A Methodological Study Of "from Evidence To Recommendation" Formulation In The Clinical Practice Guidelines Of Traditional Chinese Medicine

The standardization of traditional Chinese medicine(TCM)is an important way to promote the academic development of TCM and improve its technical level,and it is also the only way for the development of TCM.The clinical practice guidelines(CPGs)are the core technical standards in the medical field,which reflect the current level of diagnosis and treatment of medicine,which not only contribute to standardize the behavior of clinical diagnosis and treatment,improve the quality of medical services,and reduce the cost of medical treatment,but also provide clinical decision-making evidence for health personnel,so that patients can get the best treatment at present.With the introduction and development of evidence-based medicine in China,the formulation of evidence-based CPGs for TCM has gradually attracted the attention of the profession,and the number of guidelines formulated and issued is growing rapidly.However,there are still bottlenecks in the relevant important formulation links and technologies of the TCM guidelines.One of them is that there is no decision-making standard for the transformation from evidence into recommendations.Recommendations are the essence and key part of the guidelines,as well as important content for guiding clinical practice.Clear and reliable recommendations have the most direct impact on clinical decision makers.However,what factors should be considered and how to transform in the transformation from evidence to recommendation in the TCM guidelines?There is currently no systematic,transparent and scientific decision-making criteria,and there is no corresponding guidance method or instruction manual,As a result,when the TCM guideline formulation panel formed recommendations,there were widespread problems such as vague expressions,irregular reports,and even out of touch with clinical practice situation and evidence.For the TCM guidelines,formulating a clear and transparent criteria and judgments for the formation of recommendations that are in line with the characteristics of TCM,it can not only ensure that the recommendations are objective,reliable and clear,but also contribute to the clinical application and implementation of TCM guidelines.This study intends to explore the influencing factors from evidence-into-recommendations of the CPGs at domestic and overseas,so as to establish the criteria and judgments for the transformation from evidence into recommendations in CPGs of TCM.Objectives1 Realist review method was used to systematically investigate the relevant literature from domestic and overseas CPGs to the consideration factors/standards for transformation from evidence into recommendations.At the same time,combining the characteristics of TCM and the actual situation of the domestic CPGs,the initial criteria and judgments for the transformation from evidence into recommendations in TCM CPGs were determined.2 The nominal group method was used to conduct a structured discussion on the criteria and judgments,and further modified and improved them.After the demonstration of authoritative TCM clinical experts,methodologists,pharmacy experts and other experts in many fields,the criteria and judgments that were clear,transparent and in line with the characteristics of TCM were finally determined for the transformation from evidence into recommendations in TCM CPGs.MethodsThis study was mainly divided into two parts:literature research and consensus development conference.The first part was to use the realist review method to determine the initial criteria and judgments,which was divided into several steps:searched literature,screening,extraction,data integration and analysis:?First,conducted a literature search,through the international guide development manual and CNKI,WanFang,VIP,CBM,and PubMed and formulated search strategies to search,so as to obtained the related literature on influencing factors and thinking for the transformation from evidence into recommendations in CPGs.?Screening the documents that met the inclusion and exclusion criteria;?extracting the basic information from the inclusion study,at the same time,preliminary extraction of the relevant information that the considerations and the thinking for the transformation from evidence into recommendations in CPGs;?Coding and integrating the themes,The extracted data were coded and organized into themes,and the relationship between the coding themes was determined,and the initial criteria and judgments were finally determined.The second part was to adopt the nominal group technique to determine the final criteria and judgments through face-to-face discussions of experts.First of all,selected the relevant authoritative experts,prepared the relevant introduction materials before the meeting,and at the same time made the meeting minutes,modified and improved the initial criteria and judgments during the meeting,so that different opinions could reach consensus.Finally,the criteria and judgments for the transformation from evidence into recommendations in TCM CPGs had been determined.ResultsThrough systematic search and screening,95 articles were finally included in this study,including 27 guideline development manuals issued by foreign guideline development institutions/organizations and 1 domestic guideline development manual.Other included literatures are thoughts or the factors that influence the implementation/application of the transformation from evidence into recommendations in CPGs.The factors and the thoughts on the formation of the recommendations of the included domestic and foreign clinical practice guidelines recommendations were extracted,integrated,and theme analysis respectively.The results showed that the same primary themes are evidence,acceptability,availability,Implementation,clinical effect,safety,economics and outcome,the different topics are the priority of problem considered in foreign guideline handbooks,while domestic guideline formulation considers the positioning of clinical problem,but domestic and foreign first-level topics and second-level topics and specifics content is different.After the first-level topics are integrated and checked,items are formed and discussed to determine the naming and interpretation.The second level topics are integrated and checked and the judgment are determined.At the same time,experts in the field are consulted and based on the characteristics of traditional Chinese medicine and the actual situation in China,the expert group discussed and deleted the constructed items,and initially determined the items and judgments related to the transformation from evidence into recommendations in CPGs of TCM.On the basis of literature research,23 authoritative experts in multiple fields and who participated many times in the development of guidelines were invited to discuss,revised and improved them face to face,and finally determined clear,transparent,and consistent the characteristics of Chinese medicine to the criteria and judgments for the transformation from evidence into recommendations.The study identified eight criteria related to the transformation from evidence into recommendations in CPGs of TCM,namely,the advantages of TCM,TCM effectiveness,grading and sources of evidence,importance of outcomes,safety,economics,feasibility and patient acceptability.In addition,detailed judgments were also provided for each criterion,and its application scope and specific use were explained.Conclusions1 The characteristics of TCM should be fully considered for the transformation from evidence into recommendations in CPGs of TCM.At the same time,the criteria and judgments should be clear and unambiguous explained when making recommendations,so as to provide foundation for the clinical application of the guidelines and the decision-making of medical workers,and can really play the guiding role of the guidelines.2 Through the realist review and the nominal group technique to establish the criteria and judgments of the CPGs of TCM,including eight aspects,namely,the advantages of TCM,TCM effectiveness,grading and sources of evidence,importance of outcomes,safety,economics,feasibility and patient acceptability,and detailed judgments are also provided for each criterion.