[1]彭越 蒲博轩 雷璐碧 李京阔 葛金卓 王薇 于炎武 李艳 张丽华.患者报告结局在心血管临床试验中的应用[J].心血管病学进展,2023,(11):978.[doi:10.16806/j.cnki.issn.1004-3934.2023.11.005]
　PENG Yue,PU Boxuan,LEI Lubi,et al.Application of Patient-Reported Outcomes in Cardiovascular Clinical Trials[J].Advances in Cardiovascular Diseases,2023,(11):978.[doi:10.16806/j.cnki.issn.1004-3934.2023.11.005]
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患者报告结局在心血管临床试验中的应用()
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《心血管病学进展》[ISSN:51-1187/R/CN:1004-3934]

卷:
期数:
2023年11期
页码:
978
栏目:
综述
出版日期:
2023-11-25

文章信息/Info

Title:
Application of Patient-Reported Outcomes in Cardiovascular Clinical Trials
作者:
彭越 蒲博轩 雷璐碧 李京阔 葛金卓 王薇 于炎武 李艳 张丽华
(中国医学科学院 北京协和医学院 国家心血管病中心 阜外 医院 国家心血管疾病临床医学研究中心,北京 100037)
Author(s):
PENG Yue;  PU Boxuan;  LEI Lubi;  LI Jingkuo;  GE Jinzhuo;  WANG Wei;  YU Yanwu;  LI Yan ;  ZHANG Lihua
(National Clinical Research Center for Cardiovascular Diseases,National Center for Cardiovascular Diseases and Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037,China)
关键词:
患者报告结局; 临床试验; 心血管领域
Keywords:
Patient-reported outcomes; Clinical trial; Cardiovascular field
DOI:
10.16806/j.cnki.issn.1004-3934.2023.11.005
摘要:
患者报告结局（PROs）是直接来自患者的任何关于患者健康状态的报告，从患者角度为临床研究及实践提供最直接和真实的疗效评价指标。随着个体化医学模式的发展和以患者为中心医学理念的推动，PROs日益受到重视，已被越来越多的研究者关注和提倡。了解PROs在临床试验中的应用也是进一步提高临床研究质量的必要步骤。现以心血管领域为例，就临床试验中PROs的应用现状进行阐述总结，以期为国内临床试验PROs的应用和发展提供参考建议。
Abstract:
Patient-reported outcomes（PROs） are any reports on the patient’s health status that comes directly from the patient,providing the most direct and realistic efficacy evaluation indicators for clinical research and practice from the patient’s perspective. With the development of individualized medicine model and the promotion of patient-centered medicine concept,PROs are receiv ing increasing attention and have been promoted by more and more researchers. Understanding the application of PROs in clinical trials is also a necessary step to further improve the quality of clinical research. Taking the cardiovascular field as an example ,this paper elaborates and summarize s the application status of PROs in clinical trials,in order to provide reference and suggestions for the application and development of PROs in domestic clinical trials.

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更新日期/Last Update: 2023-12-13