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Case–Control and Two-Gate Designs in Diagnostic Accuracy Studies

Open access
Rutjes, Anne WS, Reitsma, Johannes B, Vandenbroucke, Jan P, Glas, Afina S, Bossuyt, Patrick MM·2005·Clinical Chemistry

Abstract

Background: In some diagnostic accuracy studies, the test results of a series of patients with an established diagnosis are compared with those of a control group. Such case–control designs are intuitively appealing, but they have also been criticized for leading to inflated estimates of accuracy. Methods: We discuss similarities and differences between diagnostic and etiologic case–control studies, as well as the mechanisms that can lead to variation in estimates of diagnostic accuracy in studies with separate sampling schemes (“gates”) for diseased (cases) and nondiseased individuals (controls). Results: Diagnostic accuracy studies are cross-sectional and descriptive in nature. Etiologic case–control studies aim to quantify the effect of potential causal exposures on disease occurrence, which inherently involves a time window between exposure and disease occurrence. Researchers and readers should be aware of spectrum effects in diagnostic case–control studies as a result of the restricted sampling of cases and/or controls, which can lead to changes in estimates of diagnostic accuracy. These spectrum effects may be advantageous in the early investigation of a new diagnostic test, but for an overall evaluation of the clinical performance of a test, case–control studies should closely mimic cross-sectional diagnostic studies. Conclusions: As the accuracy of a test is likely to vary across subgroups of patients, researchers and clinicians might carefully consider the potential for spectrum effects in all designs and analyses, particularly in diagnostic accuracy studies with differential sampling schemes for diseased (cases) and nondiseased individuals (controls).

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Metadata

Authors
Rutjes, A. W., Reitsma, J. B., Vandenbroucke, J. P., Glas, A. S., & Bossuyt, P. M.
Venue
Clinical Chemistry
Published
2005-08-01
Volume
51
Issue
8
Pages
1335-1341
ISSN
  • 0009-9147 (ISSN-L)
  • 1530-8561
OpenAlex
W2126137484
Cited by
501
References
5
FWCI
4.99
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Case–Control and Two-Gate Designs in Diagnostic Accuracy Studies. https://app.cochat.ai/papers/10.1373/clinchem.2005.048595
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Rutjes, A. W., Reitsma, J. B., Vandenbroucke, J. P., Glas, A. S., & Bossuyt, P. M. (2005). Case–Control and Two-Gate Designs in Diagnostic Accuracy Studies. Clinical Chemistry. https://doi.org/10.1373/clinchem.2005.048595

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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