诊断组之间eConsent的差异
Deborah Profit1, William Carson1, Leonard Chuck2
1Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center Dr., Princeton, NJ, USA.
Contemporary clinical trials communications
|September 6, 2023
概括
电子知情同意 (eConsent) 在诊断过程中显示了患者参与度的多样性. 了解这些差异可以个性化临床试验过程,以更好地理解参与者.
科学领域:
- 临床试验 临床试验
- 在知情同意的情况下同意.
- 患者参与 患者参与
背景情况:
- 电子知情同意 (eConsent) 为临床试验中的参与者理解提供了潜在的好处.
- 尽管有优点,但eConsent的采用是有限的.
- 不同患者群体对eConsent使用和有效性的差异尚不清楚.
研究的目的:
- 分析来自27项临床试验的eConsent数据.
- 调查不同诊断组在电子知情同意过程中的差异.
- 确定患者诊断如何影响临床试验期间的参与和理解.同意.
主要方法:
- 分析eConsent数据,包括视频交互,参与度指标和知识检查分数.
- 对不同患者诊断组的同意过程指标进行比较.
- 统计评估花在教学视频和参与度水平上的时间.
主要成果:
- 与精神分裂症患者相比,患有双相情感障碍的参与者观看教学视频的时间较短.
- 精神分裂症患者的参与率最高,而患有自身主导多囊性病 (ADPKD) 患者的参与率最低.
- 被诊断为注意力缺陷多动性障碍 (ADHD) 的参与者在知识检查中获得了明显较低的分数.
结论:
- 基于诊断,eConsent数据揭示了参与者参与和理解的显著差异.
- 这些见解对于开发更以患者为中心的eConsent设计至关重要.
- 调整eConsent体验以满足特定患者需求可以提高临床试验中的理解和遵守.
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