Human ; Research ; Information Dissemination ; Reference Standards

The number of studies related to health economics evaluation is increasing. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) contains 28 items. Based on CHEERS 2013, CHEERS 2022 adds a health economic analysis plan, model sharing, and community, patient, public, and other relevant stakeholders' participation in the statement, taking into account the future development direction of health economics evaluation. It provides a useful review tool for peer reviewers, editors, and readers and supports health technology assessment agencies in establishing standard reporting standards for health economics evaluations. In this study, we briefly introduced and interpreted the CHEERS 2022 statement and analyzed an example of health economics evaluation in infectious disease epidemiology to provide a reference for researchers to report studies regarding health economics evaluation standardly.
Humans ; Cost-Benefit Analysis ; Checklist ; Economics, Medical ; Reference Standards ; Research Report

As one of the key components of clinical trials, blinding, if successfully implemented, can help to mitigate the risks of implementation bias and measurement bias, consequently improving the validity and reliability of the trial results. However, successful blinding in clinical trials of traditional Chinese medicine (TCM) is hard to achieve, and the evaluation of blinding success through blinding assessment lacks established guidelines. Taking into account the challenges associated with blinding in the TCM field, here we present a framework for assessing blinding. Further, this study proposes a blinding assessment protocol for TCM clinical trials, building upon the framework and the existing methods. An assessment report checklist and an approach for evaluating the assessment results are presented based on the proposed protocol. It is anticipated that these improvements to blinding assessment will generate greater awareness among researchers, facilitate the standardization of blinding, and augment the blinding effectiveness. The use of this blinding assessment may further advance the quality and precision of TCM clinical trials and improve the accuracy of the trial results. The blinding assessment protocol will undergo continued optimization and refinement, drawing upon expert consensus and experience derived from clinical trials. Please cite this article as: Wang XC, Liu XY, Shi KL, Meng QG, Yu YF, Wang SY, Wang J, Qu C, Lei C, Yu XP. Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol. J Integr Med. 2023; 21(6): 528-536.
Drugs, Chinese Herbal/therapeutic use* ; Medicine, Chinese Traditional/methods* ; Outcome Assessment, Health Care ; Reference Standards ; Reproducibility of Results ; Research Design ; Clinical Trials as Topic

The research on the processing mechanism of Chinese medicine is the key and core foundation to improve processing technologies of Chinese medicine, formulate the quality standards of Chinese medicinal pieces, enhance the clinical efficacy of Chinese medicine, enrich Chinese medicine processing theories, and promote the development of Chinese medicine processing. Many researc-hers have conducted in-depth exploration on the processing mechanism of Chinese medicine in the 20 years in the 21 st century. Significant progress has been made in the transformation of chemical components during the processing, the change of active components in the body, the law of toxicity attenuation in the processing of toxic Chinese medicine, the mechanism of efficacy enhancement and toxicity attenuation of processing with auxiliary materials, and the application of new biomedical technologies. At present, the processing mechanism of multiple Chinese medicines has been preliminarily clarified, which has greatly promoted the development of Chinese me-dicine processing. The development of the processing mechanism of Chinese medicine reveals that the in vitro transformation of chemical components is combined with the in vivo absorption, transport, and metabolism, and the macroscopic biological effects of the organism are combined with the cells, molecules, targets, and pathways in the study of the processing mechanism of Chinese medicine. More attention has been paid to exploring the processing mechanism from the overall level, and a modern systematic research system on the processing mechanism of Chinese medicine has been initially formed. To further promote the scientific development of Chinese me-dicine processing, the present study proposed that the research on the processing mechanism of Chinese medicine should take Chinese medicine properties into account, focus on the influence of disease condition on the mode of action and effect strength of the drugs, comply with the characteristics of clinical compound compatibility of Chinese medicine, use the holistic view research strategies of systems bio-logy, and deeply explore the processing mechanism of Chinese medicine from traditional Chinese medicine theories and the characteristics of clinical medication of Chinese medicine.
Drugs, Chinese Herbal/pharmacology* ; Medicine, Chinese Traditional ; Reference Standards ; Research Design ; Technology

By analyzing the main problems existing in the current management of medical devices for clinical trials, this study proposes a feasible management model and specific requirements for acceptance, distribution, storage and recovery combining with the characteristics of medical consumable equipment and diagnostic reagent, which provides a favorable guarantee for the authenticity and reliability of clinical trials.
Clinical Trials as Topic ; Equipment and Supplies/standards* ; Indicators and Reagents/standards* ; Reproducibility of Results ; Research Design/standards*

