Developing A Clinical Evidence Grading System Of Chinese Medicine Interventions Based On The GRADE System

ObjectiveThe purpose of this research was to develop a clinical evidence grading system of Chinese medicine(CM)interventions based on the GRADE system and taken into considerations of the unique characteristics of CM practice.Using the literature published on chronic obstructive pulmonary disease(COPD)as an example,the CM clinical evidence including famous doctors’experience,modern clinical studies and classical literature evidence were evaluated to validate the applicability of this new grading system.In addition,a clinical survey was conducted to explore the feasibility of this system.The system was revised and validated based on these feedbacks during the procedure of the evaluation.MethodsThe scope and theoretical framework of the clinical evidence grading system of Chinese medicine(CM)interventions was developed according to the rules of GRADE system and Evidence-based medicine.Delphi survey was conducted to get consensus for the scope and details of new grading system.Both the grading system for the evidence of classical literature evidence and famous doctors’ experience were discussed and revised during the survey.In addition,they will be integrated with GRADE system to form the clinical evidence grading system of Chinese medicine(CM)interventions based on the survey.We systematically assessed the evidence of the commonly used Chinese herb formula for the treatment of COPD involving clinical trial,classical literature and famous doctors’ experience.The applicability was performed for the grading system during the evidence assessment.We collected modern clinical studies and evaluated them according to the Cochrane review methods.Chinese and English database were retrieved involving PubMed,Embase,CENTRAL,CBM,CNKI and Wanfang.Data were synthesized by Meta-analysis.We used the GRADE approach to assess the certainty of evidence.The classical literature was collected in the fifth edition Zhong Hua Yi Dian.Data were screened by the diagnostic similarity evaluation method.The relevant evidence was evaluated by the grading system of classical literature developed in this study.The evidence of famous doctors’ experience was searched by Gu Jin Yi An Yun Ping Tai and National Service Platform for Academic Experience of Famous Traditional Chinese Medicine Doctor.Also,the relevant evidence was evaluated by the grading system of famous doctors’experience developed in this study.We summarized the evidence of modern clinical studies,classical literature and famous doctors’ experience of Chinese herb formula for the treatment of COPD.The questionnaire was developed based on the results of evaluation and the construction procedure of clinical evidence grading system.The clinical understanding and applicability evaluation was completed through the feedback of clinicians’ survey.ResultsTwo rounds of Delphi surveys were conducted involving 25 experts across the country.The evaluation fields of the grading system of classical literature include the source of classical literature records,the comprehensiveness of the treatment details and the inheritance.The score was assigned based on the weight of fields and items.The total score of grading system for classical literature is 7 points.Three levels of evidence with high,moderate and low were evaluated according to the different score.The fields of the evidence grading system of famous doctors’ experience include the qualification of expert,the comprehensiveness of the treatment details and the inheritance of experience.Masters of traditional Chinese medicine and national level doctors were only included to evaluate the field of qualification.The score was also assigned based on the weight of fields and items.The total score of famous doctors’ experience is 6 points.Three levels of evidence with high,moderate and low were also evaluated as the evidence of classical literature.The first step of the clinical evidence grading system of CM interventions is evaluating the modern clinical studies,followed by the evidence of classical literature and famous doctors’experience.The level of evidence was evaluated as high,moderate,low and very low followed by GRADE system approach.The evidence of classical literature and famous doctors’experience would not be provided if the level of evidence is high or moderate for GRADE system.In addition,the classical literature and famous doctors’experience would be provided as supplementary evidence when the level of evidence is low or very low for GRADE system.The level of clinical evidence grading system of CM interventions was not changed even if the high quality was evaluated for the evidence of classical literature or famous doctors’experience.The response rate of questionnaire is 100%in the Delphi survey.The authority coefficient of the experts is greater than 0.8,indicating the research were with good authority.After two rounds of survey,more than 85%of experts agreed with the content and principles of the evidence grading system,indicating the good consistency.For the applicability evaluation of clinical evidence grading system of CM interventions,a total of 24015 modern