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[关于建立桡骨远端骨折中医临床试验核心结局集的探索与思考]

[Exploration and consideration on establishing a core outcome set of Traditional Chinese Medicine clinical trials in distal radius fracture].

作者信息

Zhang Tong-Tong, Li Duo-Duo, Jiang Ke-Wei, Wang Chao-Lu, Cheng Yong-Zhong

机构信息

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.

出版信息

Zhongguo Gu Shang. 2023 Sep 25;36(9):901-4. doi: 10.12200/j.issn.1003-0034.2023.09.020.

DOI:10.12200/j.issn.1003-0034.2023.09.020
PMID:37735086
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.

摘要

在与桡骨远端骨折(DRF)相关的研究中,治疗结果、测量工具以及评估临床疗效的标准存在不一致性,这可能导致潜在的偏差,无法提供高质量的临床证据。为应对这些挑战,国际研究人员已就制定桡骨远端骨折核心结局指标集(COS-DRF)达成共识。然而,需要注意的是,现有的COS-DRF框架无法体现中医治疗的独特特征。目前,中医临床研究尚无既定的治疗结局和测量工具标准,中国的中医临床研究也未建立COS-DRF。鉴于这些差距,我们的研究团队旨在构建一套桡骨远端骨折中医临床研究的核心治疗结局指标集。这包括编制一份全面的治疗结局和测量工具清单,最初通过深入的文献综述和专家共识得出,然后根据实际临床经验进行进一步完善和更新,纳入2至3轮专家共识或德尔菲问卷调查的反馈。我们的目标是建立一个符合中医原则和实践的COS-DRF或CMS-DRF,并为临床实践提供高质量的证据。

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