| ObjectiveThe research on the formulation of this guideline refers to the technical requirements of the revision of the TCM clinical diagnosis and treatment guideline system,and the targeted TCM guidance intervention guidelines for stroke high-risk groups are formulated.Through the formulation of TCM intervention guidelines for high-risk groups of stroke,it provides standard norms and high-level evidence-based basis for TCM clinical diagnosis and treatment of high-risk groups of stroke.Through the application of evidence-based method and expert consensus-Delphi method,multi-dimensional evidence integration was carried out in the two aspects of syndrome diagnosis and non-drug therapy in high-risk groups of stroke,and the preliminary draft of TCM intervention guidelines for high-risk groups of stroke was constructed.The aim is to develop a scientific,reasonable and widely used TCM Intervention Guide for high-risk groups of stroke,to provide reference for the selection of TCM intervention clinical diagnosis and treatment plans for high-risk groups of stroke,and to provide methodological exploration for the formulation of TCM guidelines for other diseases.1 Organization managementThree levels of management are implemented: expert general guidance group,subject expert guidance group and guide working group.The expert general guidance group is mainly responsible for providing decision-making suggestions,professional consultation,theoretical guidance and technical support for the overall revision of TCM clinical diagnosis and treatment guidelines.The members of the subject expert steering group mainly provide technical guidance,review the content of the guidelines,and review the scientific nature of the guidelines.Set up a guideline formulation working group,including a leader,a secretary and 3 team members.Clear the division of labor among the members of the working group,and the leader is responsible for technical guidance and guiding the work flow and progress of the formulation of the guide;The secretary is responsible for the selection of experts and the organization and management of meetings;The team members are responsible for literature retrieval,data collection and collation,and questionnaire preparation.2 Determine the theme and purpose of the guide2.1 Selecting a TopicSearching on the topic of "Guidelines for TCM Intervention in high-risk groups of stroke",no relevant guidelines,norms or consensus has been found.2.2 Clear PurposeTo formulate targeted intervention guidelines for high-risk stroke groups guided by TCM.Through the formulation of TCM intervention guidelines for high-risk groups of stroke,it provides standard norms and high-level evidence-based basis for TCM clinical diagnosis and treatment of high-risk groups of stroke.2.3 Identify clinical problemsQuestionnaires and interviews were made to collect clinical problems encountered in the process of TCM clinical diagnosis and treatment in high-risk groups of stroke,and the questionnaire on Key clinical Issues of TCM intervention in high-risk groups of Stroke was screened and concluded.3 Collection and synthesis of evidenceIn accordance with the requirements of the revision of the guidelines,the working group carried out literature research and expert questionnaire survey,searched and screened relevant literature,including ancient Chinese medicine books,modern research,experience of famous old Chinese medicine experts,etc.,and collected evidence-based evidence through joint use of evidence-based method and Delphi method.3.1 Evidence-based evidence researchLiterature search was conducted on syndrome-type diagnosis and non-drug therapy of high-risk stroke population: Pub Med,Embase and other databases were searched in foreign countries;CNKI,Wanfang and other Chinese databases were searched in China;traditional Chinese medicine books data database of the Chinese Medical Code,Yimaitong and Dingxiang Yuan were searched in China;ancient Chinese medicine books,modern studies and clinical experience of old and famous experts related to stroke high-risk groups were sorted out,and evidence was extracted:(1)Use guidelines evaluation tool(AGREEā
”)to screen out high quality stroke high-risk groups(hypertension,diabetes,dyslipidemia,atrial fibrillation,etc.)TCM clinical diagnosis and treatment guidelines,the formation of current guidelines evidence-based evidence;(2)Literature research on TCM syndromes of high-risk groups of stroke was searched and screened,and the rules of TCM syndromes of high-risk groups of stroke were extracted and summarized by statistical methods to form evidence of TCM syndromes.Delphi method was used to form "expert consensus" on the evidence of low-quality TCM syndromes.Based on the two clinical issues of syndrome diagnosis and non-drug treatment in high-risk groups of stroke,evidence-based evidence of guidelines and expert consensus were integrated to establish the main body of evidence composed of evidence-based evidence of current guidelines,TCM syndrome research evidence and expert consensus.3.2 Implementation of Delphi LawAccording to the results of evidence-based research,TCM syndrome classification and non-drug therapy measures of stroke high-risk groups were summarized,and Delphi method was carried out for expert consultation.The working procedure of Delphi method is as follows: selection of experts,formulation of expert questionnaire,rotation of Delphi method,statistical analysis of expert questionnaire results.ResultAccording to the statistics of questionnaire recovery data of Delphi method,the positive coefficient of participating experts in the first round of questionnaire is 100%,and the adoption rate after the second round of questionnaire recovery is 75%,indicating that experts have a high enthusiasm to participate in the research.The experts were selected from 10 provinces and municipalities including Beijing,Guizhou,Guangzhou,Heilongjiang,Liaoning,Shandong,Shaanxi,Anhui,Fujian,Hunan,and 80% of the experts came from domestic third-class first-class hospitals with senior titles and rich clinical experience.According to the entry deletion criteria,the low importance(first-round questionnaire;3.0,Kj>0.5,the second round of questionnaire;3.0,Kj>0.6)and poor coordination of expert opinions(first round questionnaire;0.2.The second round of questionnaire.0.5),the coordination degree of the two rounds of questionnaires was P<0.001,the difference was statistically significant,indicating that expert opinions tended to be consistent in the two rounds of questionnaires,and the research results were reliable.Conclusion1.After the completion of two rounds of expert correspondence questionnaire,the draft of TCM Intervention Guide for high-risk groups of Stroke was formed,among which the syndrome types were: wind phlegm up-attacking syndrome,phlegm turbidity-blocking syndrome,blood stasis blocking cerebral collages-blocking syndrome,hyperactivity of liver-yang syndrome,wind Yang up-disturbing syndrome,deficiency of qi and blood,deficiency of liver and kidney syndrome.Commonly used non-drug therapies refer to National Guidelines for the Prevention and Management of Primary Hypertension(2020edition),National Guidelines for the Prevention and Management of Primary Diabetes Mellitus 2022,and Atrial Fibrillation: Current Understanding and Treatment Recommendations 2021.2.The first draft of TCM Intervention Guidelines for Stroke high-risk Groups is a body of evidence constructed by evidence-based evidence and Delphi method,which combines the professional experience and opinions of experts in this field with information from multiple aspects to form a comprehensive and systematic expert consensus.The evidence-based method and Delphi method were applied in the formulation of the guidelines,which provided evidence-based basis and scientific and reasonable guarantee for the guidelines in the clinical practice and scientific research of TCM intervention in high-risk groups of stroke,rather than a paper of empty talk.The formulation of TCM Intervention Guidelines for high-risk groups of Stroke can provide reference for the selection of treatment programs for high-risk groups of stroke in clinical and scientific research in the future,and can also provide reference methods for the formulation of TCM clinical guidelines for other diseases in the future. |