摘要
核心结局指标集(COS)研制过程中,由于默认COS对结局指标的选择受到干预措施的影响,出现了"在特定健康状态下,根据干预措施的不同而制定不同COS的情况"。针对建立具有中医药特色的结局指标的观点,本课题组认为:结局指标的本质是反映受试者的健康状态或状态变化,特定人群中评价结局指标测量工具优劣的指标是信度、效度,结局指标的差异是中国与国外文化差异,而不是中医与西医的差别,因此结局指标的选择应该根据患者需求设立而不是干预措施。针对建立具有中医药COS的观点,本课题组认为:COS的概念中体现"核心""所有临床研究""最小集合"等关键词,要求不同干预下建立相同的COS,以方便横向比较;COS提出"特定健康状态"说明了特定患者群体认为重要或者期望的结局是核心结局,而且COS制定时要求限制干预制造商的参与比例以避免COS研究中的利益冲突和偏倚。据此,否定了建立中医药COS的假设。经过分析结局指标的分类后,课题组提出建立与患者特定健康状态相关的核心结局指标集(Pa-COS)和与干预措施相关的特色结局指标集(In-SOS)的新体系,以解决当前核心结局指标集研究的困境,并为COS的发展寻找新途径,建立新方法学体系。
During the development of the core outcome sets(COS),due to the influence of the default COS selection of outcomes by the intervention,there was a situation in which‘different COS was developed depending on the intervention in a specific condition’.In view of the idea of establishing the COS with the characteristics of Chinese medicine,the project team indicates that:the essence of the outcomes is to reflect the health condition or its change of the subject,the index of evaluating the measurement instruments of the outcomes in a particular population is the internal consistency,content validity and criterion validity.And the difference of the outcomes consists in Chinese and foreign cultural adaption,not the difference between Chinese medicine and Western medicine.The choice of outcomes should therefore be based on patients’demands rather than interventions.In view of the idea of establishing COS of Chinese medicine,the project team holds that:the concept of COS embodies the‘core’,‘all clinical studies’,‘minimum set’and other keywords,which requires different interventions to establish the same COS to facilitate horizontal comparison,explains that the core outcomes are what certain patient population considered important or desired to be.COS is developed to limit the participation of intervention manufacturers to a lower percentage of participation to avoid conflicts of interest and bias in COS research.According to this,the hypothesis of establishing COS in Chinese medicine is rejected.After analyzing the classification of outcomes,the project team proposed the establishment of a new system which consists of core outcome sets related to participants(participant-related COS,pa-COS)and specific outcome sets related to interventions(intervention-related specific outcome sets,In-SOS)to solve the current dilemma in COS studies,and to find new ways to promote the development of COS as well as establish a new system of methodology.
作者
万颖
刘长信
周彦吉
张英
孙亚男
于长禾
WAN Ying;LIU Chang-xin;ZHOU Yan-ji;ZHANG Ying;SUN Ya-nan;YU Chang-he(Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700.China;Traditional Chinese Medicine Department,Xuanwu Hospital,Capital Medical University,Beijing 100053,China)
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2021年第4期2276-2281,共6页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
国家自然科学基金青年科学基金项目(No.81803956)。
关键词
核心
特色
结局
干预
方法学
中医药
核心结局指标集
Core
Characteristic
Outcome
Intervention
Methodology
Traditional Chinese medicine
Core outcome sets(COS)
