCTs) are regarded as the gold standard for assessing the efficiency and safety of drugs. However, conducting RCTs is expensive and time consumed, and providing timely evidence by RCTs for regulatory agencies and medical decision-makers can be challenging, particularly for new or emerging serious diseases. Additionally, the strict design of RCTs often results in a weakly external validity, making it difficult to provide the evidence of the clinical efficacy and safety of drugs in a broader population. In contrast, large simple clinical trials (LSTs) can expedite the research process and provide better extrapolation and reliable evidence at a lower cost. This article presents the development, features, and distinctions between LSTs and RCTs, as well as special considerations when conducting LSTs, in accordance with literature and guidance principles from regulatory agencies both from China and other countries. Furthermore, this paper assesses the potential of real-world data to bolster the development of LSTs, offering relevant researchers’ insight and guidance on how to conduct LSTs.
Objectives To analyze the labeling of drug items for patients with renal insufficiency in our hospital so as to provide reference for rational use of drugs. Methods The drug instructions used in No.1 Hospital of Jilin University in 2017 were collected. According to the classification of pharmacology, the instructions of the top 9 drugs system were selected. The annotation of drug items for patients with renal insufficiency in these pharmaceutical instructions was analyzed. Results A total of 812 drug instructions were included, in which 72.17% did not mark drug instruction for renal insufficiency patients. According to the administration system, the highest unlabeled rate were digestive system drugs; according to the method of administration, the highest unlabeled rate was external preparation of drugs, accounting for 83.33%; according to production enterprises, the highest unlabeled rate were domestic drugs, accounting for 75.55%. There were only 23.40% of the tagging items having guidance of medication, and some with a certain degree of confusion in the annotation. Conclusion The unlabelling situation of drug instructions for renal insufficiency patients is very serious. It should arouse the attention of pharmaceutical manufacturers and the pharmaceutical supervisory department is suggested to strengthen the supervision of drug instructions and regulate the contents of drug labeling in drug instructions, so as to guide the rational use of drugs in clinical practice.
There is huge clinical value in real world data from traditional Chinese medicine (TCM), but the real world study of TCM faces many challenges, because of its diverse data types, different standards, and serious data island phenomenon. Data governance is the key to transforming real world data into real world evidence. As the last step of data governance, data transformation has not been standardized. The key technologies and methods of data transformation, including data classification, natural language processing, standardization, data system construction, and derivative variables, will be discussed in this article based on the characteristics of real world data of TCM and the current development status of data transformation technology. At the same time, the suggestions of safety control and quality control of data transformation are put forward, and the data transformation system of real world study of TCM is preliminarily constructed, combined with the characteristics of TCM data. It is hoped that this paper can provide references for future real world studies of TCM.