Construction Of The Core Index Set Of Clinical Research On Chinese Medicine For Treating Influenza In Children

Purpose:Referring to the existing technical specifications of the core index set,the core index set of traditional Chinese medicine in the treatment of children’s influenza is constructed,which can provide reference for the selection of clinical research outcome indicators of traditional Chinese medicine in the treatment of children’s influenza,and provide reference for the construction of core index set in the field of traditional Chinese medicine.Material and method: Through literature analysis,this study collected domestic and foreign outcome indicators related to the treatment of children with influenza by traditional Chinese medicine.The research team initially sorted out and formed an item pool of alternative outcome indicators.After determining the relevant interest groups,a blank questionnaire was issued to further sort out and form an item pool of final outcome indicators.According to the internationally recognized Delphi method,after two consecutive rounds of Delphi survey,the importance of each alternative outcome indicator was evaluated.Finally,the expert group held a face-to-face round table meeting to discuss and finally determine the core indicator set of traditional Chinese medicine in the treatment of children’s influenza,so as to provide reference for the selection of outcome indicators of traditional Chinese medicine in the treatment of children’s influenza,and promote the high quality of traditional Chinese Medicine intervention research.Results:1.The clinical research on the treatment of children influenza by traditional Chinese medicine at home and abroad was systematically analyzed.97 articles were selected to summarize the outcome indicators,and 91 outcome indicators were finally obtained.2.The results of blank questionnaire were selected and sorted out,and 109 indexes were finally included in Delphi questionnaire.According to the functional attributes of the indicators,109 indexes were divided into 9 categories: symptom and signs,TCM syndromes,physical and chemical examination,quality of life,total efficacy indicators,safety events and health economic evaluation,long-term prognosis and satisfaction indicators.3.According to the distribution and coefficient of variation(CV)analysis of the average score,1-3 score and 7-9 score of all the indicators involved in the first round of Delphi survey,the average score of 39 outcome indicators was 7 or above,the score of 50% or more members was 7-9,and the score of less than 15% members was 1-3.There were 68 indicators,and the coefficient of variation ≥ 30% had 19 indicators.Finally,63 indicators meeting the standard were included to form the second round of Delphi questionnaire.Conclusion:1.Through the systematic evaluation of the outcome indicators of clinical research on children influenza treated by traditional Chinese medicine,it is found that there are many kinds of indicators and a wide range of involved.It is an urgent problem to construct a standardized and unified core index set.2.The establishment of standardized,recognized and unified core index set can greatly improve the scientificity,rationality and feasibility of TCM clinical research scheme,effectively improve the quality of TCM clinical research,increase the recognition of research results,improve the level of TCM clinical research.