Evaluation Of Clinical Evidence Of Traditional Chinese Medicine Based On GRADE System

Objective: Traditional Chinese medicine(TCM)evidence-based practice cannot be separated from TCM clinical evidence,and a scientific and characteristic TCM evidence-based evaluation system is needed to evaluate its quality.At present,there are many TCM clinical evidence evaluation systems,which have many problems,such as different grading standards,unclear grading factors,opaque grading process,and difficult practical application.To develop a systematic,structured and operable evaluation method for TCM clinical evidence can enable researchers to evaluate the quality of TCM evidence more scientifically and measure the authenticity and reliability of evidence more rigor.It will further provide strong support for the development of TCM clinical practice guidelines and evaluation criteria,TCM evidence management and information services.Methods: This study is divided into two parts.The first part is the research on the current situation of TCM clinical evidence evaluation system.The main research methods are literature research and questionnaire survey.Through literature analysis of the existing evidence evaluation system of TCM,extract the relevant content of evidence classification,such as evidence composition,classification system,evaluation method and process,study the development status of evidence evaluation system of TCM.Questionnaire survey method was used to study the cognition and application of TCM clinical evidence evaluation system,to study its actual use and existing problems,and to provide reference and realistic basis for the formation of items in the next step of evaluation tool research.The second part is the evidence-evaluation tool study of TCM clinical randomized controlled trials based on GRADE system,which is divided into expert questionnaire survey based on modified Delphi method and expert consensus meeting.Firstly,literature analysis was carried out on the GRADE system adaptation situation abroad.Based on literature research,revised items of TCM clinical evidence evaluation based on GRADE system were formulated,and expert questionnaire was developed.Secondly,two rounds of modified Delphi expert questionnaire survey were conducted,and then the revised items were further discussed and agreed upon through expert consensus meeting.Finally,an evidence-evaluation tool for TCM clinical randomized controlled trials based on GRADE system was initially formed.Results: In the first part,a total of 69 literatures were included.The external characteristics of the literatures were analyzed by bibliometrics,and the contents of the literatures(including the classification of evidence quality,the classification of evidence recommendation,the composition of evidence body,the factors influencing the classification of evidence,the development methodology,etc.)were extracted and analyzed.At present,the main research methods of TCM evidence evaluation system are literature research,Delphi method and expert consensus method.The construction of the evaluation system mainly refers to the classic five level evidence system.The evidence body covers modern research evidence,including randomized controlled trials,non randomized controlled trials,cohort studies,case reports,etc.,and includes TCM characteristic evidence as case,expert consensus and expert opinions.Based on the classification factors such as the version of ancient books,the degree of influence and circulation,the consensus of experts,and the completeness of records,the TCM characteristic evidences such as classic works,medical records and expert experience were evaluated.Of 307 returned questionnaires,284 were noted to be valid,and the effective recovery rate was 92.5%.Our analyses showed that the respondents demonstrated a better understanding of clinical evidence-based evaluation systems and that they used these occasionally.For the TCM evidence evaluation systems,the respondents generally showed poor overall understanding,rendering the systems impractical.Among the respondents who were exposed to the existing evidence evaluation system for TCM.More than 70% of the respondents remarked that it was difficult to obtain high-quality evidence using any existing methods to evaluate TCM clinical evidence,that there was a lack of clear evaluation criteria,and that it was difficult to grasp the evaluation process.To analyze the modified version of GRADE system in the world,and 39 references were included.The basic information of literature and GRADE versions,the content of versions were extracted.The main points of the adaptation are mainly focused on four aspects:(1)simplifying the classification,merging ‘low’ and ‘very low’ level evidence into ‘low’ level evidence;(2)increase or reduce evidence upgrade/downgrade factors;(3)adjust the preset evidence level,combined with OCEBM standard or other standards;(4)adjust the recommendation level,simplify the description of recommendation level to facilitate understanding and use.Eleven amendments based on grade are proposed,which involve four aspects: the source of high-level evidence,the degradation of evidence,the upgrading of evidence and the grading of recommendation strength.Thirty-one experts from the fields of evidence-based medicine,Chinese medicine philology,basic research and clinical practice of TCM were invited to conduct expert questionnaire survey.In the first round,27 valid questionnaires were collected and 5 revised items reached consensus;in the second round,24 valid questionnaires were collected and 5 revised items reached consensus.Experts in relevant fields are invited to further discuss and reach consensus on the items that have not been reached,and to demonstrate the revised items that have reached consensus.After summarizing,we initially formed the "Evidence evaluation tool for TCM clinical randomized controlled trials based on GRADE system".Conclusion: Domestic scholars have combined the concept of evidence-based medicine with the characteristics of TCM practice to explore the TCM clinical evidence evaluation system: 1)combine the existing international grading standards with TCM to establish a relatively unified grading system;2)establish independent evaluation standards based on TCM theories and characteristics of TCM inheritance.The evaluation system of clinical evidence of TCM has a certain degree of recognition among practitioners and shows a high willingness to use it.However,the actual use experience is not ideal,there are many problems and obstacles,and also expect to have a more consistent with the clinical characteristics of traditional Chinese medicine evidence evaluation system.After two rounds of modified Delphi expert surveys and consensus meeting discussion,to formed the "Evidence evaluation tool for TCM clinical randomized controlled trials based on GRADE system",and it revised the adaptability and simplification of traditional Chinese medicine to GRADE system.In the high-quality evidence sources,N-of-1 randomized controlled trial which can reflect the characteristics of TCM treatment were added.The evaluation process of evidence overall research quality is simplified.The adaptation of TCM was revised to reduce the grade(research limit,heterogeneity and indirectness)and upgrade factors.