Process / pipelinediagnostic evaluation

Diagnostic Accuracy Study Design

A diagnostic accuracy study evaluates how well a new diagnostic test (or biomarker, imaging modality, clinical assessment) detects the presence or absence of disease compared to a reference standard (gold standard). Standardized since 2003 by the STARD (Standards for Reporting of Diagnostic Accuracy Studies) initiative, diagnostic accuracy studies are fundamental to clinical medicine, determining whether and how new tests can improve patient diagnosis and treatment.

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Sources

  1. Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., ... & de Vet, H. C. (2003). Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Annals of Internal Medicine, 138(1), 40–44. DOI: 10.7326/0003-4819-138-1-200301070-00010
  2. Cohen, J. F., Korevaar, D. A., Altman, D. G., Bruns, D. E., Gatsonis, C. A., Hooft, L., ... & Bossuyt, P. M. (2016). STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ Open, 6(11), e012799. DOI: 10.1136/bmjopen-2016-012799
  3. Jaeschke, R., Guyatt, G. H., & Sackett, D. L. (1994). Users' guides to the medical literature. III. How to use an article about a diagnostic test. A. Are the results of the study valid? JAMA, 271(5), 389–391. DOI: 10.1001/jama.1994.03510290057038

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Referenced by

ScholarGateDiagnostic Accuracy Study Design (Diagnostic Test Accuracy Study (Sensitivity, Specificity, Likelihood Ratios)). Retrieved 2026-06-04 from https://scholargate.app/en/clinical-research/diagnostic-accuracy-study