ObjectiveTo construct the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke, to determine the weight of indicators, and to provide references for the comprehensive evaluation of the efficacy, safety, and economy of Chinese patent medicines.MethodsTwo rounds of expert consultation by Delphi method were applied to establish the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke, and the weight of each indicator was determined by the analytic hierarchy process method.ResultsQuestionnaire recovery rates of 2 rounds were 92.59% and 96.00%, the expert authority coefficient was greater than 0.7, and the coordination coefficients of experts in the total index were 0.224 and 0.370 (P<0.001). A three-level comprehensive evaluation indicator system for Chinese patent medicines for ischemic stroke was established and the three first-level indicators included efficacy, safety, and economy. And there were 15 second-level indicators, and 33 third-level indicators. Through the analytic hierarchy process method, the weights of each first-level indicator were 0.626 4, 0.301 2, and 0.072 4, respectively.ConclusionThe comprehensive evaluation indicator system contains efficacy, safety and economy, and provides a basis for a comprehensive evaluation of Chinese patent medicines for ischemic stroke. The indicator system is of great significance for the design of outcomes for clinical trials of ischemic stroke, the conduction of systematic reviews, and the development of clinical practice guidelines for ischemic stroke patients when selecting study outcomes.
A comprehensive evaluation system of Chinese patent medicine (CPM) is considered as a critical tool to measure the value of CPM. The "guideline for multi-dimensional and multi-criteria comprehensive evaluation for Chinese patent medicine" (abbreviated as guideline) has been released, proposing a comprehensive evaluation system of CPM (1st) comprising six aspects: safety, effectiveness, economy, applicability, scientificity and standardization. This paper elaborated the development method and explained the evaluation dimensions and criteria, so as to help the researchers understand and use the comprehensive evaluation system in the future when evaluating CPM.
It is very important to develop and revise expert panel consensus on Chinese patent medical clinical application. The contents of the expert panel consensus include determination of the subject, clarity of the application scope, indications, dosage and administration, and safety of Chinese patent medicine. In the process, clinical researchers establish project team, formulate clinical management questions, select the outcome index, retrieve and make the evidence, and develop expert consensus with consensus methods strictly according to the requirements of methodology.
ObjectiveTo analyse the quality of implementation in clinical application guidelines of the Chinese patent medicines for the treatment of common diseases. MethodsWe retrieved clinical application guidelines of the Chinese patent medicines for the treatment of common diseases published from February, 2019 to August, 2022 in databases. The clinical practice guideline (CPG) implementation evaluation tool was used to evaluate the implementation of the included guidelines. ResultsA total of 29 guidelines were included. The implementation quality of included guidelines was moderate. Thirteen (44.8%) were high quality and 16 (55.2%) were moderate quality. ConclusionThe quality of implementation of clinical application guidelines of the Chinese patent medicines for the treatment of common diseases is higher than that of other traditional Chinese medicine CPG. The CPG implementation evaluation tool can be used in traditional Chinese medicine CPGs and particularity of TCM should also be considered.
ObjectiveThis study aims to conduct a systematic review and quality assessment of published domestic and foreign studies on the pharmacoeconomics of Chinese patent medicines, with the goal of identifying relevant issues and proposing improvement suggestions. MethodsThe methods used in this study involved systematic searches of the CNKI, WanFang Data, VIP, and PubMed databases for domestic and foreign studies related to the pharmacoeconomics of Chinese patent medicines, with a search deadline of May 20, 2022. The studies were evaluated systematically based on various aspects such as title, year, author, journal, research perspective, research type, disease area, research object, research design type, research method, application model, model calibration, sensitivity analysis, cost calculation, effectiveness indicators, and adverse reaction comparison. The evaluation of report quality and methodological quality was conducted using the consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) and the quality of health economic studies (QHES) tools, respectively. ResultsThis study included a total of 249 articles, including 247 in Chinese and 2 in English. The first article on the pharmacoeconomics of Chinese patent medicine was published in 2000. The diseases studied covered 59.26% of the ICD-11 disease areas. Articles reporting on the research perspective accounted for 16.87% of the total number of studies, while 32.4% of studies provided an explanation of the research type. The main method used was cost-effectiveness analysis, accounting for 86.75% of the studies, and the main cost component was direct medical costs, accounting for 89.56%. The primary effectiveness indicator was the overall effective rate, accounting for 78.31% of the studies. The average compliance rate with the CHEERS 2022 standard was 43.58%, and the average QHES score was 56.7. ConclusionA considerable part of the existing research on the pharmacoeconomics of traditional Chinese medicine (TCM) suffers from problems such as the lack of research methods or non-standardized methods. Therefore, the relevant research abilities of researchers who conduct TCM pharmacoeconomic research need to be improved.
