生物等效性试验中受试者病房满意度调查及改进对策研究  

Investigation on the satisfaction to ward of participants and researh on improvement countermeasures in the bioequivalence trial

作　　者：王燕[1] 陶艺 池贝佳 WANG Yan;TAO Yi;CHI Beijia(Phase I Clinical Trial Ward,the First Affiliated Hospital of Chongqing Medical University,Chongqing 400016,China)

机构地区：[1]重庆医科大学附属第一医院Ⅰ期临床试验病房,重庆400016

出　　处：《现代医药卫生》2023年第14期2363-2367,共5页Journal of Modern Medicine & Health

基　　金：重庆市科技局技术创新与应用发展面上项目(cstc2020jscx-msxmX0090)。

摘　　要：目的了解生物等效性试验中受试者对该院Ⅰ期临床试验病房满意度情况,进而探讨并提出进一步改进病房硬件及软件的对策及建议。方法采用自制问卷对2021年1-6月324例到该院Ⅰ期临床试验病房参加过生物等效性试验的受试者进行问卷调查,了解受试者对该病房硬件及软件的满意度。共回收有效问卷316份,问卷回收率为97.5%。运用χ2检验分析比较不同性别、年龄、入住病房时间受试者对该院Ⅰ期临床试验病房满意度的差异。结果不同性别、年龄、入住病房时间受试者对隐私保护、医疗处理、工作人员服务态度满意度比较,不同年龄、入住病房时间受试者对病房环境满意度比较,不同年龄、入住病房时间受试者对病房餐饮情况满意度比较,不同性别、年龄受试者是否继续参加试验比较,差异均无统计学意义(P>0.05);不同性别受试者对病房环境满意度比较,不同性别受试者对餐饮情况满意度比较,不同入住病房时间受试者是否继续参加试验比较,差异均有统计学意义(P<0.05)。结论Ⅰ期临床试验病房应从加强硬件建设、增加食谱多样性提升患者满意度;并在试验中对受试者进行分层次管理进而增加受试者依从性,提高临床试验质量。Objective To investigate the satisfaction of the participants in the bioequivalence trial in the Phase I Clinical Trial Ward of the First Affiliated Hospital of Chongqing Medical University,and the measures and suggestions were discussed to improve the hardware and software of the ward.Methods A self-designed questionnaire was applied to survey 324 participants who had participated in the bioequivalence trial in the Phase I Clinical Trial Ward of the First Affiliated Hospital of Chongqing Medical University,to understand the satisfaction of ward′s hardware and software.A total of 316 valid questionnaires were collected in this survey,and the questionnaire recovery rate was 97.5%.The chi-square test was used to analyze the differences in satisfaction of participants with different gender,age,and days staying in the ward.Results There was no significant difference in satisfaction with privacy protection,medical treatment and staff service attitude among subjects of different gender,age and time in ward,satisfaction with ward environment,satisfaction with ward catering,and whether subjects of different gender and age continued to participate in the experiment(P>0.05).There were statistically significant differences in the satisfaction of subjects of different sexes with ward environment,the satisfaction of subjects of different sexes with catering situation,and whether the subjects continued to participate in the experiment at different hospitalization time(P<0.05).Conclusion PhaseⅠWard should strengthen hardware construction and increase diet diversity to improve patient satisfaction;and in the bioequivalence trial,the participants should be treated in different ways to increase their compliance thus improve the quality of clinical trials.

关 键 词：生物等效性试验 受试者管理 满意度 调查 对策 

分 类 号：R97[医药卫生—药品]