摘要
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。
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.
作者
张桐桐
李多多
蒋科卫
王朝鲁
成永忠
ZHANG Tong-tong;LI Duo-duo;JIANG Ke-wei;WANG Chao-lu;CHENG Yong-zhong(Department of Tuina and Pain Management,Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Beijing 100700,China;The Second Joint Department,Wangjing Hospital of China Academy of Chinese Medical Sciences,Beijing 100102,China;Orthopaedics Trauma Department,Wangjing Hospital of China Academy of Chinese Medical sciences,Beijing 100102,China;The First Trauma Department,Wangjing Hospital of China Academy of Chinese Medical sciences,Beijing100102,China)
出处
《中国骨伤》
CAS
CSCD
2023年第9期901-904,共4页
China Journal of Orthopaedics and Traumatology
基金
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)。
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
Core outcome
Chinese medicine
Efficacy evaluation
Clinical trial
Distal radius fracture
