在癌症临床试验单位使用电子平台从患者收集不良事件数据的试点研究
Minna Grahvendy1,2, Bena Brown3,4, Laurelie R Wishart5,6,7,8
1Cancer Trials Unit, Princess Alexandra Hospital, Queensland Health, 199 Ipswich Rd, Woolloongabba, QLD, 4102, Australia. minna.grahvendy@health.qld.gov.au.
Drugs - real world outcomes
|November 2, 2024
概括
癌症试验中患者报告的不良事件数据与临床医生数据的一致性较低,但减少了员工的工作负担. 电子平台提高了对不良事件收集的数据完整性和效率.
科学领域:
- 临床试验 临床试验
- 患者安全 患者安全
- 数据管理数据管理
背景情况:
- 准确的不良事件 (AE) 数据收集对于癌症临床试验中的患者安全至关重要.
- 传统的AE数据收集工作流正在发展,以整合患者报告的结果 (PRO) 以提高完整性.
- 这项研究调查了在临床试验环境中实施患者报告数据工作流程的情况.
研究的目的:
- 评估患者报告和临床医生报告的不良事件数据之间的一致性.
- 与传统方法相比,评估使用电子平台收集AE数据的效率.
- 确定患者报告数据对癌症临床试验数据完整性的影响.
主要方法:
- 澳大利亚一家三级医院的单站点研究.
- 参与者使用"我的健康我的方式" (MHMW) 电子平台每周报告症状,持续24周.
- 来自MHMW的AE数据与患者医疗病历,评估协议 (Kappa,Gwet的AC1) 和时间/缺席数据的比较.
主要成果:
- 在患者和临床医生报告的不良事件之间观察到的低一致性 (Kappa: -0.482,Gwet的AC1: -0.159).
- 据报道,这两种来源报告的AE总量仅为30%.
- 与医疗笔记相比,MHMW显著减少了数据编译时间 (2.19分钟与5.73分钟相比) 和缺失数据点 (1.4与7.8相比).
结论:
- 证实了患者和临床医生报告的AE数据之间的低一致性.
- 电子患者报告平台可以显著减少研究人员在AE数据收集方面的工作负担.
- 电子平台的实施提高了癌症试验中AE数据的效率和完整性.
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