clinical studies were retrieved for CM for the treatment of COPD.Nineteen Chinese herb formulas were confirmed to evaluate for stable and acute exacerbation COPD according to the monograph and clinical practice guideline.114 studies were finally included in the analysis.There was not clinical research evidence for Renshenhutao decoction,Sanziyangqin decoction and Zhenwu decoction according the inclusion and exclusion criteria.For the evidence of stable COPD,Bufei decoction,Liujunzi decoction,Yupingfeng powder,Buzhongyiqi decoction,Bailing capsule and Jinshuibao capsule could improve lung function,effective rate and other clinical outcomes respectively.For the evidence of acute exacerbation of COPD,Xiaoqinglong decoction,Dingchuan decoction,Suzijiangqi decoction,Erchen decoction,Sangbaipi decoction,Maxingshigan decoction,Qingqihuatan decoction,Ditan decoction,Weijing decoction,Erchen decoction combined with Sanziyangqin decoction could improve lung function and arterial blood gases.The certainty of evidence was assessed by GRADE approach for modern clinical studies.The evidence of Bufei decoction,Yupingfeng powder were evaluated as moderate quality for stable COPD when comparing with placebo.Other Chinese herb formulas were low or very low quality for the treatment of COPD.For the evidence of classical literature,a total of 10246 citations were retrieved by Zhong Hua Yi Dian.Seventeen Chinese herb formulas hit 3823 citations expect for the two modern pharmaceutical preparations of Bailing capsule and Jinshuibao Capsule.Taking 12 commonly used formulas as examples,16 relevant records were included according to the inclusion and exclusion criteria.Yupingfeng powder,Dingchuan decoction,Sanziyangqin decoction,Weijing decoction and Xiaoqinglong decoction were evaluated as moderate level according to the evidence grading system of classical literature.There was not relevant intervention evidence for six formulas involving Bufei decoction,Suzijiangqi decoction,Renshenhutao decoction,Sangbaipi decoction,Qingqihuatan decoction and Ditan decoction.For the evidence of famous doctors’ experience,110 records for the treatment of COPD were retrieved in Gu Jin Yi An Yun Ping Tai and National Service Platform for Academic Experience of Famous Traditional Chinese Medicine Doctor based on 12 formulas.Except for Renshenhutao decoction,there were medical records for other formulas.The high level evidence was evaluated for Xiaoqinglong decoction,Dingchuan decoction,Suzijiangqi decoction,Maxingshigan decoction,Sanziyangqin decoction and Weijing decoction.The evidence of Yupingfeng powder,Bufei decoction,Sangbaipi decoction,Ditan decoction were assessed as moderate level,followed the low level for Qingqihuatan decoction.The evidence of modern clinical studies,classical literature and famous doctors’experience were integrated together.Most of herb formulas were evaluated as low or very low quality,except the moderate quality for Bufeitang decoction and Yupingfeng powder.Xiaoqinglong decoction,Dingchuan decoction,Maxingshigan decoction,Sanziyangqin decoction and Weijing decoction were showed higher quality both in the evidence of classical literature and famous doctors’ experience,indicating these may be the preferred treatments for clinical practice and future clinical research.Twelve clinicians were investigated to evaluate the process of the grading system development and the results of evidence assessment for COPD.The results showed that it is understandable and feasible in clinical practice for the methods of grading system.The evidence evaluated by the grading system may be a good guidance for clinical practice and further research.Also,the feedback showed that more practice is needed to improve the operability and consistency during the evaluation.ConclusionThe clinical evidence grading system of CM interventions based on Delphi methods mainly focus on the evidence of modern clinical studies,classical literature and famous doctors’ experience.Three fields were confirmed for the grading system of classical literature,including the source of classical literature records,the comprehensiveness of the treatment details and the inheritance.The qualification of expert,the comprehensiveness of the treatment details and the inheritance of experience were included for the evidence grading system of famous doctors’ experience.The level of grading system of CM interventions followed by GRADE approach.The evidence of classical literature and famous doctors’ experience will be provided to support the CM clinical practice when the low or very low level evidence were showed in clinical studies by GRADE approach.Most of Chinese herb formulas were low or very low level evidence for the treatment of COPD.Yupingfeng powder,Bufei decoction,Xiaoqinglong decoction,Dingchuan decoction,Maxingshigan decoction,Sanziyangqin decoction and Weijing decoction were showed potential advantages during the evidence assessment of classical literature and famous doctors’ experience.The applicability assessment showed that it is understandable and feasible in clinical practice for the grading system.Further research is still needed in terms of the consistency of evaluation for the grading system.