1.Application of Ancient Books in Clinical Practice Guidelines and Expert Consensus of Traditional Chinese Medicine: Current Status and Methodological Recommendations
Changhao LIANG ; Dingran YIN ; Jing CUI ; Xinshuai YAO ; Xinyi GU ; Yifei YAN ; Wanting LIU ; Yingqiao WANG ; Yingqi CHANG ; Haoyu DONG ; Mengqi LI ; Yuanyuan LI ; Yutong FEI
Journal of Traditional Chinese Medicine 2024;65(8):801-809
ObjectiveTo explore the current status and issues regarding the application of ancient books in clinical practice guidelines and expert consensus of traditional Chinese medicine (TCM) published in China, and to provide methodological recommendations for the incorporation of ancient books in the development of TCM guidelines. MethodsWe searched China National Knowledge Infrastructure (CNKI), WanFang Data, VIP, SinoMed, PubMed, Embase, as well as six industry websites including China Association of Chinese Medicine, National Group Standards Information Platform, and Chinese Association of the Integration of Traditional and Western Medicine,etc. TCM clinical practice guidelines or expert consensus issued during January 1st, 2017, to November 26th, 2022 were searched. Clinical practice guidelines or expert consensus that explicitly referred to ancient books were included, and the content regarding the searching for ancient books, sources of access to ancient books, methods of evaluating the level of evidence, methods of evaluating the level of recommendation, and methods of evaluating the evidence for the ancient books were analysed. ResultsA total of 1,215 TCM clinical practice guidelines or expert consensus were retrieved, with 442 articles explicitly mentioning the application of ancient books, including 300 (67.87%) clinical practice guidelines and 142 (32.13%) expert consensus. Sixty of the 442 publications explicitly reported that ancient books searching had been conducted (13.57%); among these 60 publications 27 (45.00%) explicitly reported ancient books searching strategies, and the most frequent method was manual searching with a total of 24 articles (40.00%). The most popular search source was Chinese Medical Dictionary, a TCM classics database, with a total of 18 articles. 197 articles (44.57%) explicitly reported the evaluation criteria for the level of evidence, of which 141 articles (71.57%) involved the evaluation criteria for the ancient books; 413 articles (93.44%) mentioned ancient books in the recommendations, and only the source of formula name was mentioned in 409 (99.03%) of the publications. ConclusionThe current application of ancient books in TCM clinical practice guidelines and expert consensus is limited, with issues of non-standard searching and evaluation methods. Standar-dization and uniformity are needed in evidence grading and recommendation standards. Future research should clarify the scope and methods of applying ancient book, emphasize their integration with modern research evidence, and enhance their value and quality in the development of TCM clinical practice guidelines.
2.Exploring the Essential Factors of Applying the Consensus Methods in the Development of Traditional Chinese Medicine Guidelines: A Qualitative Interview
Changhao LIANG ; Dingran YIN ; Meijun LIU ; Guanxiang YIN ; Xun LI ; Yaqi WANG ; Siqi LIU ; Min TONG ; Pengwei LIU ; Xiangfei SU ; Yutong FEI
Medical Journal of Peking Union Medical College Hospital 2023;15(4):942-952
This study delves into the pivotal factors influencing the consensus process within traditional Chinese medicine guideline development, with the objective of augmenting the quality of this process through methodological recommendations aimed at elevating standardization. Semi-structured qualitative interviews were used to interview guideline leaders, working groups and consensus groups to explore the pertinent elements impacting the credibility of consensus and gather insights into the constitution and progression of the consensus methodology. The study encompassed interviews with 26 participants, yielding 212 codes that were subsequently categorized into five domains: establishment of the consensus group, integration of patient participation, adeptness of the meeting moderator, preparation for consensus formulation, and overarching factors influencing consensus. The research distilled three fundamental phases for forming a consensus group and delineated 17 fundamental tenets for applying the consensus methodology. In forthcoming guideline development endeavors, it is advisable to bolster methodological training ahead of the consensus process while ensuring comprehensive engagement of methodologists. Encouraging experts to navigate differences judiciously and prioritizing meticulous methodology and evidentiary groundwork are recommended. The process should involve openly disclosing the selection of consensus group members, heightening the involvement of patients, and effective management and disclosure of conflicts of interest. This collective approach helps curtail bias, enhance transparency, bolster reliability, and fortify the scientific rigor of consensus outcomes.