The Establishment And Method Research Of The Evaluation System Of Clinical Practice Guidelines Of Traditional Chinese Medicine

The standardization of traditional Chinese medicine(TCM)is an inherent requirement for inheriting and promoting the cause of TCM,and it is also an indispensable part of the development of TCM.TCM clinical practice guidelines(CPGs)are an effective carrier to reflect the best treatment plan of TCM,and an effective way to guide TCM clinical practice and ensure safety and clinical efficacy.With the rapid development of evidence-based medicine and the expansion of its influence in the medical field,the formulation and revision of TCM clinical practice guidelines has become the basic work of standardization of TCM,and it is also the top priority of standardization of TCM.The formulation of TCM guidelines started late,but the development rate is very considerable,and the number of guidelines is growing rapidly.However,the quality of TCM guidelines is not good,resulting in a low clinical application rate of the guidelines,and some of the guidelines are not fully used to guide clinical practice,which leads to the waste of resources.In order to improve the quality of the guidelines and make that the guidelines play a role in clinical practice,it is necessary to evaluate the guidelines reasonably with scientific and effective evaluation methods.After searching and sorting out,the existing guideline evaluation tools at home and abroad cannot be directly applied to the guidance of TCM due to their limitations.China still lacks the evaluation tools that are in line with China's national conditions and the characteristics of traditional Chinese medicine,so it is urgent to establish the evaluation system of clinical practice guidance of TCM that is in line with the national conditions.In order to ensure the rapid development of TCM guidelines and give priority to solving the problem of lack of evaluation system of TCM guidelines,this study explored the establishment of an evaluation system of TCM clinical practice guidelines,and forms the framework of TCM guidelines evaluation system and the corresponding evaluation list.Objectives1 Based on the combination of realist review and the Delphi method,the basic framework and field of the TCM clinical practice guideline evaluation system are formed through reference,comparison,and complementarity,combined with domestic conditions and characteristics of TCM.2 Systematized search the international and domestic published literatures on evaluation tools of guidelines,screen and extract the items.Considering the domestic situation and the characteristics of TCM,the items were revised and improved to form the list of quality evaluation and Implementability evaluation of TCM clinical practice guidelines.MethodsThis study is divided into three parts.Study 1 uses realist review to initially set up an evaluation system framework,which is divided into several parts:determine the research scope and purpose,form a hypothetical theoretical framework,retrieval,screening and extraction,data integration and analysis.(DFirst,determine the scope and purpose of the study,and consult experts to form a hypothetical theoretical framework after discussion;?Literature search,by searching CNKI,Wanfang,VIP,CBM,PubMed to obtain relevant documents for guide evaluation;?Screening documents that meet the inclusion criteria and extracting information that influences guideline evaluation and guideline practicality;?Classification and integration of the extracted data,merging topics,establishing the relationship between hypothesis theory and topic concepts,and initially constructing the framework and fields of the guideline evaluation system.Study 2 uses Delphi method to distribute survey questionnaires to experts through an online questionnaire platform.Firstly,relevant authoritative experts are selected,and then a group of people with evidence-based professional background is formed to discuss the research questions and question options on the basis of the practical literature review method to design the questionnaire.Based on the research results of the first two parts,study 3 mainly refers to the development methods of authoritative evaluation tools at home and abroad,such as AGREE,GLIA and AGREE-china to formulate the method of item generation in this study,which is divided into screening and extraction,formation of preliminary drafts,expert argumentation and other links.ResultsAccording to the integration analysis of the results of study 1 and study 2 by Delphi method,the framework of the evaluation system of TCM clinical practice guidelines was finally formed,which includes three parts:quality evaluation,Implementability evaluation and application investigation.In the third part of the study,by searching,extracting and systematically combing the published guidelines evaluation tools at home and abroad,the items were summarized and refined.Combined with the domestic situation and the characteristics of traditional Chinese medicine,through expert demonstrations,the items were reasonably supplemented,perfected or adapted.Finally,a suggestion checklist and interpretations of quality evaluation of TCM clinical practice guidelines,a suggestion checklist and interpretations of Implementability evaluation of TCM clinical practice guidelines and an application questionnaire of TCM clinical practice guidelines were formed.There are 16 items in the suggestion list of quality evaluation of TCM clinical practice guidelines,and they are interpreted accordingly.The purpose is to evaluate the quality of the methodology in the process of guideline development to measure whether the entire guideline development process is scientifically rigorous.The suggestion checklist of Implementability evaluation of TCM clinical practice guidelines is divided into three areas,including the overall,clarity,and enforceability of the guidelines.It can be easily used by evaluators with the interpretation of documents,reflecting the compatibility of the guidelines with clinical practice.The application questionnaire of TCM clinical practice guidelines is divided into four parts,aimed at understanding the application and problems of the guidelines in clinical practice.Conclusions1 For the current research status of guidelines in the field of TCM,it is necessary to establish a comprehensive guideline evaluation standard system,especially an evaluation standard system that conforms to the characteristics of TCM,and has certain practical significance.2 The framework of the evaluation system of TCM clinical practice guidelines was formed by Realist Review and Delphi Method,including quality evaluation,Implementability evaluation,and applicability investigation.The suggestion list and interpretation of quality evaluation of TCM guidelines,the suggestion list and interpretation of Implementability evaluation recommendations,and application questionnaires are preliminary attempts in China.