ProAE:一个R包,用于图形工具和对患者报告的结果和不良事件数据的标准化分析
Blake Langlais1, Brie Noble1, Briant Fruth1
1Mayo Clinic, Department of Quantitative Health Sciences, Division of Biostatistics and Clinical Trials, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.
BMC medical informatics and decision making
|December 20, 2025
概括
一个新的R包,ProAE,为分析癌症临床试验的患者报告结果 (PROs) 提供了标准化的工具. 这个免费资源增强了使用PRO-CTCAE数据分析症状不良事件 (AE).
科学领域:
- 在瘤学瘤学.
- 生物统计学 生物统计学
- 临床试验 临床试验
背景情况:
- 患者报告的症状性不良事件 (AE) 对于评估癌症治疗耐受性至关重要.
- 常用术语标准对不良事件 (PRO-CTCAE®) 的患者报告结果版本被广泛使用.
- 目前对PRO-CTCAE数据的分析和报告方法缺乏标准化和可访问的工具.
研究的目的:
- 为分析PRO-CTCAE数据开发一个统一和公开的R包.
- 为瘤学临床试验提供标准化的统计分析工具.
- 为了促进假设测试,描述性统计和PRO数据的纵向数据可视化.
主要方法:
- 国家癌症研究所联盟开发了R包"ProAE".
- 在ProAE包中实施和验证已建立的分析方法.
- 将ProAE部署到像CRAN这样的开源平台上,以实现广泛的可访问性.
主要成果:
- 现在可以使用ProAE R包作为一个免费的开源工具.
- 它提供了分析PRO-CTCAE数据的标准化方法,包括假设测试和纵向图形.
- 该软件包可以在没有专有软件的情况下有效地应用已公布的分析方法.
结论:
- 在瘤学研究中,ProAE为分析PRO-CTCAE数据提供了现代,高效和具有成本效益的解决方案.
- 该工具支持更好地描述治疗耐受性,并为临床决策提供信息.
- ProAE促进在癌症研究中对患者报告的结果进行标准化报告和分析.
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