Quantifying the Accuracy of a Diagnostic Test or Marker

被引:125
|
作者
Linnet, Kristian [1 ]
Bossuyt, Patrick M. M. [2 ]
Moons, Karel G. M. [3 ]
Reitsma, Johannes B. R. [3 ]
机构
[1] Univ Copenhagen, Dept Forens Med, Sect Forens Chem, Fac Hlth Sci, DK-2100 Copenhagen, Denmark
[2] Univ Amsterdam, Acad Med Ctr, Dept Clin Epidemiol Biostat & Bioinformat, NL-1105 AZ Amsterdam, Netherlands
[3] UMC Utrecht, Julius Ctr Hlth Sci & Primary Care, Utrecht, Netherlands
关键词
OPERATING CHARACTERISTIC CURVES; DEEP-VEIN THROMBOSIS; CLINICAL-CHEMISTRY; PRIMARY-CARE; BIAS; SPECIFICITY; SENSITIVITY; AREAS; THEOREM; DESIGN;
D O I
10.1373/clinchem.2012.182543
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
BACKGROUND: In recent years, increasing focus has been directed to the methodology for evaluating (new) tests or biomarkers. A key step in the evaluation of a diagnostic test is the investigation into its accuracy. CONTENT: We reviewed the literature on how to assess the accuracy of diagnostic tests. Accuracy refers to the amount of agreement between the results of the test under evaluation (index test) and the results of a reference standard or test. The generally recommended approach is to use a prospective cohort design in patients who are suspected of having the disease of interest, in which each individual undergoes the index and same reference standard tests. This approach presents several challenges, including the problems that can arise with the verification of the index test results by the preferred reference standard test, the choice of cutoff value in case of a continuous index test result, and the determination of how to translate accuracy results to recommendations for clinical use. This first in a series of 4 reports presents an overview of the designs of single-test accuracy studies and the concepts of specificity, sensitivity, posterior probabilities (i.e., predictive values) for the presence of target disease, ROC curves, and likelihood ratios, all illustrated with empirical data from a study on the diagnosis of suspected deep venous thrombosis. Limitations of the concept of the diagnostic accuracy for a single test are also highlighted. CONCLUSIONS: The prospective cohort design in patients suspected of having the disease of interest is the optimal approach to estimate the accuracy of a diagnostic test. However, the accuracy of a diagnostic index test is not constant but varies across different clinical contexts, disease spectrums, and even patient subgroups. (C) 2012 American Association for Clinical Chemistry
引用
收藏
页码:1292 / 1301
页数:10
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