Development of Core Outcome Set for Clinical Effectiveness Trials of Heart Failure with Preserved Ejection Fraction
10.11842/wst.20240712004
- VernacularTitle:射血分数保留的心力衰竭疗效评价临床试验核心指标集的研制
- Author:
Yongcheng LIU
1
;
Yujiao SHI
;
Siyu LIU
;
Chenguang YANG
;
Wenbo QIAO
;
Xiaoyu LIANG
;
He ZHANG
;
Lizhi LI
;
Guoju DONG
Author Information
1. 中国中医科学院西苑医院 北京 100091
- Publication Type:Journal Article
- Keywords:
Heart failure with preserved ejection fraction;
Clinical trials;
Efficacy evaluation;
Core outcome set
- From:
World Science and Technology-Modernization of Traditional Chinese Medicine
2025;27(5):1335-1342
- CountryChina
- Language:Chinese
-
Abstract:
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.