A Study On Core Outcome Set Of Traditional Chinese Medicine For Treatment Of Chronic Obstructive Pulmonary Disease(COPD-COS-TCM)

Objective:According to the core outcome measures in effectiveness trials(comet)working group’s core indicator set report and development specification,aiming at the existing problems of many and complex efficacy evaluation indicators of traditional Chinese medicine in the treatment of COPD,large index differences,unreasonable and nonstandard,lack of practicability and so on,According to the different stages of COPD(acute exacerbation stage and stable stage)and the advantages of traditional Chinese medicine in the treatment of different stages of the disease,carry out the research on the core outcome index set of COPD,form the core index set of traditional Chinese medicine in the treatment of COPD on the basis of clinical stages,standardize the clinical efficacy evaluation index of traditional Chinese medicine in the treatment of COPD,and provide a reference for evaluating the efficacy of traditional Chinese medicine in the treatment of chronic obstructive pulmonary disease and how to select the outcome index.Methods:Part I: Construction of TCM outcome index item pool for chronic obstructive pulmonary diseaseConstruction of COPD outcome index item pool and computer retrieval of CNKI,VIP,Wan Fang Data,Sino Med,Pub Med,Embase,Cochrane Library and Web of Science,To search the clinical randomized controlled trial of traditional Chinese medicine intervention in the treatment of chronic obstructive pulmonary disease,And search the Chinese Clinical Trial Registry,Chi CTR and the U.S.clinical trials.gov,There are different emphases on the outcome indicators of different stages,The acute exacerbation stage and stable stage of COPD will be analyzed and sorted out separately.The outcome indicators paid attention to by doctors and patients were obtained through questionnaire,and the entry pool of COPD outcome indicators was formed through integration and standardization.Part 2: Formation of core outcome set for clinical research of traditional Chinese medicine in chronic obstructive pulmonary diseaseThe electronic questionnaire is made according to the integrated standardized index item pool,and two rounds of Delphi surveys are conducted.The electronic questionnaire is sent to experts through face-to-face,e-mail or network platform,and relevant experts are invited to score the indicators.The working group sorts the indicators by "importance",and retains the indicators of importance "≥70%"(i.e.the percentage of ≥4 points),and then selects the indicators suggested by experts to form the second round of Delphi questionnaire,Then invite relevant experts to score.According to the scoring results,the working group will sort the indicators "key" and select the indicators to enter the expert consensus meeting.Finally,an expert consensus meeting will be held.Experts will score and fully discuss each indicator at the meeting,and finally form the core indicator set of Chinese medicine for the treatment of chronic obstructive pulmonary disease.Result:993 RCTs were obtained through database retrieval,including 536 articles in acute exacerbation stage and 457 articles in stable stage.The databases of Chinese clinical trial registry(Chi CTR)and American clinical trials registry(clinical trials.Gov)were searched,and a total of 16 clinical registration studies were obtained.59 respiratory clinicians and 20 COPD patients were invited to provide important outcome indicators.After sorting,an initial index item list was formed,including 88 indicators,including 40 indicators in acute exacerbation period and 48 indicators in stable period.The indicators in the initial index item list were included in the first round of Delphi survey.The Delphi survey invited clinicians(doctors of traditional Chinese medicine,doctors of Western medicine and doctors of integrated traditional Chinese and Western Medicine),methodological experts,journal editors,administrators and representatives of pharmaceutical enterprises to score the outcome indicators of COPD,Through expert scoring and open-ended questions,experts suggest increasing the number of outpatient visits in the stable period,finally,29 outcome indicators of acute exacerbation period and 35 outcome indicators of stable period entered the second round of Delphi survey and passed the expert scoring again,Finally,19 acute exacerbations and 28 stable periods were determined,and a total of 47 indicators entered the final consensus meeting.The indicators finally reached at the consensus meeting include TCM disease and syndrome,physical and chemical examination,symptoms and signs,long-term prognosis,economic indicators and safety indicators.Six indexes of acute exacerbation were achieved,including dyspnea,inflammatory index,pulmonary ventilation function,blood gas analysis,TCM syndrome score and duration of acute attack.At the same time,the sub index of inflammatory index: tumor necrosis factor(TNF)was recommended-α,C-reactive protein(CRP),Lung Qi function sub indexes: FEV1 / FVC,FEV1%,blood gas analysis sub indexes:PO2,p CO2,Dyspnea sub index: MMRC score;Five stable period indicators were achieved,which were TCM syndrome score,quality of life,number of acute attacks,cost-effectiveness ratio(C/E)and adverse reactions.At the same time,the sub indicators of quality of life are recommended: BODE index(body weight,BMI,FEV1%,MMRC score,6-minute walking distance).Conclusion:After this study,the outcome indicators of traditional Chinese medicine in the treatment of chronic obstructive pulmonary disease were systematically evaluated.It was found that there were some problems to be solved,such as non-standard,non-uniform and complex types of outcome indicators.After systematic literature review,the questionnaire of clinicians and patients formed the initial index item list.After two rounds of Delphi survey and an expert consensus meeting,Finally,the core index set of traditional Chinese medicine in the treatment of chronic obstructive pulmonary disease based on clinical stages is formed,in which there are 6 acute weighting periods,which are dyspnea,inflammatory index,pulmonary ventilation function,blood gas analysis,TCM syndrome score and acute attack duration;There are five stable periods,which are TCM syndrome score,quality of life,number of acute attacks,cost-effectiveness ratio(C / E)and adverse reactions.The indicators reached a consensus well reflect the general criteria of COPD evaluation and the characteristics of TCM Intervention,effectively improve the quality of COPD clinical research and reduce unnecessary research waste.