Clinically Adjudicated Reference Standards for Evaluation of Infectious Diseases Diagnostics

Authors

Robin Patel, Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN  USA.
Ephraim L. Tsalik, Emergency Medicine Service, Durham VA Health Care System, Durham, NC  USA.
Scott Evans, Biostatistics Center and the Department of Biostatistics and Bioinformatics, George Washington Milken Institute School of Public Health, George Washington University, Washington, DC  USA.
Vance G. Fowler, Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine, Durham, NC  USA.
Sarah B. Doernberg, Division of Infectious Diseases, Department of Medicine, University of California, San Francisco, CA  USA.

Document Type

Journal Article

Publication Date

10-20-2022

Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

DOI

10.1093/cid/ciac829

Abstract

Lack of a gold standard can present a challenge for evaluation of diagnostic test accuracy of some infectious diseases tests, particularly when the test's accuracy potentially exceeds that of its predecessors. This approach may measure agreement with an imperfect reference, rather than correctness, since the right answer is unknown. Solutions consist of multi-test comparators, including those that involve a test under evaluation if multiple new tests are being evaluated together, latent class modeling, and clinically adjudicated reference standards. Clinically adjudicated reference standards may be considered as comparator methods when no pre-defined test or composite of tests is sufficiently accurate; they emulate clinical practice in that multiple data pieces are clinically assessed together.

APA Citation

Patel, Robin; Tsalik, Ephraim L.; Evans, Scott; Fowler, Vance G.; and Doernberg, Sarah B., "Clinically Adjudicated Reference Standards for Evaluation of Infectious Diseases Diagnostics" (2022). GW Authored Works. Paper 1752.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/1752

Department

Biostatistics and Bioinformatics