某院临床试验用药品信息化管理效果分析

Effect Analysis of Information Management for Clinical Investigational Products in a Hospital

目的促进医院临床试验用药品的信息化管理。方法基于医院信息系统(HIS),开发临床试验用药品管理模块。采用回顾性分析法,随机抽取HIS中2020年1月至12月(应用前,共335张)与2021年3月至2022年3月(应用后,共791张)的处方,各150张,统计并比较信息化管理模块应用前后的处方差错率;采用问卷调查法,以参与临床试验的研究者、临床监查员、临床协调员、药房管理员及受试者为调查对象,调查并比较应用前后的满意度。结果应用后,处方差错率由15.33%(23/150)降至0.67%(1/150),差异显著(P<0.05)。共发放问卷467份,有效回收462份,有效回收率为98.93%;应用后,调查对象的整体满意度为(96.13±3.24)%,显著高于应用前的(79.08±6.65)%(P<0.05)。结论基于HIS管理临床试验用药品,可降低临床试验用药品的处方差错率,提高各方的满意度,促进临床试验用药品的信息化管理。

Objective To promote the information management for clinical investigational products in hospitals.Methods The management module for clinical investigational products was developed based on the hospital information system(HIS).The prescriptions in the HIS from January to December 2020(before the application of information management module)and from March 2021 to March 2022(after the application of information management module)were randomly selected and retrospectively analyzed.Before the application of the above module,150 prescriptions were selected from 335 prescriptions,and after the application of the above module,150 prescriptions were selected from 791 prescriptions.The error rate of prescriptions before and after the application of information management module was counted and compared.With researchers,clinical research associates,clinical research coordinators,pharmacy administrators and subjects who participated in the clinical trials as the respondents,their satisfaction level before and after the application of information management module was investigated and compared by the questionnaire survey method.Results After the application of information management module,the error rate of prescriptions decreased from 15.33%(23/150)to 0.67%(1/150),with significant difference(P<0.05).A total of 467 questionnaires were distributed,and 462 effective questionnaires were recovered,with an effective recovery rate of 98.93%.After the application of information management module,the overall satisfaction level of the respondents was(96.13±3.24)%,which was significantly higher than(79.08±6.65)% before the application of the above module(P<0.05).Conclusion The management for clinical investigational products based on the HIS can reduce the error rate of prescriptions,improve the satisfaction level of relevant personnel,and promote the information management of clinical investigational products.