1.Exploratory Study on the Theory of the Spatiotemporal Structure of Visceral Manifestation
Houfang MA ; Xiaoying XU ; Linghao MENG ; Haili ZHANG ; Nannan SHI
Journal of Traditional Chinese Medicine 2025;66(16):1629-1634
The "integrated time-space" perspective of life in traditional Chinese medicine holds that structure and function respectively belong to the realms of space and time. The orderly integration of time and space not only supports the existence and development of life, but also serves as the foundation for biological evolution. Based on this standpoint, this paper proposes the spatiotemporal structural theory of visceral manifestation, characterized by the fusion of time and space, the integration of internal and external dimensions, and the absence of primary or secondary distinctions. Using the individual human body as the boundary, it delineates the man and nature spatiotemporal structure, based on the theory of the "correspondence between man and nature", and the internal spatiotemporal structure of the living body. The man and nature spatiotemporal structure, with yin-yang and the five phases as its core, reveals the correspondence and connectivity between the external environment and the internal zang-fu organs within the spatiotemporal dimension. The internal temporal structure of the body refers to the collective physiological rhythms related to the zang-fu organs, while the spatial structure refers to the tangible forms, spatial positions, and connective structures of the zang-fu organs. The proposal of the spatiotemporal structural theory of visceral manifestation represents a rational reconstruction and practical exploration of the essential connotations of visceral manifestation, aiming to provide new perspectives for subsequent theoretical research and clinical applications.
2.Exploration of an Intelligent Evidence Achieve Mode of Evidence-Based Chinese Medicine:Take Systematic Review of Coronary Heart Disease Syndrome Research as an Example
Qianzi CHE ; Qingyang ZENG ; Tian SONG ; Lin CHEN ; Jing WAN ; Nannan SHI
Journal of Traditional Chinese Medicine 2025;66(15):1597-1603
ObjectiveTo construct an intelligent model for literature screening, retrieval, and data extraction with a systematic review of coronary heart disease syndromes as an example, so as to improve the efficiency of evidence-based Chinese medicine research. MethodsBased on China National Knowledge Infrastructure (CNKI), VIP and Wanfang Data Resource System, the articles related to coronary heart disease syndrome research published from January 1, 2000 to December 31, 2023 were retrieved. Automated tools were used to batch retrieve paper metadata. Using text similarity algorithms, papers were merged, deduplicated, and subjected to preliminary screening based on titles and abstracts. Further screening was performed using object detection and image processing technologies on the full texts and statistical tables. Natural language processing (NLP) techniques and pre-trained models were applied to extract information. ResultsThe initial search retrieved 56 255 coronary heart disease syndrome-related articles. By artificial intelligence-assisted preliminary and secondary screening, the manual verification scope was narrowed to 1075 articles. Ultimately, 646 coronary heart disease syndrome related studies were included manually. With accuracy verification showing over 90% consistency in semantic recognition and element decomposition processes, we achieved data extraction and standardization processing for both basic literature information and 38 syndrome element statistics. ConclusionBy incorporating natural language processing, pre-trained models, artificial intelligence image processing and other technologies, this study enabled efficient retrieval, screening and standardized data extraction of Chinese medicine research literature.
3.Preliminary Construction of Comprehensive Evaluation System for TCM Clinical Practice Guidelines Based on Bibliometric Analysis and Core Element Extraction
Xue CHEN ; Gezhi ZHANG ; Danping ZHENG ; Fangqi LIU ; An LI ; Junjie JIANG ; Nannan SHI ; Wei YANG ; Xinghua XIANG ; Mengyu LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(24):209-219
ObjectiveTo construct a comprehensive evaluation indicator system for clinical practice guidelines of traditional Chinese medicine (TCM) that is scientific, systematic, and reflects the characteristics of TCM. MethodsA systematic search was conducted in Chinese and English databases, including CNKI, Wanfang, VIP, SinoMed, PubMed, Embase, and Cochrane Library, to include literature on domestic and international guideline evaluation tools and TCM-related research. Document analysis and CiteSpace were utilized for keyword co-occurrence and clustering analysis. ResultsA total of 65 relevant studies were included, from which seven core thematic domains were identified. Based on the research objectives, a two-step construction strategy was adopted: first, an external evaluation framework was established by referencing international tools to cover methodological rigor and procedural standardization; second, an internal evaluation framework was developed to reflect the distinctive features of TCM clinical practice, including syndrome differentiation and efficacy feedback. Through expert consensus, the indicator system was refined, resulting in a dual-layered structure comprising 8 primary indicators, 22 secondary indicators, and 62 evaluation criteria. ConclusionThe comprehensive evaluation system for TCM clinical practice guidelines, based on bibliometric analysis and core element extraction, integrates both theoretical integrity and practical applicability. This study provides a preliminary research foundation for further optimization, validation, and development of a refined comprehensive evaluation system.
