摘要
目的建立射血分数保留的心力衰竭(Heart failure with preserved ejection fraction,HFpEF)疗效评价临床试验核心指标集(Core outcome set,COS)。方法通过数据库文献检索、临床专家问卷调查和患者半结构化访谈收集结局指标,构建指标池并进行指标域划分。通过两轮德尔菲调查筛选出COS候选指标。最后召开共识会议确定COS并达成共识。结果通过文献研究、问卷调查和半结构化访谈共收集到317个结局指标,可划分为6个指标域。两轮德尔菲调查共筛选出15个COS候选指标。共识会议形成了包含6个条目的COS并达成共识。结论本研究建立了HFpEF疗效评价临床试验COS,有利于疗效评价的标准化和规范化。
Objective To develop a core outcome set(COS)for clinical effectiveness trials of heart failure with preserved ejection fraction(HFpEF).Methods Outcome measures were collected through database literatures search,clinical experts questionnaire survey and semi-structured patients interview.Then,the outcome measures pool was constructed and domains were divided.Candidate outcome measures of COS were screened through two rounds of Delphi survey.Finally,a consensus meeting was held to determine COS and reach a consensus.Results A total of 317 outcome measures which could be divided into 6 domains were collected through literature research,questionnaire survey and semi-structured interview.15 candidate outcome measures of COS were screened through two rounds of Delphi survey.Finally,the consensus meeting reached consensus on a COS with 6 entries.Conclusion In this study,a COS for clinical effectiveness trials of HFpEF was developed,which is conducive to the standardization of efficacy evaluation.
作者
刘永成
石玉姣
刘思雨
杨晨光
乔文博
梁小雨
张贺
李立志
董国菊
LIU Yongcheng;SHI Yujiao;LIU Siyu;YANG Chenguang;QIAO Wenbo;LIANG Xiaoyu;ZHANG He;LI Lizhi;DONG Guoju(Xiyuan Hospital of China Academy of Chinese Medical Sciences,Beijing 100091,China;National Clinical Research Center of Cardiovascular Diseases of Chinese Medicine,Beijing 100091,China)
出处
《世界科学技术-中医药现代化》
北大核心
2025年第5期1335-1342,共8页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
中国中医科学院西苑医院能力提升项目(XYZX0201-02):基于治未病思想构建射血分数保留心衰早期“四位一体”的中医诊疗方案,负责人:董国菊。
关键词
射血分数保留的心力衰竭
临床试验
疗效评价
核心指标集
Heart failure with preserved ejection fraction
Clinical trials
Efficacy evaluation
Core outcome set
