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1
Department of Pathology, University of Virginia School of Medicine, Charlottesville, VA 22908.
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Annals of Internal Medicine, 190 N.
Independence Mall West, Philadelphia, PA 19106-1572.
3
Department of Clinical Biochemistry, Amager Hospital,
Italiensvej 1, DK2300 Copenhagen, Denmark.
4
Department of Pathology and Laboratory Medicine,
University of Pennsylvania, 3400 Spruce St., Philadelphia, PA
19104-4283.
a Author for correspondence. Fax 1-904-979-7599; e-mail dbruns{at}virginia.edu
Background: "Diagnostic accuracy" refers to the ability of medical tests to provide accurate information about diagnosis, prognosis, risk of disease, and other clinical issues. Published reports on diagnostic accuracy of medical tests frequently fail to adhere to minimal clinical epidemiological standards, and such failures lead to overly optimistic assessments of evaluated tests. Our aim was to enumerate key items for inclusion in published reports on diagnostic accuracy, with a related aim of making the reports more useful for systematic reviews.
Methods: We examined published reports on shortcomings of studies of diagnostic accuracy. We prepared an initial draft of a checklist to address common errors and presented it at a meeting of editors. After incorporation of comments from editors, we published a revised version in Clinical Chemistry in 1997 for comment from readers. One of us (E.M.) additionally circulated copies of the draft to methodologists and others interested in Evidence-Based Medicine. We updated the checklist with input from these sources.
Results: The updated document lists items for inclusion in the title, abstract, methods, results, and discussion sections of published papers. Depending on the nature of the study, the total number of items for a single paper is ~40. We invite comments on this document, which is freely available at Clinical Chemistry Online, where it can accessed readily from the Table of Contents for the July 2000 issue at www.clinchem.org/content/vol46/issue7/. Comments (eLetters) can be posted there for general reading.
Conclusions: The suggested revisions incorporated in this report appear useful to ensure inclusion of additional information that can allow assessment of the validity of the conclusions and the applicability of the study in other settings. The list can be useful in formulating guidelines and a checklist, which will require testing by authors and study of their effect on published studies of diagnostic accuracy.
The following articles in journals at HighWire Press have cited this article:
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  A Caselli, V Spallone, G A Marfia, C Battista, C Pachatz, A Veves, and L Uccioli Validation of the nerve axon reflex for the assessment of small nerve fibre dysfunction J. Neurol. Neurosurg. Psychiatry, August 1, 2006; 77(8): 927 - 932. [Abstract] [Full Text] [PDF]
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 A. Carroccio, L. Di Prima, G. Pirrone, C. Scalici, A. M. Florena, M. Gasparin, G. Tolazzi, A. Gucciardi, C. Sciume, and G. Iacono Anti-Transglutaminase Antibody Assay of the Culture Medium of Intestinal Biopsy Specimens Can Improve the Accuracy of Celiac Disease Diagnosis Clin. Chem., June 1, 2006; 52(6): 1175 - 1180. [Abstract] [Full Text] [PDF]
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C. P. Price, R. G. Newall, and J. C. Boyd Use of Protein:Creatinine Ratio Measurements on Random Urine Samples for Prediction of Significant Proteinuria: A Systematic Review Clin. Chem., September 1, 2005; 51(9): 1577 - 1586. [Abstract] [Full Text] [PDF]
