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
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Univ Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, NL-3508 GA Utrecht, NetherlandsUniv Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, NL-3508 GA Utrecht, Netherlands
Moons, Karel G. M.
de Groot, Ions A. H.
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Univ Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, NL-3508 GA Utrecht, NetherlandsUniv Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, NL-3508 GA Utrecht, Netherlands
de Groot, Ions A. H.
Linnet, Kristian
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Univ Copenhagen, Dept Forens Med, Fac Hlth Sci, Sect Forens Chem, DK-1168 Copenhagen, DenmarkUniv Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, NL-3508 GA Utrecht, Netherlands
Linnet, Kristian
Reitsma, Johannes B. R.
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Univ Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, NL-3508 GA Utrecht, NetherlandsUniv Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, NL-3508 GA Utrecht, Netherlands
Reitsma, Johannes B. R.
Bossuye, Patrick M. M.
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Univ Amsterdam, Acad Med Ctr, Dept Clin Epidemiol Biostat & Bioinformat, NL-1012 WX Amsterdam, NetherlandsUniv Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, NL-3508 GA Utrecht, Netherlands
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Univ Bristol, Bristol Med Sch, Populat Hlth Sci, Bristol BS8 1QU, Avon, EnglandUniv Bristol, Bristol Med Sch, Populat Hlth Sci, Bristol BS8 1QU, Avon, England
Jones, Hayley E.
Gatsonsis, Constantine A.
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Brown Univ, Sch Publ Hlth, Dept Biostat, Ctr Stat Sci, Providence, RI 02912 USA
Brown Univ, Sch Publ Hlth, Ctr Evidence Synth Hlth, Providence, RI 02912 USAUniv Bristol, Bristol Med Sch, Populat Hlth Sci, Bristol BS8 1QU, Avon, England
Gatsonsis, Constantine A.
Trikalinos, Thomas A.
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Brown Univ, Sch Publ Hlth, Ctr Evidence Synth Hlth, Providence, RI 02912 USAUniv Bristol, Bristol Med Sch, Populat Hlth Sci, Bristol BS8 1QU, Avon, England
Trikalinos, Thomas A.
Welton, Nicky J.
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Univ Bristol, Bristol Med Sch, Populat Hlth Sci, Bristol BS8 1QU, Avon, EnglandUniv Bristol, Bristol Med Sch, Populat Hlth Sci, Bristol BS8 1QU, Avon, England
Welton, Nicky J.
Ades, A. E.
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Univ Bristol, Bristol Med Sch, Populat Hlth Sci, Bristol BS8 1QU, Avon, EnglandUniv Bristol, Bristol Med Sch, Populat Hlth Sci, Bristol BS8 1QU, Avon, England
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Univ Hosp Birmingham NHS Fdn Trust, NIHR Birmingham Biomed Res Ctr, Birmingham, W Midlands, England
Univ Birmingham, Birmingham, W Midlands, England
Univ Birmingham, Inst Appl Hlth Res, Test Evaluat Res Grp TERG, Birmingham, W Midlands, EnglandUniv Hosp Birmingham NHS Fdn Trust, NIHR Birmingham Biomed Res Ctr, Birmingham, W Midlands, England
Sitch, Alice J.
Dekkers, Olaf M.
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Leiden Univ, Dept Clin Epidemiol, Med Ctr, Leiden, Netherlands
Leiden Univ, Dept Endocrinol, Med Ctr, Leiden, NetherlandsUniv Hosp Birmingham NHS Fdn Trust, NIHR Birmingham Biomed Res Ctr, Birmingham, W Midlands, England
Dekkers, Olaf M.
Scholefield, Barnaby R.
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Univ Birmingham, Inst Inflammat & Ageing, Birmingham Acute Care Res Grp BACR, Birmingham, W Midlands, England
Birmingham Women & Childrens Hosp NHS Fdn Trust, Paediat Intens Care Unit, Birmingham, W Midlands, EnglandUniv Hosp Birmingham NHS Fdn Trust, NIHR Birmingham Biomed Res Ctr, Birmingham, W Midlands, England