关于新研究设计和药物服用史研究终点的建议
Theresa Terstegen1, Marietta Kirchner1,2, Walter E Haefeli1
1Medical Faculty Heidelberg/Heidelberg University Hospital, Heidelberg University, Internal Medicine IX, Department of Clinical Pharmacology and Pharmacoepidemiology, Cooperation Unit Clinical Pharmacy, Heidelberg, Germany.
Journal of pharmaceutical policy and practice
|September 10, 2024
概括
药物病史错误是很常见的. 这项研究提出了一种更有效的方法,使用患者现有的药物文件作为比较器,减少资源使用和患者负担,以改善药物安全研究.
科学领域:
- 临床药房 临床药房
- 医疗保健服务研究 医疗服务研究
- 患者安全 患者安全
背景情况:
- 医院入院时的药物病史错误很常见,并影响患者的护理.
- 目前评估药物病史质量的方法资源密集且繁重.
- 在药物史研究中,需要更高效的研究设计.
研究的目的:
- 开发一种资源高效的研究设计,用于评估药物服用史.
- 引入一种新的初级终点来评估药物病史质量.
- 为了减少患者和医疗人员在研究期间的压力.
主要方法:
- 确定了现有研究设计的缺陷.
- 开发了一个新的设计,使用患者的预先存在的药物文件作为比较器.
- 定义了一个新的初级终点:每个患者的更新次数 (药物史上的差异).
主要成果:
- 拟议的设计利用了患者现有的药物记录,而不是第二种药物史.
- 定义了一个新的初级终点,即"每位患者更新次数".
- 建议包括最佳实施的准备和基线阶段.
结论:
- 提出了一种更节约资源的研究设计,具有新的终点.
- 这种新设计的可行性将在试点项目中进行测试.
- 这种方法旨在提高药物服用史研究的有效性.
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