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在临床研究中使用患者特定信息进行随机化:一项随机化试验

Jakub Furmaga^1,2, Jonathan Reeder^1,3, Robert Turer^1,3

¹Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.

Journal of the American College of Emergency Physicians open

|July 18, 2025

概括

这项研究验证了使用电子医疗记录随机化方法 (EMRRM) 进行实用性试验. 基于患者ID的随机化有效地将患者分配到研究小组,确保试验完整性.

科学领域:

临床研究方法论临床研究方法论
医疗信息学医疗信息学
生物统计学生物统计学

背景情况:

技术公司利用A/B测试通过自动化实验来优化产品.
医学实用试验反映了这一点,在常规患者护理中进行实验.
有效的随机化对于实用临床试验的有效性至关重要.

研究的目的:

评估使用患者特定信息来随机将参与者分为研究组的有效性.
为实用性试验验证基于电子医疗记录的随机化方法 (EMRRM).

主要方法:

开发了一个EMRRM,利用遭遇识别 (ID) 和患者ID号码的平价进行组分配.
追溯地将EMRRM应用于门诊,住院和急诊室患者数据.
使用国家标准与技术研究所 (NIST) 的统计包和A/A测试来评估随机化质量.

主要成果:

无论是遭遇ID还是患者ID方法,在所有临床环境中都通过了11项适用的NIST随机性测试中的10项或11项.
一对一的测试证实,这两种方法都成功地将患者随机分为具有相似人口统计,实验室结果,停留时间和入院率的组.

结论:

验证了对实用研究的遭遇ID和基于患者ID的EMRRMs的使用.
基于患者信息的EMRRM提供了一种可靠的方法,用于实用性试验中的自动随机研究组分配.

关键词:

一个A / A测试测试.临床研究是临床研究.加密标准是加密的标准.电子医疗记录电子医疗记录实用性试验试验试验实用性试验试验试验随机化方法是一种随机化方法.随机化表现的表现是随机化的.

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