Chinese Journal of Stroke ›› 2025, Vol. 20 ›› Issue (8): 1029-1034.DOI: 10.3969/j.issn.1673-5765.2025.08.012

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Application of the Modified Rankin Scale in Outcome Assessment for Stroke Clinical Trials and Research on Statistical Methods

ZHU Jinqiao1,2, XIA Xue2,3, XU Qin2,3, FENG Tao1, WANG Anxin2,3,4   

  1. 1 Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China
    2 Department of Clinical Epidemiology and Clinical Trial, Capital Medical University, Beijing 100070, China
    3 Department of Epidemiology, Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China
    4 China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China
  • Received:2024-02-21 Revised:2025-07-24 Accepted:2025-07-31 Online:2025-08-20 Published:2025-08-20
  • Contact: WANG Anxin, E-mail: wanganxin@bjtth.org

改良Rankin量表用于卒中临床试验结局评价及其统计方法研究

朱金巧1,2,夏雪2,3,胥芹2,3,冯涛1,王安心2,3,4   

  1. 1 北京 100070 首都医科大学附属北京天坛医院神经病学中心
    2 首都医科大学临床流行病学与临床试验学系
    3 首都医科大学附属北京天坛医院,北京市神经外科研究所流行病学研究室
    4 首都医科大学附属北京天坛医院,国家神经系统疾病临床医学研究中心
  • 通讯作者: 王安心 wanganxin@bjtth.org
  • 基金资助:
    北京市自然科学基金-海淀原始创新联合基金(L222123)

Abstract: The mRS is a commonly used endpoint assessment tool in stroke clinical trials. However, many current clinical trials still lack standardized definitions of health conditions corresponding to different mRS cut-off points, and the statistical analysis methods applicable to mRS also vary in different clinical trials. This article aims to provide an overview of the application of mRS in stroke clinical trials and discusses the recommended terminology and statistical analysis methods of mRS.

Key words: Modified Rankin scale; Stroke; Clinical trial

摘要: mRS是卒中临床试验中常用的终点评估工具。然而,目前许多临床试验对不同mRS切点对应健康状况的定义仍欠规范,mRS的统计分析方法在不同临床试验中也存在差异。本文旨在对mRS在卒中临床试验中的应用进行概述,并对mRS的推荐术语及统计分析方法进行重点讨论。

关键词: 改良Rankin量表; 卒中; 临床试验

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