Research On The Method Of Forming "TCM Expert Evidence" In Clinical Practice Guideline

Evidence-based clinical practice guidelines are essential for standardizing and rationalizing clinical diagnosis and treatment of specific diseases using traditional Chinese medicine(TCM).In the internationalization process of TCM,the development of high-quality evidence-based clinical practice guidelines becomes even more important.While considering high-quality clinical research evidence,the development process of TCM guidelines also needs to consider TCM-specific evidence such as ancient literature and the opinions and experiences of renowned TCM experts.Currently,some scholars abroad have incorporated"expert evidence" into the guideline development process,but this concept is not entirely applicable to the development of TCM guidelines.Therefore,this study aims to link the concept of expert evidence abroad with TCM-specific evidence,explore the definition and formation methods of TCM expert evidence(TCMEE),and how to apply it in the guideline development process,so as to enhance the authority and credibility of the guideline development process.Purpose1.To summarize the concept of TCMEE in clinical practice guidelines.2.To explore the application environment of TCMEE in the process of guideline development.3.To developing a methodology for collecting and evaluating TCMEE.MethodThis study consists of three chapters.Chapter 1 conducted a scoping review to systematically search and organize literature materials.This includes the following steps:1)determining the scope and objectives of the study;2)systematically searching various databases,including the China National Knowledge Infrastructure(CNKI),Wanfang Data Knowledge Service Platform(Wanfang Data),Chongqing VIP Chinese Science and Technology Journals Database(VIP),China Biology Medicine database(CBM),US National Library of Medicine(PubMed),Embase,Web of Science Core Collection(SCI&SSCI)database,and consulting the official websites of major guideline societies or organizations;3)screening literature based on inclusion and exclusion criteria;4)extracting information,including the approaches taken by guideline development organizations when evidence is lacking,basic information of included studies,the process of incorporating traditional Chinese medicine evidence into guidelines,and the methods of collecting expert opinions,experiences,and evidence during the guideline development process;5)summarizing the information through thematic framework analysis and organizing the summary themes into a framework;6)using the information to formulate the concept of TCMEE,preliminary TCMEE collection items and identify the application environment of TCMEE.Chapter 2 uses a questionnaire survey to consult experts in multiple fields to modify and improve the collection items identified in the previous section.This includes the following steps:1)selecting survey subjects;2)developing and distributing survey questionnaires;3)analyzing the survey results;4)modifying and adding to the items identified in the research based on the statistical analysis results and collected suggestions.Chapter 3 organizes a panel of authoritative experts in the field to hold a conference(expert argumentation)to further improve and interpret the results.This includes the following steps:1)determining the conference theme and agenda;2)forming an expert committee;3)preparing materials before the conference;4)holding the conference to discuss the research results;5)summarizing and improving the research findings.ResultIn the first chapter,a summary was made of 81 sources,including 70 journal articles,1 conference paper,and 10 web sources.The second chapter collected questionnaires from 105 experts,including 89 clinical experts,10 methodological experts,2 pharmaceutical experts,1 nursing expert,1 basic medical expert,and 2 standardization management experts.There were 14 participating experts in the expert argumentation,including 9 clinical experts,3 methodological experts,and 2 experts with multiple roles.Combining the results of the literature review in the first chapter,the multidisciplinary questionnaire analysis in the second chapter,and the discussion results of the authoritative experts in the third chapter,this study finally formed the concept,application environment,and collection items of TCMEE in the development of clinical practice guidelines.1.The concept of TCMEETCMEE refers to the TCM clinical experts who have professional knowledge and clinical experience in the field of diseases,possess TCM clinical experience that has been systematically collected and organized,supported by TCM theories,and verified by inheritance over generations.2.The application environment of TCMEE in the guideline development processBefore using expert evidence,it is necessary to determine which clinical questions cannot be answered by existing research evidence,such as cases where a certain intervention therapy is widely used in current clinical practice but there is little or poor-quality clinical evidence,or when the disease is a rare disease.It is recommended to use expert evidence when time resources are relatively sufficient.At the same time,attention should be paid to the following two points:(1)the scope of expert selection:experts within the guideline development working group should be selected,taking into account practical considerations and needs,and external experts can also be invited for evidence collection.