在诊断试验的截止值确定中,一种利益风险方法
Jeng Mah1, Robert Magari2, Karen Kw Lo2
1Department of Biostatistics and Data Management, Beckman Coulter, Inc. Chaska, MN, USA.
概括
确定诊断测试的最佳截止值至关重要. 拟议的净益与风险 (BR) 方程有助于通过考虑疾病流行率和诊断准确性来优化测试性能,正如SARS-CoV-2测试所示.
科学领域:
- 生物医学工程 生物医学工程
- 医学诊断 医学诊断 医学诊断
- 医疗信息学 医疗信息学
背景情况:
- 准确的诊断测试依赖于建立适当的切断点,以区分负和阳性结果.
- 诊断测试结果的准确性直接影响了临床决策和患者的结果.
- 利益与风险 (BR) 分析提供了一个框架,通过量化潜在的利益和风险来优化这些切断点.
研究的目的:
- 提出一种定量方法来确定诊断测试的最佳切断点.
- 为优化诊断测试性能引入净益与风险 (线性BR) 方程.
- 为基于其益处风险概况的诊断测试提供一个比较诊断测试框架.
主要方法:
- 开发一个净收益-风险 (线性BR) 方程.
- 在未经治疗的疾病的风险单位中缩放利益和风险组件.
- 在BR方程中使用诊断参数,疾病流行率和准确度指标.
- 该方法应用于生物传感器快速抗原检测SARS-CoV-2.
主要成果:
- 拟议的净BR方程提供了一个函数来确定诊断测试的最佳切断点.
- 该方法允许基于其整体益处和风险对不同诊断测试进行比较.
- 该框架使用SARS-CoV-2快速抗原测试的现实实例进行了有效的说明.
结论:
- 净效益风险方程提供了一个强大的方法来优化诊断测试截止点.
- 这种定量方法通过平衡准确诊断的好处与错误风险来增强临床决策.
- 该框架广泛适用于各种诊断试验,改善其临床实用性和设计.
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