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用于评估诊断试验的研究设计。

Study design for the evaluation of diagnostic tests.

作者信息

Daya S

机构信息

Department of Obstetrics & Gynecology, McMaster University, Hamilton, Ontario, Canada.

出版信息

Semin Reprod Endocrinol. 1996 May;14(2):101-9. doi: 10.1055/s-2007-1016317.

DOI:10.1055/s-2007-1016317
PMID:8796932
Abstract

Diagnostic tests, like therapeutic procedures, require proper analysis prior to incorporation into clinical practice. In studying diagnostic tests, an evaluation should be made of the reproducibility, accuracy, variation among those without the disease, and variation among those with the disease. Both diseased and disease-free states should be identified using a gold standard, if available. Three main guidelines can be used in evaluating and applying the results of diagnostic tests: validity of the study, expression of the results, and assessment of the generalizability of the results. Validity requires an independent, blind comparison with a reference standard. Methodology should be fully explained. Results should include sensitivity, specificity, and a receiver operating characteristic plot. Several categories of results should be provided in the form of likelihood ratios. Management decisions can be made on the basis of the posttest probability of disease after including both the pretest probability and the likelihood ratio in the calculation.

摘要

与治疗程序一样,诊断测试在纳入临床实践之前需要进行适当分析。在研究诊断测试时,应评估其可重复性、准确性、无病者之间的差异以及患病者之间的差异。如有可能,应使用金标准来识别患病和无病状态。在评估和应用诊断测试结果时可采用三条主要准则:研究的有效性、结果的表达以及结果可推广性的评估。有效性要求与参考标准进行独立、盲法比较。应充分解释方法。结果应包括敏感性、特异性和受试者工作特征曲线。应以似然比的形式提供几类结果。在计算中纳入检验前概率和似然比后,可根据疾病的检验后概率做出管理决策。

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引用本文的文献

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Medical Diagnostic Tests: A Review of Test Anatomy, Phases, and Statistical Treatment of Data.医学诊断测试:测试解剖学、阶段和数据统计处理的回顾。
Comput Math Methods Med. 2019 May 28;2019:1891569. doi: 10.1155/2019/1891569. eCollection 2019.
2
Diagnostic Testing and Decision-Making: Beauty Is Not Just in the Eye of the Beholder.诊断检测与决策:美不只是在观察者眼中。
Anesth Analg. 2018 Oct;127(4):1085-1091. doi: 10.1213/ANE.0000000000003698.