中国医学伦理学2024，Vol.37Issue(4)：448-452,5.DOI:10.12026/j.issn.1001-8565.2024.04.11
我国临床研究受益评估指标框架的探讨与构建
Exploration and construction of an evaluation indicator framework for clinical research benefits in China
摘要
Abstract
Objective:The aim is to construct an evaluation framework for clinical research benefits,and provide a reference for the formulate of evaluation standards for clinical research benefits.Methods:The Delphi method was used to carry out expert consultation,and the mean,score of importance,coefficient of variation and coordination,etc.of evaluation indicators were summarized and calculated,to screen evaluation indicators for clinical research benefits.Results:Twenty-three experts in this field were selected for correspondence,and their enthusiasm was 100%in both rounds,the authority coefficients were≥0.90,and Kendall's coefficients of concordance were<0.25(P<0.001).By referring to the mean and coefficient of variation of the indicators,as well as combining them with expert suggestions,an evaluation framework for clinical research benefits was ultimately formed with 2 primary indicators,5 secondary indicators,and 8 tertiary indicators.Conclusion:The evaluation framework for clinical research benefits constructed in this paper can comprehensively evaluate the research benefits,as well as provide a basis for reasonably determining the research risk-benefit ratio and developing quantitative evaluation tools for clinical research benefits.关键词
临床研究收益/风险受益/医学伦理/伦理审查Key words
clinical research benefits/risk-benefit/medical ethics/ethical review分类
医药卫生引用本文复制引用
张艾一,陈虎,盛艾娟,白楠,陈燕芬,余中光..我国临床研究受益评估指标框架的探讨与构建[J].中国医学伦理学,2024,37(4):448-452,5.基金项目
国家自然科学基金青年基金项目"临床研究伦理审查风险与受益评估指标体系研究"(72104255) （72104255）
中国医学科学院医学与健康科技创新工程项目"基于卫生健康体系学的健康中国建设战略研究"(2021-I2M-1-046) （2021-I2M-1-046）
中日友好医院高水平项目"临床研究风险评估量表开发与应用研究——以呼吸领域项目为例"(2023-NHLHCRF-GLMS-14) （2023-NHLHCRF-GLMS-14）
