...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>JMIR Medical Informatics >Expedited Safety Reporting Through an Alert System for Clinical Trial Management at an Academic Medical Center: Retrospective Design Study
【24h】

Expedited Safety Reporting Through an Alert System for Clinical Trial Management at an Academic Medical Center: Retrospective Design Study

机译：通过学术医疗中心的临床试验管理警报系统加急安全报告：回顾性设计研究

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Background Early detection or notification of adverse event (AE) occurrences during clinical trials is essential to ensure patient safety. Clinical trials take advantage of innovative strategies, clinical designs, and state-of-the-art technologies to evaluate efficacy and safety, however, early awareness of AE occurrences by investigators still needs to be systematically improved. Objective This study aimed to build a system to promptly inform investigators when clinical trial participants make unscheduled visits to the emergency room or other departments within the hospital. Methods We developed the Adverse Event Awareness System (AEAS), which promptly informs investigators and study coordinators of AE occurrences by automatically sending text messages when study participants make unscheduled visits to the emergency department or other clinics at our center. We established the AEAS in July 2015 in the clinical trial management system. We compared the AE reporting timeline data of 305 AE occurrences from 74 clinical trials between the preinitiative period (December 2014-June 2015) and the postinitiative period (July 2015-June 2016) in terms of three AE awareness performance indicators: onset to awareness, awareness to reporting, and onset to reporting. Results A total of 305 initial AE reports from 74 clinical trials were included. All three AE awareness performance indicators were significantly lower in the postinitiative period. Specifically, the onset-to-reporting times were significantly shorter in the postinitiative period (median 1 day [IQR 0-1], mean rank 140.04 [SD 75.35]) than in the preinitiative period (median 1 day [IQR 0-4], mean rank 173.82 [SD 91.07], P ≤.001). In the phase subgroup analysis, the awareness-to-reporting and onset-to-reporting indicators of phase 1 studies were significantly lower in the postinitiative than in the preinitiative period (preinitiative: median 1 day, mean rank of awareness to reporting 47.94, vs postinitiative: median 0 days, mean rank of awareness to reporting 35.75, P =.01; and preinitiative: median 1 day, mean rank of onset to reporting 47.4, vs postinitiative: median 1 day, mean rank of onset to reporting 35.99, P =.03). The risk-level subgroup analysis found that the onset-to-reporting time for low- and high-risk studies significantly decreased postinitiative (preinitiative: median 4 days, mean rank of low-risk studies 18.73, vs postinitiative: median 1 day, mean rank of low-risk studies 11.76, P =.02; and preinitiative: median 1 day, mean rank of high-risk studies 117.36, vs postinitiative: median 1 day, mean rank of high-risk studies 97.27, P =.01). In particular, onset to reporting was reduced more in the low-risk trial than in the high-risk trial (low-risk: median 4-0 days, vs high-risk: median 1-1 day). Conclusions We demonstrated that a real-time automatic alert system can effectively improve safety reporting timelines. The improvements were prominent in phase 1 and in low- and high-risk clinical trials. These findings suggest that an information technology-driven automatic alert system effectively improves safety reporting timelines, which may enhance patient safety.
机译：背景技术临床试验期间不良事件（AE）发生的早期检测或通知对于确保患者安全是必不可少的。临床试验利用创新策略，临床设计和最先进的技术来评估疗效和安全性，然而，需要系统地改善调查人员对AE发生的早期意识。目的本研究旨在建立一个系统，以便在临床试验参与者向急诊室或医院内部其他部门进行外部访问外，迅速通知调查人员。方法制定了不良事件意识系统（AEA），当学习参与者在我们中心的急诊部门或其他诊所自动发送短信时，通过自动发送短信来迅速通知调查人员和研究AE发生的协调员。我们于2015年7月在临床试验管理系统中建立了艾雅。我们将AE报告时间表数据与305 AE发生的AE报告时间表数据从74项临床试验（2015年12月 - 2015年12月）和PostInitiveive期间（2016年6月 - 2016年6月）之间（2016年6月）在三个AE意识绩效指标方面：发病，对报告的意识，并开始报告。结果包括74项临床试验中共有305次初始AE报告。前列时间内所有三个AE意识性指标都显着降低。具体而言，发育后期的发病至报告时间明显较短（中位数1天[IQR 0-1]，平均排名140.04）比在预防期内（中位数1天[IQR 0-4]） ，平均秩173.82 [SD 91.07]，P≤001）。在亚群分析中，阶段1研究的提高认识和发病到报告指标比在前一期中显着降低了（预防：中位数：1天，意识到报告47.94的意识47.94，VS发行性：中位数0天，报告报告的意识的平均级别35.75，p = .01;和预防：中位数1天，平均发病率为报告47.4，与发育病发布性：中位数1天，平均发病率为35.99，p = .03）。风险级别亚组分析发现，低风险和高风险研究的发病时间明显下降（预防：中位数4天，平均低风险研究的级别18.73，VS Postinitive：中位数1天，意味着低风险研究的排名11.76，p = .02;和预防：中位数1天，平均高风险研究的级别117.36，与前进症：中位数1天，平均高风险研究97.27，p = .01） 。特别是，在低风险试验中，报告的发病比高风险试验（低风险：中位数4-0天，VS高风险：中位数1-1天）。结论我们表明，实时自动警报系统可以有效地改善安全报告时间表。改善在1阶段和低风险临床试验中突出。这些调查结果表明，信息技术驱动的自动警报系统有效改善了安全报告时间表，这可能会提高患者安全性。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号