摘要
目的探索并构建研究者发起的临床研究(IIT)实施过程的质量评价指标体系。方法通过文献分析法拟定IIT实施过程质量评价指标体系,于2024年5月29日至6月28日使用德尔菲法构建评价指标体系,采用层次分析法确定各指标权重。基于构建的指标体系,应用模糊评价法对1项干预性IIT项目进行质量评价。评判集采用{优秀、合格、不合格},根据最大隶属原则,取评判向量中最大值对应的等级作为项目评判结果。结果构建的IIT实施过程质量评价指标体系有5个一级指标(备案和注册情况、受试者保护、执行质量、数据管理和实验管理)和23个二级指标。指标体系信度分析结果显示Cronbach′sα系数为0.909,折半信度系数为0.817;效度分析结果显示各指标水平的内容效度指数值为0.857~1.000,量表水平的内容效度指数为0.977,结构效度KMO值为0.864,Bartlett′s球形检验的χ^(2)值为1489.461(P<0.001),显示指标体系信效度良好。一级指标权重最高者为受试者保护(0.394),最低者为实验管理(0.105)。1项干预性IIT项目的综合评判结果为(0.246,0.333,0.421),根据最大隶属原则,判定为"不合格",隶属度为42.1%。结论本研究构建的IIT实施过程质量评估体系具有一定应用价值,其一级指标紧密贴合IIT管理核心需求,二级指标强化项目实践的重要性。该指标体系可用于医疗卫生机构,对IIT项目进行内部监管与全周期管控,助力提升IIT项目质量。
Objective To explore and establish a quality evaluation index system for the implementation process of the investigator-initiated trial(IIT).Methods The IIT quality evaluation indicator system was drafted through literature review,developed by Delphi method from May 29 to June 28,2024.The weights of each indicator were determined by the analytic hierarchy process.Based on the indicator system,the quality of 1 interventional IIT project was assessed by fuzzy comprehensive evaluation.The judgment set comprised{excellent,qualified,unqualified}.Following the maximum membership principle,the project evaluation result was determined by the grade corresponding to the maximum value in the judgment vector.Results The IIT quality evaluation indicator system included 5 first-level indicators(filing and registration status,subject protection,implementation quality,data management,and experiment management)and 23 second-level indicators.Reliability analysis revealed a Cronbach′sαcoefficient of 0.909 and a split-half reliability coefficient of 0.817.Validity analysis showed content validity indices of 0.857 to 1.000 for individual indicators,the scale-level content validity index was 0.977.Structural validity was supported by a KMO value of 0.864 and a Bartlett′s sphericity testχ^(2)value of 1489.461(P<0.001).These results indicated good reliability and validity of the indicator system.The highest first-level indicator was subject protection(0.394),and the lowest was experimental management(0.105).The comprehensive evaluation result for a interventional IIT project was(0.246,0.333,0.421).Based on the maximum membership principle,it was judged as"unqualified"with a membership degree of 42.1%.Conclusions In this study,the IIT implementation quality assessment system developed practical applicability.First-level indicators closely addressed core IIT management needs,while second-level indicators emphasized the importance of project implementation.This indicator system can be applied in healthcare institutions for internal oversight and full-cycle management of IIT projects,thereby enhancing IIT quality.
作者
张玥
谢双华
张宁宁
张迎媛
阴赪宏
岳文涛
Zhang Yue;Xie Shuanghua;Zhang Ningning;Zhang Yingyuan;Yin Chenghong;Yue Wentao(Department of Research Management,Beijing Obstetrics and Gynecology Hospital,Capital Medical University,Beijing Maternal and Child Health Care Hospital,Beijing 100026,China;Department of Central Laboratory,Beijing Obstetrics and Gynecology Hospital,Capital Medical University,Beijing Maternal and Child Health Care Hospital,Beijing 100026,China)
出处
《中华医院管理杂志》
北大核心
2025年第9期692-697,共6页
Chinese Journal of Hospital Administration
基金
北京市医院管理中心"青苗"计划专项(QML20231404)。
关键词
质量管理
研究者发起的临床研究
德尔菲法
层次分析法
模糊综合评价法
Quality management
Investigator initiated trial
Delphi method
Analytic hierarchy process
Fuzzy comprehensive evaluation
