药物临床试验研究护士培训体系的构建

Construction of research nurses’ training system for drug clinical trial

目的 构建药物临床试验研究护士培训体系,为我国研究护士的培养与培训提供理论依据。方法 通过文献研究法拟定药物临床试验研究护士培训体系的初稿,运用德尔菲法通过专家函询明确各级指标的条目,最后采用层次分析法计算各级指标的权重。结果 本研究共开展2轮专家函询,问卷回收率分别为100%和83.3%,专家权威系数分别为0.870和0.907,肯德尔和谐系数分别为0.107和0.135。各指标的重要性赋值均数为4.50~5.00,变异系数为0~0.225;最终构建的药物临床试验研究护士培训体系包括4项一级指标,14项二级指标,56项三级指标。结论 本研究构建的药物临床试验研究护士培训体系,研究方法科学严谨,内容真实完整,研究结果合理可靠,可为我国药物临床试验研究护士的培训提供坚实的理论依据。

Objective To construct the training system of research nurse for drug clinical trial and provide theoretical basis for the cultivation and training of research nurses in China. Methods The first draft of research nurses’ training system for drug clinical trial was prepared by literature research method. Index items at all levels were defined by Delphi method through two rounds of expert letter consultation, and the weight of indexes at all levels was calculated by analytic hierarchy process. Results Two rounds of expert letter consultation were carried out in this study. The questionnaire recovery rates were 100% and 83.3%, expert authority coefficients were 0.870 and 0.907, and Kendall’s harmony coefficients were 0.107 and 0.135, respectively. The mean value of importance assigned to each indicator was 4.50-5.00, and the coefficient of variation was 0-0.225. The final training system for clinical trial nurses included 4 first-level indicators, 14 second-level indicators, and 56 third-level indicators. Conclusion The training system of research nurses for drug clinical trial constructed in this study has scientific and rigorous research methods, true and complete content, and reasonable and reliable results. It can provide a solid theoretical basis for research nurses’ training of drug clinical trial in China.