评估在临床试验中完成电子收集的患者报告结果所花费的时间
Lucy Andersen1, Michael Williams2, Sheryl Pease1
1Johnson & Johnson, Raritan, NJ, USA.
Therapeutic innovation & regulatory science
|March 8, 2025
概括
电子患者报告结果 (PROs) 由临床试验参与者有效地完成,平均每项16秒,每仪器2分钟. 这表明PROs是临床研究中可行的和有价值的数据来源.
科学领域:
- 临床试验 临床试验
- 患者报告的结果
- 医疗信息学 医疗信息学
背景情况:
- 患者报告的结果 (PROs) 对于评估临床试验疗效至关重要.
- 然而,PROs可以被认为是对参与者和员工来说耗时的.
- 电子数据捕获旨在简化这一过程.
研究的目的:
- 评估参与者完成电子PRO的时间投资.
- 专注于不同治疗领域的2期和3期临床试验.
- 量化每项和每种仪器所花费的时间.
主要方法:
- 来自约翰逊和约翰逊试验 (2016-2023) 的电子临床结果评估 (eCOA) 数据的分析.
- 包括82项试验,包括33633名参与者的数据和100多万次PRO测量.
- 根据每项时间和每种仪器的时间检查完成时间.
主要成果:
- 参与者的平均时间:每个项目16秒,每个PRO仪器2分钟.
- 在不同疾病领域完成时间的显著差异.
- 完成eCOA主要发生在现场平板电脑 (68%) 或个人设备 (31%) 上.
结论:
- 电子PRO完成对临床试验参与者来说是时间效率高的.
- 平均完成时间是最小的 (16s/item,2min/instrument).
- 在临床研究中,PRO仍然是一个关键的,有效收集的数据组件.
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