基于德尔菲法的我国临床研究风险评估指标框架构建  

Construction of risk assessment index framework for clinical research in China based on Delphi method

作　　者：张艾一 陈虎[2] 盛艾娟[3] 白楠[4] 陈燕芬[5] 余中光[5,6] ZHANG Ai-yi;CHEN Hu;SHENG Ai-juan;BAI Nan;CHEN Yan-fen;YU Zhong-guang(Peking Union Medical College Hospital,Beijing 100005,China;Cangzhou Central Hospital,Cangzhou 061017,China;Beijing You'an Hospital,Capital Medical University,Beijing 100069,China;Chinese PLA General Hospital,Beijing 100039,China;China-Japan Friendship Hospital,Beijing 100029,China;School of Economics and Management,Wuhan University,Wuhan 430072,China)

机构地区：[1]中国医学科学院北京协和医院,北京100005 [2]沧州市中心医院,沧州061017 [3]首都医科大学附属北京佑安医院,北京100069 [4]中国人民解放军总医院,北京100039 [5]中日友好医院,北京100029 [6]武汉大学经济与管理学院,武汉430072

出　　处：《中国新药杂志》2024年第15期1580-1585,共6页Chinese Journal of New Drugs

基　　金：国家自然科学基金青年基金资助项目(72104255);中国医学科学院医学与健康科技创新工程资助项目(2021-I2M-1-046);中日友好医院高水平资助项目(2023-NHLHCRF-GLMS-14)。

摘　　要：目的:构建基于我国国情的临床研究风险评估指标框架,为临床研究风险评估提供参考标准与依据。方法:在前期文献研究和专家访谈法的基础上,开展2轮德尔菲法咨询,从均数、变异指数、协调系数等角度对专家咨询结果进行评价,进一步筛选和优化临床研究风险评估核心指标。结果:选取本领域23名专家进行问卷调查,2轮专家积极程度均为100%,2轮权威系数均≥0.90,根据指标均值和变异系数,并结合专家修改建议,最终形成一级指标4个、二级指标10个、三级指标45个的临床研究风险评估框架。结论:本研究构建的临床研究风险评估框架可帮助医疗机构伦理委员会快速评估并发现潜在风险点,提升伦理审查质量与水平,亦可为后期开发量化的临床研究风险评估工具提供依据。Objective: To construct a clinical research risk assessment index framework based on China's national conditions, providing standards and basis for clinical research risk assessment. Methods: On the basis of previous literature review and expert interviews, two rounds of Delphi consultation were conducted. The results of expert consultation were evaluated from the perspectives of mean, variation index and coordination coefficient, and the core indicators of clinical research risk assessment were further screened and optimized. Results: A total of 23 experts in this field were selected to conduct this questionnaire survey. The positive degree of experts in the two rounds was 100% with the authority coefficient ≥0.90. According to the mean value and coefficient of variation of the indicators, combined with expert's modification suggestions, a clinical research risk assessment framework was finally constructed, including 4 first-level indicators, 10 second-level indicators and 45 third-level indicators. Conclusion: The clinical research risk assessment framework constructed in this study can help ethics committees of medical institutions to quickly assess and find potential risk points, improve the quality and the level of ethical review, providing a basis for the future development of quantitative clinical research risk assessment tools.

关 键 词：德尔菲法 临床研究 风险评估指标 问卷调查 伦理审查 

分 类 号：R95[医药卫生—药学]