应用专家共识法制定中医药领域病例-对照研究技术规范的研究  

Study on developing methodological guideline for case-control study in Chinese medicine based on Delphi method

作　　者：刘澳林 欧阳文伟 温泽淮 周莉[2] LIU Aolin;OUYANG Wenwei;WEN Zehuai;ZHOU Li(Second Clinical College of Guangzhou University of Chinese Medicine,Guangzhou 510405,P.R.China;Key Unit of Methodology in Clinical Research,Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510120,P.R.China;Science and Technology Innovation Center of Guangzhou University of Chinese Medicine,Guangzhou 510405,P.R.China)

机构地区：[1]广州中医药大学第二临床医学院,广州510405 [2]广州中医药大学第二附属医院临床研究方法学重点研究室,广州510120 [3]广州中医药大学科创中心,广州510405

出　　处：《中国循证医学杂志》2024年第8期951-958,共8页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金项目(编号:81703938);广东省科学技术厅-广东省中医药科学院联合科研专项资金(编号:2011B032200011);广东省中医院院内专项基金(编号:YN2019QL14)。

摘　　要：目的通过专家共识方法形成中医药领域病例-对照研究技术规范的基本条目,以便制定该技术规范详细文本。方法参考国际认可的方法学指南或技术规范的制定流程,采用Delphi法,以问卷形式对全国范围内44位专家进行三轮专家咨询调查。结果三轮问卷回收率分别为73.3%、86.4%和86.8%;专家权威系数分别为0.82、0.85和0.86;专家意见协调系数分别为0.356、0.349和0.422。专家的积极性、权威性、意见集中性和协调程度均较高。关于如何测量中医证候、体质、时点以及选择新发病例方面是专家共识意见较多的条目。结论中医药领域的病例-对照研究应注意涉及到中医特色方面。初步形成的技术规范草稿涉及研究设计和报告阶段,将有助于此类研究的方法学和报告质量的提高。Objective The basic terms of the technical specifications for case-control studies in the field of traditional Chinese medicine(TCM)are formed by expert consensus methods,in order to develop detailed texts of the technical specifications.Methods According to the process of international guidelines,a total of 44 experts participated in the Delphi survey.Results The three rounds of questionnaire response rates were 73.3%,86.4%,and 86.8%,respectively.The experts'authority coefficients were 0.82,0.85,and 0.86,respectively;and the expert opinion coordination coefficients were 0.356,0.349,and 0.422,respectively.Expert enthusiasm,authority,opinion centralization,and degree of coordination were relatively high.There were many opinions raised in the expert consensuses on how to measure TCM syndrome,TCM constitution,the time point of measurement and the selection of new cases.Conclusion The casecontrol studies in TCM field should pay more attention to the characteristics of TCM.The draft of technical specification involves the study design and reporting,which can improve the methodological and reporting quality of case-control studies.

关 键 词：中医药 病例-对照研究 技术规范 德尔菲法 

分 类 号：R2-03[医药卫生—中医学]