在OHDSI ATLAS软件的临床研究中实施包括和排除标准
Romina Blasini1, Kornelia Marta Buchowicz2,3, Henning Schneider2,3
1Institute of Medical Informatics, Justus Liebig University, Giessen, Germany. romina.blasini@informatik.med.uni-giessen.de.
Scientific reports
|December 17, 2023
概括
临床试验招聘支持系统增强了参与者招聘. 亚特拉斯软件可以描绘临床研究的资格标准,尽管完整实施和更广泛的应用需要改进.
科学领域:
- 医疗信息学 医疗信息学
- 临床试验管理 临床试验管理
- 医学分类系统 医学分类系统
背景情况:
- 临床试验经常面临参与者招募的挑战,导致研究取消.
- 临床试验招聘支持系统旨在改善受试者识别和招生.
- 亚特拉斯软件有助于根据特定标准建立患者队列.
研究的目的:
- 评估ATLAS软件在临床试验招聘支持系统中的能力.
- 确定ATLAS是否可以准确地代表临床研究资格标准.
- 在队列定义中识别ATLAS的优点,弱点和局限性.
主要方法:
- 分析了30项临床试验中的223个资格标准.
- 将医疗分类代码 (ICD,OPS,LOINC,ATC) 集成到ATLAS中.
- 基于ATLAS实施能力的标准和研究的分类.
主要成果:
- 分析的纳入标准中有51%是完全可以在ATLAS中实现的.
- 10%的研究完全可以通过ATLAS描绘,73%的研究部分描绘.
- 确定了技术限制和与医疗分类系统的相互作用.
结论:
- 亚特拉斯显示出代表资格标准的潜力,但有局限性.
- 与研究人员的密切合作和精心选择术语系统对于精确的队列定义至关重要.
- 需要进一步的研究来优化提取的标准的意义和范围.
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