4.Methodological Consideration on Combination Model of TCM Clinical Practice Guidelines and Real-world Study
Guozhen ZHAO ; Huizhen LI ; Ning LIANG ; Haili ZHANG ; Bin LIU ; Qianzi CHE ; Feng ZHOU ; He LI ; Xiaowen CHEN ; Long YE ; Jiahao LIN ; Xingyu ZONG ; Dingyi WANG ; Nannan SHI ; Yanping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):87-93
The clinical practice guidelines of traditional Chinese medicine (TCM) have problems such as limited clinical application and unclear implementation effects, which may be related to the lack of clinical practice evidence. To provide reliable and precise evidence for clinical practice, this article proposes a model of combining TCM guidelines with real-world study, which includes 4 steps. Firstly, during the implementation process of the guidelines, a high-quality research database is established. Secondly, the recommendations in the guidelines are evaluated based on the established database in multiple dimensions, including applicability, effectiveness, safety, and cost-effectiveness, and thus their effectiveness in practical applications can be determined. Thirdly, based on the established database, core prescriptions are identified, and the targeted populations and medication plans are determined. That is, the best treatment regimen is established based on the analysis of abundant clinical data regarding the effects of different medication frequencies, dosages, and duration on efficacy. Fourthly, the guidelines are updated according to the real-world evidence. The research based on this model can provide real-world evidence for ancient and empirical prescriptions, improving their application in clinical practice. Moreover, this model can reduce research costs and improve research efficiency. When applying this model, researchers need to pay attention to the quality of real-world evidence, ensuring that it can truly reflect the situation in clinical practice. In addition, importance should be attached to the clinical application of guideline recommendations, ensuring that doctors can conduct standardized diagnosis and treatment according to the guidelines. Finally, full-process participation of multidisciplinary experts is encouraged to ensure the comprehensiveness and scientificity of the study. In conclusion, the application of this model will contribute to the development of TCM guidelines responsive to the needs of clinical practice and achieve the goal of promoting the homogenization of TCM clinical diagnosis and treatment.
5.Methods and Challenges for Identifying and Controlling Confounding Factors in Traditional Chinese Medicine Observational Studies
Guozhen ZHAO ; Ziheng GAO ; Chen ZHAO ; Huizhen LI ; Ning LIANG ; Bin LIU ; Qianzi CHE ; Haili ZHANG ; Yixiang LI ; Feng ZHOU ; He LI ; Bo LI ; Nannan SHI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):120-126
As a supplement to randomized controlled trials, observational studies can provide evidence for the effectiveness of traditional Chinese medicine (TCM) treatment measures. They can also study influencing factors of diseases, etiology, and prognosis. However, there is a confounding effect due to the lack of randomization, which seriously affects the causal inference between the study factors and the outcome, resulting in confounding bias. Therefore, identifying and controlling confounding factors are key issues to be addressed in TCM observational studies. According to the causal network and the characteristics of TCM theory, confounding factors can be categorized into measured and unmeasured confounding factors. In addition, attention must be paid to identifying confounding factors and intermediate variables, as well as the interaction between confounding factors and study factors. For methods of controlling confounding factors, measured confounding factors can be controlled by stratification, multifactor analysis, propensity scores, and disease risk scores. Unmeasured and unknown confounding factors can be corrected using instrumental variable methods, difference-in-difference methods, and correction for underlying event rate ratios. Correcting and controlling confounding factors can ensure a balance between groups, and confounding bias can be reduced. In addition, methods such as sensitivity analysis and determination of interactions make the control of confounding factors more comprehensive. Due to the unique characteristics of TCM, observational studies of TCM face unique challenges in identifying and controlling confounding factors, including the ever-changing TCM treatment measures received by patients, the often-overlooked confounding effects in the four diagnostic information of TCM, and the lack of objective criteria for TCM evidence-based diagnosis. Some scholars have already conducted innovative explorations to address these issues, providing a methodological basis for conducting higher-quality TCM observational studies, so as to obtain more rigorous real-world evidence of TCM and gradually develop quality evaluation criteria for OS that are consistent with the characteristics of TCM.
