构建慢性腰背痛中医临床研究核心结局指标集的思考  

Consideration on constructing core outcome indicators set of TCM clinical research on chronic back pain

作　　者：孙亚男[1] 翁志文[2] 刘长信[2] 杜渐[3] 刘雅莉 邱瑞瑾[5] 卿伦学 杨金 万颖 于长禾[2] SUN Ya-nan;WENG Zhi-wen;LIU Chang-xin;DU Jian;LIU Ya-li;QIU Rui-jin;QING Lun-xue;YANG Jin;WAN Ying;YU Chang-he(Traditional Chinese Medicine Department.Xuanwu Hospital,Capital Medical University,Beijing 100053,China;Tuina and Pain Management Department,Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Beijing 100700,China;The 1st Orthopedics Department.Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Beijing 100700,China;National Children's Center,Clinical Epidemiology and Evidence-based Medicine Center of Beijing Children's Hospital Affiliated to Capital Medical University,Beijing 100045,China;Ministry of internal Medicine Education of Tniditional Chinese Medicine and Beijing Key Laboraiory,Dongzhimen Hospiial Affilialed(o Beijing University of Chinese Medicine,Beijing 100700,China;Dongzhimen Hospital Affiliated to Beijing University of Chinese Mcdiciiie,Beijing 100700,Chinn)

机构地区：[1]北京首都医科大学宣武医院中医科,北京100053 [2]北京中医药大学东直门医院推拿疼痛科,北京100700 [3]北京中医药大学东直门医院骨伤一科,北京100700 [4]国家儿童医学中心,首都医科大学附属北京儿童医院临床流行病学与循证医学中心,北京100045 [5]北京中医药大学东直门医院中医内科学教育部和北京市重点实验室,北京100700 [6]北京中医药大学第一临床医学院,北京100700

出　　处：《中华中医药杂志》2019年第11期5275-5279,共5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)~~

摘　　要：慢性腰背痛(CBP)临床研究中存在报告指标、测量工具、判效标准不一致问题,导致研究结果不能纳入系统评价或Meta分析,无法提供高级别的证据。国外建立CBP核心结局指标集(COS-CBP)来解决此问题,但由于西医COS不能反映中医临床研究特点、国外COS-CBP结果不一致、推荐工具缺少我国的测量学性能评价等问题,导致国外成果不适合中医临床研究,而且我国尚未构建适合中医临床研究的COS-CBP。因此,基于前期中医药COS构建方法与实例研究,构建中医临床研究COS-CBP及核心指标测量工具集(CMS-CBP),以适应CBP中医临床研究。基于文献、专家推荐等建立CBP中医临床研究的结局指标及测量工具清单,通过2~3轮德尔菲调查问卷与专家共识会议构建COS-CBP及CMS-CBP,进而通过临床实践对其进行检验、优化,并探索构建中医药COS的方法学流程,提高国内临床研究质量,提供科学临床决策。There are inconsistencies in reporting indicators, measuring tools and criteria in clinical studies of chronic back pain(CBP). As a result, the research results can not be included in systematic evaluation or Meta-analysis, and can not provide high-level evidence. To solve this problem, a set of CBP core outcome indicators has been set up in foreign countries. However, because COS of western medicine can not reflect the characteristics of TCM clinical research, the results of COSCBP abroad are inconsistent, and the recommendation tools are lack of measurement performance evaluation in China, the results of foreign countries are not suitable for TCM clinical research, and China has not yet constructed a suitable TCM clinical research COS-CBP. Therefore, based on the previous COS construction methods and case studies of TCM, the COS-CBP and the core index measurement tool set for TCM clinical research are constructed to adapt to the TCM clinical research of CBP. Based on the literature and expert recommendation, a list of outcome indicators and measurement tools for CBP clinical research was established. COS-CBP and CMS-CBP were constructed through 2-3 rounds of Delphi questionnaires and expert consensus meetings, and then tested and optimized through clinical practice. Meanwhile, the methodological process of constructing TCM COS was explored to improve domestic clinical research. To study quality and provide scientific clinical decision-making.

关 键 词：核心结局 核心指标 测量工具 疗效评价 方法学 

分 类 号：G63[文化科学—教育学]