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诊断试验准确性研究设计及临床应用

张丽帆 刘晓清

张丽帆, 刘晓清. 诊断试验准确性研究设计及临床应用[J]. 协和医学杂志, 2020, 11(1): 96-101. doi: 10.3969/j.issn.1674-9081.20190276
引用本文: 张丽帆, 刘晓清. 诊断试验准确性研究设计及临床应用[J]. 协和医学杂志, 2020, 11(1): 96-101. doi: 10.3969/j.issn.1674-9081.20190276
Li-fan ZHANG, Xiao-qing LIU. Study Design and Clinical Practice of Diagnostic Accucary Test[J]. Medical Journal of Peking Union Medical College Hospital, 2020, 11(1): 96-101. doi: 10.3969/j.issn.1674-9081.20190276
Citation: Li-fan ZHANG, Xiao-qing LIU. Study Design and Clinical Practice of Diagnostic Accucary Test[J]. Medical Journal of Peking Union Medical College Hospital, 2020, 11(1): 96-101. doi: 10.3969/j.issn.1674-9081.20190276

诊断试验准确性研究设计及临床应用

doi: 10.3969/j.issn.1674-9081.20190276
基金项目: 

北京协和医学院青年教师培养项目 2014zlgc0742

北京协和医学院研究生教育教学改革项目 10023201600109

详细信息
    通讯作者:

    刘晓清 电话:010-69155087, E-mail:liuxq@pumch.cn

  • 中图分类号: R-1

Study Design and Clinical Practice of Diagnostic Accucary Test

More Information
    Corresponding author: LIU Xiao-qing Tel: 86-10-69155087, E-mail: liuxq@pumch.cn
  • 摘要: 新的诊断方法在临床开展之前, 必须经由严格设计的诊断试验准确性研究进行评价。诊断试验准确性研究设计包括应用PICOS(P:Patient; I:Intervention; C:Comparison; O:Outcome; S:Study design)原则构建研究问题、确定诊断金标准、选择具有代表性的研究对象、估算样本量、同步盲法比较诊断试验与金标准结果、确立最佳截点值、评价诊断准确性以及遵循诊断准确性研究报告规范进行论文报告8个方面。诊断试验的准确性指标包括灵敏度、特异度、预测值和似然比。其中, 诊断试验的似然比可帮助医生从验前概率获得验后概率。当医疗环境与研究环境相似、收治患者符合研究入组标准时, 应用诊断试验研究的似然比有助于对目标疾病进行诊断与鉴别诊断。
    利益冲突  无
  • 图  1  诊断试验准确性研究设计模式图

    A.病例对照研究设计;B.横断面或队列研究设计

    图  2  受试者工作特征曲线

    图  3  诺模图

    将验前概率与似然比对应的数值连线并延长,即可得到验后概率

    表  1  诊断试验四格表

    诊断试验 金标准诊断 合计
    有病 无病
    阳性 真阳性(a) 假阳性(b) a+b
    阴性 假阴性(c) 真阴性(d) c+d
    合计 a+c b+d a+b+c+d
    a.真阳性,指金标准诊断为“有病”且诊断试验结果是“阳性”的例数;b.假阳性,指金标准诊断为“无病”但诊断试验结果是“阳性”的例数;c.假阴性,指金标准诊断为“有病”但诊断试验结果是“阴性”的例数;d.真阴性,指金标准诊断为“无病”且诊断试验结果是“阴性”的例数
    下载: 导出CSV
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出版历程
  • 收稿日期:  2019-12-11
  • 刊出日期:  2020-01-30

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