6.Characteristics of Emergency Health Systems Guidance Based on AGREE-HS
Danping ZHENG ; Wei YANG ; Nannan SHI ; Dongfeng WEI ; An LI ; Gezhi ZHANG ; Xue CHEN ; Fangqi LIU ; Zhaoshuai YAN ; Weixuan BAI ; Xinghua XIANG ; Yaxin TIAN ; Mengyu LIU ; Huamin ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):137-148
This study used the Appraisal of Guidelines Research & Evaluation-Health Systems (AGREE-HS) to demonstratively compare 34 global coronavirus disease-2019 (COVID-19) health systems guidance documents (HSGs) and 6 World Health Organization (WHO) standard HSGs. The comparison involved topic, participants, methods, recommendations, and implementability, with the aim of exploring the characteristics of emergency HSGs. The results showed that the emergency HSGs had an overall average score of 49%, with topic having the highest score, recommendations having the second highest score, and participants having the lowest score. The standard HSGs had an overall average score of 79%, with high scores in all items. The emergency HSGs had lower scores in participants, methods, recommendations, and implementability than the standard HSGs (P<0.001), while the COVID-19 emergency HSGs developed by the WHO had higher score in topic than the standard HSGs (P<0.05). Compared with those released by countries, the COVID-19 emergency HSG developed by the WHO showed superiority in all items and overall scores (P=0.000 2). This indicates that emergency HSGs, represented by the COVID-19 emergency HSG, place equal emphasis on topic and recommendations as standard HSGs but have low requirements in terms of expert participation, evidence support, and comprehensive consideration in the time- and resource-limited context. They have the characteristics of prominent topics, clear purposes, orientation to demand, keeping up with the latest evidence, flexible adjustment, and timeliness, emphasizing immediate implementation effects, weakening long-term effects, and focusing on comprehensive benefits. Additionally, developers, types, and report completeness are important influencing factors.
7.Characteristics of Developing Methods for Emergency Health Systems Guidance Based on AGREE-HS
Danping ZHENG ; Wei YANG ; Dongfeng WEI ; Nannan SHI ; Lin TONG ; An LI ; Gezhi ZHANG ; Xue CHEN ; Fangqi LIU ; Weixuan BAI ; Xinghua XIANG ; Mengyu LIU ; Huamin ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):149-156
The scientific rigor and efficacy of methodologies employed in drafting emergency health systems guidance documents (HSGs) are paramount in guaranteeing the quality, reliability, and applicability of HSGs. According to the Appraisal of Guidelines for Research and Evaluation- Health Systems (AGREE-HS), we demonstratively assessed both global coronavirus disease-2019 (COVID-19) emergency HSGs and World Health Organization (WHO) standard HSGs to uncover the core attributes of methods employed in the development of emergency HSGs. Our evaluation findings revealed that across the five assessment items of AGREE-HS, methods in the 34 emergency HSGs evaluated ranked third, trailing behind topic and recommendations. Notably, criterion 2 (the best available and most contextually relevant evidence is considered) received the highest score, whereas criterion 5 (evidence of cost and cost-effectiveness of the potential options is described) scored the lowest. Compared with the WHO standard HSGs, the COVID-19 emergency HSGs exhibited low scores in methods (P<0.05), which was reflected in nine criteria (P<0.05), especially in criteria 1 (systematic and transparent methods are used to identify and review the evidence) and 9 (systematic and transparent methods are used to agree upon the final recommendations). Among the COVID-19 emergency HSGs, that developed by the WHO achieved higher scores in eight out of all nine criteria, excluding criterion 8 (P<0.05). The clinically relevant emergency HSGs had higher scores in the criteria 3 (the evidence base is current) and 8 (the rationale behind the recommendations is clear) than other types of emergency HSGs. Collectively, the methodology for developing emergency HSGs, represented by the COVID-19 emergency HSG, underscores evidence orientation and integrates expert consensus. It is characterized by adaptable evidence synthesis strategies, streamlined evidence review protocols, and contextual relevance, all of which are influenced by external, internal, and implementation-specific factors.
8.Characteristics of Participants for Developing Emergency Health Systems Guidance Based on AGREE-HS
An LI ; Gezhi ZHANG ; Xue CHEN ; Fangqi LIU ; Danping ZHENG ; Weixuan BAI ; Wei YANG ; Dongfeng WEI ; Nannan SHI ; Mengyu LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):157-163
The formulation method of emergency health systems guidance (HSG) is crucial, directly impacting the efficiency and effectiveness of responses in emergencies. A scientifically sound, systematic, and easily executable guidance document can assist health institutions at all levels in quickly coordinating resources, standardizing emergency response processes, and safeguarding public health. This study employed the Appraisal of Guidelines for Research and Evaluation for Health Systems (AGREE-HS) to analyze the characteristics of participants in developing emergency HSGs represented by the COVID-19 emergency HSG. The results showed that in the 34 HSGs included in this study, the item participants received the lowest score. Within this item, criterion 1 (diversity of development group) scored the highest (3.13±1.55), while criterion 5 (prevention of funding agency influence) scored the lowest (1.21±0.47). There were differences (P<0.05) in measures taken to mitigate funding agency influence between the six standard HSGs developed by the World Health Organization (WHO) and the four emergency HSGs. Additionally, differences (P<0.05) existed in the development group members, background, conflicts of interest, and preventive measures between the six WHO standard HSGs and the 34 emergency HSGs, as well as between the HSGs developed by the WHO and those developed by countries. The participants in developing emergency HSGs were influenced by various factors, including limited time for guideline development, modes of participation, scarce evidence, and uncertainties in expected outcomes. There is a need to downplay extensive requirements concerning the composition of group members, institutional diversity, and conflicts of interest, emphasizing the roles of key participants like government officials and professionals who can provide rapid, practical guidance in emergency situations.
