多中心药物临床试验机构研究护士培训体系的构建  

Construction of training system for research nurses in multicenter drug clinical trial institutions

作　　者：王晶晶[1] 朱旭 余姝彦 WANG Jingjing;ZHU Xu;YU Shuyan(Huashan Hospital,Fudan University,Shanghai 200040 China)

机构地区：[1]复旦大学附属华山医院,上海200040

出　　处：《护理研究》2025年第6期941-946,共6页Chinese Nursing Research

基　　金：《促进市级医院临床技能与临床创新三年行动计划》研究型医师创新转化能力培训项目,编号:SHDC2022CRS004B。

摘　　要：目的:构建多中心药物临床试验研究护士培训体系。方法:进行文献检索及分析,形成多中心药物临床试验机构研究护士培训体系初稿,进行2轮专家函询,根据专家意见形成多中心药物临床试验机构研究护士培训体系终稿。结果:构建的多中心药物临床试验机构研究护士培训体系包括6个一级指标(理论知识能力、专业实践能力、方案实施能力、沟通协作能力、统筹管理能力、专业发展能力)、19个二级指标、58个三级指标。2轮专家函询问卷回收率均为100.00%,专家权威系数均为0.919,变异系数分别为0.05~0.23和0.00~0.21,肯德尔协调系数分别为0.113和0.205(均P<0.001)。结论:构建的多中心药物临床试验研究护士培训体系具有一定的科学性、创新性、实用性。Objective:To construct a training system for research nurses in multicenter drug clinical trial institutions.Methods:Literature retrieval and analysis were conducted to draft the initial training system for research nurses in multicenter drug clinical trial institutions.Two rounds of expert consultation were carried out,and based on the feedback received,the final version of training system for research nurses in multicenter drug clinical trial institutions was developed.Results:The constructed training system for research nurses in multicenter drug clinical trial institutions included 6 first-level indicators(theoretical knowledge ability,professional practical ability,program implementation ability,communication and collaboration ability,overall management ability,professional development ability),19 second-level indicators,and 58 third-level indicators.The questionnaire return rates for both rounds of expert consultations were 100.00%,with expert authority coefficients of 0.919 for both rounds.The coefficients of variation were ranged from 0.05 to 0.23 and ranged from 0.00 to 0.21,respectively,while Kendall′s W were 0.113 and 0.205(both P<0.001).Conclusions:The constructed training system for research nurses in multicenter drug clinical trial institutions had certain scientificity,innovation,and practicality.

关 键 词：多中心临床试验 研究护士 德尔菲法 培训体系 护理 

分 类 号：R47-4[医药卫生—护理学] C975[医药卫生—临床医学]