在诊断测试准确性研究中进行中间分析时,应考虑实用和分析方面的考虑
Susannah Fleming1, Lazaro Mwandigha2, Thomas R Fanshawe3
1Department of Primary Care Health Sciences, University of Oxford, Woodstock Road, Oxford, OX2 6GG, UK. susannah.fleming@phc.ox.ac.uk.
Diagnostic and prognostic research
|August 19, 2024
概括
临时分析可以提前停止诊断准确性研究,如果测试表现不佳. 这种方法专注于徒劳,提高了临床研究的效率.
科学领域:
- 医学统计 医学统计
- 诊断测试评价 诊断测试评价
- 临床试验方法论 临床试验方法论
背景情况:
- 在临床试验中建立了临时分析,但在诊断准确性研究中未得到充分利用.
- 由于徒劳而提前终止可以防止资源浪费,如果测试显示诊断性能差 (灵敏度,特异性).
研究的目的:
- 描述诊断准确性研究中临时分析的实际和分析考虑.
- 专注于制定停止这些研究中徒劳的规则.
- 为在诊断准确性研究中实施中间分析提供一种可适应的方法.
主要方法:
- 对诊断准确性测试的精确组序列方法的调整.
- 为拟议方法的实际实施提供R代码.
- 使用模拟数据集和真实世界SARS-CoV-2护理点测试准确性研究的插图.
主要成果:
- 该论文详细介绍了在诊断准确性研究中规划和执行中间分析的考虑因素.
- 介绍了一种针对诊断测试的适应群体顺序方法,并提供了实际实施指南.
- 该方法的实用性通过模拟和案例研究来证明.
结论:
- 临时分析是提高诊断准确性研究效率的宝贵工具.
- 提出的方法和指导可以帮助研究人员决定何时实施中间分析.
- 在这个领域进一步的方法发展是有必要的.
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