9.Characteristics of Recommendations for Emergency Health Systems Guidance Based on AGREE-HS
Gezhi ZHANG ; Cuifang LIU ; Danping ZHENG ; Xue CHEN ; An LI ; Fangqi LIU ; Dongfeng WEI ; Wei YANG ; Nannan SHI ; Mengyu LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):164-170
Recommendations, consensus-based syntheses of the best available evidence, constitute the core content of a guideline. This paper analyzes the characteristics of emergency health systems guidance documents (HSGs), represented by the coronavirus disease-2019 (COVID-19) emergency HSG, regarding the item "recommendations" and its eight evaluation criteria in the Appraisal of Guidelines for Research and Evaluation for Health Systems (AGREE-HS). The World Health Organization (WHO) standard HSGs were used as reference to explore the characteristics of emergency HSGs that are different from non-emergency HSGs. The results showed that the “recommendations” scored second after “topic” among the five items. Criterion 7 relating to operability scored higher than others among the eight criteria, and criterion 3 dealing with ethical principles scored lower than other criteria. Compared with the standard HSGs, the emergency HSGs showed decreased scores (P<0.05) of the item recommendations and the criteria of this item except criterion 4 concerning equity promotion. Among the HSGs with different developers, those developed by the WHO had higher (P<0.05) scores of recommendations than nationally developed HSGs, as evidenced by criterion 4, criterion 5 involving acceptability to and alignment with sociocultural and political interests, and criterion 8 for updating plans. The HSGs regarding global or country strategy scored higher (P<0.05) on criterion 2 relating to comprehensiveness than those involving specific guidance on clinical or material issues. Overall, the emergency HSGs, represented by the COVID-19 emergency HSGs, differ from the standard HSGs in a number of ways in terms of their recommendations. Emergency HSGs have more condensed content and weaker articulation of expected outcomes. They incline to put more emphasis on updating plans, rather than comprehensiveness or integrative requirements in terms of ethics, equity, and sociocultural and political interests.
10.Characteristics of Topic for Emergency Health Systems Guidance Based on AGREE-HS
Xue CHEN ; An LI ; Fangqi LIU ; Danping ZHENG ; Gezhi ZHANG ; Nannan SHI ; Wei YANG ; Dongfeng WEI ; Mengyu LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):171-177
The clear definition of the topic in emergency health systems guidance (HSG) ensures the relevance, scientific rigor, and practicality of the guidance, providing a clear direction and a framework for a rapid and effective public health response. This study used the Appraisal of Guidelines for Research & Evaluation-Health Systems (AGREE-HS) to demonstratively evaluate the global COVID-19 emergency HSGs and World Health Organization (WHO) standard HSGs, aiming to explore the characteristics of topic in emergency HSGs. The results showed that in the 34 HSGs included, the item topic received the highest score. Specifically, criterion 4 relating to relevant and applicable factors scored the highest (5.59), while criterion 3 concerning the prioritization of health system challenges scored the lowest (2.76). There were differences (P<0.05) in criterion 1 between standard HSGs and overall emergency HSGs, as well as between WHO and national emergency HSGs. Criterion 3 also showed differences (P<0.05) between standard HSGs and emergency HSGs, as well as between WHO and national emergency HSGs. Criterion 4 displayed differences (P<0.000 1) between WHO and national emergency HSGs. No differences were observed in intra-group or inter-group comparisons of different emergency HSG subcategories (P<0.05). Overall, emergency HSGs represented by the COVID-19 emergency HSG focus on detailing the challenges faced by the health system, including the natures of challenges, affected populations, and other relevant and applicable factors, while aligning with stakeholder concerns. The prioritization is downplayed, with emphasis placed on rapid responses to and flexible handling of urgent issues. Influenced by factors such as the evidence base, phase timing, and effectiveness, the topic setting shows variations.

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