Development Of The Core Outcome Set Of Clinical Research On Treatment Of Chinese Medicine For Hyperlipidemia

ObjectiveReferring to methods of the core outcome set completed at home and abroad,the core outcome set of Chinese medicine(CM)treatment for hyperlipidemia was developed by Delphi method and expert consensus meeting,which provided data basis for the selection of outcomes of CM treatment for hyperlipidemia,and provided reference for the selection of appropriate outcomes for clinical evaluation of CM.MethodsThrough systematic literature review,this topic collects the outcome variables related to treatment of Chinese medicine for hyperlipidemia at home and abroad,and further collates the pool of alternative outcomes.According to the internationally recognized Delphi method,after three successive rounds of progressive surveys,preliminary consensus is reached on the importance of each candidate outcomes,through an expert group(study advisory group,SAG)composed of core stakeholders.Face-to-face meetings were held to discuss and finalize the core outcome set of CM treatment for hyperlipidemia,providing reference for the selection ofoutcomes of CM treatment for hyperlipidemia,and filling in the blank of this research,so as to promote the development of more high-quality CM intervention clinical research.Due to the limited research time in the postgraduate stage,this dissertation only completed the first round of the Delphi survey.ResultsBy systematically reviewing the outcomes of CM treatment for hyperlipidemia at home and abroad,3547 citations of literature were screened,including 3461 in Chinese and 86 in English.After sorting out and summarizing 437 outcome indicators,through deleting and merging the same types of outcome indicators,the final study advisory group(SAG)consulting group questionnaire is divided into eight categories,including 355 outcome indicators.According to the scoring of each outcome indicator by the SAG group,after discussion by SAG group,we finally supplement the outcome indicators that the SAG group considers important and should include,and the outcome indicators of hyperlipidemia in the ClinicalTrails.gov registry database and the China Clinical Trial Registry in recent three years.Finally,71 outcome indicators were included in the Delphi survey,which can be divided into eight categories.The results of the first round of Delphi survey showed that 70 stakeholders participated in the survey,71 outcome indicators scored more than or equal to 4 points,all of which will be included in the second round of Delphi survey,and some experts suggested supplementing two outcome indicators.ConclusionThe results of systematic evaluation of the outcomes of CM treatment of hyperlipidemia showed that the types of outcomes were various and the scope of the types involved was wider.There was no standardized and unified standard for naming the outcomes indicators.Building the integration of the core outcomes of CM treatment of hyperlipidemia is an urgent problem to be solved in promoting clinical research of CM.After deleting the name of the merged indicators,the final outcome indicators included in the Delphi survey were sorted out.We should supplement and improve the remaining studies so as to obtain the final core outcomes of CM treatment of hyperlipidemia,and provide reference for clinical research.The results of Delphi survey indicate that there are some shortcomings in this study:(1)different stakeholders may have certain selection bias because of their different educational background and interest focus;(2)there is no uniform criterion for the number of people involved in each stakeholder group,which may affect the scoring results of each outcome index.