DxGoals:用于确定和分析临床上有意义的分类准确性目标的软件工具,用于诊断测试
Ngoc-Ty Nguyen1, Gene A Pennello2
1U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, United States.
The journal of applied laboratory medicine
|September 3, 2024
概括
DxGoals是一个新的R-Shiny应用程序,有助于确定诊断测试准确性的临床有意义的目标. 它有助于评估青素过敏和癌症等疾病的测试性能,改善诊断测试评估.
科学领域:
- 生物统计学 生物统计学
- 医疗信息学 医疗信息学
- 诊断测试评价 诊断测试评价
背景情况:
- 分类准确度指标,如灵敏度和特异性,对于评估诊断测试至关重要,特别是对于低患病率的疾病.
- 然而,为这些指标建立临床上有意义的目标是具有挑战性的.
- 为了解决这个问题,提出了一个风险分层框架,强调需要支持软件应用程序.
研究的目的:
- 介绍DxGoals,一个免费可用的R-Shiny软件应用程序.
- 为了使诊断测试的分类准确性目标能够确定,可视化和分析.
- 为了促进临床上有意义的独立和比较诊断试验性能的评估.
主要方法:
- DxGoals利用贝叶斯定理将所需的正预测值 (PPV) 和负预测值 (NPV) 转换为等价的目标,以获得正概率比 (PLR) 和负概率比 (NLR).
- 该软件根据用户定义的流行率和预测价值目标来确定灵敏度和特异性的暗示目标.
- 它还分析了提供的研究数据,以评估目标的实现,并促进了测试之间的比较分析.
主要成果:
- 使用对青素过敏,卵巢癌和宫癌的诊断测试来说明DxGoals应用程序.
- 输入参数,如患病率 (p),目标PPV (PPV*) 和目标负预测值 (NPV*),由临床管理指南提供信息.
- 该软件成功地确定,可视化和分析了这些示例的分类准确性目标.
结论:
- DxGoals提供了一个用户友好的平台,用于设定和评估具有临床意义的诊断测试准确性目标.
- 该应用程序支持独立和比较测试评估.
- DxGoals对于参与诊断测试评估的研究人员和临床医生来说是一个有价值的工具.
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