摘要/Abstract
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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