With the development of society, more and more foreign natural medicines have entered China, but they are faced with the problem that they are not given with the traditional Chinese medicine(TCM) properties when they are used with other TCM. When we carried out the research on introducing foreign natural plant resources to TCM, gradually, a new research model and field with original characteristics of TCM--the study of new foreign introducing TCM had been formed. In the process of it, we explored and summarized research rules to form the research paradigm, which will be conducive to the standardization and scientization of new foreign introducing TCM research. For the research of foreign introducing TCM, we analyzed the research background, reviewed the application history, sorted out the research status, elaborated the concept and summarized the research achievements. On this basis, we put forward the concept and system of the modern research paradigm of new foreign introducing TCM, studied and clarified the core elements, properties and research principles of this paradigm, and summarized the research contents and methods of new foreign introducing TCM. We interpreted the foundation of paradigm construction from multiple perspectives. The paradigm was the practical application of theoretical innovation of TCM. Under the guidance of it, more and more varieties of new foreign introducing TCM will be studied, the study will be more standardized, the conclusions will be more scientific and reliable, which will inspire and guide more researchers to focus on the research of new foreign introducing TCM, and the paradigm itself will be constantly improved. The construction and application of the paradigm will certainly accelerate the innovative research of foreign introducing TCM and play a historic role in promoting the enrichment of traditional Chinese medicine varieties.
China ; Drugs, Chinese Herbal ; Internationality ; Medicine, Chinese Traditional ; Plant Preparations/standards* ; Research Design

Health food containing Chinese materia medica has many advantages in health preservation and reducing the risk of disease occurrence,which meets people's demands for " great health" and " preventive treatment of disease". However,due to its complex ingredients,diverse quality of raw materials,as well as the vagueness and lack of integrity for existing quality standards,chaos is caused in the health food market,which restricts its healthy development and also poses new challenges to the quality control of healthy food. At present,the total component content or single component content is determined in most functional/marker component examinations. Safety and microbial detection methods fail to cover the contamination range of the raw materials of Chinese materia medica.Therefore,it is impossible to meet the purpose of ensuring authenticity,safety and efficacy. In recent years,a lot of Chinese materia medica extracts have been used as raw materials for food products,but many extracts lack standards. The author believes that the quality control of health food containing Chinese materia medicas should start with the quality control of Chinese materia medica extracts. In this way,product quality is controlled from source to ensure product consistency; secondly,the overall quality control should be strengthened to ensure the authenticity of the products; the scope of safety inspection shall be expanded to fundamentally ensure the safety of products. At the same time,we should strengthen the quality control of whole process and strengthen the overall quality control of raw materials to produce health food of high quality.
Food ; standards ; Materia Medica ; standards ; Medicine, Chinese Traditional ; Quality Control ; Research Design

Temporary prescription preparation is the preparation processed into different dosage forms by relevant pharmacist according to the temporary preparation requirement and the personalized prescription made by the doctor in accordance with the syndrome differentiation and drug performance.It is an important part in personalized pharmaceutical services.Rational design of process route,production equipment and quality control method for the temporary prescription preparation,and establishment of technology research strategy and mode in accordance with the characteristics of traditional Chinese medicine temporary prescription preparations play an important role in promoting the development of the temporary prescription preparations.To promote the normalization,standardization and intelligent development of temporary prescription preparations,we would comprehensively summarize the significance,policy,technology characteristics,technology research status quo and existing problems in this paper,and put forward the research direction of temporary prescription preparation technology based on the physical properties of raw materials,equipment research strategy,and intelligent manufacturing technology.Thus it will push the inheritance and innovation of temporary prescription preparation.
Medicine, Chinese Traditional ; Prescriptions ; standards ; Quality Control ; Research Design

With the development of the methodology of clinical trials and the appearance of medical big data, the real-world study (RWS) presents its unique advantages, plays a role in clinical practice and research, and its importance is more and more recognized by scholars in recent years. In surgical research field, due to the specificity of surgical diseases and operational procedures, confounding factors and risk of bias are greatly higher than those of traditional medications. Therefore, using unique advantages of the RWS to solve the actual clinical problem in surgical field is the main goal of performing surgical RWS. This article will systematically elucidate how to perform the surgical RWS and the special matters of concern in carrying out surgical RWS.
Clinical Studies as Topic ; methods ; standards ; General Surgery ; standards ; Humans ; Research Design ; standards ; Surgical Procedures, Operative ; standards

Construction of research-based surgery department includes standardizing surgical practices, collecting and analyzing clinical data, discovering problems in clinical practices, designing and conducting reliable and high-level clinical research, improving and innovating surgical technologies according to research conclusions, working out technical specifications and promoting them through clinical education, and creating new clinical research needs arised by innovative and cutting-edge technologies and theories. By integrating technology, research, standardization, promotion and evaluation, and making close connections between different parts of clinical practices, scientific research and clinical teaching, it helps achieve coordinated development of surgical practices and translational research, and will finally promote the cultivation of medical talents and the progress of medical technologies. Since 2010, the General Surgery Department of Nanfang Hospital has established the basic idea of subject construction of "research-oriented surgery with data as the core, minimally invasive surgery with laparoscopic as the characteristic, and specialized surgery with high-efficiency service as the guidance", and has taken a series of measures to build it into a well-known research-based gastrointestinal surgery in China. The achievements of this speciaty have emerged from nothing, research platforms from few to many, the talent echelon from following to leading, and the influence from regional to international. The discipline construction has achieved a leap from quantitative to qualitative changes.
Biomedical Research ; standards ; China ; Digestive System Surgical Procedures ; standards ; Gastrointestinal Diseases ; surgery ; Hospitals ; standards ; Humans ; Minimally Invasive Surgical Procedures ; standards ; Program Development ; Surgery Department, Hospital ; standards