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Problems of spectrum and bias in evaluating the efficacy of diagnostic tests.
To determine why many diagnostic tests have proved to be valueless after optimistic introduction into medical practice, we reviewed a series of investigations and identified two major problems that can cause erroneous statistical results for the "sensitivity" and "specificity" indexes of diagnostic efficacy. Unless an appropriately broad spectrum is chosen for the diseased and nondiseased patients who comprise the study population, the diagnostic test may receive falsely high values for its "rule-in" and "rule-out" performances. Unless the interpretation of the test and the establishment of the true diagnosis are done independently, bias may falsely elevate the test's efficacy. Avoidance of these problems might have prevented the early optimism and subsequent disillusionment with the diagnostic value of two selected examples: the carcinoembryonic antigen and nitro-blue tetrazolium tests.
PMID: 692598 [PubMed - indexed for MEDLINE]
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Cited by 100 PubMed Central articles
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Individual patient data meta-analysis of diagnostic and prognostic studies in obstetrics, gynaecology and reproductive medicine.
Broeze KA, Opmeer BC, Bachmann LM, Broekmans FJ, Bossuyt PM, Coppus SF, Johnson NP, Khan KS, ter Riet G, van der Veen F, et al.
BMC Med Res Methodol. 2009 Mar 27; 9:22. Epub 2009 Mar 27.
[BMC Med Res Methodol. 2009]
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Predictive Role of p53 Protein as a Single Marker or Associated to Ki67 Antigen in Oral Carcinogenesis.
Montebugnoli L, Felicetti L, Gissi DB, Cervellati F, Servidio D, Marchetti C, Prati C, Flamminio F, Foschini MP.
Open Dent J. 2008; 2:24-9. Epub 2008 Feb 21.
[Open Dent J. 2008]
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Advantages of the nested case-control design in diagnostic research.
Biesheuvel CJ, Vergouwe Y, Oudega R, Hoes AW, Grobbee DE, Moons KG.
BMC Med Res Methodol. 2008 Jul 21; 8:48. Epub 2008 Jul 21.
[BMC Med Res Methodol. 2008]
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