电子患者报告结果中的患者坚持和反应时间:来自三项纵向临床试验的见解
Andrzej Nowojewski1, Erik Bark2, Vivian H Shih3
1Imaging & Data Analytics, Clinical Pharmacology & Safety Sciences, AstraZeneca, R&D BioPharmaceuticals, Cambridge, UK. andrzej.nowojewski@astrazeneca.com.
概括
随着时间的推移,临床试验中患者对每日电子问卷的遵守程度会下降,特别是在年轻人中. 响应时间根据访问时间表和症状严重程度而异,为患者的行为提供了洞察力.
科学领域:
- 临床试验 临床试验
- 健康 结果 研究 研究 结果
- 数字健康数字健康
背景情况:
- 患者报告的结果测量 (PROM) 对于在临床试验中收集疾病症状数据至关重要.
- 纵向研究在维持患者的坚持和对日常家庭调查问卷的一致响应时间方面存在挑战.
研究的目的:
- 在纵向临床研究中分析患者完成每日PROM的模式和变化.
- 了解影响临床试验参与者的坚持和反应时间的因素.
主要方法:
- 分析了来自三个呼吸系统临床试验的1342名患者的数据.
- 电子手持设备捕获了PROM开始和完成时间.
- 贝叶斯概括的线性混合效应模型确定了影响PROM坚持和响应时间的因素.
主要成果:
- 随机化后,随着时间的推移,坚持性下降,年轻患者的坚持性下降更为急剧.
- 随机化前的坚持预测了整个研究的坚持;患者在工作日更坚持.
- 老年患者的反应时间较长,但所有患者在第一个月的反应时间都减少了. 响应时间在临床诊所和更高的症状负担周围增加.
结论:
- 分析PROM坚持和响应时间趋势为纵向临床研究中的患者行为提供了宝贵的见解.
- 高基线坚持对于有效地解释这些行为趋势很重要.
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