Objective The modification of Chinese patent medicines (CPM) instructions is currently the focus of national drug regulation, with policies and regulations being established. Nevertheless, the policies pertaining to CPM instructions have not been thoroughly investigated. This study analyzes the direction and current issues with existing policy items to give a reference for future optimization and adjustment of policies linked to CPM instructions. Methods The official website of the National Medical Products Administration (NMPA) and National Health Commission (NHC) were searched to collect policy documents related to the CPM instructions issued at the national level in China from January 1st 2000 to June 1st 2024. Based on the classification of policy tools (supply-based policy tools, demand-based policy tools, environment-based policy tools) and the dimension of policy development (policy planning, policy implementation, policy supervision, and policy evaluation ), a two-dimensional analytical framework of "policy tools and policy process" was constructed by using the content analysis method and the quantitative analysis method, and policy documents were analyzed. Results The 27 policy texts included in the analysis generated 104 policy entries in total, wherein, environment-based policy tools (74.04%) were used the most in the dimension of policy tools, followed by demand-based policy tools (24.04%) and supply-based policy tools (1.92%). In the dimension of policy development, policy planning tools, policy implementation tools, policy supervision tools, and policy evaluation tools accounted for 24.04%, 52.88%, 17.31%, and 5.77%, respectively. An in-depth analysis of the content of the policy entries discovered that the existing policy took into account the specification of the content of the instruction and the standardization of the expression of writing, the instruction application guidance, etc, and more and more attention was being paid to the content of the characteristics of TCM in the instruction. Conclusion Currently, there is an insufficient amount of policy documents on CPM standards, which are overly focused on environment-based policy tools and the policy implementation process. To achieve the policy goal of regulating and applying CPM specifications, it is recommended to create a balanced and coordinated structure of policy instruments, emphasise the direct promotion and pulling effect of supply and demand, increase the weight of policy evaluation and supervision, and develop a standard system for evaluating CPM specifications.
The preferred reporting items for comprehensive evaluation of Chinese patent medicine (PRICE-CPM) regulate the specific requirements of forming integrity, clear, and transparent reports from title to conclusion. It contains six domains with twenty-one items and seventy-two sub-items and is important to promote the integrity, scientificity, transparency, and applicability of relevant reports. Additionally, it indicates that comprehensive evaluation results reports of post-marketing Chinese patent medicine should refer to PRICE-CPM. Therefore, this article provides a detailed interpretation of the report list and references for future users.
Our team proposed and constructed an Expert-knowledge and Data-driven Comprehensive Evaluation Model of Chinese Patent Medicine (EDCEM-CPM) using the machine learning algorithm. This model could improve the system of the comprehensive evaluation of the Chinese patent medicine in technology and provide measurement tools for Chinese patent medicine according to its characteristics. The model evaluates the multi-dimensional value of Chinese patent medicine by data pre-treatment, clustering algorithms, and data training steps, such as automatic learning weighting. This evaluation model is already in practice. In this paper, we introduced the establishment of the model with the calculation process for reference.
Comprehensive evaluation research of Chinese patent medicine (CPM) is performed to demonstrate the comprehensive value of CPM from multiple dimensions and to clarify the clinical value and positioning, so as to provide references for decision-making in health or drug policies. Therefore, to standardize and promote comprehensive evaluation studies on CPM, the current guideline introduced the specific requirements on the applicable subject, basic principles, and major evaluation content, thereby providing guidance for researchers in the future.