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.
Mixed methods research (MMR) is the third research paradigm that combines quantitative and qualitative research. MMR can overcome limitations of qualitative and quantitative methods by integrating the advantages of these two. The environment of real world research is complicated. When using real world data to assess the health status of patients, process of treatment, outcomes of prevention and treatment, prognosis and prediction, and support for medical policy development, MMR can be applied to tackle research questions more comprehensively for the quality of research.
Assessment of Real World Observational Studies (ArRoWS) is a tool developed by the Leicester Real World Evidence (LRWE) Unit of the Diabetes Research Centre of the University of Leicester in the United Kingdom to assess the quality of real world evidence research, and has been reported to have good practicability. ArRoWS can be used to quickly and specifically assess the quality of real world evidence research that uses electronic health record information. The tool contains 16 items, nine of which are common items, and seven of which are related to specific research designs. The current study introduces the development background, development process, assessment items, assessment criteria, and application methods of ArRoWS and other related aspects, to provide references for real world researchers in China.
Compared with traditional clinical trials, the real-world studies set higher requirements on the authenticity (reality), applicability, and timeliness of the evidence obtained. In this paper, we brought up a hypothesis that creating synergies between observational and experimental studies may meet these requirements. And then it was discussed in three aspects including providing evidence, research design and execution. In addition, data analysis facilitated generating efficient and robust evidence which was in support of decision making. Finally, some enlightenment may be offered for Traditional Chinese Medicine evaluation methods based on the synergies of both study types.
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.
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.
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.
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.
In January 2020, the State Food and Drug Administration issued the guiding principles of real world evidence supporting drug research & development (R&D) and evaluation (Trial) to guide the development of real world study (RWS) for drug R&D and review decision-making in the future. This guideline has important reference value for developing RWS of health food. Based on the interpretation of the core content of the guiding principles, combined with the common points of RWS and health food interventions, this paper preliminarily discusses the application of RWS to support health food regulatory decision-making so as to provide references for further promoting the application of RWS in the field of health food.