上海交通大学学报(医学版) ›› 2020, Vol. 40 ›› Issue (10): 1430-1436.doi: 10.3969/j.issn.1674-8115.2020.10.023

• 论著·公共卫生 • 上一篇    

研究者发起的干预性临床研究质量评价体系的构建

史文涛1,吴思成1,崔东琦1,陈凌燕1,陈世杰1,王步轶1,林晓涵1,张 靓1,瞿轶慧1,许 锋2#,吴 皓3, 4#   

  1. 1. 上海交通大学医学院附属第九人民医院临床研究中心,上海 200011;2. 上海交通大学医学院附属第九人民医院学科规划处,上海 200011;3. 上海交通大学医学院附属第九人民医院耳鼻咽喉头颈外科,上海 200011;4. 上海交通大学医学院耳科学研究所,上海市耳鼻疾病转化医学重点实验室,上海 200125
  • 出版日期:2020-10-28 发布日期:2020-11-27
  • 通讯作者: 许 锋,电子信箱:xufenghhou@163.com。吴 皓,电子信箱:wuhao622@sh163.net。#为共同通信作者。
  • 作者简介:史文涛(1990—),男,助理研究员,博士;电子信箱:shiwentaotobe@163.com。
  • 基金资助:
    上海申康医院发展中心管理研究项目(2018SKMR-08);上海申康医院发展中心临床管理优化项目(SHDC12017628);上海交通大学中国医院发展研究院项目(CHDI-2019-A-02)。

Construction of quality evaluation system of experimental investigator-initiated trial

SHI Wen-tao1, WU Si-cheng1, CUI Dong-qi1, CHEN Ling-yan1, CHEN Shi-jie1, WANG Bu-yi1, LIN Xiao-han1, ZHANG Liang1, QU Yi-hui1, XU Feng2#, WU Hao3, 4#   

  1. 1. Clinical Research Center, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; 2. Department of Discipline Planning, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; 3. Department of Otolaryngology-Head and Neck Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; 4. Institute of Otology, Shanghai Jiao Tong University School of Medicine; Shanghai Key Laboratory of Translational Medicine on Ear and Nose Diseases, Shanghai 200125, China
  • Online:2020-10-28 Published:2020-11-27
  • Supported by:
    Management Research Project of Shanghai Shenkang Hospital Development Center (2018SKMR-08); Clinical Management Optimization Project of Shanghai Shenkang Hospital Development Center (SHDC12017628); Project of China Hospital Development Institute, Shanghai Jiao Tong University (CHDI-2019-A-02).

摘要: 目的·构建研究者发起的干预性临床研究(experimental investigator-initiated trial, EIIT)质量评价体系,为EIIT质量控制提供依据。方法·通过文献分析法与研究小组内部讨论会,确定EIIT质量评价体系初稿;采用德尔菲法,对35名专家进行咨询,最终确定EIIT质量评价体系;并运用层次分析法计算各指标的权重。结果·3轮专家咨询有效回收率分别为100%、91.43%、91.43%,权威系数分别为0.84、0.91、0.89。经过3轮咨询,各指标的重要性均值均>3.50,变异系数均<0.30,肯德尔协调系数为0.177~0.331(P<0.01),最终形成了3个一级指标、18个二级指标、70个三级指标的EIIT质量评价体系。一级指标(启动期、实施期和总结期)的权重值分别为0.310 8、0.493 4和0.195 8。同时确立了二级和三级指标的权重。各级指标层次单排序和整体排序的一致性比率(consistency ratio, CR)均<0.1,具有良好的逻辑一致性。结论·构建的EIIT质量评价体系具有较高的科学性和可靠性,对提升EIIT质量具有参考价值。

关键词: 质量评价, 指标体系, 研究者发起, 干预性临床研究

Abstract:

Objective · To construct a quality evaluation system of experimental investigator-initiated trial (EIIT), and provide reference for EIIT quality control. Methods · The original draft of EIIT quality evaluation system was determined through literature analysis and internal discussion of the research group. Thirty-five experts were consulted using the Delphi method and then the quality evaluation system was determined. Analytic Hierarchy Process (AHP) was used to calculate the weight of each index. Results · The effective recovery rates of three rounds of experts' consultation were 100%, 91.43%, and 91.43% respectively. The authoritative coefficient were 0.84, 0.91, and 0.89 respectively. After three rounds of experts' consultation, the average scores of all indexes were>3.50, the coefficient of variation of each index was<0.30, and Kendall coefficients of concordance (Kendall's W) were 0.177- 0.331 (P<0.01). Finally, an EIIT quality evaluation system with three first-class indexes, eighteen second-class indexes and seventy third-class indexes was constructed. There were three first-class indexes including start-up period, implementation period and summary period and their weight values were 0.310 8, 0.493 4, and 0.195 8 respectively. The weight values of the second-class indexes and the third-class indexes were determined at the same time. The consistency ratios of single-sort and overall sort of all indexes were<0.1, which shows good logical consistency. Conclusion · The EIIT quality evaluation system constructed in this research is highly scientific and reliable, with guiding significance for improving the quality of EIIT.

Key words: quality evaluation, index system, investigator initiated, experimental trial

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