| Background: With the transformation of medical model and human health concept,traditional Chinese medicine(TCM)has shown its unique value due to its characteristics such as "holistic concept","treatment based on pattern identification" and "preventing a disease before it arises".TCM has achieved rapid development In recent years,but internationalization of TCM still faces challenges such as the difficulty in quantifying clinical efficacy indicators and the lack of standardized treatment procedures.Standardization of TCM is a prerequisite for the internationalization of TCM,and clinical practice guidelines(referred to as "TCM guidelines" in the following text)are one of the effective ways to achieve standardization of TCM.Developing TCM guidelines in accordance with international guideline methodology can help TCM align guidelines with international standards and fully tap into the role of TCM in disease prevention and health promotion for humans.However,there is currently a lack of research on the internationalization of TCM guideline development.Objectives:(1)To conduct a systematic review on TCM guideline handbooks and the current internationalization status of TCM guideline development.(2)To explore the dimensions of defining international TCM guidelines and develop key items for the internationalization of TCM guideline development.Methods:(1)Literature analysis method: We systematically searched the databases of China National Knowledge Infrastructure(CNKI),Wanfang Data,China Biology Medicine disc(CBM),Pub Med,Web of Science and Embase up to April 6,2023.Supplementary search of reputable medical institutions and organizations,as well as retrospective references were conducted and screened.We included and extracted TCM guidelines handbooks,TCM guidelines published in English and Chinese with "international" in the title(referred to as "TCM guidelines with an international perspective" in the following text).(2)Modified Delphi method: We invited TCM experts and guideline methodologists for two rounds of consultation and used the Chinese version of Research Electronic Data Capture(REDCap)for data collection.We conducted a descriptive analysis of the definition dimensions of international TCM guidelines,screened items based on the results of experts’ ratings on the necessity and importance of items,and modified items by combining the experts’ suggestions to finally form the key items for internationalization of TCM guideline development.Results:(1)A total of six TCM guideline handbooks were included,published between 2013 and 2021.All handbooks suggested the following aspects to promote the internationalization of TCM guideline development: 1)searching domestic and international databases and international related websites,including Cochrane Library(6),CBM(4),CNKI(3),Medline(3),Wanfang Data(2),Embase(2)and Pub Med(2);2)selecting international and domestic published evidence grading criteria based on the characteristics of the literature,including Grading of Recommendations for Assessment,Development and Evaluation(GRADE)(5),evidence grading proposed by Pro.Liu Jianping(3),Oxford Centre for Evidence-Based Medicine(OCEBM)(1)and evidence grading proposed by Pro.Wang Shouchuan(1).3)using internationally accepted consensus methods to reach consensus,including Delphi(6),consensus development conferences(5),nominal group technique(4),modified Delphi(1),and GRADE grid(1).(2)A total of 60 TCM guidelines with an international perspective were included,of which 47(78.33%)were published in English and 13(21.67%)were published in Chinese.The earliest TCM guideline in English was published in 2011,and the number of TCM guidelines with an international perspective showed an increasing trend between 2011 and 2023,and reached the peak in 2021(18,30.00%).The TCM guidelines were published in 23 domestic and international journals,with the majority in World Chinese medicine(12,20.00%)and Chinese journal of integrative medicine(8,13.33%);English TCM guidelines were published in 21 journals,and the impact factor of the published journals generally showed an increasing trend year by year,with the highest impact factor was Pharmacological research(IF2021=10.334).80.00% of the TCM guidelines were first developed by societies/associations(35,58.33%)and universities/research institutes(13,21.67%),and the former were mainly the World Federation of Chinese Medicine Societies(18,51.42%)and the China Association of Chinese Medicine(10,28.57%)and the latter were mainly the China Academy of Chinese Medicine Science(6,46.15%).For the ICD-11,the top three disease classifications were diseases of the respiratory system(10,16.67%),diseases of the genitourinary system(7,11.67%),and diseases of the musculoskeletal system or connective tissue(5,8.33%).Three(5.00%)TCM guidelines for the ICD-11 were Supplementary Chapter Traditional Medicine Conditions-Module I.For internationalization characteristics,more than 60.00% of TCM guidelines with an international perspective searched domestic and international databases(61.67%),used internationally or nationally recognized evidence grading tools(78.33%),and described quality of evidence and strength of recommendations(73.33%).31.67%(19)of the TCM guidelines included foreign experts,with the median percentage of foreign experts was 16.90%(interquartile range: 12.50%-20.99%)and the median number of countries represented by experts was 6.50(interquartile range: 3.00-7.25).(3)The results of the modified Delphi method study showed that international TCM guidelines can be defined in the following dimensions: internationalization of the guideline working group(96.77%),development of guidelines using internationally recognized methods(87.10%),reporting as international TCM guidelines in the title(77.42%),and being included in the international guideline platform(54.84%).Further research found that 48.39% of experts agreed that internationalization of the guideline working group required the participation of international experts,70.96% of the experts agreed that the participation of international experts ranged from 10% to 30%,and57.14% of the experts suggested that guideline developers from five or more countries should be involved in an international TCM guideline development.(4)Through literature analysis and two rounds of expert consultation,a total of 30 key items for internationalization of TCM guideline development were identified,covering eight topics: guideline selection,protocols and registries,guideline working groups,funding and conflicts of interest,evidence,recommendations,guideline reporting,and dissemination and implementation.Conclusion:(1)The current TCM guidelines handbook has limited and scattered content on internationalization methodology for TCM guideline development,lacking relevant chapters and items on internationalization.The alignment between TCM guidelines and international standards needs to be improved.(2)The internationalization of the guideline working group is the most important dimension for defining international TCM guidelines,and the participation of international experts is an important reflection of internationalization of TCM guidelines.Further exploration is needed to define international TCM guidelines.(3)The key items for the internationalization of TCM guideline development systematically propose suggestions to promote the internationalization of TCM guideline development from the perspective of guideline methodology,providing a basis for the alignment of TCM guidelines with international standards and also serving as a reference for the internationalization of western medicine guidelines in China. |
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