中医药指南制订中共识法应用关键要素的定性研究  

Exploring the Essential Factors of Applying the Consensus Methods in the Development of Traditional Chinese Medicine Guidelines:A Qualitative Interview

作　　者：梁昌昊 尹丁冉 刘美君 尹冠翔 李迅[1,2,3] 王雅琪 刘思岐 佟敏 刘鹏伟 苏祥飞 费宇彤 LIANG Changhao;YIN Dingran;LIU Meijun;YIN Guanxiang;LI Xun;WANG Yaqi;LIU Siqi;TONG Min;LIU Pengwei;SU Xiangfei;FEI Yutong(Center for Evidence-based Medicine,Beijing University of Traditional Chinese Medicine,Beijing 100029,China;School of Traditional Chinese Medicine,Beijing University of Traditional Chinese Medicine,Beijing 100029,China;Beijing GRADE Center,Beijing 100029,China;Xinjiang Uygur Autonomous Region Academy of Traditional Chinese Medicine,Urumqi 830001,China;China Association of Chinese Medicine,Beijing 100000,China)

机构地区：[1]北京中医药大学循证医学中心,北京100029 [2]北京中医药大学中医学院,北京100029 [3]北京GRADE中心,北京100029 [4]新疆维吾尔自治区中医药研究院,乌鲁木齐830001 [5]中华中医药学会,北京100000

出　　处：《协和医学杂志》2024年第4期942-952,共11页Medical Journal of Peking Union Medical College Hospital

基　　金：新疆维吾尔自治区重点研发计划(2022B03011-4);中华中医药学会研究与评价专项课题(CACMRE2021-A-04)。

摘　　要：目的探索共识法在中医药指南制订中的关键要素,为改善共识的规范性和客观性提供方法学建议,为未来指南制订中规范应用共识法提供新思路。方法采用半结构化定性访谈法,对指南牵头人、工作组及共识组进行访谈,探讨共识可信度的影响因素,以及对共识主体构成和共识过程的看法。结果共访谈了26名专家,对访谈内容进行归纳和整理,形成212条编码,深化为5个领域,分别为组建共识组、患者参与、会议主持人、共识准备及共识影响因素;概括了组建共识组的3个基本步骤,以及共识法应用的17个基本考虑。结论在指南制订过程中,建议增加共识前的方法学培训,方法学家应全程参与,鼓励专家合理看待分歧,重视指南制订方法及证据资料,公开共识组遴选过程、增加患者参与、管理和报告利益冲突,以减少偏倚,提高共识的透明性、可靠性和科学性。Objective This study delves into the pivotal factors influencing the consensus process within traditional Chinese medicine guideline development,with the objective of augmenting the quality of this process through methodological recommendations aimed at elevating standardization.Methods Semi-structured qualitative interviews were used to interview guideline leaders,working groups and consensus groups to explore the pertinent elements impacting the credibility of consensus and gather insights into the constitution and pro-gression of the consensus methodology.Results The study encompassed interviews with 26 participants,yield-ing 212 codes that were subsequently categorized into five domains:establishment of the consensus group,inte-gration of patient participation,adeptness of the meeting moderator,preparation for consensus formulation,and overarching factors influencing consensus.The research distilled three fundamental phases for forming a consen-sus group and delineated 17 fundamental tenets for applying the consensus methodology.Conclusions In forth-coming guideline development endeavors,it is advisable to bolster methodological training ahead of the consen-sus process while ensuring comprehensive engagement of methodologists.Encouraging experts to navigate differ-ences judiciously and prioritizing meticulous methodology and evidentiary groundwork are recommended.The process should involve openly disclosing the selection of consensus group members,heightening the involvement of patients,and effective management and disclosure of conflicts of interest.This collective approach helps cur-tail bias,enhance transparency,bolster reliability,and fortify the scientific rigor of consensus outcomes.

关 键 词：共识法 定性访谈 指南制订 临床实践指南 方法学 

分 类 号：R181.2[医药卫生—流行病学] R197.4[医药卫生—公共卫生与预防医学]