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.
The number of clinical practice guidelines for traditional Chinese patent medicine has been increasing recently. However, the quality of guidelines was still low compared to international guidelines. Considering the characteristics of traditional Chinese patent medicine, we suggested the following items should be taken into account when developing traditional Chinese patent medicine guidelines: ensuring the standardized guidelines of traditional Chinese patent medicine research problem is scientific based on reliable evidence; identifying the common questions according to these research problems; understanding the strength of evidence and how to recommend correctly; inviting some experts in other fields to take part in the development of guidelines; paying more attention on the changes of disease burden and the impact of new methods and technologies when developing the guideline; paying more attention to the non-consensus opinions and evidence supporting these opinions; insisting on quality is the priority, while speed is secondary.
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.
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.
The preferred reporting items for comprehensive evaluation of Chinese patent medicine (PRICE-CPM) were developed, and comprised six domains, 21 items and 72 sub-items. The EQUATOR collaboration network for the formulation and revision of reporting specifications was referred to and the final report list items were established by adopting the literature analysis method, the expert committee discussion and the Delphi method, and considering the characteristics of CPM evaluation.
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.
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.
Objective To systematically evaluate the quality of published pharmacoeconomics studies on Chinese patent medicines for neoplasms. Methods Datasets including CNKI, WanFang Data, VIP, SinoMed, PubMed, Web of Science, Cochrane Library, and EMbase were searched to collect pharmacoeconomics studies of Chinese patent medicines in neoplasms from the establishment of the database to September 30, 2022. Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) and quality of health economics studies (QHES) were used to evaluate the reporting quality and methodological quality. Results A total of 25 studies were included, with an average CHEERS 2022 coincidence rate of 40.09% and an average QHES score of 53.2. Conclusion The quantity and quality of pharmacoeconomics studies on Chinese patent medicines in neoplasms are insufficient and flawed. It is suggested to strenthen the collaboration between scientific research institutions and hospitals and standardize the pharmacoeconomics studies on Chinese patent medicines in neoplasms to provide hygienic decision-making evidence for Chinese patent medicines in neoplasms.
ObjectiveTo systematically review the studies on the clinical comprehensive evaluation system of drugs at home and abroad. MethodsThe PubMed, EMbase, Cochrane Library, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect the literature and policy documents of the clinical comprehensive evaluation system of drugs from inception to October 31, 2022. The evaluation organization, evaluation perspective, application scope, domains and criteria were sorted out, and the evaluation of different types of drugs was analyzed in detail. ResultsA total of 101 clinical comprehensive evaluation systems of drugs were included. The publishing time was from 2009 to 2022, and the number of published articles increased. The first author mainly came from 26 countries, including China (n=34), Canada (n=11), the United States (n=10), and Spain (n=10). Forty-seven articles reported the evaluation perspective. All evaluation systems could be used for drug evaluation, of which 43 could be used as universal evaluation tools, and 58 could be used for the evaluation of specific drugs, mainly including anti-tumor drugs (n=15), orphan drugs (n=10) and traditional Chinese medicine (n=7). The number of evaluation domains varied from 2 to 22, and the number of criteria varied from 4 to 56. Among them, economics (n=73), effectiveness (n=72), safety (n=54), disease demand/burden (n=34), and innovation (n=24) were the most frequent evaluation domains. ConclusionThe research on clinical comprehensive evaluation of drugs at home and abroad has grown up. During the implementation of clinical comprehensive evaluation of Chinese patent medicine, it is necessary to clarify the evaluation perspective, define the evaluation scope, and determine the evaluation domains.