(2)Quality control during evidence collection:review the evidence provided by experts,monitor the evidence provided by experts in real time,and implement openness.Save the submission records of expert evidence for verification and tracing at any time.(3)Present expert evidence as a type of independent evidence source with TCM characteristics at consensus meetings.3.Collection items for TCMEEBased on the research results and the concept of TCMEE that has been formed,this study compiled 16 detailed items and options for collecting expert evidence in the guideline development process,which are divided into three dimensions:classical TCM theory support,theoretical inheritance,and modern medical practitioners’ clinical application.The specific details are as follows.Dimension 1:Theoretical support from ancient literature for expert evidenceItem 1.Which types of ancient literature are the theoretical sources for expert evidence?(Multiple choices)A.The Four Classics B.Official/governmental documents C.Representative works of schools of thought or specialized writings D.Works of medical practitioners from different dynasties,medical case records,and personal experiences E.Other ancient books or historical records F.Not clearItem 2.Do the descriptions(original text and annotations)of patients’ diseases,syndromes,and symptoms in ancient literature match or correspond to those in this guideline?A.Completely the same B.Mostly the same C.Partially the same D.Not the same E.Not clearItem 3.Is the information on treatment principles/treatment methods in ancient literature the same or similar in meaning as expert evidence?A.Completely the same B.Mostly the same C.Partially the same D.Not the same E.Not clearItem 4.Does ancient literature report clear and reasonable TCM etiology and pathogenesis?A.Yes B.Partially C.No D.Not clearItem 5.Does ancient literature report a complete process of TCM diagnosis and treatment?A.Yes B.Partially C.No D.Not clearDimension 2:Theoretical inheritance of expert evidenceItem 6.Has the therapy used undergone historical transmission and is it still applied today?A.Yes B.No C.Not clearItem 7.Has this therapy been included in modern TCM textbooks/industry standards/norms/guidelines?A.Yes B.No C.Not clearItem 8.Are there relevant monographs on this therapy in modern times(such as collections of experiences from famous TCM doctors)?(Skip item 9 if the answer is "No.")A.Yes B.No C.Not clearItem 9.What is the level of the publishing institution of the above monographs?A.National publishing house B.Provincial publishing house C.Local publishing house D.Other publishing houseItem 10.Have any papers on this therapy been published in modern times(such as reviews or commentaries)?(Skip item 11 if the answer is "No.")A.Yes B.No C.Not clearItem 11.What is the level of the journal where the above papers were published?A.Core journal and above B.Professional general journal C.Non-professional general journal D.Popular science journalDimension 3:Clinical application of expert evidenceItem 12.What percentage of cases you have treated has used this therapy for this disease?A.More than 60%B.31%to 60%C.11%to 30%D.Less than 10%Item 13.Do you think this therapy has advantages compared to Western medicine treatment?A.Obviously advantageous B.Not significantly advantageous C.Equally effective D.Not clearItem 14.What is the treatment effect of this therapy for different outcome indicators of patients?14.1 Outcome indicator 1 A.Significant effect B.Comparatively effective C.Ineffective D.No effect E.Not clear14.2 Outcome indicator 2 A.Significant effect B.Comparatively effective C.Ineffective D.No effect E.Not clear14.3 Outcome indicator 3 A.Significant effect B.Comparatively effective C.Ineffective D.No effect E.Not clear.......Item 15.Have any adverse reactions occurred in patients treated with this therapy?A.Yes,very serious.Please specify the specific adverse reactions and measures takenB.Yes,but not serious.Please specify the adverse reactions and measures takenC.No adverse reactions.D.Not sure.Item 16.What is the rate of follow-up visits(number of follow-up patients/number of all patients)in the past year?A.76%～100%B.51%～75%C.26%～50%D.≤25%E.Not sure.ConclusionBy scoping review,questionnaire survey and expert argumentation,the concept,application environment,and collection items of TCMEE were systematically summarized.We created a possible implementation path for transforming experience into evidence in the field of TCM.This brings new thinking to incorporate TCM-specific evidence into the evidence system.However,further optimization and practical verification of the research results are still needed to improve the collection and evaluation of expert evidence in the process of developing evidence-based guidelines,and to facilitate the promotion and application of traditional Chinese medicine therapies internationally.