目的 探讨语音播报提醒功能对早期药物临床试验中采血时间准确性的影响。方法 自Sample Guide智能样本管理系统数据库中调取2018年6月—2019年10月无语音播报提醒功能条件下6 558个血液样本采集时间作为对照组；2019年12月—2021年2月启用语音播报提醒功能后12 768个血液样本采集时间作为试验组。比较两组实际采血时间与计划采血时间的偏离程度、采血时间超窗发生率、采血时间记录异常发生率。结果 启用语音播报提醒功能后，实际采血时间与计划采血时间的偏离程度较小，差值绝对值比较差异有统计学意义（P<0.05）；采血时间超窗发生率明显降低，差异有统计学意义（P<0.05）；采血时间记录异常的发生率明显降低，差异有统计学意义（P<0.05）。结论 语音播报提醒功能可以缩短实际采血时间与计划时间的偏离程度，有效减少药物临床试验中采血时间超窗次数的发生，提高了早期药物临床试验中采血时间的准确度。

Objective To investigate the influence of voice broadcast reminder on the accuracy of blood collection time in early phase clinical trial. Methods A total of 6 558 blood samples collected from June 2018 to October 2019 under the condition of Sample Guide intelligent Sample management system without voice notification were selected as the control group, and 12 768 blood samples collected from December 2019 to February 2021 after the use of voice broadcast reminder were selected as the experimental group. The deviation degree of actual blood collection time and planned blood collection time, the incidence of beyond time window of blood collection time, and the incidence of abnormal blood collection time record were compared between the two groups. Results With the voice broadcast reminder, the deviation degree and fluctuation range of actual blood collection time and planned blood collection time was much smaller (P < 0.05), the incidence of beyond time window of blood collection time was significantly decreased (P < 0.05), and the incidence of abnormal blood collection time record was significantly decreased (P < 0.05). Conclusion Voice broadcast reminder effectively shorten the deviation between actual blood collection time and planned time, reduced the rate of beyond time window of blood sample collection, and improved the accuracy of blood collection time.

R965.2

北京市医院管理中心“登峰”计划专项经费资助项目（DFL20190803）；北京市医院管理中心“青苗”计划专项经费资助项目（QMS20200811）；首都科技领军人才项目（Z191100006119017）