| 构建桡骨远端骨折中医临床研究核心结局指标集的探索与思考 |
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Received:June 18, 2023
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| 作者 | Author | 单位 | Unit | E-Mail |
| 张桐桐 |
ZHANG Tong-tong |
北京中医药大学东直门医院推拿疼痛科, 北京 100700 |
Department of Tuina and Pain Management, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100700, China |
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| 李多多 |
LI Duo-duo |
北京中医药大学东直门医院推拿疼痛科, 北京 100700 |
Department of Tuina and Pain Management, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100700, China |
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| 蒋科卫 |
JIANG Ke-wei |
中国中医科学院望京医院关节二科, 北京 100102 |
The Second Joint Department, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing 100102, China |
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| 王朝鲁 |
WANG Chao-lu |
中国中医科学院望京医院骨伤综合科, 北京 100102 |
Orthopaedics Trauma Department, Wangjing Hospital of China Academy of Chinese Medical sciences, Beijing 100102, China |
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| 成永忠 |
CHENG Yong-zhong |
中国中医科学院望京医院创伤一科, 北京 100102 |
The First Trauma Department, Wangjing Hospital of China Academy of Chinese Medical sciences, Beijing 100102, China |
bless518@139.com |
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| 期刊信息：《中国骨伤》2023年36卷，第9期，第901-904页 |
| DOI：10.12200/j.issn.1003-0034.2023.09.020 |
| 基金项目:中国中医科学院科技创新工程(编号:CI2021A02008);北京中医药薪火传承“3+3”工程刘寿山名家研究室(编号:2022-SZ-A-50) |
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| 桡骨远端骨折(distal radius fractures,DRF)相关研究中存在结局指标与测量工具不统一、疗效评定标准不一致等问题,导致研究存在偏倚风险,临床上无法提供高质量的证据。为了解决这些问题,国外研究者达成共识,构建桡骨远端骨折核心结局指标集(core outcome sets of DRF,COS-DRF)。考虑到国外现有COS-DRF不能体现中医诊疗的特点,我国目前缺乏关于DRF临床研究相关结局指标及测量工具的标准,并未建立中医临床研究的COS-DRF。因此,在目前国内已有COS研究的基础上,通过查阅文献、专家共识等提出DRF临床研究的结局指标和测量工具清单,在桡骨远端骨折的中医临床研究中,将开展核心结局指标集的构建,并通过临床实践优化更新。COS-DRF或桡骨远端骨折核心指标测量工具集(CMS-DRF)将会经过2~3轮专家共识或德尔菲法的构建,总结出适合中医临床研究、为临床提供优质证据的方法学过程。 |
| [关键词]:核心结局指标 中医 疗效评价 临床研究 桡骨远端骨折 |
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| Exploration and consideration on establishing a core outcome set of Traditional Chinese Medicine clinical trials in distal radius fracture |
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| Abstract:There are inconsistencies in treatment outcomes,measurement instruments,and criteria for assessing clinical effectiveness in studies related to distal radius fractures (DRF),resulting in potential biases and failing to provide high-quality clinical evidence. To address these challenges,international researchers have reached a consensus on developing the core outcome indicator set for distal radius fractures(COS-DRF). However,it's important to note that the existing COS-DRF framework could not reflect the unique characteristics of Traditional Chinese Medicine (TCM) treatment. Currently,there are no established standards for treatment outcomes and measurement instruments specific to TCM clinical research,nor has a COS-DRF been established for TCM clinical studies in China. In light of these gaps,our research team aims to construct a core set of treatment outcomes for TCM clinical research on distal radius fractures. This involves compiling a comprehensive list of treatment outcomes and measurement instruments,initially derived from a thorough literature review and expert consensus,which will then undergo further refinement and updates based on real-world clinical experiences,incorporating feedback from 2 to 3 rounds of expert consensus or Delphi questionnaire surveys. Our goal is to establish a COS-DRF or CMS-DRF that aligns with the principles and practices of TCM,and provide high-quality evidence for clinical practice. |
| KEYWORDS:Core outcome Chinese medicine Efficacy evaluation Clinical trial Distal radius fracture |
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| 引用本文，请按以下格式著录参考文献： |
| 中文格式: | 张桐桐,李多多,蒋科卫,王朝鲁,成永忠.构建桡骨远端骨折中医临床研究核心结局指标集的探索与思考[J].中国骨伤,2023,36(9):901~904 |
| 英文格式: | ZHANG Tong-tong,LI Duo-duo,JIANG Ke-wei,WANG Chao-lu,CHENG Yong-zhong.Exploration and consideration on establishing a core outcome set of Traditional Chinese Medicine clinical trials in distal radius fracture[J].zhongguo gu shang / China J Orthop Trauma ,2023,36(9):901~904 |
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