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G. Soletormos, A. Semjonow, P. E.C. Sibley, R. Lamerz, P. H. Petersen, W. Albrecht, P. Bialk, M. Gion, F. Junker, H.-P. Schmid, et al. Biological Variation of Total Prostate-Specific Antigen: A Survey of Published Estimates and Consequences for Clinical Practice Clin. Chem., August 1, 2005; 51(8): 1342 - 1351. [Abstract] [Full Text] [PDF]
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 N. Smidt, A. W. S. Rutjes, D. A. W. M. van der Windt, R. W. J. G. Ostelo, J. B. Reitsma, P. M. Bossuyt, L. M. Bouter, and H. C. W. de Vet Quality of Reporting of Diagnostic Accuracy Studies Radiology, May 1, 2005; 235(2): 347 - 353. [Abstract] [Full Text] [PDF]
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R. Rej Clinical Chemistry through Clinical Chemistry: A Journal Timeline Clin. Chem., December 1, 2004; 50(12): 2415 - 2458. [Abstract] [Full Text] [PDF]
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J.-C. Wasmuth, B. Grun, B. Terjung, A. Homrighausen, and U. Spengler ROC Analysis Comparison of Three Assays for the Detection of Antibodies against Double-Stranded DNA in Serum for the Diagnosis of Systemic Lupus Erythematosus Clin. Chem., November 1, 2004; 50(11): 2169 - 2171. [Full Text] [PDF]
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N. A. Obuchowski, M. L. Lieber, and F. H. Wians Jr. ROC Curves in Clinical Chemistry: Uses, Misuses, and Possible Solutions Clin. Chem., July 1, 2004; 50(7): 1118 - 1125. [Abstract] [Full Text] [PDF]
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 G. Zou From Diagnostic Accuracy to Accurate Diagnosis: Interpreting a Test Result with Confidence Med Decis Making, June 1, 2004; 24(3): 313 - 318. [Abstract] [PDF]
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P. M.M. Bossuyt The Quality of Reporting in Diagnostic Test Research: Getting Better, Still Not Optimal Clin. Chem., March 1, 2004; 50(3): 465 - 466. [Full Text] [PDF]
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B. Lumbreras-Lacarra, J. M. Ramos-Rincon, and I. Hernandez-Aguado Methodology in Diagnostic Laboratory Test Research in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine Clin. Chem., March 1, 2004; 50(3): 530 - 536. [Abstract] [Full Text] [PDF]
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C. Stephan, S. Wesseling, T. Schink, and K. Jung Comparison of Eight Computer Programs for Receiver-Operating Characteristic Analysis Clin. Chem., March 1, 2003; 49(3): 433 - 439. [Abstract] [Full Text] [PDF]
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D. E. Bruns The STARD Initiative and the Reporting of Studies of Diagnostic Accuracy Clin. Chem., January 1, 2003; 49(1): 19 - 20. [Full Text] [PDF]
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I. E.A. Hoffman, I. Peene, E. M. Veys, and F. De Keyser Detection of Specific Antinuclear Reactivities in Patients with Negative Anti-nuclear Antibody Immunofluorescence Screening Tests Clin. Chem., December 1, 2002; 48(12): 2171 - 2176. [Abstract] [Full Text] [PDF]
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I. Ryden, P. Pahlsson, and S. Lindgren Diagnostic Accuracy of {alpha}1-Acid Glycoprotein Fucosylation for Liver Cirrhosis in Patients Undergoing Hepatic Biopsy Clin. Chem., December 1, 2002; 48(12): 2195 - 2201. [Abstract] [Full Text] [PDF]
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A. Carroccio, G. Vitale, L. Di Prima, N. Chifari, S. Napoli, C. La Russa, G. Gulotta, M. R. Averna, G. Montalto, S. Mansueto, et al. Comparison of Anti-Transglutaminase ELISAs and an Anti-Endomysial Antibody Assay in the Diagnosis of Celiac Disease: A Prospective Study Clin. Chem., September 1, 2002; 48(9): 1546 - 1550. [Abstract] [Full Text] [PDF]
