Construction Of A Core Index Set For Clinical Research On Chinese Medicine In The Treatment Of Children With Community-acquired Pneumonia

Purpose : Construction of the core index set of traditional Chinese medicine in the treatment of children with community-acquired pneumonia(CAP);Objective to provide reference for the selection of outcome indicators in clinical research of traditional Chinese medicine in the treatment of children with community-acquired pneumonia;It also provides a reference for the construction of core index set in the field of traditional Chinese medicine.Material and method:Through systematic literature analysis,this study collected the outcome indicators related to the treatment of children’s community-acquired pneumonia with traditional Chinese Medicine published at home and abroad in recent five years,and distributed blank questionnaires to doctors and patients to collect the outcome indicators related to cap concerned by relevant interest groups.By sorting out the literature and blank questionnaire,the pool of alternative outcome indicators was obtained.According to the internationally recognized Delphi method,two consecutive rounds of advanced surveys were conducted to obtain a preliminary consensus on the importance of alternative outcome indicators.Next,an expert group composed of core stakeholders held a face-to-face expert consensus meeting.After expert discussion,the core index set of cap in children treated by traditional Chinese medicine was finally determined.Results:1.Through the systematic analysis of the outcome indicators of Chinese medicine treatment of cap in recent five years at home and abroad,135 literatures were selected,and 145 outcome indicators were obtained.2.44 indicators were obtained by doctor blank questionnaire and patient blank questionnaire,and 157 indicators were obtained by literature analysis and blank questionnaire.The indicators were divided into 9 domains: symptoms / signs,TCM related indicators,physical and chemical indicators,quality of life,total efficacy indicators,long-term prognosis,safety events,health economics evaluation,treatment satisfaction,and all of them were included in the first round of Delphi questionnaire.3.Experts participated in the first round of Delphi survey,and through the analysis of the average,1-3 and 7-9 score distribution and coefficient of variation(CV)of each outcome index,85 outcome indexes were finally included in the second round of Delphi survey.According to the suggestions of experts,and according to the discussion of the research group,five outcome indicators were added,and the occurrence of gastrointestinal reactions and cross infection were classified as the occurrence of adverse reactions.Finally,89 outcome indicators were included in the second round of Delphi questionnaire,and the first draft of the second round of Delphi questionnaire was formed.Conclusion:1.In this study,through a systematic review of the literature on the outcome indicators of cap clinical research in children treated with traditional Chinese medicine,we found that the range of outcome indicators is relatively wide and there are many kinds.Therefore,the construction of a standardized and unified core index set is an urgent problem to be solved in the clinical research of traditional Chinese medicine.2.The results of Delphi survey show that there are some shortcomings in this study: different stakeholders may have certain selection bias because of their different interests,educational background and region.