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 M. J. Khoury Commentary: Epidemiology and the Continuum from Genetic Research to Genetic Testing Am. J. Epidemiol., August 15, 2002; 156(4): 297 - 299. [Full Text] [PDF]
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M. Martinez, F. Espana, M. Royo, J. M. Alapont, S. Navarro, A. Estelles, J. Aznar, C. D. Vera, and J. F. Jimenez-Cruz The Proportion of Prostate-specific Antigen (PSA) Complexed to {alpha}1-Antichymotrypsin Improves the Discrimination between Prostate Cancer and Benign Prostatic Hyperplasia in Men with a Total PSA of 10 to 30 {micro}g/L Clin. Chem., August 1, 2002; 48(8): 1251 - 1256. [Abstract] [Full Text] [PDF]
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J.-C. Wasmuth, D. Oliver y Minarro, A. Homrighausen, L. Leifeld, J. K. Rockstroh, T. Sauerbruch, and U. Spengler Phospholipid Autoantibodies and the Antiphospholipid Antibody Syndrome: Diagnostic Accuracy of 23 Methods Studied by Variation in ROC Curves with Number of Clinical Manifestations Clin. Chem., July 1, 2002; 48(7): 1004 - 1010. [Abstract] [Full Text] [PDF]
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E. J. Lee, E.-J. Oh, Y.-J. Park, H. K. Lee, and B. K. Kim Soluble Transferrin Receptor (sTfR), Ferritin, and sTfR/Log Ferritin Index in Anemic Patients with Nonhematologic Malignancy and Chronic Inflammation Clin. Chem., July 1, 2002; 48(7): 1118 - 1121. [Full Text] [PDF]
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J. Ricny, L. Simkova, and A. Vincent Determination of Anti-Acetylcholine Receptor Antibodies in Myasthenic Patients by Use of Time-resolved Fluorescence Clin. Chem., March 1, 2002; 48(3): 549 - 554. [Abstract] [Full Text] [PDF]
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N. Ferre, J. Camps, E. Prats, E. Vilella, A. Paul, L. Figuera, and J. Joven Serum Paraoxonase Activity: A New Additional Test for the Improved Evaluation of Chronic Liver Damage Clin. Chem., February 1, 2002; 48(2): 261 - 268. [Abstract] [Full Text] [PDF]
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R. F. Anton, C. Dominick, M. Bigelow, and C. Westby Comparison of Bio-Rad %CDT TIA and CDTect as Laboratory Markers of Heavy Alcohol Use and Their Relationships with {gamma}-Glutamyltransferase Clin. Chem., October 1, 2001; 47(10): 1769 - 1775. [Abstract] [Full Text] [PDF]
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N. Hayashi, T. Kawamoto, M. Mukai, A. Morinobu, M. Koshiba, S. Kondo, S. Maekawa, and S. Kumagai Detection of Antinuclear Antibodies by Use of an Enzyme Immunoassay with Nuclear HEp-2 Cell Extract and Recombinant Antigens: Comparison with Immunofluorescence Assay in 307 Patients Clin. Chem., September 1, 2001; 47(9): 1649 - 1659. [Abstract] [Full Text] [PDF]
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D. E. Bruns Laboratory-related Outcomes in Healthcare Clin. Chem., August 1, 2001; 47(8): 1547 - 1552. [Abstract] [Full Text] [PDF]
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N. Bizzaro, G. Mazzanti, E. Tonutti, D. Villalta, and R. Tozzoli Diagnostic Accuracy of the Anti-Citrulline Antibody Assay for Rheumatoid Arthritis Clin. Chem., June 1, 2001; 47(6): 1089 - 1093. [Abstract] [Full Text] [PDF]
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G. Soletormos and F. Bach Cerebrospinal Fluid Cytokeratins for Diagnosis of Patients with Central Nervous System Metastases from Breast Cancer Clin. Chem., May 1, 2001; 47(5): 948 - 950. [Full Text] [PDF]
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R. Claeys, C. Groven, and F. K. Gorus Capillary Zone Electrophoresis of Proteins in Body Fluids: Comparison of Capillary and Agarose Gel Electrophoresis Clin. Chem., May 1, 2001; 47(5): 967 - 970. [Full Text] [PDF]
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